The Development Of Schisandra Chinensis Dual Drug Release Capsules

Schisandra chinensis?Turcz.?Baill again called Bei Schisandra chinensis?Turcz.?Baill, is included in The 2015 edition pharmacopeia. Schisandra chinensis?Turcz.?Baill is choosed as the model drug in this subject, and used to develop one kind preparations which can release drug in double dose.The preparation is able to cure insomnia,and improve the quality of sleep that can be reduced by being asleep with difficulty and being awake during the sleep.This drug release system contains two layers that take medicine, the dose of the first released layer account for 70% of the total dose, and can be released completely in 30 minutes. Dose of the second layer account for 30% of the total dose, and can be release after 3 or 4 hours, and release drug completely in 1 hour. The patients can take once before going to sleep, the first released dose is able to releve symptoms of being asleep with difficulty; The second released layer can be used to improve the symptoms of being awake during sleep. This paper was carried on as follows:Study on extraction process of Schisandra chinensis?Turcz.?Baill, taking the total lignans in Schisandra chinensis?Turcz.?Baill as the effective parts, extract lignans from Schisandra chinensis?Turcz.?Baill with methods of refluxing extraction, extraction ratio as the indicator, on the basis of the single factor test, optimizing the best extraction process by means of Star design-response surface method. The best parameters are as follows:85%ethanol, time?50minutes?, ratio of material to liquid?1:10?.Study on purification process of Schisandra chinensis?Turcz.?Baill, macroporous adsorption resin was used to purify the extractive. Screening the kind of macroporous adsorption resin through atatic adsorption experiments, taking the adsorption rate and the elution rate as indicators, the single factor text was used to screen the most compatible parameters, finally, the best parameters are as follows:concentration of samples?1.5mg/mL?, speed(1BV�h^-1), maximal amount?6BV?, amount of water?5BV?, 5BV of 95%ethanol, rate(3BV�h^-1).Study on pre-prescription and quality control, inspect the angle of repose and hygroscopic of the intermediates. The mobility is benign, the CRH is 70.68%, establishing the method of content determination and determination of releasing degree.Study on forming process and quality standard, fluidied bed coating technology was taken to produce the double dosage-released micro pill, firstly, the first released layer, then the isolation layer, the controlled release layer, lastly, the second released layer and protective clothing layer. In the end, take proper micro pill into the empty capsule?No.2?. Qualitative identification and qualitative analysis were carried on through methods of thin-layer chromatography and ultraviolet visible scenery.