含黄芩苷注射剂中突发性热原污染的去除研究
Research on Removing Sudden Pyrogen Contamination in Baicalin Injection
-
摘要: 目的 优选含黄芩苷的注射剂中突发性污染的热原去除工艺。方法 采用动态浊度法和HPLC法检测不同浓度活性炭及不同截留分子量的超滤膜使用前后黄芩苷药液中细菌内毒素及有效成分含量，分别计算细菌内毒素去除率和黄芩苷回收率。结果 在热原突发污染情况下，测得0.10%，0.50%，1.00% 3种浓度活性炭对黄芩苷药液的细菌内毒素去除率分别为80.2%，91.7%和95.6%，同时黄芩苷回收率分别为90.8%，73.1%和51.3%；黄芩苷药液经5和10 kDa相对截留分子量的超滤膜的细菌内毒素去除效率均接近100%，黄芩苷回收率分别为52.6%和94.3%。结论 该实验明确了各种浓度活性炭都不能有效去除黄芩苷类药液的热原且对黄芩苷吸附率很高，而超滤法对黄芩苷药液热原的去除效果较好且成分回收率也很高，为中药注射剂生产工艺中去除热原提供依据。Abstract: OBJECTIVE To optimize the pyrogen removing process of sudden contamination in injections containing baicalin. METHODS The bacterial endotoxin (BE) and effective composition contents in baicalin solution were detected by kinetic turbidity method and HPLC before and after using different concentrations of activated carbon and different molecular weight cut off (MWCO) ultrafiltration membranes to calculate the removal rate of BE and baicalin recovery rate， respectively. RESULTS Under the condition of pyrogen sudden pollution， BE removal rate in baicalin solution were 80.2%， 91.7% and 95.6% when using 0.10%， 0.50% and 1.00% activated carbon， and recovery rate of baicalin were 90.8%， 73.1% and 51.3%. BE removal rate in baicalin solution were nearly 100% when using 5 and 10 kDa MWCO ultrafiltration membrane， the recovery rate of baicalin were 52.6%， 94.3%. CONCLUSION The experiments confirmed that different concentrations of activated carbon cannot effectively remove the pyrogen of baicalin solution， and the adsorption rate of baicalin was high; while ultrafiltration showed better results in pyrogen removal with high recovery rate， thus providing the basis for the production of Chinese medical injections.
下载: