脂必泰胶囊溶出度测定的方法研究

施磊; 叶隽; 宋磊

doi:10.3969/j.issn.1006-0111.2019.02.014

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脂必泰胶囊溶出度测定的方法研究

施磊, 叶隽, 宋磊

文章导航 > 药学实践与服务 > 2019 > 37(2): 170-172,187

施磊, 叶隽, 宋磊. 脂必泰胶囊溶出度测定的方法研究[J]. 药学实践与服务, 2019, 37(2): 170-172,187. doi: 10.3969/j.issn.1006-0111.2019.02.014

引用本文:

施磊, 叶隽, 宋磊. 脂必泰胶囊溶出度测定的方法研究[J]. 药学实践与服务, 2019, 37(2): 170-172,187. doi: 10.3969/j.issn.1006-0111.2019.02.014

SHI Lei, YE Jun, SONG Lei. Study on the dissolution determination of Zhibitai capsules[J]. Journal of Pharmaceutical Practice and Service, 2019, 37(2): 170-172,187. doi: 10.3969/j.issn.1006-0111.2019.02.014

Citation:

SHI Lei, YE Jun, SONG Lei. Study on the dissolution determination of Zhibitai capsules[J]. Journal of Pharmaceutical Practice and Service, 2019, 37(2): 170-172,187. doi: 10.3969/j.issn.1006-0111.2019.02.014

脂必泰胶囊溶出度测定的方法研究

doi: 10.3969/j.issn.1006-0111.2019.02.014

施磊¹,
叶隽¹,
宋磊^2,

1.
上海市静安区食品药品检验所, 上海 200435
2.
上海市交通大学医学院附属同仁医院, 上海 200050

Study on the dissolution determination of Zhibitai capsules

SHI Lei¹,
YE Jun¹,
SONG Lei^2
,

1.
Shanghai Jingan Institute for Food and Drug Control, Shanghai 200435, China
2.
Tongren Hospital Affiliated to School of Medical, Shanghai Jiaotong University, Shanghai 200050, China

摘要: 目的建立脂必泰胶囊溶出度的测定方法。方法采用ZABAX-C₁₈色谱柱（250 mm×4.6 mm，5 μm），甲醇-0.05%磷酸（80：20）为流动相；流速1.0 ml/min；检测波长238 nm。按《中华人民共和国药典》2015年版四部溶出度测定第三法（小杯法），采用SOTAX AT7智能药物溶出仪，通过对溶出介质、转速和取样时间的优化选择，确定脂必泰胶囊中红曲的有效成分洛伐他汀溶出度测定方法。结果本研究建立的色谱条件，专属性良好。洛伐他汀的线性范围1.63~122.2 μg/ml （r=1.000 0）。样品的溶出度均一性良好，以含1.0%十二烷基硫酸钠的磷酸盐溶液（pH 7.0）为溶出介质，取样时间为45 min，转速为100 r/min。溶出度均不低于80%。结论本研究建立的方法可用于脂必泰胶囊溶出度的测定，能有效控制药品的质量，为提高脂必泰胶囊质量标准提供依据。
- 脂必泰胶囊 /
- 洛伐他汀 /
- 溶出度 /
- 色谱法 /
- 高效液相
Abstract: Objective To develop a method for the determination of the dissolution of Zhibitai capsules. Methods The chromatographic analysis was carried out on a ZABAX-C₁₈column(250 mm×4.6 mm,5 μm)with methanol-0.05% phosphate solution(60∶40) as mobile phase.The flow rate was 1.0 ml/min and the detection wavelength was 238 nm.According to the third dissolution method (small glass-method) described in the Pharmacopoeia of the People's Republic of China (2015Edition,Volume 4),the dissolution determination conditions were established using SOTAX AT7 intelligent drug dissolution instrument,and dissolution medium,rotational speed and sampling time were selected. Results The method showed perfect specificity under the established chromatographic conditions.The linear ranges of lovastatin was 1.63-122.2 μg/ml(r=1.000 0).The dissolution rates of the samples were consistent.The 1.0% sodium dodecyl sulfate in phosphate solution (pH 7.0) was selected as release media,rotational speed was 100 r/min,the sampling time point was 45 min.The dissolution limit was not less than 80% of the labeled amount. Conclusion The established method could be used for the dissolution determination and the quality control,and provide reference for the improvement of quality standards of Zhibitai capsules.
- Zhibitai capsules /
- lovastatin /
- dissolution /
- chromatography /
- high performance liquid

