CAJ | 학술논문

目的：研究养阴生肌膜的成型工艺及其质量标准。方法采用单因素考察及正交设计的试验方法筛选养阴生肌膜的成型工艺；用高效液相色谱法测定盐酸小檗碱的含量，建立其质量标准。结果羧甲基纤维素钠与聚乙烯醇17-88的质量比例为2：3，羧甲基纤维素钠与聚乙烯醇17-88的总质量在膜浆中的浓度为4%，药粉质量在膜浆中的浓度为2.5%，是养阴生肌膜的最佳处方工艺；盐酸小檗碱的进样量在2.62~13.1 ng 范围内进样量与峰面积呈良好的线性关系（r =0.9993），平均回收率为99.4%，RSD =1.48%（n =6）。结论筛选出的成型工艺稳定可靠，含量测定方法简便、重现性好、专属性强，为该制剂的质量评价提供了依据。
목적：연구양음생기막적성형공예급기질량표준。방법채용단인소고찰급정교설계적시험방법사선양음생기막적성형공예；용고효액상색보법측정염산소벽감적함량，건립기질량표준。결과최갑기섬유소납여취을희순17-88적질량비례위2：3，최갑기섬유소납여취을희순17-88적총질량재막장중적농도위4%，약분질량재막장중적농도위2.5%，시양음생기막적최가처방공예；염산소벽감적진양량재2.62~13.1 ng 범위내진양량여봉면적정량호적선성관계（r =0.9993），평균회수솔위99.4%，RSD =1.48%（n =6）。결론사선출적성형공예은정가고，함량측정방법간편、중현성호、전속성강，위해제제적질량평개제공료의거。
Objective To study the molding process and quality standard of Yangyin Shengji Membrane. Methods The optimum conditions about molding process of Yangyin Shengji Membrane were optimized by the single factor test and the means of the orthogonal design;The content of berberine hydrochloride was determined by HPLC and its quality standard was established. Results The best molding process of Yangyin Shengji Membrane as follow:the mass ratio of CMC - Na and PVA17 -88 was 2:3,the total mass of CMC - Na and PVA17 -88 in the plasma membrane was 4%,the concentration of the medicine in the plasma membrane was 2. 5%. The linear range of berberine hydrochloride was 2. 62 ~ 13. 1 ng( r = 0. 999 3). The average recovery was 99. 4%,RSD =1. 48%(n =6). Conclusion The screened molding process was stable and reliable. The method of measurement was simple and had good reproducibility and specificity. It can provide a basis for the quality evaluation of Yangyin Shengji Membrance.