更新于：2024-11-01
Xiaoer douqiao Qingre Syrup
小儿豉翘清热糖浆
更新于：2024-11-01
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基本信息
原研机构 |
在研机构 |
非在研机构- |
最高研发阶段批准上市 |
首次获批日期 中国 (2023-11-17), |
最高研发阶段(中国)批准上市 |
特殊审评- |
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关联
2
项与 小儿豉翘清热糖浆 相关的临床试验Efficacy and safety of Xiao'er Chiqiao Qingre Syrup in treating pedo-anemopyretic cold in children with stagnant syndrome: a randomized, double-blind, double-simulation, original dosage form parallel-controlled, multicenter study
小儿豉翘清热糖浆治疗小儿风热感冒夹滞证评价有效性安全性随机、双盲双模拟、原剂型平行对照、多中心研究
100 项与 小儿豉翘清热糖浆 相关的临床结果
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100 项与 小儿豉翘清热糖浆 相关的转化医学
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100 项与 小儿豉翘清热糖浆 相关的专利（医药）
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1
项与 小儿豉翘清热糖浆 相关的文献（医药）2022-11-01Zhongguo Zhong yao za zhi = Zhongguo zhongyao zazhi = China journal of Chinese materia medica
[Optimization and evaluation of Xiaoer Pudilan Xiaoyan Syrup based on characterization of material properties].
Article
作者: Zhu, Fa-Gen ; Jia, Xiao-Bin ; Ding, Ke ; Jiang, Meng-Hua ; Shao, Jian-Guo ; Yang, Dang ; Li, Chao ; Sun, E ; Feng, Liang ; Li, Xuan
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.
100 项与 小儿豉翘清热糖浆 相关的药物交易
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 普通感冒 | 中国 | 2023-11-17 |
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