Study On Standard Improvement Of Kangguzengsheng Pill

Kanggu zengsheng pill(Kgzs)is one of Chinese patent medicines listed in the national basic medical care insurance medicine catalogue.Its prescription is composed of the Chinese medicinal materials of Epimedii folium,Rehmanniae radix praeparata,Cistanches herba,Cibotii rhizoma,Ligustri lucidi fructus,Spatholobi caulis,Fried raphani semen,Drynariae rhizoma,and Achyranthis bidentatae radix.It was formed by combining some raw herb powders from herbs of Rehmanniae radix praeparata,Cibotii rhizoma,Epimedii folium,and the condensed extract from remaining herbs.It can be made into three dosage forms(water-honeyed pill,small honey pill and big honey pill).The quality standard of Kgzs which contained microscopic identification of Rehmanniae radix praeparata and Cibotii rhizoma,chemical identification of alkaloids and flavonoids,and formulation inspection was originally issued by the Ministry of Health of the People’s Republic of China(No.WS3-B-0084-89),and then has included in the 1995 edition of "Chinese Pharmacopoeia".Improvement of standard in CP(2010 edition)added the TLC identification of Epimedii folium,Ligustri lucidi fructus,and the content of icariin as reference,and eliminated the chemical identification.1.Study on quality status of KgzsIn total,150 batches of samples,including 32 batches of big honey pill,1 batch of small honey pill and 117 batches of water-honeyed pill,involving 12 production companies were collected.The 7 sets of samples from manufacturing enterprise and 143 from market were distributed in 29 provinces.Based on "Chinese Pharmacopoeia",the quality evaluation of Kgzs has been systematically studied.It was carried out using two different editions of CP according to the different production date.The results show that the percentage of pass rates is 100%.The microscopic features of some samples appear to be non-medicinal tissue cells and unknown black masses.The Quality Standard of Kgzs in CP is unsuitable,due to lacking the quality control methods of herbs expect Rehmanniae radix praeparata,Cibotii rhizome,Ligustri lucidi fructus and Epimedii folium.So it’s necessary to study on the quality control for Kgzs.Meanwhile,the survey found that commercial Spatholobi caulis,Drynariae rhizome,and Epimedii folium were mostly adulterant species;there were big differences in the quality of the products from various manufacturers due to different production processes and quality of raw materials and supplementary materials.2.Improvement study of quality standard of KgzsIt was carried out to supplement and improve the TLC and determination,and drafting thequality standard of Kgzs.TLC: Added the TLC method of Rehmanniae radix praeparata,Drynariae rhizoma and Achyranthis bidentatae radix.Improved the TLC method of Ligustri lucidi fructus and Epimedii folium,and gave a better resolution by adjusting eluent constitute.Determination: Added echinaco,acteoside and naringin as reference,and modified the determination method of icariin,so qualitative identification method is more scientific and suitable.HPLC fingerprint:Established HPLC FP method of Kgzs by using echinaco as reference,and determined 25 common peaks showing the information of Rehmanniae radix praeparata,Epimedii folium,Fried raphani semen,Spatholobi caulis,Achyranthis bidentatae radix,Drynariae rhizoma and Cistanches herba.Other analysis : Studied on Safety of Pesticide Residues and Heavy Metals of Kgzs,and screened illegal substances.This project is to systematically evaluate the quality of commercially available drug and drug safety,and provides scientific basis for the establishment of more comprehensive quality standards and drug safety supervision.