RESUMO
OBJECTIVE： To investigate the rationality of TLC identification method （3） of （R，S）-epigoitrin in Isatis indigotica stated in 2015 edition of Chinese Pharmacopeia （partⅠ） （later abbreviated as pharmacopeia）， and make some improvements. METHODS： Three batches I. indigotica were collected and prepared into decoction pieces according to the processing method of I. indigotica in pharmacopoeia. TLC identification of （R，S）-goitrin in I. indigotica decoction piece and medicinal material were conducted according to identification method （3） in pharmacopeia （80％ ethanol as solvent for sample treatment， ultrasound extraction）； the rationality of pharmacopoeia method was investigated. Then the method was improved by changing the extraction solvent and pretreatment method （method one： using water as solvent， ultrasound extraction； method two： soaking in water for 1 h， then adding into methanol， ultrasound extraction； method three： the sample was wetted and then dried， using 80％ methanol as solvent， ultrasound extraction） of samples， and the optimal method was verified. According to the optimal method， the TLC identification of （R，S）-goitrin was detected by using chromatographic plates from different manufacturers， under the conditions of low temperature and low humidity （7 ℃， relative humidity 48％） and high temperature and high humidity （35 ℃， relative humidity 75％） respectively，to investigate the durability of the method. RESULTS： According to the method of pharmacopeia， in the chromatograms of decoction pieces， the same color spots appeared at the corresponding chromatographic positions of reference substance， but no corresponding spots appeared in the medicinal material chromatograms. After the samples were treated by three improvement methods， in medicinal material chromatograms， the same color spots appeared in the corresponding chromatographic positions of reference substances. There were single chromatographic spot after medicinal materials were treated with method one， and there were more spots after medicinal materials were treated with method two and three， and method two consumed less time than method three. The results of validation tests and method durability tests showed that after the treatment of I. indigotica and its decoction pieces according to method two， the same color spots appeared in the corresponding positions of the decoction pieces and the medicinal materials chromatograms as those of the control. CONCLUSIONS： The improved TLC identification method is effective， the chromatographic spots are clear， and the repeatability is good.
RESUMO
OBJECTIVE: To provide reference for strengthening safe use and supervision of set prescription preparations containing toxic decoction pieces [called "Chinese patent medicine (CPM) containing toxicity" for short] in clinic. METHODS: The CPM containing toxicity in 2015 edition of Chinese Pharmacopoeia (part I) were summarized and analyzed to put forward the suggestion on improving safe use of them in clinic. RESULTS & CONCLUSIONS: A total of 474 CPM containing toxicity are included in 2015 edition of Chinese Pharmacopoeia (part I), accounting for 31. 75％ of set prescription preparations. There are 435 oral preparations (12 preparations both for oral and external use), 38 preparations for external use, one intramuscular injection, accounting for 91. 77％, 8. 02％, 0. 21％ of CPM containing toxicity, respectively. There are 318, 93, 32, 31 set prescription preparations containing 1, 2, 3 or more ingredients toxic decoction pieces, accounting for 67. 09％, 19. 62％, 6. 75％, 6. 54％, respectively. At present, basic research on CPM containing toxicity is weak; the information of the instructions is not perfect; guidance for clinical drug use is absent. It is suggested to strengthen basic research on CPM containing toxicity, develop drug use study among special population, improve rational use of Chinese patent medicine and strengthen post-marketing safety reevaluation so as to guarantee the safety of CPM containing toxicity use in clinic.
RESUMO
Pharmaceutical excipients are important ingredients of drugs, and the quality of it directly related to the safety of drug. Compared to the 2010 edition, one of the most significant improvement of the 2015 edition of Chinese pharmacopoeia is the monographs of pharmaceutical excipients will be available in an individual book (Chinese Pharmacopoeia Book IV). And also, some new features will be found in the new edition: the doubled varieties of chronicled pharmaceutical excipients, the application of new techniques, the strict standards of the excipients for injection, the establishment of functionality-related characteristics. This article will interpret the developing trend of the standards of pharmaceutical excipients and the effect of the trend on the entire pharmaceutical industry in the future via the improvement of Chinese Pharmacopoeia.