由實驗結果的種種數據得知，並以有關藥劑學顆粒劑、錠劑的物理參 數特性作為理論基礎，藉此也能透過動手操作、學習、設計，去印證教課 書所寫的理論，間接判斷出加入不同的賦形劑對於顆粒劑和錠劑間相互影 響的關聯性，以供日後作為更深入探討劑型設計的參考和基礎。
中藥錠劑是由一種或一種以上的藥物細粉或提取物加適宜的賦型劑 混合後，壓製而成的。天麻素為天麻的主要有效成分，先前(9)用本法HPLC 測定天麻錠劑中 GA 和 HBA 的含量，被測成分分離效果良好，藥材中的 其他成分不會干擾成分的測定。該方法簡便、穩定、準確、 再現性好，
可作為該製劑含量測定的檢測方法。
打錠前，要優先考慮顆粒的流動性和可壓縮性，若粉末流動性若不 佳，在打錠過程中會導致藥物分層現象或壓製出的錠劑重量與藥物含量均 一度不均等問題。天麻浸膏本身影響的因素包括了組成成分、物理性質，
所以在賦型劑的選擇上，以選擇吸附劑、崩散劑、稀釋劑為主，像本實驗 就選用了吸附劑 Avicel、崩散劑 Starch、稀釋劑 Dicalcium phosphate 和 Lactose。而其他賦型劑像 Carboxymethylcellulose calcium、Fructose、
Kaolin、Sodium alginate、Povidone，則不適合當此天麻浸膏錠劑實驗用的 賦型劑。且在製粒過程中發現一顆錠劑最少需要120 mg 吸附劑 Avicel，才 可減少浸膏黏度以達錠劑需含25 mg GA 的要求，加入崩散劑 Starch 可減 短崩散時間，加入稀釋劑Dicalcium phosphate 和 Lactose 也可幫助溶離。
經一般物性測定，包括安息角、硬度、脆度、外觀之形狀觀察，皆可 達一般錠劑之要求。且天麻錠劑依中華藥典對錠劑規定之物性，包括重量 差異度、含量均一度等，均可以符合藥典要求。在崩散、溶離試驗上，主 要影響因素是主成分 GA 含量、加入賦型劑 Avicel、崩散劑 Starch、稀釋 劑Dicalcium phosphate、Lactose 和製造方法。之後實驗結果比較 R1 ∼R10 處方的差異性，整體上以 R4 崩散溶離效果最好，製造方法上比較 RA、
但在成分含量上則無法達到25 mg GA 的高含量設計，可能原因 GA 浸膏 黏度大需加水稀釋、賦型劑的量要多，產品產量小。所以要設計成含量高、
產量少的天麻錠劑以濕式造粒法較易達到。
天麻18 公斤
加入10 倍 70% Alcohol
溫浸 1 小時(60 )℃ 過濾
濾液 藥渣
加入10 倍 70%
Alcohol 溫浸 1 小時(60 )℃
合併 濾液 沉澱
減壓濃縮 浸膏
加入賦型劑
造粒、製粒
烘箱乾燥或噴霧乾燥 打錠
Fig. 1 天麻浸膏及錠劑製造流程圖
Fig. 2 天麻素 (Gastrodin, GA) 紫外吸收光譜圖
Gastrodin conc.(ug/ml)
0 10 20 30 40 50 60 70
ABS
0 1 2 3
Fig. 3 GA 標準溶液檢量線 y = 0.0312x + 0.0046
R2 = 0.9992
Fig. 4 空白溶液及內標乙醯胺酚 (Acetaminophen, ASA) 之 HPLC 圖
Fig. 5 空白溶液中之 GA、天麻苷元 (ρ-Hydroxybenzyl alcohol, HBA) 及內標ASA 之 HPLC 圖
Fig. 6 天麻浸膏之 GA、HBA 及內標 ASA 之 HPLC 圖
ASA
ASA HBA GA
HBA ASA
GA
Fig. 7 配方 R1 之 GA、HBA 及 Fig. 8 配方 R2 之 GA、HBA 及 內標ASA 之 HPLC 圖 內標 ASA 之 HPLC 圖
Fig. 9 配方 R3 之 GA、HBA 及 Fig. 10 配方 R4 之 GA、HBA 及 內標 ASA 之 HPLC 圖 內標 ASA 之 HPLC 圖
Fig. 11 配方 R5 之 GA、HBA 及 Fig. 12 配方 R6 之 GA、HBA 及
GA GA
HBA HBA
HBA HBA
HBA HBA
GA
GA
GA GA
ASA ASA
ASA
ASA ASA
ASA
內標ASA 之 HPLC 圖 內標 ASA 之 HPLC 圖
Fig. 13 配方 R7 之 GA、HBA 及 Fig. 14 配方 R8 之 GA、HBA 及 內標ASA 之 HPLC 圖 內標 ASA 之 HPLC 圖
Fig. 15 配方 R9 之 GA、HBA 及 Fig. 16 配方 R10 之 GA、HBA 及 內標ASA 之 HPLC 圖 內標 ASA 之 HPLC 圖
Fig. 17 配方 RA 之 GA、HBA 及 Fig. 18 配方 RB 之 GA、HBA 及 內標ASA 之 HPLC 圖 內標 ASA 之 HPLC 圖
GA GA
GA GA
GA GA
HBA ASA
ASA ASA
ASA ASA
HBA HBA
HBA HBA
HBA ASA
particle size distribution for R1
particle size distribution for R2
mesh
particle size distribution for R3
mesh
particle size distribution for R4
mesh
particle size distribution for R5
mesh
particle size distribution for R6
mesh
particle size distribution for R7
particle size distribution for R8
mesh
particle size distribution for R9
mesh
particle size distribution for R10
mesh
particle size distribution for RA
mesh
particle size distribution for RB
mesh
0 20 40 60 80 100
>20 20
30 50
80 100
R2 R1 R4 R3
R6 R5 R8 R7 R10 R9
w e ig h t (% )
m esh
formula tion
Fig. 31 配方R1~R10顆粒的粒徑分佈柱狀圖
m o istu re so rp tion pro file
Fig. 34 配方R1~R10 和 RA、RB 的錠劑成品外觀攝影
R2
R1 R3 R4 R5
R6 R7 R8 R9 R10
RA RB
R2
R1 R3 R4 R5
R6 R7 R8 R9 R10
RA RB
R1 in pH 1.2, 4.5, 6.8 medium
time(min.)
0 50 100 150 200
dissolved(%)
0 20 40 60 80 100 120
R1 in pH 1.2 R1 in pH 4.5 R1 in pH 6.8
Fig. 35 dissolution profile of GA from R1 formulation in pH 1.2, 4.5 and 6.8 media
R2 in pH 1.2, 4.5, 6.8 medium
time(min.)
0 20 40 60 80 100 120 140 160 180 200
dissolved(%)
0 20 40 60 80 100 120
R2 in pH 1.2 R2 in pH 4.5 R2 in pH 6.8
Fig. 36 dissolution profile of GA from R2 formulation in pH 1.2, 4.5 and 6.8
R3 in pH 1.2, 4.5, 6.8 medium
time(min.)
0 20 40 60 80 100 120 140 160 180 200
dissolved(%)
0 20 40 60 80 100 120
R3 in pH 1.2 R3 in pH4.5 R3 in pH 6.8
Fig. 37 dissolution profile of GA from R3 formulation in pH 1.2, 4.5 and 6.8 media
R4 in pH 1.2, 4.5, 6.8 medium
time(min.)
0 20 40 60 80 100 120 140 160 180 200
dissolved(%)
0 20 40 60 80 100 120
R4 in pH 1.2 R4 in pH 4.5 R4 in pH 6.8
Fig. 38 dissolution profile of GA from R4 formulation in pH 1.2, 4.5 and 6.8 media
R5 in pH 1.2, 4.5, 6.8 medium
time(min.)
0 20 40 60 80 100 120 140 160 180 200
dissolved(%)
0 20 40 60 80 100 120
R5 in pH 1.2 R5 in pH 4.5 R5 in pH 6.8
Fig. 39 dissolution profile of GA from R5 formulation in pH 1.2, 4.5 and 6.8 media
R6 in pH 1.2, 4.5, 6.8 medium
time(min.)
0 20 40 60 80 100 120 140 160 180 200
dissolved(%)
0 20 40 60 80 100 120
R6 in pH 1.2 R6 in pH 4.5 R6 in pH 6.8
Fig. 40 dissolution profile of GA from R6 formulation in pH 1.2, 4.5 and 6.8
R7 in pH 1.2, 4.5, 6.8 medium
time(min.)
