Research Of Jiechangan Enteric-coated Tablets

Jiechangan Enteric-coated Tablets is a kind of preparation composed of traditional Chinese Medicine (TCM). It is expericed from effective prescription of TCM after properly-disposed according to pharmacological results and clinical practices.The prescription is prepared by extracts from four kinds of TCM including Cortex phellodendri、Chinese bulbul、White atractylodes、Donnel、Roasted liquorice which are all recorded in the Chinese Pharmacopoeia.The pharmaceutical formulation of Jiechangan Enteric-coated Tablets is compounded with rationality and it is creatively used in the treatment of ulcerative colitis.The aim of this experiment is to study the preparation procedure and the quality control standards of Jiechangan Enteric-coated Tablets. Enteric-coated Tablets as the preparation tablet, we study the dissertation including preparation procedure, quality control standards and stability research. The results are as follows:(1)The extraction technology of Jiechangan Enteric-coated Tablets(1) The alcohol extraction technics was studied by testing the content of berberine hydrochloride and the rate of dry paste. The extraction time, the extraction times and the alcohol amount were selected as the investigating factors.The optimum preparation procedure was studied by orthogonal text and then the reasonable and available process conditions were established.(2) The water decocting method was studied by testing the content of paste. The water amount,the decoction time, the decoction times were chosen as the consideration factors and the optimum preparation technology was studied by orthogonal text so as to establish the reasonable and available process conditions.(2)The molding preparation procedure of Shenhua fukang capsuleThe kinds of accessories, the dosage of the accessories and other adjuvants of the Jiechangan Enteric-coated Tablets were studied in detail and then optimum preparation modeling technique was established.(3) The quality standards studyCortex phellodendri、Chinese bulbul、White atractylodes、Donnell、Roasted liquorice were identified by TLC. The results showed that the spots on the chromatograms were reproducibility,clear,characteristic withing no interference by negative materials. The methods are considerable to control the standards of Jiechanaan Enteric-coated Tablets. The content of berberine hydrochloride was determined by HPLC. The results showed that the linearity, stability, precision, reproducibility and recovery were all satisfactory. The total content limits was regulated:the total content of berberine hydrochloride was no less than1.8mg per tablet.(4) The stability researchWe studied the preparation appearance, the distinction, the load difference, the disintegration time limit, the content and the microorganism limit items by using the normal temperature test. The normal temperature test is tested for3months. The results not obviously changed, showing the stability of the tablet was good.(5) acute toxicity testThe result of Jiechangan Enteric-coated Tablets showed the Foam was safe.The results suggested that the preparation procedure of Jiechangan Enteric-coated Tablets was reasonable in technics, good in stability and controllable in quality.