摘要
目的为控制医院制剂质量,建立高效毛发生长素的质量标准,保证药物有效、安全、可靠。方法根据Molish反应原理,采用α-萘酚硫酸法对高效毛发生长素中当归多糖、黄芪多糖等总糖进行鉴别。采用高效液相色谱(HPLC)法,同时测定高效毛发生长素中补骨脂素、异补骨脂素、二苯乙烯苷及大黄素含量。根据连续生产的15批次产品测定结果,建立补骨脂素、异补骨脂素、二苯乙烯苷及大黄素质控标准。结果 15批次供试品均为黄棕色澄明溶液,Molish反应均为阳性。HPLC法同时测定补骨脂素、异补骨脂素、二苯乙烯苷及大黄素,在0.50~8.00μg·mL^(-1)范围内,各对照品线性关系良好,r>0.999。平行操作6次,测定结果 RSD均小于3.0%,具有较好的重复性,且加样回收率在90.0%~110%之间,表明该定量分析方法准确可行。结论该方法简单可行,重现性好,可作为高效毛发生长素质量评价标准建立的依据,能较好地评价院内制剂工艺稳定性,保证药物安全有效。
OBJECTIVE To establish the quality standard of efficient hair auxin to control the quality of hospital preparations. In order to ensure hospital preparations is effective,safe and reliable. METHODS According to the principle of Molish reaction,the total sugar of Angelica sinensis polysaccharide and Astragalus polysaccharides were identified by α-naphthol sulfuric acid method. The contents of psoralen,isopsoralen,stilbene glucoside and emodin in efficient hair auxin were determined by high performance liquid chromatography（HPLC）. According to the continuous production of 15 batches of product measurement results,establish on HPLC method for determination of psoralen,isopsoralen,stilbene glucoside and rhubarb. RESULTS The 15 batches of the test products were yellowish brown clear solution,Molish reaction were positive. The HPLC method could well determinate psoralen,isopsoralen,stilbene glucoside and emodin in the range of 0.50-8.00 μg·mL^-1,the linear relationship between each control was good,and R was more than 0.999. RSD was less than 3. 0% for six repeatable detection,showed that the method had enough reproducibility. And the adding standard recoveries were between 90.0% and 110%,which indicated that the quantitative analysis was feasible. CONCLUSION The method is sensitive,accurate and reliable for the quality standard of efficient hair auxin,which can be well evaluate the stability of the hospital preparation process to insure its safety and efficacy.
出处
《今日药学》
CAS
2018年第1期14-17,22,共5页
Pharmacy Today
