| Compound Manshanghong Soft Capsules is made of Manshanghong, liquorice and balloon-flower,have the efficacy of phlegm removing, cough relieving and asthma smoothing which have a good effect in the clinic cure on chronic bronchitis. Compound Manshanghong Soft Capsules get a increase of liquorice and balloon-flower bases on the Xiaokechuan Syrups that overcome the disadvantages of the former including: high content of alcohol,large dose, indisposition to women, children and alcohol sensitive person, easy to deposit, limit the market development and extending of medicine user. It is very important that conduct the research and review of the Compound Manshanghong Soft Capsules' manufacture procedure, quality standard, medicine effective to establish the preparation procedure, quality inspection standard and medicine effective test method in order to make it apply in the need of the industry production and push the North Medicine Strategy ahead. Methods:1.Research on pharmacy of Compound Manshanghong Soft CapsulesWith the guide of Chinese medicine theory, conduct the analyses on the medicine of the prescription. Establish the distill method and conduct procedure pick-up depending on the component of Chinese medicine. 1 .1Research on preparation procedure :Manshanghong contents naphtha, flavone, lactone, hydroxybenzene acid, three terpene and tan characters. Both the alcohol and water part have the different effect on phlegm removing, cough relieving and asthma smoothing. Pharmacologic test shows that the farrerol in the flavone is efficacy to breathing system. So double distill method is used in distill of naphtha and water-solubility component,desiccation the medicine dregs and distill with alcohol. Including the positive cross test plan on the ethanol distill procedure condition,review the consistencyof alcohol(50%,60%,70%), alcohol adding quantity(9times,12times,15times),distill time(1hour,2hours,3hours),establish the best distill procedure with the content of farrerol as the component index. Conduct the review of naphtha distill procedure,with the index of average oil reception, review the effect to average oil reception by water quantit(9times, 12times, 15times,18times) and distill time(1hour,3hours,5hours,7hours)Liquorice contains liquorice sweet element,is a kind of liquorice hypo- acid which is made through hydrolyze of three terpene soap licorice hydrolyze,and contains few liquorice licorice,is a kind of flavone element. Water distill method is applied with the liquorice, balloon-flower according to the character that balloon-flower contains balloon-flower soap licorice, and carry on the positive cross test plan,review water quantity(8times,10times,12times),distill time(1hour,2hours,3hours)and distill times(1time,2times,3times) with the index of cream rate and liquorice acid content,establish perfect distill procedure. 1.2 Research on shaping procedure: Review glycerin glutin proportionment of capsule material with the index of capsule material pliability. Choose a perfect capsule material pliability which will apply with the time limit of crash. With the index of water content,review in spissation cream desiccation time. Choose the excipient of capsule preparation and vacuum drying cream comminution level with the stability of mixed hanging system as index. With the index of fluidity of mixed vacuum drying cream, review the dosage of PEG 400. 2. Quality Standards2.1Determination of Farrerol in Manshanhong HerbsAdopting Hypersil 100× 4.6mm,5um ODS columnwith the mobile phase of methanol-water(60:40), at a flower rate of 1ml/min and the detection at 297nm. According to HPLC (addendaⅥB of 2000 edition CP),with the 0.003mg/ml farrerol as contrast liquor,according to the farrerol peak calculation the number of theoretical plates not less than 5000 and measure the peak area of farrerol, then account its content. At the sametime conduct the elective test to measure the wave length, elective test for solv... |
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