银丹解毒颗粒质量标准的建立及急性毒性试验

刘敏; 陈丽芳; 田佳懿; 刘洋; 张轩齐; 刘炜

文章摘要

刘敏,陈丽芳,田佳懿,刘洋,张轩齐,刘炜.银丹解毒颗粒质量标准的建立及急性毒性试验[J].中国药事,2022,36(3):313-321

银丹解毒颗粒质量标准的建立及急性毒性试验

Establishment of Quality Standards for Yindan Jiedu Granules and Its Acute Toxicity Test

DOI：10.16153/j.1002-7777.2022.03.012

中文关键词: 银丹解毒颗粒质量标准高效液相色谱法急毒试验

英文关键词: Yindan Jiedu Granules quality standards HPLC acute toxicity test

基金项目:国家自然科学基金面上基金资助项目(编号82073741)；北京市属医院科研培育计划(编号PZ20190701)；首都医科大学附属北京世纪坛医院青年基金(编号2017q-45)；银丹解毒颗粒医疗机构制剂备案研究(编号2020-B06)

作者	单位
刘敏	首都医科大学附属北京世纪坛医院药学部,北京 100038 ；临床合理用药评价北京市重点实验室,北京 100038
陈丽芳	首都医科大学附属北京世纪坛医院药学部,北京 100038 ；临床合理用药评价北京市重点实验室,北京 100038
田佳懿	首都医科大学附属北京世纪坛医院药学部,北京 100038 ；临床合理用药评价北京市重点实验室,北京 100038
刘洋	首都医科大学附属北京世纪坛医院药学部,北京 100038 ；临床合理用药评价北京市重点实验室,北京 100038
张轩齐	中国药科大学工学院,南京 210009
刘炜	首都医科大学附属北京世纪坛医院药学部,北京 100038 ；首都医科大学附属北京佑安医院药学部,北京 100069

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中文摘要:

目的：建立银丹解毒颗粒的质量标准并进行急性毒性试验。方法：采用高效液相色谱法 (HPLC)测定银丹解毒颗粒中黄芩苷的含量，采用Agilent EClipse SB-C₁₈色谱柱(4.6 mm×250 mm， 5 μm)，以甲醇-水-磷酸(47∶53∶0.2)为流动相，流速1.0 mL·min^-1，检测波长280 nm，柱温 30 ℃，进样量10 μL。采用薄层色谱法(TLC)定性鉴别银丹解毒颗粒中的金银花、黄芩、麻黄、桑白皮。急毒试验设置阴性对照组和银丹解毒颗粒给药组，连续观察14天并记录相关指标。结果：黄芩苷进样量在0.8072~10.09 μg范围呈良好线性关系(r=0.9998)，平均回收率为98.72%，RSD=1.98% (n=9)；精密度、稳定性、重复性试验的RSD均小于2%。金银花、黄芩、麻黄、桑白皮的TLC图特征性斑点清晰，分离度好，专属性强，阴性对照无干扰。大鼠银丹解毒颗粒单日灌胃给药169.80 g·kg^-1，相当于临床剂量的57.52倍，未见明显毒性。结论：建立的方法操作简便、精确度高、结果可靠，可用于银丹解毒颗粒的质量控制；银丹解毒颗粒临床剂量安全可靠。

英文摘要:

Objective: To establish the quality standards for Yindan Jiedu Granules and test its acute toxicity. Methods: High performance liquid chromatography(HPLC)method was used to measure the content of baicalin in Yindan Jiedu Granules. The Agilent EClipse SB-C₁₈ (4.6 mm×250 mm, 5 μm) column was used as the analytical column, and the methanol-water-phosphoric acid (47: 53: 0.2) was used as the mobile phase with the flow rate of 1.0 mL·min^-1, the detection wavelength of 280 nm, the column temperature of 30 ℃ and the injection volume of 10 μL. Thin layer chromatography(TLC)was adopted to identify the honeysuckle, scutellaria, ephedra and mulberry bark in Yindan Jiedu Granules. A negative control group and a Yindan Jiedu Granules administration group were set in the emergency drug test, and the relevant indexes were recorded for 14 consecutive days. Results: The injection amount of baicalin showed a good linear relationship (r=0.9998) in the ranges of 0.8072~10.09 μg . The average recovery rate was 98.72%, the RSD value was 1.98% (n=9) , and the RSD values of precision, stability and repeatability tests were all less than 2%. The characteristic spots of TLC diagrams of honeysuckle, scutellaria, ephedra and mulberry bark were clear with good separation, strong specificity and no interference from the negative control group. The oral administration of Yindan Jiedu Granules in rats was 169.80 g·kg^-1 on a single day, which was 57.52 times of the clinical dose, and no obvious toxicity was found. Conclusion: The established method is easy to operate, and it has high accuracy and reliable results, so it can be used for the quality control of Yindan Jiedu Granules. The clinical dose of Yindan Jiedu Granules is safe and reliable.

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