Objective To establish a method for content determination of total flavones and polysaccharides in Fangshu Qingre mixture by UV-Vis Spectrophotometry. Methods The contents of total flavones and polysaccharides in Fangshu Qingre mixture were determined by UV-Vis spectroscopy with rutin and anhydrous glucose as reference substance, and the wavelength was set at 508 nm and 487 nm. Results The contents were from 0.00 to 59.20 μg/ml for total flavones and from 10.92 to 109.20 μg/ml for total polysaccharides in Fangshu Qingre mixture. The recoveries of total flavones and total polysaccharides were 104.4% and 104.8% respectively. Conclusion The method of using ultraviolet spectroscopy was simple, reproducible, accurate and reliable, which could be preferably used as the method for content determination of total flavones and polysaccharides in Fangshu Qingre mixture.

OBJECTIVE:To optimize the dry granulation technology conditions for Yinqiao baidu tablet. METHODS:Using granulating difficulty degree and disintegration time as investigation indexes,ratio and amount of accessories microcrystalline cellu-lose and compressible starch in Yinqiao baidu tablet,moisture content of the sprayed powder were screened. Using yield of particle and angle of repose as indexes,L9(34)orthogonal test was used to optimize the wheel pressure,rotating speed and feeding speed in dry granulation technology,and verification test was conducted. RESULTS:The ratio of microcrystalline cellulose and compress-ible starch was 7:3,and mixing ratio of the two with spray powder+inclusion compound was 1:5. The moisture content of spray powder was controlled in 1％-2％. The optimal technology was as follow as wheel pressure of 3.5 MPa,roller speed of 4 r/min and feeding speed of 10 r/min. In verification test,average yield of particle was 69.2％ and angle of repose was 31.5 °. Transfer rate of chlorogenic acid had reached over 92％,and RSD of each index was below 2.53％(n=3). CONCLUSIONS:Each index of parti-cle prepared by optimized accessories formulation and technology shows good reproducibility and feasibility,and the technology is stable and suitable for production.

Objective: To investigate the content of ethylparaben in potassium chloride solution.Methods: According to the guidance for antibacterial effect test stated in Chinese Pharmacopoeia(the 4th volume of 2015 edition), 5 standard bacterial strains including Staphylococcus aureus,Escherichia coli,Pseudomonas aeruginosa,Candida albicans and Aspergillus niger were used as the challenging strains.Using the logarithm decrease of bacteria number as the index, the antimicrobial effectiveness of ethylparaben at different concentrations was studied to screen out the optimal concentration in the solution.Results: The growth of the 5 standard bacterial strains was inhibited effectively by potassium chloride solution containing 0.05% ethylparaben, which was also the minimum effective concentration.Conclusion: 0.05% Ethylparaben is suitable as the bacteriostatic agent for potassium chloride solution.

Objective To establish a method for the determination of the total flavonoids content in compound Yinchen mixture by UV spectrophotometry .Methods Using rutin as comparison ,three coloration methods were studied to find the op-timal assay method .Results The sample was detected at 508 nm wavelength by NaNO2-Al(NO3 )3-NaOH reaction with rutin as reference .The rutin content had a liner relationship in the range of 0 .0125-0 .0626 g/L (n=9 ,r=0 .9999) ,and the aver-age recovery rate was 99 .49％ with RSD of 0 .84％ .Conclusion The NaNO2-Al(NO3 )3-NaOH coloration method is proved to be simple ,quick ,stable and reliable for the determination of total flavonoids in compound Yinchen mixture .

Objective:To establish the bacterial endotoxin test method and the abnormal toxicity test method for reduced glutathi -one for injection.Methods:According to the requirements and methods in Chinese Pharmacopoeia (2015 edition, part IV), the bacte-rial endotoxin test and the abnormal toxicity test for reduced glutathione were studied .Results:The limit of bacterial endotoxin for re-duced glutathione was 0.125 EU· mg-1 , and the limit of abnormal toxicity was 1.0 g· kg-1 .Conclusion: The bacterial endotoxin test method and the abnormal toxicity test method are feasible .The abnormal toxicity should be supplemented in the quality standard for reduced glutathione , and the bacterial endotoxin test can replace the pyrogen test .

Objective:To establish the quality standard for compound Yinchen mixture. Methods:A TLC method was used to i-dentify Artemisiae scopariae Herba,Gardeniae Fructus, and Rhei Radix et Rhizoma in the mixture. An HPLC method was used to quan-titatively analyze the concentration of chlorogenic acid and geniposide. Results:The TLC spots were clear without any interference the negative control. The linear range of chlorogenic acid was 0. 04-0. 20 mg·ml-1 ,and that of geniposide was 0. 05-0. 25 mg·ml-1 . The average recovery of chlorogenic acid was 94. 4% with RSD of 1. 85%, and that of geniposide was 102. 2% with RSD of 1. 15%( n=6). Conclusion:The method is accurate,reliable,specific and reproducible,which can be used for the quality control of compound Yinchen mixtures.