0 20 40 60 80 100 120 140 160 180 200
dissolved(%)
0 20 40 60 80 100 120
R7 in pH 1.2 R7 in pH 4.5 R7 in pH 6.8
Fig. 41 dissolution profile of GA from R7 formulation in pH 1.2, 4.5 and 6.8 media
R8 in pH 1.2, 4.5, 6.8 medium
time(min.)
0 20 40 60 80 100 120 140 160 180 200
dissolved(%)
0 20 40 60 80 100 120
R8 in pH 1.2 R8 in pH 4.5 R8 in pH 6.8
Fig. 42 dissolution profile of GA from R8 formulation in pH 1.2, 4.5 and 6.8 media
R9 in pH 1.2, 4.5, 6.8 medium
time(min.)
0 20 40 60 80 100 120 140 160 180 200
dissolved(%)
0 20 40 60 80 100 120
R9 in pH 1.2 R9 in pH 4.5 R9 in pH 6.8
Fig. 43 dissolution profile of GA from R9 formulation in pH 1.2, 4.5 and 6.8 media
R10 in pH 1.2, 4.5, 6.8 medium
time(min.)
0 20 40 60 80 100 120 140 160 180 200
dissolved(%)
0 20 40 60 80 100 120
R10 in pH 1.2 R10 in pH 4.5 R10 in pH 6.8
Fig. 44 dissolution profile of GA from R10 formulation in pH 1.2, 4.5 and 6.8 media
R1-R10 in pH 1.2 medium
time(min.)
0 20 40 60 80 100 120 140 160 180 200
disso lved (%)
0 20 40 60 80 100 120
Fig. 45 dissolution profile of GA from R1 ~ R10 formulations in pH 1.2 media
R1 R2 R3 R4 R5 R6 R7 R8 R9 R10
R1-R10 in pH 4.5 medium
time(min.)
0 20 40 60 80 100 120 140 160 180 200
d issolved(%)
0 20 40 60 80 100 120
Fig. 46 dissolution profile of GA from R1 ~ R10 formulations in pH 4.5 media
R1 R2 R3 R4 R5 R6 R7 R8 R9 R10
R1-R10 in pH 6.8 medium
time(min.)
0 20 40 60 80 100 120 140 160 180 200
d issolved(%)
0 20 40 60 80 100 120
Fig. 47 dissolution profile of GA from R1 ~ R10 formulations in pH 6.8 media
R1 R2 R3 R4 R5 R6 R7 R8 R9 R10
RA, RB in pH 1.2, 4.5, 6.8 medium
time(min.)
0 50 100 150 200
dissolv ed(%)
0 20 40 60 80 100 120
Fig. 48 dissolution profile of GA from RA and RB formulations in pH 1.2, 4.5 and 6.8 media
R A in p H 1 .2 m e d iu m R A in p H 4 .5 m e d iu m R A in p H 6 .8 m e d iu m R B in p H 1 .2 m e d iu m R B in p H 4 .5 m e d iu m R B in p H 6 .8 m e d iu m
Fig. 49 配方 R1~R10 加溫一個月安定性試驗
Fig. 51 配方 R1~R10 加溫三個月安定性試驗
Table 5 不同濃度的 GA 溶液在不同波長下的紫外光譜分析 ABS 測定次數
吸 收 波 長 (nm)
GA
(µg/mL) 1 2 3 Mean S.D. C.V. (%) 25 0.97 1.02 0.93 0.97 0.05 4.63 32 1.08 0.99 1.02 1.03 0.05 4.45 200
64 1.06 1.05 1.08 1.06 0.02 1.44 25 0.98 1.05 1.06 1.03 0.04 4.23 32 1.18 1.08 1.09 1.12 0.06 4.93 220
64 2.02 2.15 2.16 2.11 0.08 3.70 25 0.13 0.14 0.12 0.13 0.01 7.69 32 0.13 0.12 0.14 0.13 0.01 7.69 240
64 0.20 0.20 0.18 0.19 0.01 5.97 25 0.12 0.13 0.12 0.12 0.01 4.68 32 0.12 0.13 0.14 0.13 0.01 7.69 260
64 0.20 0.20 0.19 0.20 0.01 2.94 25 0.13 0.13 0.12 0.13 0.01 4.56 32 0.14 0.13 0.14 0.14 0.01 4.22 280
64 0.21 0.22 0.20 0.21 0.01 4.76 25 0.05 0.06 0.06 0.06 0.01 10.19 32 0.05 0.05 0.06 0.05 0.01 10.83 300
64 0.05 0.06 0.05 0.05 0.01 10.83
Table 6 不同 pH 值的 GA 溶液之紫外光譜分析
Table 7 賦型劑對紫外光譜分析的影響 ABS 測定次數 (220 nm)
溶媒pH 值
1 2 3 Mean S.D. C.V. (%) 1.2 1.19 1.13 1.17 1.16 0.03 2.63 4.5 1.01 1.12 1.17 1.10 0.08 7.44 6.8 1.08 1.06 1.11 1.08 0.03 2.32
ABS 測定次數 (220 nm) 賦型劑的種類
1 2 3 Mean S.D. C.V. (%) Avicel 102 0.13 0.13 0.12 0.13 0.01 4.56 Starch 0.13 0.12 0.14 0.13 0.01 7.69 Dicalcium phosphate 0.19 0.18 0.17 0.18 0.01 5.56 Lactose 0.11 0.11 0.12 0.11 0.01 5.09
Table 8 GA (2 µg/mL) 標準溶液的安定性試驗結果
Table 11 天麻藥材乾粉 GA 與 HBA 的含量測定結果
Table 12 天麻濃縮液 GA 與 HBA 的含量測定結果 NO. 1mg/mL 天麻乾粉 GA 含量
(µg)
1mg/mL 天麻乾粉 HBA 含量 (µg)
1 14.40 0.22
2 14.81 0.25
3 14.89 0.24
4 14.44 0.21
5 13.58 0.22
6 13.73 0.26
Mean (µg) 14.31 0.23
S.D. 0.54 0.02
C.V. (%) 3.80 8.43
NO. 1mL 天 麻 濃 縮 液 GA 含 量 (µg)
1mL 天麻濃縮液 HBA 含量 (µg)
1 5.40 0.41
2 5.36 0.40
3 5.48 0.39
4 5.49 0.42
5 5.66 0.48
6 5.59 0.47
Mean (µg) 5.50 0.43
S.D. 0.11 0.04
C.V. (%) 2.05 8.79
Table 13 天麻浸膏 GA 與 HBA 的含量測定結果
Table 14 天麻浸膏經流動床乾燥之顆粒中 GA 與 HBA 的含量測定結果 NO. 1 mg/mL 天麻浸膏 GA 含量
(µg)
1 mg/mL 天麻浸膏 HBA 含量 (µg)
1 92.73 6.88
2 96.75 8.06
3 99.25 7.83
4 94.53 8.16
5 102.46 8.53
6 93.53 7.82
Mean (µg) 96.54 7.88
S.D. 3.74 0.55
C.V. (%) 3.88 7.04
NO. 1mg/mL 天麻浸膏經流動床乾 燥後的GA 含量 (µg)
1mg/mL 天麻浸膏經流動床乾 燥後的 HBA 含量 (µg)
1 29.17 1.39
2 27.56 1.83
3 28.24 1.54
4 29.24 1.49
5 29.22 1.61
6 28.57 1.53
Mean (µg) 28.67 1.57
S.D. 0.68 0.15
C.V. (%) 2.37 9.49
Table 15 配方 R1~R10 安息角之測定結果
Table 16 配方 RA、RB 安息角之測定結果 測定次數(角度度數)
Formulation
NO. 1 2 3 MEAN S.D. C.V. (%)
R1 32.0 34.0 30.5 32.17 1.76 5.46 R2 31.0 29.5 30.0 30.17 0.76 2.53 R3 29.8 30.0 30.1 29.97 0.15 0.51 R4 28.0 28.5 29.0 28.50 0.50 1.75 R5 29.0 29.5 30.0 29.50 0.50 1.69 R6 29.1 29.0 29.2 29.10 0.10 0.34 R7 29.0 29.4 29.3 29.23 0.21 0.71 R8 30.4 31.1 30.0 30.50 0.56 1.83 R9 31.2 31.5 31.2 31.30 0.17 0.55 R10 31.5 31.2 31.8 31.50 0.30 0.95
測定次數(角度度數) Formulation
NO. 1 2 3 MEAN S.D. C.V. (%)
RA 30.5 31.2 31.6 31.10 0.56 1.79 RB 32.8 33.2 33.5 33.17 0.35 1.06
Table 17 配方 R1~R10 顆粒密度測定結果
Table 18 配方 RA、RB 顆粒密度測定結果 Formulation
NO.
