2.4.4驗證試驗按優選處方的比例進行3批樣品的驗證試驗,結果表明,所確定的優選處方配比適宜,重複性較好。表明該基質處方合理、穩定可行。
3討論
本實驗采用凝膠流體學性質對凝膠影響因素進行客觀準確評分,排除了主觀評分的幹擾,同時建立了凝膠基質質量與流體學參數相關關係函數,通過回歸函數,根據外用凝膠劑的質量要求,在一定的pH範圍內可預測卡波姆的用量,並且利用均勻設計法篩選機製處方能以較少的試驗次數在更多試驗水平下對中藥外用劑型處方進行優化。利用本方法獲得的祛斑凝膠劑外觀細膩,黏度適中,觸變性良好。通過數學模型的建立來更好的預測和控製處方的組成,為進一步研究中藥外用製劑處方的篩選提供了合理的參考。
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Optimization of formulas of Quban gel by uniform design
GUO Hong-ye, YAN Xiao-ping*, YI Bo-wen, ZHENG Rui, KUANG Ying
(Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing , China)
[Abstract] Objective: To optimize formulas of Quban gel. Method: The U6 (62×3) uniform design was adopted to optimize gel formulas, with rheological parameters, such as viscosity and yield value in room temperature, viscosity and yield value in average temperature of skin, thixlotropy. Result: The optimum proportion of matrix was made of 1.0 g carbomer 940, 5 mL glycerin and pH value 5-6.Conclusion: The regression model for gel matrix quality and gel rheological parameters was established to directly reflect the impacting effect of various factors, and provide certain preference basis for the screening of gel matrix formulas. Quban gel prepared by the method was evenly distributed, moderately viscous and highly thixotropic
[Key words] uniform design; Quban gel; rheology; matrix formula
doi:10.4268/cjcmm