摘要
目的:研究穿琥宁直肠用原位凝胶的处方和制备工艺。方法:以外观、黏度突变温度、胶凝温度、稳定性等为指标,采用单因素试验考察泊洛沙姆的种类和用量、抗氧化剂和抗菌剂种类;以穿琥宁含量降低百分率为指标,以乙二胺四乙酸二钠质量分数、苯甲醇质量分数、羟丙基-β-环糊精(HP-β-CD)质量分数为考察因素,采用正交试验结合单因素试验优选抗菌剂的用量和抗氧化剂的种类和用量;并对有效期进行预测。结果:优选的处方为10 g穿琥宁,18 g泊洛沙姆407,6.0 g泊洛沙姆188,0.5 g苯甲醇、6 g HP-β-CD,加水至100 g;胶凝温度为(36.5±0.5)℃;制剂有效期为1.57年。结论:优选的处方合理、可行,可用于制备穿琥宁直肠用原位凝胶。
OBJECTIVE：To study the prescription and formulation technology of Chuanhuning rectum in situ gel.METHODS： Using appearance,viscosity mutation temperature and gelling temperature and the stability as index,amount and type of poloxamor,the amount of antioxidant and types of antiseptic were investigated by single factor test.The amount of antiseptic,types and amount of antioxidant were optimized by orthogonal test and single factor test with the percentage of the decrease of potassium dehydroandrographolide succinate as index using the contents of disodium ethylenediamine tetraacetic acid,benzil alcohol and HP-β-CD as factors.The period of validity of the gel was predicted.RESULTS：Optimal formulation was as follows：potassium dehydroandrographolide succinate of 10 g,poloxamer 407 of 18 g,poloxamer 188 of 6.0 g,benzil alcohol of 0.5 g,HP-β-CD of 6 g,adding high purity water of 59.5 g;gelling temperature of（36.5±0.5）℃;The period of validity was 1.57 years.CONCLUSIONS：The optimal formulation is reasonable and feasible,and it is suitable for the preparation of Chuanhuning rectum in situ gel.
出处
《中国药房》
CAS
CSCD
2013年第35期3296-3298,共3页
China Pharmacy
基金
国家科技支撑计划课题(No.2006BAI09B08-05)
关键词
穿琥宁原位凝胶
制剂工艺
处方
Chuanhuning rectum in situ gel
Preparation technology
Formulation