Bulk
density(g/mL)
Tapped density(g/mL)
Compressibility
index (%) MEAN S.D. C.V.(%) 1 0.32 0.36 11.11
2 0.31 0.36 11.11 RA
3 0.32 0.37 13.51
11.91 1.39 11.63 1 0.28 0.33 15.15
2 0.28 0.34 17.65 RB
3 0.28 0.33 15.15
15.98 1.44 9.03
Table 19 配方 R1~R10 顆粒粒徑之測定結果
Table 21 配方 R1 顆粒的吸溼試驗結果
Table 24 配方 R4 顆粒的吸溼試驗結果
Table 27 配方 R7 顆粒的吸溼試驗結果
Table 30 配方 R10 顆粒的吸溼試驗結果 室溫顆粒吸溼重量百分比(%)
Time(min.)
1 2 3 MEAN S.D. C.V. (%) 0 0 0 0 0 0 0 30 1.55 1.70 1.62 1.62 0.06 3.78 60 2.31 2.79 2.74 2.61 0.22 8.24 90 2.82 3.17 3.07 3.02 0.15 4.87 120 3.39 3.97 3.84 3.73 0.25 6.66 150 4.17 4.47 4.11 4.25 0.16 3.71 180 4.34 4.55 5.28 4.72 0.40 8.53 360 8.8 8.35 9.28 8.81 0.38 4.31
Table 31 配方 R1~R10 顆粒的含水量之測定結果
Table 32 配方 R1~R10 錠劑的硬度試驗結果
Table 34 配方 R1~R10 錠劑的厚度試驗結果
Table 36 配方 R1~R10 錠劑之 Tensile strength
Table 37 配方 RA、RB 錠劑之 Tensile strength
計算公式如下：
Dtπ σ = 2P
σ：Tensile strength (Kg) P：錠劑硬度 (Kg/cm2) D：錠劑直徑 (mm)
t：錠劑厚度 (mm) Formulation NO.
錠劑之Tensile strength (σ) (Kg)
R1 0.67 R2 0.64 R3 0.61 R4 0.63 R5 0.64 R6 0.85 R7 0.80 R8 0.65 R9 0.62 R10 0.55
Formulation NO.
錠劑之Tensile strength (σ) (Kg)
RA 1.00 RB 0.65
Table 38 配方 R1~R10 錠劑的重量差異試驗結果
499.13 501.00 501.23
R1 498.78 502.03 497.50 499.95 1.74 0.35 500.15 501.47 499.88
R2 499.91 498.83 501.33 500.26 0.99 0.20 500.00 500.11 499.21
R3 498.56 499.26 501.23 499.73 0.93 0.19 498.95 500.24 499.56
R4 501.05 500.64 498.48 499.89 1.00 0.20 500.61 501.29 498.97
R5 499.88 499.37 502.36 500.41 1.27 0.25 498.51 499.32 500.12
R6 500.98 498.97 499.88 499.63 0.88 0.18 501.77 500.08 498.14
R7 497.69 499.44 498.19 499.22 1.54 0.31 500.77 501.91 498.67
R8 499.85 500.84 500.28 500.39 1.09 0.22 500.34 501.67 498.85
R9 498.97 500.36 498.57 499.79 1.20 0.24 500.21 499.39 498.97
R10 500.71 500.66 499.48 499.90 0.73 0.15
499.47 499.21 499.37
RA 498.99 498.97 498.28 499.05 0.43 0.09 499.13 499.85 497.68
Table 40 配方 R1~R10 天麻錠劑的 GA 含量測定結果 24.50 23.12 22.24 25.05 24.69
R1 22.33 22.10 24.53 22.54 24.51 23.56 1.19 5.07 23.78 22.69 22.66 23.81 23.14
R2 23.77 24.91 22.81 21.47 24.69 23.37 1.03 4.41 21.25 21.33 21.98 22.35 22.92
R3 23.70 22.07 24.05 21.58 22.21 23.34 0.95 4.25 26.47 26.69 22.87 22.89 23.96
R4 24.25 23.58 23.45 23.67 23.45 24.13 1.36 5.63 24.63 23.45 23.44 23.51 24.22
R5 24.58 24.36 23.78 23.64 24.77 24.04 0.53 2.20 22.78 26.67 25.42 24.33 25.64
R6 23.64 25.38 23.41 22.87 24.98 24.51 1.31 5.34 25.86 26.68 24.17 24.31 23.38
R7 22.02 23.54 24.15 23.57 23.74 24.14 1.31 5.41 23.04 21.62 25.14 23.41 23.18
R8 25.70 22.66 23.41 22.58 25.01 23.58 1.30 5.51 25.30 22.44 24.56 22.65 22.47
R9 23.65 22.36 24.57 23.69 22.87 23.46 1.06 4.53 24.48 28.01 26.04 26.55 27.41
R10 28.01 27.66 25.63 27.44 28.12 26.94 1.22 4.53 11.57 12.38 12.17 12.58 11.54
RA 12.48 11.57 12.69 13.57 13.26 12.38 0.70 5.65 13.89 13.17 15.99 14.35 14.27
RB 14.34 0.81 5.63
Table 42 配方 R1~R10 天麻錠劑的 HBA 含量測定結果
Table 44 配方 R1~R10 錠劑的脆度試驗結果
Table 46 配方 R1~R10 錠劑的崩散度試驗結果
Table 48 the dissolution data of GA from R1 in pH 1.2 medium Test no.(%) (n=6)
1 2 3 Time(min)
4 5 6
MEAN S.D. C.V. (%) 35.13 35.37 35.98
2 35.60 35.44 35.87 35.57 0.32 0.90 48.39 50.10 47.02
5 49.12 49.87 48.68 48.86 1.12 2.29 54.71 57.59 53.39
10 55.12 55.24 55.69 55.29 1.37 2.48 60.17 62.94 59.13
20 61.25 61.32 61.32 61.02 1.28 2.10 64.29 67.07 62.76
30 65.58 65.21 64.22 64.86 1.46 2.25 68.43 71.95 66.57
60 70.45 75.21 74.63 71.21 3.41 4.79 73.27 77.34 70.34
90 71.46 71.69 75.81 73.32 2.73 3.73 83.25 85.21 79.89
120 80.21 82.64 82.51 82.29 1.98 2.41 98.74 98.29 98.72
150 99.54 99.21 98.91 99.07 0.60 0.60 100.00 100.00 100.00
180 100.00 100.00 100.00 100.00 0.00 0.00
Table 49 the dissolution data of GA from R1 in pH 4.5 medium Test no.(%) (n=6)
1 2 3 Time(min)
4 5 6
MEAN S.D. C.V. (%) 34.04 35.12 36.15
2 35.60 35.44 35.87 35.37 0.74 2.10 45.92 47.14 47.63
5 46.18 46.15 47.91 46.82 0.85 1.81 52.46 53.36 54.68
10 51.81 55.10 54.79 53.70 1.27 2.54 58.14 58.36 60.52
20 60.65 62.55 60.39 60.10 1.64 2.72 62.70 62.65 64.80
30 62.91 62.77 62.82 63.11 0.83 1.32 66.66 66.46 69.56
60 67.87 66.81 67.58 67.49 1.15 1.71 71.82 71.49 75.37
90 72.64 71.35 73.11 72.63 1.51 2.07 82.18 81.56 83.54
120 80.31 82.61 81.61 81.97 1.09 1.33 99.44 99.63 100.00
150 99.67 99.64 99.87 99.71 0.20 0.20 100.00 100.00 100.00
180 100.00 100.00 100.00 100.00 0.00 0.00
Table 50 the dissolution data of GA from R1 in pH 6.8 medium Test no.(%) (n=6)
1 2 3 Time(min)
4 5 6
MEAN S.D. C.V. (%) 38.90 40.02 38.42
2 39.54 38.84 39.21 39.16 0.57 1.45 43.60 43.46 40.18
5 42.52 43.15 41.25 42.36 1.37 3.23 48.69 47.11 43.76
10 45.63 45.91 44.19 45.88 1.83 4.00 51.65 50.67 48.26
20 51.26 52.64 51.66 51.02 1.50 2.94 58.79 57.13 53.76
30 55.69 56.47 56.91 56.46 1.67 2.96 64.84 63.92 59.86
60 62.54 63.15 62.25 62.76 1.71 2.72 74.53 74.15 71.88
90 73.33 72.51 74.95 73.56 1.20 1.63 84.00 84.02 82.18
120 83.26 83.11 83.28 83.31 0.68 0.81 98.97 98.46 98.61
150 99.13 98.98 99.64 98.97 0.42 0.42 100.00 100.00 100.00
180 100.00 100.00 100.00 100.00 0.00 0.00
Table 51 the dissolution data of GA from R2 in pH 1.2 medium Test no.(%) (n=6)
