不同包装材料对宣肺清热颗粒剂稳定性的影响研究

Investigation on the stability of Xuanfeiqingre granules in different packaging materials

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。

Objectives： To estimate the stability of Xuanfeiqingre granules by determining chemical compositions of the granule＇s ingredient Ephedrine, Citrusreticulate, Glycyrrhiza, Belamcan-da, Zhejiang fritillary and the quantity control of the indexes ephedrine, hesperidins and glycyrrhizic and to give base for predict the granule＇s condition of storage and packaging requirement. Methods： The ehemieal compositions were determined by think layer chroma- tography （TLC） method, the contents of above indexes were determined by reversed - phase HPLC method. The dosage form was carried of： （1） Stress test： under the condition in the pharmacopoeia stress test, exposed the granules to high moisture （90±5）, high temperature （60℃） and tungsten lamp （4 500±500） Lx for 10 days with different packaging, determine the effect of these condition to the granules by the result of different indexes. （2） Moisture stability test： put the granules under relative humidity （RH） 30%, 40%, 50%, 60%, 70%, 80%, 90% condition for 7 days, estimate this granules critical relative humidity （CRH）. Results： （1）. Results of TLC： the granules compositions stability by TLC were stable and there was not any difference between the experiment result and stability control standard. （2） Result of quantity control： （1） Stress test made it certain that this granules ingredient had certain moisture stability, photo stability and temperature stability. These experiments also indicated that the medical using complex bag can improve the granules moisture stability. （2） The CRH was 68.1%. Conclusion： Xuanfeiqingre granules is a Chinese medicine composed of kinds of herb, belong to solid dosage form, which is multiple phase system. So there are kinds of factor influence its stability. There fore by variety of indexes to estimate the stability of Chinese medicine in different condition may be the better way than one simple index.