Pharmaceutical Research Of SJCS Capsule

Irritable bowel symdrome which is a common digestive diseases causes great inconvenience to the patients in their daily lives.Western medicine has no clear efficacy to it. Traditional Chinese medicine has the exact effect to it, but at the same time there has some problems, such as less traditional Chinese medicine, uneven efficacy. It is urgent to develop the good efficacy specific for patients to select.SJCS capsule is composed of dried orange peel, elecampane, root of herbaceous peony, fumitory, bitter orange and so on. The function is arylating and amusing spleen, regulating liver and intestine, regulating the flow of Qi and spasmolysis. It is used for irritable bowel syndrome. Who have instant abdominal pain, more pain then diarrhea then pain relief and gloomy tongue and thin white greasy coating of tongue and smooth vein. According to clinical needs, characteristic of medicine and daily drug dose. It processes into capsule. Regard the drug registration as criterion. The subject studies the pre-clinical pharmaceutical part of the capsule.Design process plan. Adopt orthogonal test. Select the multiple indicator assessment. Determine the process and parameters as follow:Crash41.7g fumitory into a fine powder. Sieve and set aside. Dried orange peel, elecampane and bitter orange extract the volatile oil and then it is included by β-cyclodextrin for use. Liquid is stored in another device for use. Residue extract1hour. Filtration and the filtrate merge the previous liquid. Root of herbaceous peony and the other half of fumitory extract1.5hours for3times. Filtration and the filtrate merge the previous liquid. Concentrate to the relative density of1.15-1.20(60℃). Mix fumitory powder and dry (60℃) and crash into powder. Add superfine silica gel powder and B-cyclodextrin of volatile oil. Mix and Pelletization, dry and into capsule. Made1000capsules. The process routes are stable and viable by the three batches of test to prove.In the guiding principles, it mainly researches thin layer chromatography to check and high performance liquid chromatography to determine contents. Research checks all of the herbs. Electdried orange peel, bitter orange, elecampane, fumitory as thin layer chromatographystandards. Adopt high performance liquid chromatography to determine hesperidin and naringin contents of dried orange peel and bitter orange, then conduct relative researches, tentatively decided to hesperidin and naringin contents are not less than4.3mg. Made into standard. Conduct long-term steady researches.Above indicate: SJCS capsule’s process is steady and viable. Guiding priciples are controllable. SJCS capsule’s quality is steady.