OBJECTIVE:To establish a method for the simultaneous determination of acetic acid and succinic acid in Banxia syrup. METHODS:RP-HPLC was performed on the column of GL InterSustain-C18 with mobile phase of 0.03 mol/L ammonium di-hydrogen phosphate buffer solution(pH2.0)-methanol(gradient elution)at a flow rate of 0.8 ml/min,the detection wavelength was 210 nm,column temperature was 30 ℃,injection volume was 10 μl. RESULTS:The linear range was 0.020 98-0.209 8 μg/ml for acetic acid(0.999 9)and 12.04-120.4 μg/ml for succinic acid(r=0.999 9);limits of quantification were 0.15,18.24 ng,limits of detection were 0.045, 5.53 ng;RSDs of precision, stability and reproducibility tests were lower than 2%;recoveries were 97.45%-101.68%(RSD=1.39%,n=9) and 98.31%-101.08%(RSD=1.01%,n=9). CONCLUSIONS:The method is accurate and rapid,and suitable for the simultaneous determination of acetic acid and succinic acid in Banxia syrup.

Drug Carriers ; Drug Combinations ; Drugs, Chinese Herbal ; administration & dosage ; Poloxamer ; Polyethylene Glycols ; Solubility ; Technology, Pharmaceutical ; methods

Skin sensitization (allergic contact dermatitis, ACD), is a serious condition caused by small reactive molecules and is characterized by a delayed-type hypersensitivity .Animal tests were usually used in the evaluation of sensitizing potential of chemical substances in the past .However , there is an increasing interest from the public for reducing and ultimately replacing animal tests .The European Union (EU) has posed a ban on animal testing of cosmetic ingredients that includes skin sensitization since 2013.Therefore, alternative in vitro tests are the main tendency in chemical substances and cosmetic sensitizing potential research in the future .In this study, different kinds of in vitro test methods that were adopted by OECD or on research (LLNA, DPRA, KeratinoSens TM, h-CLAT) were reviewed through recent years literature , comprehensive introduction and evaluation were made to obtain reliable hazard and potency information on potential skin sensitizers .

This study was aimed to reveal the species characteristics of Chinese patent medicines for antitussive ef-fect and provide references for developing new drugs. This research targeted Chinese patent medicines for antitussive effect which were included in the Pharmacopoeia of the People's Republic of China and the New National Chinese Patent Medicines as well as those characterized by keywords such as cough cure, cough alleviating, antitussive effect, cough, persistent cough. The analysis was made on the species characteristics, such as the number of Chinese patent medicines for antitussive effect, license number, ethnomedicine patent medicines, drugs for children use, protection of varieties of traditional Chinese medicine, the number of drugs, the generic names of drug, and drug forms. The results showed that 684 Chinese patent medicines for antitussive effect collected in this research had ac-counted for 8.60% of the total 7 260 of Chinese patent medicines. A total of 7 450 license numbers were approved, and 33% of the Chinese patent medicines shares one license number. One Chinese patent medicine owns 16.6 li-cense numbers on average. Ethnomedicine patent medicines had 3 Tibetan prescriptions such as the Shiwuwei Chenxiang pill and 4 Mongolian prescriptions, such as the Siwei Tumuxiang powder. Drugs for children accounted for 14%, including 9 forms. The type of the generic names of drug reached 16 and most of them originate from abbrevia-tions of the main drug in prescription. The number of drugs in prescription ranges from 8 to 16. Chinese patent medicines for antitussive effect involved 16 forms, of which the proportion of the use of solid preparation was higher than the liquid preparation. It was concluded that Chinese patent medicines for antitussive effect were characterized by such advantages such as a variety of species, various forms, the reasonable number of drugs, considerable medicine retail market share and drug for children use which can meet the clinical needs, and meanwhile some prob-lems, such as a lack of criteria for the generic names of drug, the homogenization of fierce competition, and inade-quacy of ethnomedicine patent medicines.

