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High quality is the premise for the implementation of high quality and good price for decoction pieces， and grade is the most direct manifestation of high quality of decoction pieces. However， there is still a lack of scientific and reasonable methods for evaluating the grade of decoction pieces， and it is urgent to establish a widely recognized and unified standard for the grade of decoction pieces to ensure the quality of the decoction pieces and guarantee the safety and efficacy of clinical use. Based on this， this paper focused on analyzing the problems of the current grade evaluation methods， such as unclear distinction between quality standards and grade standards， unreasonable selection of grade evaluation indicators， and inaccurate application of mathematical statistical methods. Based on the analysis of the grade evaluation of decoction pieces， this paper proposed four criteria for establishing the grade evaluation method of decoction pieces， namely universality， comprehensiveness， reliability and convenience， in order to establish a more reasonable and unified grade standard for decoction pieces and promote the quality improvement of decoction pieces and the development of the industry.
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Diabetes is a kind of metabolic disease characterized by hyperglycemia The oral hypoglycemic agents used currently are required to take every day,which brings inconvenience to patients.Omarigliptin is a small molecule DPP-4 (depeptidyl peptidase-4) inhibitor.The drug is developed by the Merck Co,mainly for the treatment of type two diabetes.The drug only need to be taken once a week,so as to improve the patient's compliance and adherence,thereby improving the therapeutic effect.This article introduces the information of omarigliptin from the aspects of synthesis,pharmacology,pharmacokinetics,and clinical research,which provides valuable information for pharmaceutical workers.
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Etelcalcetide (ParsabivTM) is a second generation calcimimetic agent newly developed by Amgen,mainly used for the treatment of secondary hyperparathyroidism.Etetcalcetide not only decreases calcium concentration by directly binding with the calcium sensing receptor,but also reduces the parathyroid hormone level.The European Union has approved for chronic kidney disease patients with secondary hyperparathyroidism in dialysis with Etelcalcetide injection.This paper summarized the pharmacological effects,pharmacokinetics,clinical trials,and adverse reaction of Etelcalcetide.
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Lifitegrast is a novel inhibitor of integrin,which can take effect by blocking the binding of intercellular adhesion molecule 1 and integrin lymphocyte function associated antigen 1.In July 2016,the U.S.Food and Drug Administration (FDA) officially approved the application of lifitegrast ophthalmic solution 5％ (commodity name XiidraTM).Clinical trials of the drug include a 12-week phase II clinical trial and three 12-week phase III clinical trials for dry eye disease patients.The results of clinical trials have demonstrated the efficacy and safety of the drug.Lifitegrast is the first FDA approved drug to improve and treat dry eye symptoms,and other similar drug is only cyclosporine.It is believed that in the near future clinical application of lifitegrast will be more extensive.
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OBJECTIVE:To provide reference for rational use of Chinese patent medicine. METHODS:The influencing fac-tors of rational use of Chinese patent medicine was investigated in respects of the selection of Chinese patent medicine,drug combi-nation,usage and dosage,clinical evaluation,pharmacoeconomic evaluation. RESULTS&CONCLUSIONS:Chinese patent medi-cine is a characteristic product of traditional Chinese medicine. It is a complex and important issue to use Chinese patent medicine rationally. It should be considered in many ways,not only pay attention to the principle of clinical use of Chinese patent medicine, but also need to carry out clinical evaluation of Chinese patent medicine;at the same time,the economics of Chinese patent medi-cine should be focused on.
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Objective To establish a method to determine genotoxic impurities in saxagliptin bulk drug. Methods The gas chromatography(GC)was carried out with INNOWAX capillary column. The inlet temperature was 120℃. The injection volume was 5μl and separation ratio was 1∶10. The column temperature was programmed:the initial temperature was 70℃,maintained for 1 min, raised to 190℃with a rate of 16℃/min,and then maintained for another 5 min. The detector was flame ionization detector(FID),with temperature of 250℃. The carrying gas was N2 with the flow rate of 1 ml/min. Methanol was used as solvent for saxagliptin. Results Methyl mesylate,ethyl mesylate and isopropyl mesylate could be separated completely with good linear relationship between 2.44-36.6,2.38-35.7 and 2.46-36.9μg/ml,respectively. The average recovery was 96.94%,95.96%and 105.47%(n=9),respectively. Conclusion This method is simple,reproducible and accurate enough for the determination of genotoxic impurities in saxagliptin bulk drug.
