Optimization and evaluation of Xiaoer Pudilan Xiaoyan Syrup based on characterization of material properties.
10.19540/j.cnki.cjcmm.20220609.302
- Author:
Xuan LI
1
;
Ke DING
1
;
Dang YANG
1
;
Meng-Hua JIANG
1
;
Chao LI
2
;
Fa-Gen ZHU
2
;
Jian-Guo SHAO
2
;
E SUN
1
;
Liang FENG
3
;
Xiao-Bin JIA
3
Author Information
1. Affiliated Hospital of Integrated Traditional Chinese and Western Medicine, Nanjing University of Chinese Medicine Nanjing 210028, China.
2. Jiangsu Key Laboratory of Chinese Medicine and Characteristic Preparations for Pediatrics,Jumpcan Pharmaceutical Co., Ltd. Taixing 225400, China.
3. School of Traditional Chinese Pharmacy, China Pharmaceutical University Nanjing 211198, China.
- Publication Type:Journal Article
- Keywords:
Xiaoer Pudilan Xiaoyan Syrup;
characterization of material properties;
dosage form optimization;
effectiveness;
pharmacokinetics;
taste
- MeSH:
Child;
Humans;
Drugs, Chinese Herbal;
Glucuronates
- From:
China Journal of Chinese Materia Medica
2022;47(21):5746-5756
- CountryChina
- Language:Chinese
-
Abstract:
According to the taste analysis of Pudilan Xiaoyan Oral Liquid, the unpleasant taste of the oral liquid is mainly caused by the inherent taste of Chinese medicine and the taste introduced in the preparation process, which leads to its unpopularity among children. Therefore, aiming at the special children patient group, Xiaoer Pudilan Xiaoyan Syrup was developed via technology optimization and dosage form improvement to improve the unpleasant taste and enhance the medication compliance among children. Based on the material properties of Pudilan Xiaoyan Oral Liquid and Xiaoer Pudilan Xiaoyan Syrup extracts, the authors compared the properties(pH, density, turbidity, viscosity, chromaticity, particle size), taste, content of five quality markers and in vivo pharmacokinetic characteristics of these two preparations, to evaluate the suitability of Xiaoer Pudilan Xiaoyan Syrup. The results showed that compared with those of Pudilan Xiaoyan Oral Liquid, the pH, density, turbidity, viscosity and chromaticity of Xiaoer Pudilan Xiaoyan Syrup were significantly changed, and the unpleasant taste was reduced by 26%; the transfer rate of the main active ingredients chicoric acid was increased, while the transfer rate of baicalin had small difference from that of the oral liquid. In addition, pharmacokinetics revealed that the total absorption amount of baicalin in vivo was higher, and the time to peak T_(max) of baicalin and oroxindin in the syrup and the mean residence time MRT_(last )of corynoline in vivo were significantly prolonged. The absorption degree of Xiaoer Pudilan Xiaoyan Syrup and Pudilan Xiaoyan Oral Liquid in the body was the same: baicalin>oroxindin>corynoline. The new dosage form process was simpler than that of the original dosage form, safe, environmentally friendly, reasonable and feasible, meeting the mass production demand. This provided a basis for the reasonable and scientific optimization of Xiaoer Pudilan Xiaoyan Syrup, and also laid a foundation for its further safe and rational use, so as to expand the clinical application in children.
