咳喘宁制剂的评价性检验分析

Evaluative Inspection Analysis for the Kechuanning Preparation

目的评价咳喘宁制剂的产品质量和现行质量标准的可行性。方法按照咳喘宁制剂的现行标准检验,探索性研究采用HPLC法测定咳喘宁口服液中盐酸麻黄碱的含量。结果按现行法定标准检验咳喘宁制剂100批次,合格率100%;通过探索性研究检验,可更加科学合理的控制咳喘宁口服液的产品质量。结论咳喘宁(片)现行标准有待提升和统一,咳喘宁口服液现行标准基本可行,有的项目可进一步修订提高。

OBJECTIVE To evaluate the quality of Kechuanning Prepration and feasibility of current standards.METHODS Inspection in accordance with the current standard for Kechuanning preparation , exploring the content of ephedrine hydrochloride by HPLC method for determination of Kechuanning oral liquid.RESULTS 100 batches of Kechuanning Preparation were tested ,the qualified rate of current standards test were 100%;The exploratory testing can be more scientific and reasonable control asthma Ning oral liquid on the quality of the products.CONCLUSION The current standard of Kechuanning （ tablet） needs to be improved and unified ,the current standard for Kechuanning oral liquid is basically feasible ,some projects may be further amended to improve.