| 摘要: |
| 目的:制备过敏洗剂并研究制定其质量标准。方法:依据《中国药典》2015 年版第四部通则中“洗剂冶项下的要求制备过敏洗剂,对起草的质量标准中的pH、装量和微生物限度进行检查,采用高效液相色谱(HPLC) 法分别对洗剂中金银花、防风、甘草进行鉴别,对指标成分绿原酸、升麻素苷、5鄄O鄄甲基维斯阿米醇苷、甘草酸进行含量测定,并对含量测定方法进行方法学验证。结果:过敏洗剂的性状、pH、装量和微生物限度符合规定。在样品HPLC 色谱图中有金银花、防风、甘草的指标成分绿原酸、升麻
素苷、5-O-甲基维斯阿米醇苷、甘草酸的色谱峰,并与该4 种成分的对照品色谱峰保留时间一致;4 种成分与相邻色谱峰完全分离。4 种成分的进样量与峰面积呈良好的线性关系,线性方程分别为绿原酸:Y =30.787X+0.077 3(r =0.999 8,进样量0.203 ~4.064 µg);升麻素苷:Y =45.097X+0.088 9(r =0.999 8,进样量0.072 ~1.440 µg);5-O-甲基维斯阿米醇苷:Y =43.025X+0.021(r =0.999 8,进样量0.022 ~0.440 µg);甘草酸:Y =11.066X+0.007(r =0.999 8,进样量0.039 ~0.778 µg)。结论:过敏洗剂的
制备工艺简单,本研究制定的质量标准能有效控制制剂的质量,鉴别和含量测定方法简便,重复性好。 |
| 关键词: 过敏洗剂 高效液相色谱 定性鉴别 含量测定 质量标准 |
| DOI：10.13407/j.cnki.jpp.1672-108X.2019.11.015 |
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| 基金项目: |
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| Preparation and Quality Standard of Allergy Lotion |
| Cai Yiran1 , Liang Jing2 , Huang Liangyong1 |
| (1.Taihe Hospital of Shiyan, Hubei Shiyan 442000, China; 2. Hubei University of Medicine, Hubei Shiyan 442000, China) |
| Abstract: |
| Objective: To prepare allergy lotion and formulate the quality standard. Methods: According to the requirements under the lotion from the fourth general principles of 2015 edition of the Chinese Pharmacopoeia, allergy lotion was prepared. pH, loading and microbial limits in drafted quality standards were examined. High performance liquid chromatography (HPLC) was used to identify honeysuckle, saposhnicovia divaricata and liquorice in the lotion. The contents of chlorogenic acid, cohosine glycoside, 5-O-methylvisamitol and glycyrrhizin were determined, and the content determination method was validated by methodology. Results: The characteristics, pH, loading and microbial limits of allergy lotion were in accordance with the regulations. The chromatographic peaks of the indicators of chlorogenic acid, cohosine glycoside, 5-O-methylvisamitol and glycyrrhizic acid in honeysuckle, saposhnicovia divaricata and liquorice were found in the HPLC chromatogram of the sample, and the retention time of the chromatographic peaks of the four components was consistent with that of the control substances. Four studied ingredients were completely separated from the adjacent peaks, and showed a good linearity between sample size and integral area. The linear equations were as follows, chlorogenic acid: Y =30.787X+0.077,3 (r =0.999,8, sample size 0.203 ~4.064 µg), cohosine glycoside: Y =45.097X+0.088,9 (r =0.999,8, sample size 0.072 ~1.440 µg), 5-O-methylvishisainin: Y =43.025X+0.021 (r =0.999,8, sample size 0.022 ~0.440 µg), glycyrrhizic acid:Y =11.066X+0.007 (r =0.999,8, sample size 0.039 ~ 0.780 µg). Conclusion: The preparation process of allergy lotion is simple,the quality standard established in this study can effectively control the quality of the preparation, and the identification and content determination methods are simple and reproducible. |
| Key words: allergy lotion high performance liquid chromatography qualitative identification content determination quality standard |
