Metabolism Analysis

Study on the optimum range of chuanwu gel patch initial tack, peeling degree and suitable drug loading

Expand
  • 1. Sinopharm Group Pharmaceutical Co., Ltd., Beijing 100077, China;
    2. Research and Experimental Center of Yunnan University of Traditional Chinese Medicine, Kunming 650500, China

Received date: 2020-02-17

  Online published: 2024-05-31

Abstract

Objective: To analyze the optimum range of initial adhesive force, stripping degree and suitable drug loading of Sichuan Wu gel patch. Methods: Eight kinds of gel patch from different manufacturers and grades of quality were randomLy selected for quality reevaluation from four aspects: perception, initial adhesion, adhesion and peel. Single factor experiment and mixing the material design experiment was conducted to screen the base 240 mg, 480 mg and 960 mg were prepared respectively;48 Kunming clean-grade mice were used as the research subjects were randomLy divided into 6 groups, 8 in each group, and were given blank gel patch(model group), indomethacin gel patch(positive group)and 120 mg(experiment A)and 240 mg(experiment B)Group), 480 mg (experiment C), 960 mg(experiment D) of Chuanwu gel patch, and the optimal dose of Chuanwu was evaluated by the mouse acetic acid writhing experiment. Results: The re-evaluation of the quality of the gel patch of the eight brands was quite different. Overall, the greater the initial adhesion, the holding force and the peeling degree, the worse the sensory evaluation of the gel patch;according to the test results, the optimal formula of the gel patch is: sodium polyacrylate 3%, sodium carboxymethyl cellulose 1. 5%, diatomaceous earth 4%, glycerin 25%. It could be seen from the mouse acetic acid writhing experiment that when the drug loading of each chuanwu gel patch was 480 mg and 960 mg, the shorter the incubation period of the mouse writhing, the smaller the number of writhing, the higher the analgesic rate, taking into account safety and other factors, it was believed that Chuanwu gel patch with a drug loading of 480 mg was more suitable for clinical application. Conclusion: The preparation of Chuanwu gel patch should not only ensure its analgesic and anti-inflammatory effects, but also give full consideration to its appearance, follow-up, placardability, safety and other characteristics, and control its initial adhesion, peeling degree, and drug loading within an appropriate range to promote its efficient and reasonable application in the clinic.

Cite this article

CHANG Tao, YAO Xue-zhou . Study on the optimum range of chuanwu gel patch initial tack, peeling degree and suitable drug loading[J]. Chinese Journal of Pharmaceutical Analysis, 2021 , 41(3) : 452 -459 . DOI: 10.16155/j.0254-1793.2021.03.10

