Tropical Journal of Pharmaceutical Research

Original Research Article | OPEN ACCESS

Stability and drug dissolution evaluation of Qingkailing soft/hard capsules based on multi-component quantification and fingerprint pattern statistical analysis

Ruyu Sun, Huihui Teng, Xiaonan Chen, Shuang Guo, Shan Jia, Mengcheng Zheng, Yang Lu, Jie Bai, Pengyue Li , Shouying Du

School of Chinese Materia Medica, Beijing University of Chinese Medicine, Beijing 100102, China;

For correspondence:- Pengyue Li Email: dushouying@263.net Tel:+861084738615

Accepted: 28 August 2017 Published: 30 September 2017

Citation: Sun R, Teng H, Chen X, Guo S, Jia S, Zheng M, et al. Stability and drug dissolution evaluation of Qingkailing soft/hard capsules based on multi-component quantification and fingerprint pattern statistical analysis. Trop J Pharm Res 2017; 16(9):2069-2077 doi: 10.4314/tjpr.v16i9.5

© 2017 The authors.
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Abstract

Purpose: To carry out a post-marketing evaluation of the stability and drug dissolution of Qingkailing soft/hard capsules.

Methods: High performance liquid chromatography with diode array detection (HPLC-DAD) method was developed for the determination of three key ingredients (chlorogenic acid, geniposide and baicalin) and fingerprints of QKL soft/hard capsules. Stability tests were carried out based on long-term testing. The drug release profile of Qingkailing soft and hard capsules were studied using semi-bionic incubation experiments.

Results: The linearity, precision, stability, repeatability and recovery of HPLC and fingerprint all met the requirements of CFDA. Stability data from long-term studies showed that within 6 months the contents of the three key ingredients in both soft and hard capsules remained > 90 %. However, fingerprint pattern statistical analysis showed that the soft capsule is more stable than the hard capsule. Furthermore, the key ingredients of the hard capsule dissolved much faster (p < 0.05) than from the soft capsule. The level of dissolved drug of hard capsule is about 4 times the rate of soft capsule, after a 4-h incubation in gastric lavage fluid. In intestinal lavage fluid, more than 90 % of chlorogenic acid, geniposide and baicalin of hard capsule were dissolved in 2 h, while the soft capsule displayed a 12 h sustained release. Fingerprint pattern statistical analysis also showed that most of the components of soft capsule dissolved after 8 h.

Conclusion: Compared with the hard capsule, Qingkailing soft capsule has certain advantages in stability and drug dissolution, which may affect the biopharmaceutics and the clinical effects of the drug.

Keywords: Qingkailing capsule, Chlorogenic acid, Geniposide, Baicalin, Fingerprint, Sustained release, Principal component analysis