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脂必泰胶囊溶出度测定的方法研究

doi: 10.3969/j.issn.1006-0111.2019.02.014

1. 上海市静安区食品药品检验所, 上海 200435

2. 上海市交通大学医学院附属同仁医院, 上海 200050

收稿日期: 2018-06-02
修回日期: 2018-11-12

关键词:

脂必泰胶囊 /

洛伐他汀 /

溶出度 /

色谱法 /

高效液相

摘要: 目的建立脂必泰胶囊溶出度的测定方法。方法采用ZABAX-C₁₈色谱柱（250 mm×4.6 mm，5 μm），甲醇-0.05%磷酸（80：20）为流动相；流速1.0 ml/min；检测波长238 nm。按《中华人民共和国药典》2015年版四部溶出度测定第三法（小杯法），采用SOTAX AT7智能药物溶出仪，通过对溶出介质、转速和取样时间的优化选择，确定脂必泰胶囊中红曲的有效成分洛伐他汀溶出度测定方法。结果本研究建立的色谱条件，专属性良好。洛伐他汀的线性范围1.63~122.2 μg/ml （r=1.000 0）。样品的溶出度均一性良好，以含1.0%十二烷基硫酸钠的磷酸盐溶液（pH 7.0）为溶出介质，取样时间为45 min，转速为100 r/min。溶出度均不低于80%。结论本研究建立的方法可用于脂必泰胶囊溶出度的测定，能有效控制药品的质量，为提高脂必泰胶囊质量标准提供依据。

English Abstract

Study on the dissolution determination of Zhibitai capsules

1. Shanghai Jingan Institute for Food and Drug Control, Shanghai 200435, China

2. Tongren Hospital Affiliated to School of Medical, Shanghai Jiaotong University, Shanghai 200050, China

Received Date: 2018-06-02
Rev Recd Date: 2018-11-12

Keywords:

Abstract: Objective To develop a method for the determination of the dissolution of Zhibitai capsules. Methods The chromatographic analysis was carried out on a ZABAX-C₁₈column(250 mm×4.6 mm,5 μm)with methanol-0.05% phosphate solution(60∶40) as mobile phase.The flow rate was 1.0 ml/min and the detection wavelength was 238 nm.According to the third dissolution method (small glass-method) described in the Pharmacopoeia of the People's Republic of China (2015Edition,Volume 4),the dissolution determination conditions were established using SOTAX AT7 intelligent drug dissolution instrument,and dissolution medium,rotational speed and sampling time were selected. Results The method showed perfect specificity under the established chromatographic conditions.The linear ranges of lovastatin was 1.63-122.2 μg/ml(r=1.000 0).The dissolution rates of the samples were consistent.The 1.0% sodium dodecyl sulfate in phosphate solution (pH 7.0) was selected as release media,rotational speed was 100 r/min,the sampling time point was 45 min.The dissolution limit was not less than 80% of the labeled amount. Conclusion The established method could be used for the dissolution determination and the quality control,and provide reference for the improvement of quality standards of Zhibitai capsules.

施磊, 叶隽, 宋磊. 脂必泰胶囊溶出度测定的方法研究[J]. 药学实践与服务, 2019, 37(2): 170-172,187. doi: 10.3969/j.issn.1006-0111.2019.02.014

引用本文:

施磊, 叶隽, 宋磊. 脂必泰胶囊溶出度测定的方法研究[J]. 药学实践与服务, 2019, 37(2): 170-172,187. doi: 10.3969/j.issn.1006-0111.2019.02.014

Citation: