护宝疗凝胶剂的制备及稳定性研究

Study on Preparation Quality-control Criteria and Stability of Hubaoliao Gel

目的研制护宝疗凝胶剂,建立其质量标准,考察其稳定性。方法用醇提法提取苦参碱、白头翁总皂苷,与凝胶基质混合均匀,制备护宝疗凝胶,分别进行性状观察、主要成分鉴别、含量测定及稳定性试验。结果护宝疗凝胶为棕褐色凝胶状物质,在与苦参碱对照品色谱相应位置显相同的棕色斑点,白头翁总皂苷鉴别显紫红色环。用薄层扫描法进行含量测定,苦参碱对照品溶液质量浓度在1.44～12.96mg/mL范围内与相应的峰面积值呈线性关系,回归方程A=2710.49C-608.26(r=0.9994),平均回收率为98.62%,RSD=2.4%。在高湿、强光照射条件下供试品均为棕褐色半透明凝胶,相对含量在正常范围;供试品在60℃条件下变为棕褐色半固体,含量变化超出正常范围。结论护宝疗凝胶剂质量稳定,但对高热敏感,应避免在高温下放置。

Objective To study on the preparation quality- control criteria and stability of Hubaoliao gel. Methods Sophora flavescens and Pulsatilla chinensis were extracted by 95% ethanol respectively, then they were mixed with gel to make Hubaoliao gel. The characteristics of Hubaoliao gel was observed, and its assay was determined by thin- layer chromatography scanner method. Its stability was tested by high temperature （40℃ and 60℃ ）, high humidity （75% and 92.5% ） and hard light. Results The characteristics of Hubaoliao gel was chocolate brown. Sophora flavescens identification was same as Sophora flavescens reference substance. Aubergine ring was shown in Pulsatilla chinensis identification. As for its assay, the area of peaks were linear relation with Sophora flavescens reference concentrations in the range of 1.44 - 12.96 mg, the regression equation was A = 2 710. 49 C - 608.26, r = 0. 999 4. RSD = 2.7% at stability test. RSD = 1.40% at precision test. Blank supplementary materials did not interfere the assay. The average recovery rate was 98.62% and RSD = 2.4% in recovery test. The content of Sophora flavescens was （0. 20 ± 0. 017）% by two -dot -external - standard method. In stability test, the characteristics of Hubaoliao gel did not change notably in high humidity and hard light apart from high temperature. Relative contents were in normal range apart from 60℃. Conclusion Hubaoliao gel has the good quality-control criteria. The store avoids high temperature.