1 2 3 Time(min)
4 5 6
MEAN S.D. C.V. (%) 41.37 41.62 41.00
2 41.25 42.58 40.81 41.44 0.63 1.51 49.81 50.83 50.19
5 51.23 50.21 51.57 50.64 0.68 1.35 52.47 58.49 55.69
10 59.72 56.71 55.93 56.50 2.51 0.44 57.81 59.88 63.00
20 62.58 61.97 58.45 60.62 2.21 3.65 63.32 65.17 68.40
30 67.85 65.41 66.21 66.06 1.87 2.82 74.16 75.83 73.62
60 74.01 75.95 73.64 74.54 1.07 1.43 86.53 85.60 83.26
90 85.41 84.29 85.18 85.05 1.13 1.33 96.97 93.37 92.47
120 95.66 94.51 93.48 94.41 1.66 1.76 99.08 98.15 100.00
150 99.94 99.55 100.00 99.45 0.73 0.74 100.00 100.00 100.00
180 100.00 100.00 100.00 100.00 0.00 0.00
Table 52 the dissolution data of GA from R2 in pH 4.5 medium Test no.(%) (n=6)
1 2 3 Time(min)
4 5 6
MEAN S.D. C.V. (%) 42.13 41.52 42.25
2 42.33 41.54 42.67 42.07 0.46 1.09 49.92 49.16 50.56
5 50.15 52.25 51.32 50.56 1.09 2.16 52.66 51.98 54.09
10 51.77 55.12 53.47 53.18 1.29 2.43 58.70 58.37 59.14
20 59.75 60.85 60.73 59.59 1.04 1.74 63.89 63.80 63.68
30 62.81 62.63 62.25 63.18 0.70 1.10 75.95 73.55 73.54
60 72.62 71.85 73.45 73.49 1.38 1.88 85.67 80.89 84.49
90 83.23 73.55 83.93 81.96 4.42 5.39 94.25 87.78 95.46
120 96.81 92.11 91.56 93.00 3.23 3.48 98.35 98.93 99.46
150 99.85 100.00 99.62 99.37 0.62 0.63 100.00 100.00 100.00
180 100.00 100.00 100.00 100.00 0.00 0.00
Table 53 the dissolution data of GA from R2 in pH 6.8 medium Test no.(%) (n=6)
1 2 3 Time(min)
4 5 6
MEAN S.D. C.V. (%) 41.11 40.08 35.46
2 44.80 40.15 41.25 40.48 3.00 7.42 44.74 43.85 40.43
5 48.25 45.55 47.66 45.02 2.83 6.28 47.49 46.78 44.58
10 51.86 46.45 47.96 47.52 2.42 5.10 52.04 51.58 50.14
20 56.20 54.17 54.69 53.14 2.26 4.24 57.85 57.18 55.22
30 62.69 58.81 56.82 58.10 2.55 4.38 64.67 63.27 60.06
60 68.96 67.85 64.17 64.83 3.22 4.97 74.19 75.25 69.19
90 78.08 73.45 76.15 74.39 3.01 4.05 83.42 86.22 76.45
120 88.04 86.25 85.62 84.33 4.14 4.91 94.09 92.93 93.17
150 97.27 95.28 97.94 95.11 2.11 2.22 100.00 100.00 100.00
180 100.00 100.00 100.00 100.00 0.00 0.00
Table 54 the dissolution data of GA from R3 in pH 1.2 medium Test no.(%) (n=6)
1 2 3 Time(min)
4 5 6
MEAN S.D. C.V. (%) 41.08 38.35 39.65
2 40.55 41.27 42.18 40.51 1.35 3.33 42.59 41.58 41.46
5 42.98 43.55 44.71 42.81 1.23 2.87 49.71 48.27 47.54
10 47.47 46.29 47.89 47.86 1.12 2.35 65.68 61.56 59.75
20 63.81 62.54 63.55 62.82 2.04 3.25 82.73 81.91 76.22
30 80.17 81.64 80.34 80.50 2.31 2.87 89.68 91.09 88.38
60 89.64 88.21 90.67 89.61 1.17 1.30 95.73 97.61 99.12
90 98.41 99.32 97.12 97.89 1.35 1.38 98.35 98.88 99.12
120 99.81 99.61 98.43 99.03 0.60 0.61 99.99 99.31 99.56
150 100.00 99.95 99.98 99.80 0.29 0.29 100.00 100.00 100.00
180 100.00 100.00 100.00 100.00 0.00 0.00
Table 55 the dissolution data of GA from R3 in pH 4.5 medium Test no.(%) (n=6)
1 2 3 Time(min)
4 5 6
MEAN S.D. C.V. (%) 40.28 39.81 40.01
2 41.22 41.35 40.65 40.55 0.63 1.56 42.4 40.34 42.79
5 42.33 43.64 42.82 42.39 1.11 2.61 48.27 46.94 46.97
10 46.79 47.88 45.17 47.00 1.08 2.29 60.53 60.45 59.26
20 61.54 62.57 60.66 60.84 1.12 1.84 77.92 78.95 75.44
30 72.66 73.28 78.34 76.10 2.71 3.56 87.07 92.29 86.88
60 92.41 92.15 92.57 90.56 2.78 3.07 95.75 98.00 97.57
90 97.64 98.33 96.49 97.30 0.98 1.01 98.70 99.08 98.51
120 98.98 92.11 98.73 97.69 2.74 2.80 99.85 99.08 99.50
150 100.00 100.00 99.52 99.66 0.36 0.36 100.00 100.00 100.00
180 100.00 100.00 100.00 100.00 0.00 0.00
Table 56 the dissolution data of GA from R3 in pH 6.8 medium Test no.(%) (n=6)
1 2 3 Time(min)
4 5 6
MEAN S.D. C.V. (%) 38.12 37.15 35.97
2 31.27 34.55 35.64 35.45 2.39 6.75 41.22 40.23 39.15
5 37.91 41.27 41.66 40.24 1.46 3.63 52.97 52.50 54.53
10 51.49 50.45 50.96 52.15 1.50 2.87 67.34 68.56 70.48
20 70.44 70.12 70.61 69.59 1.34 1.92 78.69 79.53 83.45
30 71.36 78.91 82.81 79.13 4.31 5.45 87.20 88.53 87.04
60 83.11 87.44 88.16 86.91 1.95 2.24 94.08 94.66 94.11
90 92.36 93.34 94.12 93.79 0.81 0.87 96.07 96.96 96.46
120 94.08 95.12 94.77 95.58 1.10 1.15 98.03 98.93 98.89
150 95.09 98.31 98.44 97.95 1.44 1.47 100.00 100.00 100.00
180 100.00 100.00 100.00 100.00 0.00 0.00
Table 57 the dissolution data of GA from R4 in pH 1.2 medium Test no.(%) (n=6)
1 2 3 Time(min)
4 5 6
MEAN S.D. C.V. (%) 35.06 35.46 37.76
2 36.55 36.21 37.21 36.38 1.02 2.81 44.89 44.64 44.51
5 44.55 43.65 43.25 44.25 0.64 1.46 60.85 60.00 60.14
10 61.23 61.87 61.08 60.86 0.70 1.15 80.50 81.66 80.60
20 81.69 80.09 80.45 80.83 0.68 0.84 94.32 91.69 91.31
30 91.05 92.64 89.74 91.79 1.56 1.70 96.49 94.74 97.49
60 97.66 97.05 98.06 96.92 1.19 1.23 97.46 96.05 97.91
90 98.47 98.46 98.68 97.84 0.98 1.01 99.12 98.28 98.35
120 99.06 98.74 99.64 98.87 0.52 0.52 99.56 99.47 99.94
150 100.00 99.97 100.00 99.82 0.24 0.24 100.00 100.00 100.00
180 100.00 100.00 100.00 100.00 0.00 0.00
Table 58 the dissolution data of GA from R4 in pH 4.5 medium Test no.(%) (n=6)
1 2 3 Time(min)
4 5 6
MEAN S.D. C.V. (%) 34.85 34.44 33.43
2 35.21 35.64 35.04 34.77 0.77 2.20 41.18 41.80 41.81
5 42.55 42.81 41.09 41.87 0.70 1.67 54.83 56.22 55.59
10 56.08 56.00 57.12 55.97 0.75 1.34 74.19 75.80 74.74
