复方胰酶散延长有效期研究

Study on the Extended Validity Duration of Compound Pancreatin Powder

目的:对复方胰酶散进行稳定性试验研究,以确认药品贮存的有效期;方法:根据化学药品稳定性试验指导原则,对连续生产的三批复方胰酶散进行研究。结果:复方胰酶散原有效期为12个月,根据稳定性试验结果,试验各项指标无明显变化、性质稳定。结论:复方胰酶散有效期可以延长至24个月。

Objective: To study the stability of the Compound Pancreatin Powder, to confirm the validity of drug storage. Methods: According to the principle of test of chemical stability, three batches of Compound Pancreatin Powder were studied in continuous production. Results:The original Compound Pancreatin Powder is valid for 12 months, according to the result of stability test, test the indicators no significant change,stable nature. Conclusion: Compound Pancreatin Powder validity period can be extended to 24 months.