止血精胶囊的制备工艺及质量标准的建立

Preparation process and quality standard of hemostatic capsules

目的确定止血精胶囊的制备工艺并进行质量标准研究。方法通过提取白芨非多糖组分和胶囊剂工艺制备,获得止血精胶囊;采用薄层色谱法(TLC)鉴别止血精胶囊中的白芨苷,依照《中国药典》2015版对制备的止血精胶囊进行检查,运用高效液相色谱(HPLC)法测定胶囊中白芨苷的含量。结果制备得到的止血精胶囊经TLC鉴别,白芨苷斑点清晰,辅料无干扰;白芨苷含量在5.09~40.72 mg/L浓度范围内具有良好的线性关系(r=0.9999),平均加样回收率为100.48%,RSD为2.52%。结论该制备工艺路线合理,建立的分析方法专属性强、重复性好,可用于评价止血精胶囊的质量。

Objective To determine the preparation process and improve quality standard of hemostatic capsule.Methods The capsule was obtained by extracting non polysaccharide components from Bletilla striata and preparation technology.The militarine of hemostatic capsule was identified by thin layer chromatography(TLC).The capsules were examined in according to the Chinese Pharmacopoeia(2015).The compound militarine in the capsules was quantified by high pressure liquid chromatography(HPLC).Results The spots of militarine in TLC were identifiable and the excipients had no interference in the analysis.Militarine had good linearity in the range of 5.09-40.72 mg/L(r=0.9999).The average recovery was 100.48%with the RSD of 2.52%.Conclusion The preparation process is reasonable,and the established analytical method has satisfactory specificity and repeatability which could be used to evaluate the quality of hemostatic capsule.