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目的:研究银翘解毒软胶囊制备过程中各环节绿原酸的转移率,为制备工艺优化及质量控制标准修订提供依据。方法:按《中国药典》所载银翘解毒软胶囊的处方与工艺,用HPLC测定制备过程各环节绿原酸的转移率及相对于上一步的保留率,并测定3个批号银翘解毒软胶囊中绿原酸的含量。结果:3批金银花投料后,乙醇回流提取、减压浓缩、与其他饮片稠膏合并干燥、与挥发油及大豆油制成软胶囊内容物4个环节绿原酸的平均转移率分别为86.1%,77.5%,73.2%,72.8%;相对于上一步的平均保留率分别为86.1%,90.0%,94.6%,99.3%。3批银翘解毒软胶囊每粒平均含绿原酸分别为3.77,3.38,3.86mg。结论:该研究可为银翘解毒软胶囊的生产过程控制和含量限量标准制定提供依据。
OBJECTIVE: To study the transfer rate of chlorogenic acid in the process of preparation of Yinqiao Jiedu soft capsule, and to provide the basis for the optimization of preparation technology and the revision of the quality control standard. Methods: According to the formulation and technology of Yinqiao Jiedu soft capsule contained in “Chinese Pharmacopoeia”, the transfer rate of chlorogenic acid and the retention rate of the previous step were determined by HPLC. Capsule chlorogenic acid content. Results: After three batches of honeysuckle were fed, the ethanol was extracted by reflux, concentrated under reduced pressure, combined with other creams and dried, and the average transfer rates of chlorogenic acid in the four sections of volatile oil and soybean oil were 86.1% 77.5%, 73.2% and 72.8%, respectively. The average retention rates from the previous step were 86.1%, 90.0%, 94.6% and 99.3% respectively. 3 batches of Yinqiao Jiedu soft capsules contain chlorogenic acid average of 3.77,3.38,3.86 mg each. Conclusion: This study can provide the basis for the production process control and content limit of Yinqiaojiedu soft capsules.