ABSTRACT
This paper, taking the formulation of national drug standards for traditional Chinese medicine (TCM) dispensing granules as a case study, explores the improvement of the formation mechanism of national drug standards, and promotes the reform of streamline administration, delegate powers, and improve regulation and services of national standards management, so as to release the vitality of the research and development of standards of drug manufacturers. After nearly two decades of pilot production of TCM dispensing granules, a large number of researches and discussions have been conducted on the formulation of unified standards of TCM dispensing granules from manufacturing enterprises to national standard administration departments, it was found that this work was difficult on the basis of the original drug standard formation mechanism. The authors tried to improve and innovate the formation mechanism of national drug standards, to provide methods and ideas for the formulation and unification of national standards for TCM dispensing granules, and to provide references for the formulation of other national drug standards.
ABSTRACT
The necessity of establishing the review system in the administration of national drug standards was analyzed, in order to provide suggestions for improving the national drug standard work. The problems existed in national drug standard administration were analyzed and summarized, the purpose and significance of standard review system was analyzed, and the implementation of standard review system in other industries was reviewed. At present, there are some problems in the administration of national drug standards, such as imperfect working mechanism, unsatisfactory progress in the improvement of standards, low participation of manufacturers in the work of national standards, and unsmooth elimination mechanism of standards. The establishment of standard review system in national drug standard administration conforms to the objective law of standard management, which is helpful to improve the top-level design of national drug standard activities, solve the bottleneck problems in the durg standard work, realize the dynamic management of national drug standard, and promote the re-evaluation work of drugs after being put on the market. In a word, the establishment and implementation of the standard review system is conducive to the development of national drug standards.
ABSTRACT
OBJECTIVE:To study varieties,indications and usage features of Tibetan medicine preparations,and provide refer-ence for the clinical treatment and new drug development for Tibetan medicine. METHODS:Tibetan medicine preparations in offi-cial standards were collected,variety features(formula scale,license number,pharmaceutical enterprise,name and dosage form, herbal medicine number),action features(indication name,clinical application)and medicine features(category and quantity,me-dicinal part,commonly used drug,frequency,three fruitsuse feature) were summarized. RESULTS:Totally 458 preparations were included,including 18 recorded in Chinese Pharmacopoeia (part 1,2015 edition),200 recorded in Pharmaceutical Stan-dards of the Ministry of Health of China(Tibetan medicine,1995 edition),240 recorded in Tibetan Medicine Standards(six prov-inces). 129 had obtained 430 license numbers,from 52 pharmaceutical companies;the prearations were mainly named byherbal medicine+principal medicine+dosage formprincipal medicine+dosage formandindication+dosage form. Dosage forms had powder,pill,cream,oil,syrup and wine; the number of herbal medicine was(13.81±13.28). The Tibetan preparations were com-monly used in the clinical treatment of diseases of the digestive system,respiratory system,genitourinary system,circulatory sys-tem,infectious and parasitic diseases,etc. 442 medicines had been used,including 297 herbal medicines,70 animal medicines, 47 mineral medicines and other 28 medicines. The common medicinal parts were seed or fruit,root or rhizome,whole grass,flow-er,stem,over-ground part,tuber or bulb,etc. The top 10 frequency of medicines were as follows as Terminalia chebula,Cartha-mus tinctorius,Aucklandia lappa,Amomum kravanh,Phyllanthus emblica,Piper longum,Inula racemosa,Punica granatum, Moschus berezovskii,Adhatoda vasica;and 19% preparations contained three fruits(T. chebula,P. emblica,Terminalia bellirica). CONCLUSIONS:Tibetan medicine preparations have rich varieties,reasonable herbal medicines,more solid preparations,widely clinic application,contain more herbal drugs and commonly usethree fruits,while fewer preparations have obtained license number.
ABSTRACT
OBJECTIVE:To analyze relevant regulations in Drug Administration Law and to study the safety of drug use. METHODS:The key points of the safety of drug use were analyzed through reasoning analysis. RESULTS&CONCLUSION:The safety of drug use was the core of medicine legislation while there were still some problems on law execution and blind spots in legislation. It is suggested to standardize the research and development of drug and purchase channel,improve system for safety of drug use and role of clinical pharmacists so as to guarantee the safety of drug use.