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目的:通过不同包装材料对宣肺清热颗粒剂稳定性的影响研究,为该颗粒剂贮存条件及包装提供实验依据。方法:薄层色谱法(TLC)鉴别颗粒剂处方中药材麻黄、甘草、射干、陈皮、浙贝母为定性指标,高效液相色谱法(HPLC)测定有效成分麻黄碱、橙皮苷、甘草酸含量为定量指标进行:(1)影响因素试验:定性及定量检查高湿(90±5)%、强光(4 500±500)Lx、高温(60)℃条件下放置10 d药用复合膜包装和普通塑料袋包装供试品对光、温度、湿度的稳定性。(2)湿度稳定性试验:相对湿度(RH)30%、40%、50%、60%、70%、80%、90%条件下放置供试品7 d,定时取样、称重,确定临界相对湿度(CRH)。结果:(1)定性指标结果:在以上稳定性试验中,不同时间各定性鉴别指标TLC结果与0 d TLC结果无差别。(2)定量指标结果:①影响因素试验:该颗粒剂对湿度、光线、温度都具一定稳定性,药用复合膜包装能提高该制剂吸湿稳定性。②湿度稳定性试验:确定该颗粒剂CRH为68.1%。结论:应用多指标评价稳定性是较好的解决以方中单味药的某中成分作为复方指控指标而与实际情况偏离问题的有效措施之一。通过不同稳定性实验结果可以认为该颗粒剂稳定性符合要求,药用复合膜包装可以提高该制剂吸湿稳定性。
OBJECTIVE: To study the effects of different packaging materials on the stability of Xuanghuqing Heat-clearing Granules to provide experimental evidences for the storage conditions and packaging of the granules. Methods: Identification of Ephedra, licorice root, Radix et Rhizoma calamitin, Fritillaria cirrhosa and Fritillaria cirrhosae by TLC as the qualitative index, and the determination of the active ingredients ephedrine, hesperidin, glycyrrhizin by high performance liquid chromatography (HPLC) (1) Influencing factors test: qualitative and quantitative examination of high-humidity (90 ± 5)%, light (4 500 ± 500) Lx, high temperature (60) ℃ placed 10 d medicinal composite membrane Packaging and general plastic bags for test light, temperature, humidity stability. (2) Humidity stability test: place the test sample for 7 days under relative humidity (RH) of 30%, 40%, 50%, 60%, 70%, 80%, 90% Relative humidity (CRH). Results: (1) Qualitative index results: In the above stability test, the TLC results of qualitative identification at different time had no difference with 0 d TLC results. (2) The results of quantitative index: (1) Influencing factors test: The granules have certain stability to humidity, light and temperature. The medical composite film packaging can improve the moisture absorption stability of the preparation. ② humidity stability test: determine the granules CRH 68.1%. Conclusion: It is one of the effective measures to evaluate the stability by using multi-index to solve the problem that some of the single ingredients in a single prescription are deviated from the actual situation as indicators of compound accusations. Through the stability of different experimental results that the stability of the granules to meet the requirements, pharmaceutical composite film packaging can improve the moisture absorption stability of the preparation.