References

[1] 杜婕莹, 曾森, 王璐, 等. 聚异丁烯骨通贴膏经皮肤给药的安全性研究[J]. 中国药房, 2016, 27(25): 3512.
DU JY, ZENG S, WANG L, et al. Study on the safety of polyisobutylene gutong plaster administered through the skin[J]. China Pharm, 2016, 27(25): 3512
[2] MARWAH H, GARG T, GOYAL AK, et al. Permeation enhancer strategies in transdermal drug delivery[J]. Drug Deliv, 2016, 23(1/3): 5466
[3] 韩霜, 冯松浩, 马旭伟, 等. 中药凝胶贴膏剂的研究进展及在产品开发中的应用[J]. 中草药, 2018, 49(21): 5197252.
HAN S, FENG SH, MA XW, et al. Research progress of traditional Chinese medicine gel plaster and its application in product development[J]. Chin Tradit Herb Drugs, 2018, 49(21): 5197252
[4] 金锐, 王宇光, 张冰. 含乌头碱中成药临床安全用药风险评估量表的构建与验证[J]. 中国中药杂志, 2018, 43(2): 222
JIN R, WANG YG, ZHANG B. Construction and verification of risk assessment scale for clinical safe use of Chinese patent medicines containing aconitine[J]. China J Chin Mater Med, 2018, 43(2): 222
[5] 吴璐, 吴维刚, 江亭, 等. 制川乌凝胶膏剂基质处方处化及体外释放研究[J]. 中国药房, 2018, 29(1): 37
WU L, WU WG, JIANG T, et al. Study on preparation and in vitro release of Chuanwu gel ointment matrix formulation[J]. China Pharm, 2018, 29(1): 37
[6] 范彬, 石晓峰, 蔺莉, 等. 祖师麻凝胶膏剂基质处方的优化[J]. 中成药, 2016, 38(7): 1632-1636.
FAN B, SHI XF, LIN L, et al. Optimization of the matrix prescription of Zushima gel ointment[J]. Chin Tradit Pat Med, 2016, 38(7): 1632
[7] 耿仲乐, 张春光. 对中国药典2015 年版贴膏剂中关于橡胶贴膏黏附力检验标准的探讨[J]. 中国药品标准, 2019, 20(1): 13
GENG ZL, ZHANG CG. Discussion on the adhesive force inspection standard of rubber plaster in Chinese Pharmacopoeia 2015 edition plaster[J]. Drug Stand China, 2019, 20(1): 13
[8] 蔡鹰, 陆瑜, 龚琳, 等. 复方大黄烫伤喷膜的制备工艺优选[J]. 时珍国医国药, 2016, 27(8): 1899
CAI Y, LU Y, GONG L, et al. Optimization of preparation process of compound rhubarb scald spray film[J]. Lishizhen Med Mater Med Res, 2016, 27(8): 1899
[9] 彭成, 郭力. 川乌提取物及其制备方法: 中国, CN200510021706. 7[P]. 2005-09-12.
PENG C, GUO L. Chuanwu extract and its preparation method: China, CN200510021706. 7[P]. 2005-09-12.
[10] 余成浩, 彭成, 余葱葱, 等. 制川乌与白芍不同配伍比例对总生物碱含量的影响[J]. 时珍国医国药, 2008, 19(1): 1
YU CH, PENG C, YU CC, et al. The effect of different compatibility ratios of Radix Aconiti and Radix Paeoniae on the content of total alkaloids[J]. Lishizhen Med Mater Med Res, 2008, 19(1): 1
[11] 许润春, 贺亚男, 裴瑾, 等. 川乌-花椒挥发油凝胶贴膏的成型工艺及配伍增效机制研究[J]. 中草药, 2020, 51(6): 1517
XU RC, HE YN, PEI J, et al. Study on the molding process and compatibility and synergistic mechanism of Chuanwu-Zanthoxylum bungeanum volatile oil gel plaster[J]. Chin Tradit Herb Drugs, 2020, 51(6): 1517
[12] 葛月宾. 艾叶油乳-水凝胶贴膏剂的制备与透皮研究[J]. 中草药, 2015, 46(24): 3661
GE YB. Preparation and transdermal study of Aiye oil emulsionhydrogel plaster[J]. Chin Tradit Herb Drugs, 2015, 46(24): 3661
[13] 王荣雪, 周蕾, 李佳, 等. 草酸艾司西酞普兰凝胶贴膏的制备及经皮透过性考察[J]. 沈阳药科大学学报, 2018, 35(1): 1, 12
WANG RX, ZHOU L, LI J, et al. Preparation of escitalopram oxalate gel plaster and its transdermal permeability[J]. J Shenyang Pharm Univ, 2018, 35(1): 1, 12
[14] 杨正明, 威则日沙, 李学学, 等. 基于多元统计分析的川产道地药材江油附子和川乌中6 种生物碱含量比较研究[J]. 中草药, 2019, 50(6): 1461
YANG ZM, WEIZRS, LI XX, et al. Comparative study on the content of 6 alkaloids in Sichuan-produced authentic medicinal materials Jiangyou Aconite and Sichuan Aconitum based on multivariate statistical analysis[J]. Chin Tradit Herb Drugs, 2019, 50(6): 1461
[15] SUNEETHA CK, UMA RB, KIRANMAI M, et al. Formulation and evaluation of transdermal drug delivery of topiramate[J]. Int J Pharm Invest, 2017, 7(1): 10
[16] 苏菊, 吴朝花, 姜丰, 等. 丹皮酚自微乳经皮给药系统的处方优选及药剂学性质评价[J]. 中国实验方剂学杂志, 2017, 23(17): 11-16.
SU J, WU CH, JIANG F, et al. Prescription optimization and evaluation of pharmacological properties of paeonol selfmicroemulsion transdermal drug delivery system[J]. Chin J Exper Tradit Med Form, 2017, 23(17): 11
[17] 杨华生, 闻丽珍, 黎晓丽, 等. 基于经皮给药研究制川乌与白芍配伍对大鼠皮肤及肝微粒体中CYP450 活性的影响[J]. 中国医院药学杂志, 2018, 38(1): 5
YANG HS, WEN LZ, LI XL, et al. The effect of the compatibility of Radix Aconiti and Radix Paeoniae Alba on CYP450 activity in rat skin and liver microsomes based on percutaneous administration research[J]. Chin J Hosp Pharm, 2018, 38(1): 5
[18] 谭丽霞, 杨华生, 闻丽珍, 等. 白芍配伍制川乌对芍药苷组织分布的影响及制川乌“引经”作用探讨[J]. 中国医院药学杂志, 2018, 38(21): 2204
TAN LX, YANG HS, WEN LZ, et al. The influence of Radix Paeoniae Radix Compatible with Radix Aconitum on the tissue distribution of paeoniflorin and the effect of“ introducing the classics” of Radix Aconitum Radix[J]. Chin J Hosp Pharm, 2018, 38(21): 2204
Outlines

/