20 75.24 75.98 75.28 75.21 0.66 0.88 91.28 91.58 91.26
30 91.36 92.68 92.19 91.73 0.58 0.64 97.18 97.49 94.94
60 95.84 95.38 95.66 96.08 1.02 1.06 97.40 98.09 98.47
90 98.15 97.64 98.22 98.00 0.40 0.41 98.31 100.00 99.01
120 99.34 98.97 99.16 99.13 0.55 0.56 99.31 100.00 99.51
150 99.94 100.00 100.00 99.79 0.30 0.31 100.00 100.00 100.00
180 100.00 100.00 100.00 100.00 0.00 0.00
Table 59 the dissolution data of GA from R4 in pH 6.8 medium Test no.(%) (n=6)
1 2 3 Time(min)
4 5 6
MEAN S.D. C.V. (%) 36.58 38.56 41.46
2 36.99 39.64 37.52 38.46 1.84 4.79 43.80 46.05 47.03
5 45.69 45.24 45.74 45.59 1.06 1.33 55.78 55.08 58.64
10 54.32 56.11 53.24 55.23 1.84 3.32 77.24 79.68 78.89
20 78.67 76.99 75.65 77.85 1.49 1.91 95.03 96.58 94.47
30 94.33 96.46 94.01 95.15 1.11 1.17 95.87 97.65 97.40
60 97.94 97.96 96.68 97.25 0.82 0.85 97.81 98.21 98.67
90 98.82 98.63 97.62 98.29 0.50 0.50 98.54 98.21 98.24
120 99.29 99.12 99.77 98.86 0.63 0.64 99.14 98.86 99.32
150 99.76 99.68 100.00 99.46 0.43 0.43 100.00 100.00 100.00
180 100.00 100.00 100.00 100.00 0.00 0.00
Table 60 the dissolution data of GA from R5 in pH 1.2 medium Test no.(%) (n=6)
1 2 3 Time(min)
4 5 6
MEAN S.D. C.V. (%) 35.79 33.9 36.22
2 35.64 35.21 34.09 35.14 0.95 2.69 44.52 41.73 43.94
5 42.67 41.96 42.75 42.93 1.10 2.55 54.04 51.24 53.83
10 52.06 52.69 52.47 52.12 1.06 2.02 76.63 75.93 76.38
20 76.18 76.15 76.64 76.32 0.28 0.37 92.27 94.09 93.81
30 92.46 92.08 91.48 92.70 1.03 1.11 97.69 98.81 97.52
60 97.84 97.23 97.48 97.76 0.55 0.57 98.09 99.45 98.05
90 98.24 98.55 98.26 98.44 0.53 0.53 98.91 100.00 99.71
120 99.15 99.72 99.64 99.52 0.41 0.41 99.13 100.00 99.80
150 100.00 100.00 99.98 99.82 0.35 0.35 100.00 100.00 100.00
180 100.00 100.00 100.00 100.00 0.00 0.00
Table 61 the dissolution data of GA from R5 in pH 4.5 medium Test no.(%) (n=6)
1 2 3 Time(min)
4 5 6
MEAN S.D. C.V. (%) 36.02 35.82 35.74
2 36.21 35.94 36.51 36.04 0.28 0.78 43.75 44.17 43.96
5 43.25 44.35 42.04 43.59 0.85 0.78 59.61 58.40 58.49
10 57.00 57.06 57.82 58.06 0.99 1.95 79.38 76.43 78.36
20 78.64 78.15 74.68 77.61 1.73 1.70 93.58 93.73 95.00
30 92.64 92.66 93.78 93.57 0.87 2.23 97.77 97.84 97.95
60 97.54 98.11 98.36 97.93 0.28 0.93 98.20 99.55 97.95
90 98.63 98.54 99.02 98.65 0.57 0.29 99.53 99.78 98.52
120 99.34 98.97 99.86 99.33 0.51 0.58 99.53 100.00 99.03
150 99.94 100.00 100.00 99.75 0.40 0.52 100.00 100.00 100.00
180 100.00 100.00 100.00 100.00 0.00 0.00
Table 62 the dissolution data of GA from R5 in pH 6.8 medium Test no.(%) (n=6)
1 2 3 Time(min)
4 5 6
MEAN S.D. C.V. (%) 35.64 34.62 35.56
2 35.61 35.04 36.00 35.41 0.49 1.40 41.32 41.06 40.11
5 40.31 41.06 41.76 40.94 0.62 1.52 54.10 53.53 50.34
10 51.27 53.64 52.44 52.55 1.49 2.83 71.22 72.74 73.68
20 73.95 72.71 73.48 72.96 0.99 1.36 90.29 90.25 89.55
30 91.25 90.67 90.47 90.41 0.56 0.62 96.16 95.54 9325
60 94.66 95.14 92.25 94.50 1.48 1.56 97.53 96.69 95.55
90 96.87 97.21 97.00 96.81 0.68 0.70 97.53 96.69 96.14
120 99.29 99.12 97.63 97.73 1.27 1.30 99.54 99.61 99.26
150 99.31 99.11 100.00 99.47 0.32 0.32 100.00 100.00 100.00
180 100.00 100.00 100.00 100.00 0.00 0.00
Table 63 the dissolution data of GA from R6 in pH 1.2 medium Test no.(%) (n=6)
1 2 3 Time(min)
4 5 6
MEAN S.D. C.V. (%) 27.85 27.25 27.56
2 28.12 27.99 28.45 27.87 0.42 1.51 30.29 30.97 30.42
5 30.21 31.33 31.04 30.71 0.46 1.51 33.14 34.83 34.71
10 35.21 35.44 34.78 34.69 0.81 2.33 38.92 42.75 40.53
20 41.33 42.57 40.66 41.13 1.43 3.47 46.04 47.77 49.44
30 48.26 47.77 45.31 47.43 1.51 3.18 65.93 66.03 70.70
60 67.88 68.49 66.85 67.65 1.80 2.67 87.08 85.55 89.64
90 86.00 87.15 86.17 86.93 1.47 1.69 95.64 97.57 97.88
120 98.15 97.34 97.19 97.30 0.88 0.91 99.67 99.92 99.66
150 100.00 100.00 99.14 99.73 0.32 0.33 100.00 100.00 100.00
180 100.00 100.00 100.00 100.00 0.00 0.00
Table 64 the dissolution data of GA from R6 in pH 4.5 medium Test no.(%) (n=6)
1 2 3 Time(min)
4 5 6
MEAN S.D. C.V. (%) 29.50 28.09 28.00
2 29.42 28.94 28.64 28.77 0.64 2.22 36.60 34.12 34.15
5 35.14 35.61 36.24 35.31 1.04 2.95 40.37 38.34 38.52
10 38.14 39.51 39.67 39.09 0.89 2.27 43.81 43.09 43.00
20 42.68 42.51 43.91 43.17 0.58 1.34 49.70 50.67 50.14
30 51.24 51.09 50.48 50.55 0.58 1.15 56.19 58.85 59.33
60 57.64 58.19 59.37 58.26 1.22 2.01 72.12 76.00 73.42
90 74.62 75.15 76.49 74.63 1.64 2.19 82.59 87.64 83.91
120 82.34 84.66 84.06 84.20 1.91 2.67 95.33 95.40 92.48
150 95.48 97.16 96.87 95.45 1.66 1.74 100.00 100.00 100.00
180 100.00 100.00 100.00 100.00 0.00 0.0
Table 65 the dissolution data of GA from R6 in pH 6.8 medium Test no.(%) (n=6)
1 2 3 Time(min)
4 5 6
MEAN S.D. C.V. (%) 28.26 25.87 29.11
2 31.47 30.25 30.87 29.31 2.05 6.99 33.75 31.19 35.09
5 36.28 35.44 35.67 34.57 1.86 5.37 38.11 35.12 39.30
10 39.67 38.67 37.14 38.00 1.67 4.40 42.76 39.77 43.37
20 45.86 42.18 41.14 42.51 2.07 4.88 49.02 45.60 47.09
30 50.77 50.11 48.51 48.52 1.92 3.96 56.13 56.68 58.50
60 66.27 59.09 61.25 59.65 3.72 6.24 72.24 78.76 73.27
90 84.47 79.64 80.41 78.13 4.61 5.90 86.58 85.22 87.00