Objective:To establish a method for the content determination of triptolide, total diterpenoids and total alkaloids in Leigongteng oral solution to provide basis for the quality control. Methods:An HPLC analysis was used to detect the content of triptol-ide, which was carried out on an Eclipse XDB-C18 column (150 mm × 4. 6 mm, 5μm) with the mobile phase consisting of acetonitrile-water with gradient elution. The flow rate was maintained at 1. 0 ml·min-1 , the column temperature was kept at 40℃ and the detec-tion wavelength was set at 218 nm. Using triptolide and wilforine as the contrast, the total diterpenoids and total alkaloids were deter-mined by UV-Vis spectrophotometry. Results:There were good linear relationship in the determination of triptolide, total diterpenoids (caculated as triptolide) and total alkaloids (caculated as wilforine) (r≥0. 999 8), the average recovery were 91. 96%, 90. 56%, 99. 18%, and the RSD were less than 3%. Conclusion:The method is with good reproducibility and stability, which can be used for the quality control of Leigongteng oral solution.

Objective:To establish an HPLC method for determining the content of aspirin and sodium salicylat in A-Liu spirits and study the stability of the two components under different storage conditions. Methods:The analytical column was Agilent Eclipse XDB-C18(150 mm ×4.6 mm, 5 μm) ,0.01 mol·L-1 potassium dihydrogen phosphate (adjusting pH to 2.3 with potassium acid) -acetonitrile-methanol(55∶15∶30) was used as the mobile phase at the flow rate of 1. 0ml·min-1 , the detection wavelength was 280 nm and the column temperature was 30℃. The contents of aspirin and sodium salicylat were regularly determined under such storage conditions as ambient temperature, constant temperature and humidity(30℃ ± 2℃,65% ± 5%) and refrigeration (4℃ ± 2℃). Re-sults:The average recovery and RSD were 100. 06% and 0. 80%(n=9) for aspirin, and 100. 53% and 0. 82%(n=9) for sodium salicylat. Aspirin and sodium salicylat showed good linear relationship within the range of 31.0-310.0 μg·ml-1(r=0.999 9)and 30. 5-305. 0 μg·ml-1(r=0. 999 5), respectively. Under the three storage conditions, the content of aspirin was decreased, while that of sodium salicylat was increased, suggesting the temperature could significantly affect the hydrolysis rate and content of aspirin Conclusion:The method is promising with good resolution, reproducibility and sensitivity. It is recommended that the method be used to determine the content of aspirin and sodium salicylat in A-Liu spirits, and aspirin isn't stable under different storage conditions.

Objective:To establish the criterion of bacterial endotoxins test for hemocoagulase atrox for injection and measure the endotoxin concentration in hemocoagulase atrox for injection by the kinetic turbidimetric technique. Methods:The limit of bacterial en-dotoxins in the product was designed according to ChP 2010. Four endotoxin concentrations were prepared to obtain the standard curve. The interfering test was done by measuring the concentration of endotoxin added into the sample solution. The endotoxin concentration in the sample solution was measured. Results:The absolute value of the correlation coefficient was 0. 988 6 (must be above or equal to 0. 980), suggesting the standard curve was valid. The recovery of the added endotoxin in the sample solution was within 50 to 200%when the concentration of the product sample was 0. 25 KU·ml-1 . The measured endotoxin concentration in the sample met the re-quirements for bacterial endotoxins. Conclusion:The bacterial endotoxins assay method for milrinone injections is established, and the kinetic turbidimetric technique is suitable for the bacterial endotoxin test of the product.

Objective:To establish an HPLC method to determine the content of chloramphenicol, salicylic acid and the related substances in compound chloramphenicol alcoholic solutions. Methods:The analytical column was Agilent Eclipse XDB-C18 (150 mm × 4. 6 mm,5 μm), 0. 8% acetic acid solution- acetonitrile(60∶40) was used as the mobile phase with the flow rate of 1. 0 ml· min-1 , the detection wavelength was 290nm for chloramphenicol and salicylic acid, and 272nm for the related substances, the column temperature was 25℃,and the injection volume was 10 μl. Results: Chloramphenicol and salicylic acid were completely separated from the related substances. The linear relationship of chloramphenicol ranged from 14. 88 to 297. 60μg·ml-1(r=0. 999 9), and the average recovery was 101. 18% with RSD of 0. 82%(n=9). The linear relationship of salicylic acid ranged from 9. 72 to 194. 40μg· ml-1(r=1. 000 0), and the average recovery was 99. 78% with RSD of 0. 27%(n=9). Conclusion:The method is good in resolu-tion, reproducibility and sensitivity. It is suitable for the determination of the two components and related substances in compound chloramphenicol alcoholic solutions.