Research Of New Traditional Chinese Medicine Qiweiqianliekang Capsule

Qiweiqianliekang Capsules is a pure traditional Chinese medicine oral prescription.The prescription is formed by the seven kinds of herbal medicine, Polygonum aviculare,Flavescens,Motherwort,Astragalus,Safflower,Stem of false physalis and Seed of false physalis,among stem of false physalis and seed of false physalis can not set standards, the remaining five herba are recorded in the Chinese Pharmacopoeia.The prescription is organized reasonable, innovative, Primarily for the treatment of chronic prostatitis.Qiweiqianliekang Capsules belongs to six categories of new drugs.In accordance with new drug review approaches and reporting requirements for approval,in this issue first we establish the draft standard of stem of false physalis and seed of false physalis;then we study the preparation process,quality control standards and the pharmacodynamics,etc.The specific study are as follows:1. Study the quality standards of stem of false physalis and seed of false physalis Determination distinguish,inspection and extract on stem of false physalis and seed of false physalis,respectively.And developed the scope of the corresponding limits in determination of water and extract; establish the draft standard of stem of false physalis and seed of false physalis. For more effectively making use of natural resources, make the false physalis medicine material get full development exploitation, carried on a research to the fatty acids composition in the seed of false physalis. Extraction of fatty oil by supercritical CO2 extraction (SFE) technique, and fatty acid composition and the relative contents of each component was also determined by GC-MS.2. Research of preparation process(1)water extract processingTesting the content of dry extract and total content of matrine and oxymatrine as index,was studied by orthogonal-test-optimized process,for the water amount, extraction time and extraction times as the investigating factors,study the optimum preparation procedure of Polygonum aviculare,Flavescens,stem of false physalis,etc.(2)water extraction and alcohol depositing processTesting the content of dry extract and total content of matrine and oxymatrine as index,was studied by selecting for 50%,60%,70% as different concentration of alcohol precipitation, get the optimal concentration of alcohol precipitation. (3)drying methodTesting the content of dry extract and total content of matrine and oxymatrine as index,was studied by comparing for ambient pressure drying and vacuum drying, get the optimal drying method. (4)molding preparation procedureStudy the bulk density, moisture content,critical relative humidity on powder contents of qiweiqianliekang Capsules , get the best preparation molding process .Preparation technique to determine for Qiweiqianliekang Cpsules:Prescription of Chinese herbal medicines,1/2 flavescens crushed into powder.Add eight times of the prescription medicines,boiled twice,each time two hours,combined the filter liquor,filter,filtrate concentrated to the relative density of 1.10～1.15 (60℃),then add ethanol to make the volume of 60% alcohol,still 24 hours, filtration, filtrate recovery ethanol,concentrated the thick paste with the relative density of 1.30～1.35 (50℃), join the flavescens powder, mix, vacuum drying(80℃),crush, sift, mounted 1000 capsules.3. Research of quality standard(1)The Motherwort,Astragalus,Stem of false physalis in the preparation of Qiweiqianliekang capsule were identified by TLC.The spots on the chromatograms are clear,characteristic,with good reproducibility and without interference by negative material.Apply to the qualitative identification of the preparation.(2)In accordance with the Chinese Pharmacopoeia 2005 version of capsule,we detect moisture level, filled volume diffeerenice, dissolution time, heavy metals ,arsenic salt, microbial limit, the results are in line with the Chinese Pharmacopoeia.(3)Esteblish a method for the determination of matrine and oxymatrine in Qiweiqianliekang capsule by HPLC,and study the methodological.The samples were separated on the NH2 column(4.6mm×150mm,5μm)which was used with acetonitrile-absolute alcohol-3%phosphoric acid(80:10:10) as mobile phase with the flow rate was 1.0ml·min-1 and the detection wavelength was 220nm. The linear ranges of matrine and oxymatrine were 0.3904～1.5616μg(r=0.9998),0.2576～1.0304μg(r=0.9996) respectively;the average recoveries were 97.1%(RSD=0.36%,n=6),97.5%(RSD=0.54%,n=6)respectively. The total content of matrine and oxymatrine is no less than 3.0mg per capusule.4. The stability researchAbout the stability of the preparation, use room temperature observation for character, distinction,filled volume diffeerenice, moisture level,dissolution time,microbial limit,as well as the the content determination were researched for 6 months. The results showed that the items mentioned did not change dobviously.This illustrates that the preparation has good stability in the storage time. 5. The pharmacodynamics researchPrepared"rats with bacterial and non bacterial prostatitis model","blood stasis syndrome model",anti-inflammatory, analgesic,diuretic and in vitro antibacterial test,observed the impact in chronic prostatitis of qiweiqianliekang capsule.The results show that Qiweiqianliekang Capsules may by inhibition, anti-inflammatory,analgesic, improve hemorheology and diuresis,that comprehensive role by symptoms also root of the problem and both. So as to achieve the purpose of"tackling the problem"for chronic prostatitis.The results showed that Qiweiqianliekang capsule is reasonable in technics, controllable in quality and good in stability,role in the prevention and treatment of chronic prostatitis. The thesis provided whole pharmaceutical document for the declaration of drug.