Simultaneous Determination of Five Components in Fufang Heishen Oral Liquid by Dual-wavelength HPLC / 医药导报

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.

Determination of Nitroglycerin Ointment by HPLC / 中国药师

Objective:To optimize and improve the content determination method for nitroglycerin ointment. Methods:An HPLC method was used,the column was Hypersil ODS(150 mm × 4. 6 mm,5 μm),the mobile phase was acetonitrile ∶water(50 ∶50),the detection wavelength was set at 220 nm,the flow rate was 1 ml·min-1 ,the column temperature was 30℃,and the injection volume was 20 μl. Results: The results showed a good linear relationship within the concentration range of 0. 020 3-0. 203 3 mg · ml-1 ( r =0. 999 9),and the average recovery was 99. 51%(RSD=1. 06%,n=9). Conclusion: The method is rapid,accurate and reproduci-ble,and can be used to determine the content of nitroglycerin in nitroglycerin ointment.

Study on quality standard of compound Heishen granules / 药学实践杂志

Objective To establish a quality standard for compound Heishen granules .Methods Scrophulariae Radix and Belamcandae Rhizoma were identified by TLC .HPLC was used to determine the content of cinnamic acid ,tectoridin and irisflo-rentin .The HPLC was performed on a column of Kromasil-C18 (150 mm × 4 .6 mm ,5 μm)with a mobile phase of acetonitrile (A)-0 .1％ hydrochloric acid (B)at a temperature 30 ℃ .The detection wavelength was set at 270 nm and the flow rate at 1 ml/min .Results The TLC method had good specificity without interference from negative control .The calibration curve showed a good linear relationship within the range of 16 .22-113 .57μg/ml for cinnamic acid(r=0 .9998) ,48 .19-337 .34μg /ml for tectoridin(r= 0.9998)and 16.40-114.80 μg/ml for irisflorentin(r= 0.9999) .The average recoveries were 99.23％ , 98.82％ ,99.17％ .Conclusion The established method is rapid ,accurate and reproducible .It can be used in the quality control of compound Heishen granules .

Validation for sterility test method of nitroglycerin ointment / 药学实践杂志

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 .

Prepraation and detection of in vitro dis solution of if nasteridec oated dispre sible tablets / 药学实践杂志

Objective To optimize the prescription and preparation technology of finasteride dispersible tablets .Methods Wet granulation technique was applied to optimize the formulation and technology of finasteride tablets .Results The formulation of fi-nasteride tablets was that microcrystalline cellulose and lactose acts as diluent , 5% of low-substituted hydroxypropyl cellulose acts as disintegrant , 5%of povidone in alcohol water mixture acts as adhesive and 15%of opadry 85 G type acts as coating solution .The per-centage of dissolution was more than 90%in 45 miniutes.Conclusion The self-made finasteride tablets had stable quality , reliable process and were suitable for industrialized mass production .

High performance liquid chromatography for determining the isofraxidin content in Feitai Capsule / 医学研究生学报

Objective Feitai Capsule,a compound of traditional Chinese herbal medicine,has been screened and refined repeatedly for many years and shown to have a good anti-tumor effect.Strict quality control and further screening of the efficacious components of the compound are of great clinical significance.The purpose of this study was to establish the methods for determining the isofraxidin content in Feitai Capsule.Methods We determined the content of isofraxidin in Feitai Capsule by high performance liquid chromatography (HPLC),using the chromatographic column Hypersil ODS-C18 (4.6 mm?150 mm,5 ?m),with the mobile phase as acetonitrile 0.2% phosphoric acid solution (21∶79),the flow rate of 1.0 ml/min,the detective wavelength of 344 nm and the column temperature at 30℃.Results Isofraxidin showed a good linearity,within the range of 2.00-10.80 ?g/ml (y=69 427x+15961,r = 0.999 9),with the average recovery of 97.89% and RSD of 1.64% (n = 6).Conclusion HPLC,accurate and reproducible,is suitable for the determination of the isofraxidin content in Feitai Capsule.