The Research On Chansu Transdermal

The Chansu of traditional Chinese medicine is used in clinical analgesic and anti-cancer, especially in the clinical treatment of cancer pain, with the advantages of quick, lasting efficacy, and lower toxicity for external use. In order to alleviate cancer patients (especially advanced cancer), be more convenient for patients in the cancer pain medication, and improve patient safety and medication compliance, the subjects developed Chansu transdermal patch.In the extraction process, according to Chansu active ingredients of Cinobufagin and Resibufogenin can be dissolved in ethanol, we set the content of Cinobufagin and Resibufogenin, and extract rate as the index base. Using L9(34) orthogonal experiment invisgaties the amount of ethanol, ethanol concentration, extraction time and extraction times on extraction results. The best extraction:Add 95% ethanol extract 3 times,24 times the first volume of extraction plus 20 minutes, plus 18 times the amount of the second extraction for 20 minutes, plus 18 times the third volume of extract for 20 minutes.In the preparation process technology, first we set initial adhesion and the malleability of backfill paste as the index base. Using L9 (34) orthogonal test to invistigate the Chansu transdermal system he matrix effect on the molding process. The results showed that best ratio of the matrix:glycerol-propanediol (2:1):PVP-PVA (3:1):CMC-Na:acrylic PSA ratio was 0.3:0.3:1:2. And adhesion and release are examined, results showed that the obtained by this method of transdermal patch results are consistent with the relevant requirements.In the vitro skin penetration test, using modified Franz device for transdermal in vitro percutaneous absorption of toad venom to mice abdominal skin as skin tested and 20% saline solution as a recipient of penetration enhancers were screened. The results show that:the content of 5% Azone Chinese toad poison when the fat toad toxin ligand and ligand in vitro transdermal best.In the quality standard, the use of TLC method preparation Chansu was exclusive identification, according to the 2005 version of Chinese Pharmacopoeia 2 AppendixⅣpatch under the requirements of the preparations for the adhesion and release checks, using HPLC method based on the preparation of Cinobufagin and Resibufogenin for the methodology was evaluated.In preparation stability study, a preliminary examination of the stability of preparations, the results show good stability of the preparation within three months.In the pharmacodynamics and toxicology studies, the results indicate that the agent has clinical value and feasibility of further development.