Study On Compound Furosemide And Spironolactone Capsules And Industrialization Investigation

Objective:Diuresis medicine is a class of drugs to promote electrolyte and water from the body,increase the urine output,and eliminate edema.According to their function parts and strength is divided into three categories:efficient diuretics,middle-effect diuretics and inefficient diuretics.Furosemide(speed urine)is efficient diuretic,spironolactone is synthetic steroid medicines which used alone effect is weak,but combined with Furosemide can achieve significant diuresis effect,and offset the hypokalemia caused by each other.Using uniform design method and correlation analysis optimized the prescription of FuSpirC,set up quality control standards,and evaluated its stability.Methods:To design many different formulations by the uniform experimental of Statistics,the blank capsules of all formulations were made,and put the disintegration time,the packing amount divergent,and dissolution experiments of capsule as inspection indexes to formulate the best formulations.Accordig to the best formulations prepared capsule used High Performance Liquid Chromatography carried out the quality control.Reference to?the State Food and Drug Administration guidelines for stability of new drugs?and the actual situation and the stability tests,the bulk drug and preparation with acid,alkali,strong oxidizing conditions of stability and strong light,high temperature,high wet on the preparation of,and had some accelerated tests and long-term test.Results:Determined the kind and dosage of accessories in the best formulations,CMS-Na is disintegrant,water is wetting agent,MCC and lactose are fillers,magnesium stearate and French chalk are lubricants.Determination of the substances are used RP-HPLC,mobile phase was methanol:0.02 mol/L potassium dihydrogen phosphate(67:33)(used 1%phosphoric acid adjust PH 4.3),flow rate 0.8 mL/min,detection wavelength was 239 nm,measured the preparation of small quantities of this product that the content label amount was 90.0%?110.0%,the determination of related substances had satisfactory results.Furosemide?spironolactone material and capsule are stable under the condiction of strong oxidizing factors,Furosemide material and capsule are unstable under the condiction of acids,spironolactone material and capsule are unstable under the condiction of alkalis.the results showed that:at high temperature(60?),strong oxidizing conditions,the capsules had no content significant changes,when the capsules at the condition of humidity(75%±5%,92.5%),both influent the stability of compound FuSpirC,suggesting that the preparations should be sealed in packaging,cool place.Agents have to use airtight package,cool place,accelerated testing and long-term stable under the experimental conditions.Conclusion:The selected optimal preparation and the formulation of FuSpirC has good process conditions,the uniform particles,hardness is appropriate,the capsule appearance neat,sputtering quickly.HPLC is specific,easy to use,can be used for determination of FuSpirC and related substances.