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ObjectiveTo study the occurrence and influence factors of drug-induced injuries of vital organs caused by traditional Chinese medicine injection.MethodsChina Hospital Knowledge Database (CHKD) from 1993-2013 and case reports concerning adverse effects and drug-induced diseases caused by traditional Chinese medicine injection from Wanfang Data Knowledge Service Platformwere retrieved. Indicator systemwasestablished and relevant contentsweresummarized and analyzed.Results34 types of traditional Chinese medicine injectionswereincluded and 699 drug-induced diseasesweresummarized, taking up 53.98% of the total adverse effects. Among them, the top three included in the drug-induced diseaseswere acanthopanax injection, safflower injection and Mailuoning injection. The non-conformance between the traditional Chinese medicine injections in the literature and instructions mainly reflects unreasonable solvent selection, large compatibility concentration and usage and dosage beyond those specified in the instructions. ConclusionThe occurrence of drug-induced injuries of vital organs caused by traditional Chinese medicine injectionis relatively high, drug instructions shall be strictly followed in accordance with requirements during clinical application.
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Objective:To establish a method to determine the residual solvents in salvianolic acid B. Methods: The headspace GC was carried out on an HP-5 capillary column(30 m × 0. 32 mm,0. 6 μm). The inlet temperature was 180℃. The injection volume was 0. 1ml and the separation ratio was 1:10. The column temperature was programmed:the initial temperature was 40℃, malntalned for 6 min, ralsed to 180℃ with a rate of 15 ℃·min-1 , and malntalned for another 5 min. The detector was FID with the temperature of 250℃. The carrier gas was N2 with the flow rate of 1. 7 ml·min-1 . DMSO was used as the solvent for salvianolic acid B. Results:All solvents could be separated completely. The linear range of ethanol, acetone and ethyl acetate was 12. 650-1. 012 × 103 μg·ml-1 (r=0.999 3),12.750-1.012 ×103 μg·ml-1(r=0.999 7) and 12.550-1.004 ×103 μg·ml-1(r=0.999 7), respectively. The average recovery of ethanol, acetone and ethyl acetate was 96. 89% (RSD=3. 81%,n=9), 99. 56% (RSD=4. 05%,n=9) and 97. 21% (RSD=4. 95%,n=9), respectively. Conclusion:The method is simple, reproducible and accurate enough for the determi-nation of residual solvents in salvianolic acid B.
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This study was aimed to optimize the near infrared (NIR) variable selection method based on multivariate detection limit (MDL). Using Qing-Kai-Ling (QKL) injection as object, three variable selection methods (interval par-tial least-squares, iPLS; backward interval partial least squares, BiPLS; moving window interval partial least squares, mwPLS) were used to establish the PLS models of baicalin in QKL injection, respectively. The prediction ability of different variable selection method was compared. MDL of all models were calculated in contrast to the MDL value of full spectra PLS model, to select optimal variable selection method. The results showed that different variable selec-tion methods had different prediction ability. Among them, iPLS had the best performance which determination coef-ficient of prediction (Rpre2) and the root mean square errors of prediction (SEP) were 0.996 5 and 602.3 μg·mL-1, re-spectively. All MDLs of different variable selection methods were reduced compared with the full spectra PLS model. The value of iPLS was the lowest comes to be 1.19 μg·mL-1. The results above indicated that the best variable se-lection method for baicalin in QKL injection was iPLS. MDL theory took the error of calibration and validation set and the leverage of external sample into account, which can comprehensively evaluate model detection performance compared to the classic chemical indicator parameters. This method was particularly suitable for the variable selec-tion method optimization of NIR quantitative model of low concentration sample such as Chinese herbal medicine.
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Objective To discovery the attributes of Chinese geoherbs and find it’s study strategy. Method Literature analysis and theory model structure. Results Both natural science and literae humaniores are attributes of Geoherbs. Conclusions Natural science combined with literae humaniores is the necessary way to study Geoberbs. The conception of Geographical Indications was favorable to discovery the literae humaniores properties. The theory about continuous variation was the key to found the scientific properties of Chinese Geoherbs.