120 94.73 89.17 85.94 88.11 3.51 3.98 95.43 95.72 95.44
150 97.45 97.87 98.24 96.69 1.30 1.35 100.00 100.00 100.00
180 100.00 100.00 100.00 100.00 0.00 0.00
Table 66 the dissolution data of GA from R7 in pH 1.2 medium Test no.(%) (n=6)
1 2 3 Time(min)
4 5 6
MEAN S.D. C.V. (%) 29.86 26.21 29.09
2 28.58 27.34 25.14 27.70 1.80 6.51 31.20 28.12 32.14
5 32.88 30.11 29.12 30.60 1.82 5.94 42.33 41.33 39.19
10 41.59 40.26 39.68 40.73 1.21 2.98 58.96 55.32 56.12
20 50.21 57.31 50.64 54.76 3.58 6.53 90.57 88.87 89.34
30 81.77 89.64 78.42 86.44 5.05 5.85 97.39 96.24 92.24
60 95.15 95.63 93.22 94.98 1.92 2.02 98.40 97.46 94.14
90 96.84 97.11 95.64 96.60 1.50 1.55 98.92 97.52 96.44
120 98.13 98.92 97.25 97.86 0.98 1.00 99.99 100.00 99.47
150 99.51 99.67 100.00 99.77 0.25 0.25 100.00 100.00 100.00
180 100.00 100.00 100.00 100.00 0.00 0.00
Table 67 the dissolution data of GA from R7 in pH 4.5 medium Test no.(%) (n=6)
1 2 3 Time(min)
4 5 6
MEAN S.D. C.V. (%) 28.17 31.16 27.28
2 29.54 29.41 30.14 29.28 1.38 4.73 32.64 34.39 33.20
5 31.24 31.15 35.41 33.01 1.70 5.14 41.34 45.26 42.28
10 40.15 39.64 42.54 41.87 2.02 4.82 55.11 62.65 58.63
20 60.27 59.17 62.15 59.66 2.74 4.59 78.93 83.77 80.43
30 83.82 81.24 83.41 81.93 2.04 2.49 90.81 95.91 98.99
60 96.67 95.62 98.15 96.03 2.87 2.99 96.17 98.45 98.65
90 97.48 97.11 98.67 97.76 1.01 1.04 98.18 99.68 99.65
120 98.17 98.45 99.12 98.88 0.70 0.71 99.42 99.79 100.00
150 99.46 99.53 99.97 99.70 0.26 0.26 100.00 100.00 100.00
180 100.00 100.00 100.00 100.00 0.00 0.00
Table 68 the dissolution data of GA from R7 in pH 6.8 medium Test no.(%) (n=6)
1 2 3 Time(min)
4 5 6
MEAN S.D. C.V. (%) 29.06 28.37 27.97
2 32.89 31.26 29.18 29.79 1.90 6.37 33.26 30.97 31.76
5 35.80 36.18 32.46 33.41 2.14 6.42 46.17 40.59 41.42
10 49.25 49.71 45.21 45.39 3.82 8.42 62.61 55.77 57.29
20 66.51 67.15 59.69 61.50 4.73 7.70 82.30 79.13 80.56
30 85.65 84.16 83.47 82.55 2.40 2.91 91.22 91.64 93.74
60 97.70 95.61 92.16 93.68 2.55 2.71 96.09 98.96 99.20
90 98.43 98.47 97.48 98.11 1.15 1.17 97.84 100.00 99.95
120 99.59 99.15 98.67 99.20 0.84 0.84 98.18 100.00 99.97
150 99.59 99.94 99.12 99.47 0.71 0.07 100.00 100.00 100.00
180 100.00 100.00 100.00 100.00 0.00 0.00
Table 69 the dissolution data of GA from R8 in pH 1.2 medium Test no.(%) (n=6)
1 2 3 Time(min)
4 5 6
MEAN S.D. C.V. (%) 28.12 27.65 28.15
2 25.14 20.14 20.11 24.89 3.85 15.48 32.12 32.05 39.64
5 42.64 38.09 30.05 35.77 5.05 14.12 41.92 45.94 50.52
10 42.64 41.57 44.19 44.46 3.38 7.60 58.12 51.21 57.49
20 50.16 52.14 58.13 54.54 3.75 6.68 85.41 84.86 80.56
30 82.49 83.77 80.64 82.96 2.08 2.51 98.41 97.64 94.79
60 97.48 97.46 98.21 97.33 1.31 1.34 98.41 99.09 97.69
90 98.62 98.68 99.01 98.58 0.51 0.51 99.03 99.39 98.33
120 99.21 99.66 99.66 99.21 0.50 0.50 99.82 99.39 99.65
150 100.00 99.82 100.00 99.78 0.23 0.23 100.00 100.00 100.00
180 100.00 100.00 100.00 100.00 0.00 0.00
Table 70 the dissolution data of GA from R8 in pH 4.5 medium Test no.(%) (n=6)
1 2 3 Time(min)
4 5 6
MEAN S.D. C.V. (%) 26.60 26.28 26.25
2 25.13 27.12 29.47 26.81 1.46 5.44 32.01 30.66 31.23
5 29.45 28.46 31.54 30.56 1.35 4.43 37.36 36.72 36.41
10 35.48 34.25 36.97 36.20 1.15 3.17 47.35 48.64 46.94
20 50.24 49.67 51.48 49.05 1.74 3.56 62.03 67.71 61.35
30 69.14 61.28 68.06 64.93 3.74 5.75 82.59 84.05 74.20
60 70.13 71.28 72.06 75.72 6.05 8.00 94.31 97.25 95.24
90 96.12 94.25 92.09 94.88 1.78 1.87 95.18 98.77 96.05
120 98.15 98.27 99.19 97.60 1.61 1.65 99.22 99.58 99.41
150 99.14 99.19 99.86 99.40 0.28 0.28 100.00 100.00 100.00
180 100.00 100.00 100.00 100.00 0.00 0.00
Table 71 the dissolution data of GA from R8 in pH 6.8 medium Test no.(%) (n=6)
1 2 3 Time(min)
4 5 6
MEAN S.D. C.V. (%) 20.72 24.56 22.33
2 21.49 25.44 26.18 23.45 2.24 9.57 31.4 30.42 30.76
5 32.04 32.54 29.87 31.17 1.01 3.24 40.13 36.94 36.76
10 40.66 38.17 39.64 38.72 1.67 4.31 55.02 48.98 47.29
20 52.14 49.49 50.34 50.54 2.71 5.37 75.63 68.79 69.37
30 79.84 71.38 71.64 72.78 4.21 5.79 89.28 85.53 75.83
60 79.84 71.38 71.64 78.92 7.37 9.33 98.16 98.65 93.50
90 98.22 93.24 93.46 95.87 2.71 2.83 99.24 99.57 97.34
120 98.65 98.39 98.16 98.56 0.80 0.81 99.99 99.86 99.78
150 99.09 99.79 99.91 99.74 0.33 0.33 100.00 100.00 100.00
180 100.00 100.00 100.00 100.00 0.00 0.00
Table 72 the dissolution data of GA from R9 in pH 1.2 medium Test no.(%) (n=6)
1 2 3 Time(min)
4 5 6
MEAN S.D. C.V. (%) 23.54 23.68 24.77
2 19.84 20.97 21.14 22.32 1.93 8.66 29.15 29.11 28.14
5 24.06 27.41 28.09 27.66 1.88 6.81 35.21 33.56 33.64
10 32.64 36.54 39.90 35.25 2.67 7.56 58.99 60.49 58.84
20 59.14 60.24 58.57 59.38 0.79 1.33 80.81 84.09 81.23
30 79.68 81.38 82.15 81.56 1.48 1.82 98.41 98.34 99.16
60 97.48 94.09 93.66 96.86 2.37 2.45 98.73 98.66 99.82
90 99.14 98.47 98.61 98.01 0.50 0.51 99.35 98.26 99.82
120 99.68 99.05 99.45 99.27 0.56 0.57 99.35 98.99 100.00
150 100.00 99.97 99.75 99.68 0.42 0.42 100.00 100.00 100.00
180 100.00 100.00 100.00 100.00 0.00 0.00
Table 73 the dissolution data of GA from R9 in pH 4.5 medium Test no.(%) (n=6)
1 2 3 Time(min)
