Research On Preparation Method And Quality Standard Of Compound Brufen Soft Capsules

NSAIDS is one of medicines that could relieve fever, inflammation and pains,furthermore NSAIDS does not contain cortex hormone. The designing concept ofbrufen drugs is to unite analgesic drugs with two different kinds of actionmechanisms in one formulation. This kind of formulation can improve analgesiceffects through the synergetic effects of different drugs and at the same time canreduce side effects because the dosage of each drug is reduced.Only Ranbaxys sub-company in China, Guangzhou Nanxin PharmaceuticalCo., Ltd. has successfully launched compound brufen tablets (baoshitai). There areno other formulations of this kind of drug launched in China yet. Stable preparationmethod and quality standard of compound brufen soft capsules using the samecombination have been established.To study the preparation method of compound buprofen capsule: Take onealiquot of gelatin, add one aliquot of water, 0.6 aliquot of glycerol and appropriateamount of ferric oxide. Melt the gel at 70 ℃ to 80℃ and transfer the mixture into avacuum flask and incubate at 55 ℃ to 65 ℃. Add the prepared suspension into thematerial feeder and press pills. After the capsules are shaped in the condition of25℃ and 30% relative humidity for 20 hours, transfer the pills into the drier. Drythe pill in the condition of 30 ℃, 20% relative humidity and wind speed of 0.6m/sfor 8 hours, washing, sorting and checking the pills.Research on quality standard of compound brufen soft capsules:Compoundbrufen soft capsules are identified through High Performance LiquidChromatography (HPLC). Dissolution rate is determined by the third method(Appendix ⅩC, Part II, Chinese Pharmacopoeia 2000), using phosphate buffer(pH7.2) as the solvent. The rotary speed is 75r/min, the temperature is 37±0.5℃and the sampling time is 45min. The dissolution amounts, related substances andcontents of brufen and N-acetyl-P-aminophenol are determined with HPLC. Theloading agent used is ODS-C18, the mobile phase is phosphate buffer (adjust pH to6.0) : methanol (70∶30), the detection wave length is 223nm, the flow rate is0.8ml/min and the temperature of the column is 30 ℃.Stability study for compound brufen soft capsules: The results of the stabilitystudy show that the properties, dissolution rate, related substances, microbial limitsand contents of this product all conform to the specifications in the quality standardof compound brufen soft capsules under room temperature, 30℃, a relativehumidity of 75%, This proves that this product is stable during the present testperiod of time.