壳聚糖避孕泡沫气雾剂质量标准研究

The Research on Quality Standard of Chitosan Contraceptive Gel Foam Agent

目的：制订壳聚糖避孕泡沫气雾剂质量标准。方法：依据《中华人民共和国药典》（2010年版二部）附录IL和附录IU的通则要求，对产品的性状、pH、粒径、黏度、喷出总量等进行了检测；采用化学方法鉴别柠檬酸和壳聚糖：采用紫外分光光度法测定壳聚糖的含量：采用酸碱滴定方法测定柠檬酸含量。并对壳聚糖避孕泡沫气雾剂杀精效果进行了检测。结果壳聚糖避孕泡沫气雾剂pH、粒径、黏度、喷出总量均符合药典要求；壳聚糖在O～0．04mg／ml范围内具有良好的线性关系，r=0．9986，加样回收率为，RSD=0．74％（n=9）。壳聚糖避孕泡沫气雾剂具有杀精作用。结论建立的质量标准检测方法简便、准确、可靠，且重现性好，可用于壳聚糖避孕泡沫气雾剂的质量控制。

Objective ：to formulate controllable quality standard for novel contraceptive formulations - chi- tosan contraceptive foam. Methods： Product detection such as characteristics, pH, particle size, viscosity and discharge quantity is carried out according to general requirements for spray in appendix IL and gel in appendix I U of “ Pharmacopoeia of the Peoples Republic of China （2010 edition two）”. Identification of citric acid and chitosan by chemical methods, the chitosan content of chitosan contraceptive foam agent is determinated based on ultraviolet spectrophotometric method; Using acid-base titration method for the determination of citric acid content. Results ：That pH, particle size, viscosity and discharge quantity of chitosan contraceptive foam agent are in line with the requirements of Pharmacopoeia;.Chitosan content in the range of 0-0.04mg/ml has good lin- ear relationship and “r” is 0.9986, sample recovery rate was 0.74% （n = 9）. Conclusion demonstrates that the method is simple, accurate and reliable and with good reproducibility, which can be used for chitosan contra- ceptive gel foam agent quality control.