4 5 6
MEAN S.D. C.V. (%) 21.41 20.44 21.19
2 22.49 25.41 22.13 22.18 1.74 7.84 33.15 32.56 32.54
5 35.12 35.24 36.77 34.23 1.74 5.07 45.68 43.41 42.13
10 46.21 45.88 46.28 44.93 1.74 3.86 63.10 60.88 62.46
20 59.12 61.33 62.16 61.51 1.41 2.30 81.98 92.30 85.61
30 82.13 81.64 82.64 84.38 4.14 4.90 92.03 97.65 96.14
60 95.16 94.33 95.67 95.16 1.89 1.99 97.30 98.79 97.18
90 97.16 97.19 98.16 97.63 0.69 0.70 98.79 99.18 98.64
120 98.45 98.67 98.99 98.79 0.26 0.27 99.59 100.00 99.64
150 99.19 99.50 99.46 99.56 0.27 0.27 100.00 100.00 100.00
180 100.00 100.00 100.00 100.00 0.00 0.00
Table 74 the dissolution data of GA from R9 in pH 6.8 medium Test no.(%) (n=6)
1 2 3 Time(min)
4 5 6
MEAN S.D. C.V. (%) 26.87 26.75 27.27
2 26.14 29.16 28.45 27.44 1.14 4.15 34.82 29.63 31.04
5 32.25 31.24 32.67 31.94 1.76 5.22 46.64 41.32 44.50
10 42.13 42.36 45.67 43.77 2.15 4.91 64.41 59.74 64.95
20 61.65 62.33 63.17 62.71 1.91 3.04 85.83 83.32 87.77
30 83.67 85.14 89.46 85.87 2.38 2.77 95.39 96.17 96.81
60 95.07 95.67 95.87 95.83 0.61 0.64 98.66 99.24 98.88
90 97.15 97.68 98.45 98.34 0.78 0.80 99.32 99.24 99.62
120 98.66 99.10 99.46 99.23 0.33 0.34 100.00 99.62 99.62
150 99.48 99.84 100.00 99.76 0.21 0.22 100.00 100.00 100.00
180 100.00 100.00 100.00 100.00 0.00 0.00
Table 75 the dissolution data of GA from R10 in pH 1.2 medium Test no.(%) (n=6)
1 2 3 Time(min)
4 5 6
MEAN S.D. C.V. (%) 19.69 20.92 19.42
2 20.33 21.25 20.87 20.41 0.73 3.59 25.07 28.71 25.96
5 26.54 26.47 25.67 26.40 1.25 4.75 37.68 41.34 40.51
10 40.68 41.65 42.18 40.67 1.59 3.91 55.40 60.41 60.15
20 58.06 59.04 59.84 58.82 1.88 3.20 78.56 83.31 84.32
30 80.26 83.06 83.47 82.16 2.24 2.73 92.97 95.68 95.75
60 95.66 95.28 95.17 95.09 1.06 1.12 97.43 97.88 98.45
90 98.14 98.21 97.61 97.95 0.39 0.39 99.40 98.91 99.95
120 98.64 99.16 98.71 92.13 0.49 0.50 99.74 99.27 100.00
150 99.98 100.00 99.64 99.77 0.29 0.29 100.00 100.00 100.00
180 100.00 100.00 100.00 100.00 0.00 0.00
Table 76 the dissolution data of GA from R10 in pH 4.5 medium Test no.(%) (n=6)
1 2 3 Time(min)
4 5 6
MEAN S.D. C.V. (%) 18.93 20.21 19.39
2 20.36 21.12 19.72 19.96 0.78 3.89 30.04 32.72 31.42
5 31.85 31.09 30.22 31.22 1.01 3.23 40.25 46.05 43.90
10 42.63 41.65 42.16 42.77 2.00 4.68 56.23 64.28 61.19
20 60.14 60.35 59.87 60.34 2.58 4.28 79.42 84.57 84.54
30 85.61 84.75 84.36 83.88 2.23 2.65 92.83 94.38 95.80
60 94.13 93.64 92.47 93.88 1.20 1.27 97.54 98.27 98.85
90 98.78 97.59 97.46 98.08 0.64 0.65 98.74 98.94 99.61
120 99.05 99.67 98.98 99.17 0.38 0.39 99.15 99.64 100.00
150 99.64 100.00 99.99 99.74 0.34 0.34 100.00 100.00 100.00
180 100.00 100.00 100.00 100.00 0.00 0.00
Table 77 the dissolution data of GA from R10 in pH 6.8 medium Test no.(%) (n=6)
1 2 3 Time(min)
4 5 6
MEAN S.D. C.V. (%) 33.83 33.98 33.54
2 35.31 36.45 34.97 34.68 1.11 3.19 46.52 47.86 44.87
5 46.37 47.13 48.76 46.92 1.34 2.86 64.89 63.97 64.49
10 63.24 62.43 63.64 63.78 0.88 1.39 86.72 86.19 89.38
20 87.16 87.15 85.64 87.04 1.29 1.48 94.68 96.29 90.01
30 92.57 95.36 93.24 93.69 2.26 2.41 98.19 99.13 99.10
60 98.64 97.46 96.37 98.15 1.07 1.09 99.07 99.55 99.54
90 99.13 98.64 97.86 98.97 0.64 0.65 100.00 99.55 100.00
120 99.67 99.97 99.18 99.73 0.33 0.33 100.00 100.00 100.00
150 99.98 100.00 100.00 100.00 0.01 0.01 100.00 100.00 100.00
180 100.00 100.00 100.00 100.00 0.00 0.00
Table 78 the dissolution data of GA from RA in pH 1.2 medium Test no.(%) (n=6)
1 2 3 Time(min)
4 5 6
MEAN S.D. C.V. (%) 2.68 3.48 3.34
2 3.48 2.59 2.73 3.05 0.43 13.95 6.48 9.76 10.10
4 7.83 7.33 7.19 8.12 1.47 18.17 12.93 18.62 17.48
6 14.78 12.93 13.63 15.06 2.44 16.19 19.64 28.94 26.47
8 22.61 18.97 19.96 22.77 4.10 18.00 28.30 40.24 37.89
10 34.78 41.38 36.76 36.56 4.69 12.83 65.75 90.05 88.50
20 73.91 74.66 74.22 77.85 9.46 12.15 94.54 95.45 93.68
30 91.30 84.48 94.59 92.34 4.10 4.44 96.22 96.32 94.59
60 93.91 90.52 96.62 94.70 2.31 2.44 97.17 97.32 96.13
90 94.78 93.97 97.52 96.15 1.48 1.54 98.65 98.1 98.97
120 95.65 98.28 98.97 98.10 1.25 1.28 99.61 99 99.12
150 96.52 99.14 98.42 98.64 1.10 1.12 100.00 100.00 100.00
180 100.00 100.00 100.00 100.00 0.00 0.00
Table 79 the dissolution data of GA from RA in pH 4.5 medium Test no.(%) (n=6)
1 2 3 Time(min)
4 5 6
MEAN S.D. C.V. (%) 3.87 4.05 5.601
2 4.35 3.43 2.84 4.02 0.94 23.27 6.72 7.84 10.12
4 6.81 7.71 11.73 8.49 2.01 23.67 10.50 15.52 23.40
6 17.09 14.57 15.14 16.04 4.22 26.35 15.92 23.85 33.15
8 22.84 22.28 23.65 23.62 5.52 23.38 21.55 31.67 44.13
10 30.91 34.28 44.47 34.50 8.73 25.29 58.82 68.88 73.34
20 67.17 72.84 81.93 70.50 7.67 10.88 67.00 91.97 85.10
30 93.05 89.97 92.72 86.64 10.06 11.61 85.48 96.42 89.81
60 92.41 92.54 99.34 92.67 4.87 5.25 90.48 97.21 93.63
90 95.69 93.40 96.71 94.52 2.52 2.67 94.00 97.89 96.60
120 95.93 98.73 98.68 96.97 1.84 1.90 97.39 98.75 98.72
150 99.12 99.83 98.96 98.80 0.80 0.81 100.00 100.00 100.00
180 100.00 100.00 100.00 100.00 0.00 0.00
Table 80 the dissolution data of GA from RA in pH 6.8 medium Test no.(%) (n=6)
1 2 3 Time(min)
4 5 6
