ABSTRACT
Objective To establish a method that could detect 5 components of Fufang Heishen oral liquid simultaneously. Methods The component was performed by high performance liquid chromatography ( HPLC) equipped with Agilent Hypersil ODS (4.6 mm×250 mm,5 μm).The mobile phase consisted of acetonitrile-0.1% Phosphoric acid with gradient elution.The flow rate was 1.0 mL·min-1with the 210 nm and 270 nm detection wavelength,20 μL injection volume and 30 ℃column temperature. Results A good linear relationship was observed with the range of 7.12-85.44 mg·L-1for Harpagide (r＝0.999 9),2.50-30.00 mg·L-1for Harpagoside(r＝0.999 8),25.35-304.20 mg·L-1for Cinnamic acid(r＝0.999 7),0.73-8.70 mg·L-1for Tectoridin(r＝0.999 7)and 1.20-14.40 mg·L-1for Irisflorentin(r＝0.999 8).The average recovery of each detected component of Fufang Heishen Oral Liquid was 98.8%,102.7%,98.8%,99.3%,99.9% the RSD were 1.23%,2.89%, 2.60%,1.44%,2.84%(n＝6). Conclusion The method is simple,rapid and accurate and can be used to detect the content of Harpagide,Harpagoside,Cinnamic acid,Tectoridin and Irisflorentin of Fufang Heishen Oral Liquid.
ABSTRACT
Objective To establish and validate a method of sterility test for nitroglycerin ointment and validate this method .Methods Ten nitroglycerin ointments of 1 g were preheated oven to 45 ℃ for sample ,and added to conical flask which containing melted span 80 ,polysorbate 80 sterile mixture and sterile glass beads ,and were shake after mixing ,the sample fully emulsified by adding to 100 ml 45 ℃ pH 7 .0 sterile sodium chloride-peptone water buffer .According to the method of mem-brane filtration ,bacteria and fungus in each membrane with 300 ml pH 7 .0 sterile sodium chloride-peptone water buffer flush , the bacteriostatic activity was eliminated .Results By the method validation ,nitroglycerin ointment sample group ,negative control group were sterile growth ,and test group in each filter of the test bacteria compared with control groups were growing well ,so the samples had no inhibitory effect or the antimicrobial effect would not take into account .Conclusion Membrane fil-tration was reliable ,which could be used for sterility test for nitroglycerin ointment .
ABSTRACT
Objective To establish a method for microbial limit test of fast vertical liquid hand disinfectant gel .Methods The membrane filtration method, in accordance with the Chinese Pharmacopoeia 2010 Edition (part two) relevant requirements of microbial limit test method for validation of microbial limit test for fast vertical liquid hand disinfectant gel .Bacillus subtilis, Staphylococcus aureus, Escherichia coli, Candida a lbicans, Aspergillus niger were taken as test bacteria , Pseudomonas aeruginosa and Staphylococcus aureus were taken as control bacteria .Verification test was carried out in parallel test for 3 independent , recoveries and every trail rate were calculat-ed.Results In bacteria, molds and yeasts count method validation test , recovery test strain rate , the control bacteria test results met the requirements.Conclusion The membrane filtration method was feasible and effective , which could be used for microbial limit test of fast vertical liquid hand disinfectant gel .