This study was aimed to reveal characteristics of functions, main indications and applications of Chinese patent medicines in order to provide references for development of new Chinese patent medicines for antitussive ef-fect. Chinese patent medicines recorded in the Pharmacopoeia of the People's Republic of China and the New Na-tional Chinese Patent Medicines were taken as research subjects. Chinese patent medicines classified in the function and indication with key words of cough-relieving, cough-suppressing, cough and chronic cough were col-lected. Analysis was made on the prescription characteristics, such as functions, main indications and applications. The results showed that there were 684 Chinese patent medicines and 462 terms, which were used for a total of 1533 times. The frequently-used terms are antitussive effect with expectorant, antitussive effect, expectorant, heat-clearing and exterior-releasing, antiasthmatic, wind-expelling and antipyretic, antitussive effect with antiasthmatic, purging lung heat, relieving exterior syndrome and moistening the lungs. All 684 Chinese patent medicines were used 48 ma-jor treatments for a total of 1107 times. The main indications include acute and chronic trachitis / bronchitis, exoge-nous wind-heat type of common cold, exogenous wind-cold type of common cold, cough with abundance of phlegm due to phlegm-heat obstructing the lung, acute upper respiratory tract infection, asthma, acute and chronic pharyngi-tis, lung heat cough, and etc. All 684 Chinese patent medicines used a total of 537 kinds of herbs and chemical medicines, including 441 kinds of herbal medicine, 36 kinds of animal medicine, 25 kinds of mineral medicine and 35 kinds of chemical medicine. The top ten herbs in terms of using frequency are Glycyrrhizae radix et rhizoma, Platycodonis radix, Armeniacae semen amarum, Menthae haplocalycis herba, Citri reticulatae pericarpium, Ephedrae herba, Scutellariae radix, Perilla frutescens (L.) Britt, Pinelliae rhizoma, Fritillariae cirrhosae bulbus. Among them, 1/4 of Chinese patent medicines used extract. Five kinds of food or fruits were also used, which were orange, fresh gin-ger, pear, watermelon and dried mushroom. It was concluded that Chinese patent medicines for antitussive effect can be adopted in the treatment of various kinds of diseases, especially for the treatment of cough(heat cough in partic-ular), abundance of phlegm, asthma, pharyngitis, laryngitis, and etc. The treatment methods of clearing heat, dis-pelling wind and relieving exterior syndrome played an important role in the realization of antitussive effect. However, the expression of functions and main indications is far from standardized and clear. Drugs commonly used are herbal medicine plus animal medicine, mineral medicine and chemical medicine as well as food and fruit. The discovery of preparations with certain clinical curative effect from ethnomedicine and the using of their extracts as a major ingre-dient are one important way to develop new Chinese patent medicines with antitussive effect.

OBJECTIVE： To establish a method for simultaneous determination of nine components in Huoxiang zhengqi oral liquid， and to improve and perfect the quality standard of Huoxiang zhengqi oral liquid. METHODS： The contents of nine components in 10 batches of Huoxiang zhengqi oral liquid were determined by HPLC， such as licorice coumarin， isorlicin， liquiritinapioside， narirutin， liquiritin， saponins， hesperidin， magnolol and honokiol. The determination was performed on Kromasil Eternity XT-5-C18 column with mobile phase consisted of acetonitrile-0.05％ phosphoric acid solution （gradient elution） at the flow rate of 1 mL/min. The detection wavelength was set at 220 nm， and column temperature was 25 ℃. The sample size was 10 μL. RESULTS： The linear range of licorice coumarin， isorlicin， liquiritinapioside， narirutin， liquiritin， saponins， hesperidin， magnolol and honokiolin were 0.000 5-0.007 5， 0.000 8-0.025 0， 0.006 1-0.976 0， 0.001 6-0.250 0， 0.007 8-0.025 0， 0.000 4- 0.062 7， 0.008 6-0.276 0， 0.010 0-0.500 0， 0.010 0-0.500 0 mg/mL （r＝0.999 2-1.000 0）. The detection limits were 0.001 3， 0.000 1， 0.004 7， 0.005 0， 0.012 0， 0.001 3， 0.007 8， 0.007 7 0， 0.005 8 μg/mL， and the quantitative limits were 0.013 0， 0.000 8， 0.047 0， 0.050 0， 0.120 0， 0.013 0， 0.078 0， 0.070 0， 0.058 0 μg/mL， respectively； RSD of precision， stability and repeatability tests were less than 3.0％ （n＝6）. Average recovery rates were 98.67％， 101.85％， 98.97％， 103.05％， 100.00％， 97.78％， 97.91％， 100.13％， 101.95％； RSDs were 1.14％， 2.18％， 0.40％， 0.17％， 1.38％， 0.85％， 1.38％， 0.10％， 1.35％ （n＝6）. CONCLUSIONS： The established method is accurate and reliable， which can provide reference for the establishment of the overall quality control evaluation system and the improvement of quality standard for Huoxiang zhengqi oral liquid.