MEAN S.D. C.V. (%) 4.61 4.53 4.79
2 3.97 3.86 2.90 4.11 0.70 16.98 12.68 6.83 9.99
4 9.21 8.70 9.76 9.53 1.91 20.06 23.44 11.44 16.09
6 15.50 16.43 14.49 16.23 3.96 24.42 35.54 20.59 24.69
8 22.71 25.12 21.26 24.99 5.48 21.91 45.36 24.90 28.83
10 41.28 38.65 40.58 36.60 7.95 21.72 63.95 34.58 45.81
20 50.48 60.00 71.11 54.32 13.29 24.47 94.02 62.2 61.75
30 84.69 80.39 81.55 77.43 12.90 16.65 95.43 93.49 91.24
60 89.53 82.50 95.36 91.26 4.88 5.34 96.57 96.48 93.22
90 91.57 95.36 96.81 95.00 2.14 2.26 98.00 97.68 96.34
120 98.06 98.07 98.07 97.70 0.68 0.70 98.83 99.12 98.69
150 99.22 98.65 99.61 99.02 0.37 0.37 100.00 100.00 100.00
180 100.00 100.00 100.00 100.00 0.00 0.00
Table 81 the dissolution data of GA from RB in pH 1.2 medium Test no.(%) (n=6)
1 2 3 Time(min)
4 5 6
MEAN S.D. C.V. (%) 5.01 4.80 4.97
2 3.69 5.92 4.60 4.83 0.72 14.91 8.60 8.43 7.00
4 7.27 8.20 9.20 8.12 0.83 10.27 10.99 11.11 9.58
6 13.11 15.48 12.85 12.19 2.07 17.03 13.46 13.62 11.75
8 14.12 17.21 16.61 14.46 2.07 14.29 15.03 16.15 13.86
10 14.39 19.13 19.99 16.43 2.56 15.59 25.43 26.93 23.58
20 23.50 26.14 22.70 24.71 1.69 6.84 38.79 39.02 34.24
30 32.70 37.52 33.70 36.00 2.77 7.71 60.89 63.85 56.34
60 54.28 56.56 42.51 55.74 7.36 13.20 76.33 95.40 74.71
90 71.49 76.96 65.34 76.71 10.10 13.17 86.44 98.49 82.13
120 78.05 89.89 84.18 86.53 7.09 8.19 96.72 99.41 97.40
150 96.27 95.99 98.38 97.36 1.32 1.36 100.00 100.00 100.00
180 100.00 100.00 100.00 100.00 0.00 0.00
Table 82 the dissolution data of GA from RB in pH 4.5 medium Test no.(%) (n=6)
1 2 3 Time(min)
4 5 6
MEAN S.D. C.V. (%) 6.08 4.37 6.59
2 4.98 6.59 4.84 5.58 0.97 17.32 10.64 8.03 12.23
4 9.74 15.60 13.17 11.57 2.68 23.19 14.62 10.49 17.27
6 14.06 17.22 16.05 14.95 2.55 17.06 18.18 12.49 22.05
8 16.97 19.15 17.49 17.72 3.13 17.66 21.66 14.35 26.38
10 20.89 24.42 21.06 21.46 4.10 19.10 36.47 24.34 41.47
20 31.63 33.13 33.03 33.35 5.66 16.96 49.76 33.90 53.84
30 35.04 41.74 35.50 41.63 8.44 20.27 77.73 60.89 80.13
60 58.17 62.92 52.40 65.37 11.11 16.99 93.66 82.97 92.21
90 86.38 85.61 76.57 86.23 6.25 7.25 96.41 94.49 94.39
120 92.44 98.48 92.84 94.84 2.27 2.40 98.59 98.44 99.37
150 99.27 98.78 99.75 99.03 0.51 0.51 100.00 100.00 100.00
180 100.00 100.00 100.00 100.00 0.00 0.00
Table 83 the dissolution data of GA from RB in pH 6.8 medium Test no.(%) (n=6)
1 2 3 Time(min)
4 5 6
MEAN S.D. C.V. (%) 5.89 5.87 6.22
2 4.68 5.93 4.65 5.54 0.69 12.45 8.86 10.61 16.86
4 10.19 14.05 12.64 12.20 2.93 24.05 11.67 14.64 21.93
6 14.81 15.51 12.98 15.26 3.56 23.31 14.34 18.24 27.75
8 17.78 17.24 16.78 18.69 4.64 24.84 20.08 21.58 31.11
10 23.52 21.99 20.20 23.08 4.13 17.91 33.12 36.37 41.29
20 35.65 29.29 22.94 33.11 6.36 19.20 43.47 48.27 49.10
30 37.87 37.59 34.06 41.73 6.18 14.81 81.75 78.28 69.84
60 57.96 56.66 42.96 64.58 14.73 22.80 90.75 86.69 85.91
90 75.46 77.10 66.03 80.32 9.15 11.39 95.70 92.36 94.92
120 83.98 90.05 91.73 91.46 4.21 4.61 98.64 96.96 99.15
150 97.87 96.90 98.70 98.04 0.95 0.97 100.00 100.00 100.00
180 100.00 100.00 100.00 100.00 0.00 0.00
Table 84 配方 R1~R10 錠劑待溶量(%)半對數作圖
Table 85 配方 R1~R10 錠劑 in pH 1.2 medium 溶離參數
R1 21.40 33.61 57.91 -0.0109 R2 17.67 29.89 54.18 -0.0109 R3 11.66 20.65 38.55 -0.0148 R4 4.43 12.50 28.55 -0.0165 R5 0.79 8.72 24.48 -0.0168 R6 31.47 50.22 87.52 -0.0071 R7 10.68 18.85 35.10 -0.0163 R8 19.19 28.84 48.03 -0.0138 R9 10.09 18.68 35.77 -0.0155 R10 11.77 19.60 35.18 -0.0170
R1 20.15 35.11 64.86 -0.0089 R2 16.34 28.02 51.25 -0.0114 R3 11.28 19.25 35.11 -0.0167 R4 2.21 10.43 26.78 -0.0162 R5 3.31 10.83 25.79 -0.0177 R6 24.58 33.76 52.03 -0.0145 R7 11.74 20.22 37.09 -0.0157 R8 9.89 17.42 32.38 -0.0177 R9 10.60 18.20 33.34 -0.0175 R10 11.89 19.95 36.00 -0.0165
Table 87 配方 R1~R10 錠劑 in pH 6.8 medium 溶離參數
Log (100-T) = M x + b (溶離量半對數作圖求得) T ：累積溶出百分率的時間
T
50：即累積溶離百分率 50 % 的時間T
d ：即累積溶離百分率 63.2 % 的時間T
80：即累積溶離百分率 80 % 的時間M ：為斜率 (Table 84 可得知)
Formulation NO.
T
50(min)
T
d(min)
T
80(min)
M
R1 24.72 39.35 68.45 -0.0091 R2 23.57 44.05 84.80 -0.0065 R3 9.04 22.09 48.06 -0.0102 R4 0.74 8.95 25.30 -0.0162 R5 4.52 14.31 33.78 -0.0136 R6 29.72 46.15 78.85 -0.0081 R7 10.12 18.60 35.47 -0.0157 R8 17.71 26.09 42.74 -0.0159 R9 9.75 17.49 32.88 -0.0172 R10 1.60 8.13 21.11 -0.0204
Table 88 配方 R1 錠劑之安定性試驗結果 GA 含量測定(mg/tablet) (n=3)
Time
Table 89 配方 R2 錠劑之安定性試驗結果 GA 含量測定(mg/tablet) (n=3)
Time
Table 90 配方 R3 錠劑之安定性試驗結果 GA 含量測定(mg/tablet) (n=3)
Time
Table 91 配方 R4 錠劑之安定性試驗結果 GA 含量測定(mg/tablet) (n=3)
Time
Table 92 配方 R5 錠劑之安定性試驗結果 GA 含量測定(mg/tablet) (n=3)
Time
Table 93 配方 R6 錠劑之安定性試驗結果 GA 含量測定(mg/tablet) (n=3)
Time
Table 94 配方 R7 錠劑之安定性試驗結果 GA 含量測定(mg/tablet) (n=3)
Time
Table 95 配方 R8 錠劑之安定性試驗結果 GA 含量測定(mg/tablet) (n=3)
Time
Table 96 配方 R9 錠劑之安定性試驗結果 GA 含量測定(mg/tablet) (n=3)
Time
Table 97 配方 R10 錠劑之安定性試驗結果 GA 含量測定(mg/tablet) (n=3)
Time
Table 98 配方 R1~R10 和 RA、RB 錠劑之溶離度均一性試驗
Table 99 配方 R1 錠劑在水中安定性測試結果
Table 101 配方 R3 錠劑在水中安定性測試結果
Table 103 配方 R5 錠劑在水中安定性測試結果
Table 105 配方 R7 錠劑在水中安定性測試結果
Table 107 配方 R9 錠劑在水中安定性測試結果
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