Dissolution test and evaluation of Guizhi Fuling Capsules.
10.19540/j.cnki.cjcmm.20220127.301
- Author:
Zhao-Bo HUANG
1
;
Long WANG
1
;
Yao KANG
1
;
Tuan-Jie WANG
2
;
Zhen-Zhong WANG
2
;
Hong-da ZHANG
2
;
Gang BAI
3
;
Zheng LI
1
;
Wen-Long LI
1
Author Information
1. College of Pharmaceutical Engineering of Traditional Chinese Medicine, Tianjin University of Traditional Chinese Medicine Tianjin 300193, China.
2. Jiangsu Kanion Pharmaceutical Co., Ltd. Lianyungang 222001, China State Key Laboratory of New-tech for Chinese Medicine Pharmaceutical Process Lianyungang 222001, China.
3. College of Pharmacy, Nankai University Tianjin 300071, China.
- Publication Type:Journal Article
- Keywords:
Guizhi Fuling Capsules;
dissolution behavior;
quality consistency between batches;
quality control
- MeSH:
Capsules;
Wolfiporia;
Solubility;
Hydrochloric Acid;
Drugs, Chinese Herbal/chemistry*;
Chromatography, High Pressure Liquid
- From:
China Journal of Chinese Materia Medica
2022;47(19):5256-5263
- CountryChina
- Language:Chinese
-
Abstract:
Because of the complex components, simple content determination can hardly reflect the overall quality of Guizhi Fuling Capsules. Therefore, it is necessary to carry out a multi-component dissolution test. The variability of quality among different batches of products from different manufacturers is a common problem of Chinese medicine solid preparations. To comprehensively control the quality of Guizhi Fuling Capsules, we studied the dissolution behaviors of 7 index components in the capsules under different conditions, and investigated the consistency of dissolution behaviors among different batches of products from the same manufacturer. The basket method of general rule 0931 in Chinese Pharmacopoeia was adopted, and the rotating speeds were set at 50, 75, and 100 r·min~(-1), respectively. The hydrochloric acid solution(pH 1.2), acetate buffer solution(pH 4.0), pure water, and phosphate buffer solution(pH 6.8) were used as the dissolution media. Automatic sampling was carried out at the time points of 5, 10, 20, 30, 45, and 60 min, respectively. The cumulative dissolution of 7 index components was measured through ultra-performance liquid chromatography(UPLC). The difference factor f_1 and similarity factor f_2 were calculated to comprehensively evaluate the similarity of the dissolution curves among 8 batches of Guizhi Fuling Capsules, and a variety of dissolution and release equations were fitted. The results showed that multiple components had faster dissolution rates at higher rotating speed and in hydrochloric acid medium. The 8 batches of Guizhi Fuling capsules showed the average f_1 value lower than 15 and the average f_2 value higher than 50, which indicated that different batches of products had similar dissolution behaviors. Most components had synchronous dissolution behaviors and similar release cha-racteristics. This study provides a reference for the quality consistency evaluation among batches, processing optimization, and dosage form improvement of Guizhi Fuling Capsules.
