宣肺止咳糖浆的制备与质量控制标准

Preparation techniqe and quality standards of Xuan-fei-zhi-ke syrup

目的 :确定宣肺止咳糖浆剂的制备工艺及其质量控制指标。方法 :采用 3种不同制备工艺 (水煎煮法、水煎醇沉法、分别煎煮醇沉法 )制成宣肺止咳糖浆样品Ⅰ、Ⅱ、Ⅲ。利用麻黄碱成色定性分析和黄芩苷定量分析的方法 ,比较样品Ⅰ、Ⅱ、Ⅲ中的麻黄碱和黄芩苷含量。结果 :宣肺止咳糖浆样品Ⅲ中的麻黄碱和黄芩苷的含量最高。结论 :第 3种工艺 (分别煎煮醇沉法 )制备工艺最隹 ,所制备的宣肺止咳糖浆样品中的黄芩苷含量应不低于 0 2mg/ml,麻黄碱、黄酮类。

OBJECTIVE:To determine the techniqe and quality standards of Xuan fei zhi ke syrup. METHODS:Three techniques(decocting,decocting+ethanol precipitating,separate decocting + ethanol-precipitating ) were adopted to prepare the syrup sample Ⅰ, Ⅱ,and Ⅲ respectively.The 3 samples were evaluated by qualitative and quantitative analysis.RESULTS:The ephedrine and baicalin in sample Ⅲ were the highest among the 3 samples. CONCLUSION:The separate decocting plus ethanol precipitating is the best preparation techniqe for Xuan fei zhi ke syrup.The quality standards for Xuan fei zhi ke syrup are that baicalin content must be more than 0 2mg/ml,and the qualitative analysis of ephedrine, flavonoids and saponins must be positive reaction.