Gold Jujube Polygala Capsule Preparation Technology And Quality Standards Of Research

The JinZaoYuanZhi capsule originates from clinical experience prescription, it’s made from six traditional Chinese medicines including herba hyperici perforati, white peony root, milkwort, coptis chinensis, spine date seed, schisandra chinensis, and has effects of dredging liver and relieving melancholy, cutting down fire and clearing phlegm, relieving uneasiness of mind and body tranquilization, and can be used for curing anxiety disorder. The original description is decoction, has been used in clinical for many years, the effect is excellent. However, it has the advantages of medicament method not advanced, big taking mount and not easy for carry with and so on. This topic changed the decoction to capsule by using modern scientific technologies, and made research on Preparation Technique, quality standard and stability.Research methods including orthogonal testing and comparison testing were used to study the preparation Technique, and pilot plant test was made to determine the preparation process: add70%ethanol of8times the amount to herba hyperici perforati, coptis chinensis, spine date seed and schisandra chinensis, then immerse them for2hours, reflux extraction for1.5hours, iltering, add70%ethanol of6times its amount to the residue, reflux extraction for1.5hours, filtering, merge all the extracted liquid together, recycle the Ethanol and conduct vacuum drying concentration (temperature55°C, vacuum0.07-0.08Mpa) until it becomes the paste whose relative density reaching1.25-1.30(60°C), vacuum drying (temperature60-70°C, vacuum0.08-0.09Mpa), and get the dried paste; get White peony root, Milkwort, then add water of8times their amount to them, immerse4hours, conduct boiling extraction for3times, each extraction lasts1hour, add water of6times their amount for second and third extractions, filter, merge the extracted liquid, condense it until the relative density reaching1.02-1.07(60°C), add ethanol until the ethanol content reaching60%, standing it for12hours, get the clear liquid, recycle the ethanol and conduct vacuum drying concentration(temperature55°C, vacuum0.07-0.08Mpa) until it becomes the paste with relative density reaching1.25-1.30(60°C), vacuum drying (temperature60-70°C, vacuum0.08-0.09Mpa), and get the dry extract; merge the dry extract and smash it, then sieve it with80-mesh sieve, add20%microcrystalline cellulose, blend it, add appropriate amount of ethanol and make it softwood, sieve it with30-mesh sieve for granulation, dry it in temperature of60°C, sieve it with20-mesh sieve, add1%magnesium stearate and blend them, and put them into NO.0capsule.A "Draft Quality Standard" was made for the preparation to restrict checkpoint moisture, disintegration time, content uniformity, and microbial limit; Thin Layer Chromatography was used to qualitatively identify herba hyperici perforati, white peony root and milkwort in the preparation; Liquid chromatography was used to determine the herba hyperici perforate content in finished product, and a content limit was set.Experimental study was made on accelerated stability and long-term stability, and the result showed that all indexes of the preparation during the observation period reached the requirements of "Draft Quality Standard" of the product, determined using polyethylene plastic bottle to pack the product, which should be sealed for storing under normal temperature, with temporarily determined validity of24months.The study shows that the preparation Technique for JinZaoYuanZhi capsule is rational and feasible, with steady and controllable quality, which means a great potential of development and application.