Preparation And Quality Study Of Qingyaozhuanggu Cataplasm

Lumbar muscle strain is the chronic injury of the waist muscles, fascia, ligaments and other soft tissue. It is the most common diseases, also known as functional low back pain, chronic lumbar strain and so on. It is often referred to as Traditional Chinese Medicine Kidney pain in TCM. Repeatedly exercises and over-load working of waist can easily lead to the strain. Therefore, the disease is common in athletes, middle-aged and elderly, or people who has been long time engaged in office work. The disease seriously affects people's normal life and work. Qiangyaozhuanggu plaster has effective treatment for kidney deficiency, lumbar muscle strain, as well as the old soft tissue injury. But as rubber plaster, There are many shortcomings, such as strong adhesion, skin irritation and low drug loading.In this paper, using of hydrophilic polymer material as matrix material, Qingyao zhuanggu cataplasm were prepared, the hydrogel patch had a suitable viscosity, bio- compatibility, and nonallergenic characteristics. The main results are as follows:(1) After detecting the Chinese herbal medicines, extraction process of Chinese herbal medicines extract compound was determined by the ratio of extract and the content of Ginsenoside Rg1. In the optimal extraction process, the ratio of extract compound reached the rate of 28% ~ 32%(the relative density of 1.25 ~ 1.30 (80℃)).The content of Ginsenoside Rg1 is 2.215 mg·g-1 .(2) Qingyaozhuanggu cataplasms had been selected by orthogonal and formulation optimization experiment. The best formula of hydrophilic cataplasm matrix could included sodium polyacrylate(5%), cross-linking agent(0.3%), filler(2.0%), tackifier-1(2%), tackifier-2 (4%), tackifier-3 (0.5%), pH adjustment agent(0.1%), the regulation of crosslinking agent (0.02%), the excipients (2%) and moisture (30%).The prepared hydrogel patch had advantages of good moisture permeability and skin compatibility. Compared with the rubber plaster, the prepared hydrogel patch had no allergic phenomena.(3) According to 2005 Edition of Chinese Pharmacopoeia, Qingyaozhuanggu cataplasm's adhesion, paste content and shaped characteristic were inspected. The results indicated that the adhesiveness was moderate, and shaped property of the cataplasms was excellent. The ointment content of the cataplasm on 100 square centimeters was 8.58 g.(4) HPLC method (Hypersil BDS C18 column and UV-detector) was selected by determination of content determination. Supplementary material avoid interference. Ginsenoside Rg1 had a good linear relationship in the scope of 25.2～252.0μg·mL-1. It had high stability and good accuracy. The prepared hydrogel patch content uniformity.