| The Compound GuiPiao tablet consist of Cinnamon,Mangnolia officinalis,Angelica sinensis,Poria cocos,Syzygium aromaticum,Radix Paeoniae Alba,Chinese-date.This prescription has a good effect in treating stomach pain which can initiate indigestion,gastritis,stomach or duodenal ulcer and so on many kinds of disease,that caused by excessive cold in the spleen and stomach.The reaserch of this program bsaed on traditional Chinese Medicine theory,according to the effective ingredients and prescription drug pharmacological research of medicinal materials in prescription,and to requirements by "Methods of Medicine Registration and Management"of SDA,modern extraction,separation,purification technology were adopted in the literature research of Compound GuiPiao tablet,the mainly research content the literature research,extraction technology research,preparation technology research,quality standards and stability studies.1 The literature researchWith the guidance of Traditional Chinese Medicine,the survey of the studies and the significance of developing the issue are elaborated widely.At the same time,we sum up the physical and chemical properties and pharmacological action of the drugs in the prescription.2 Extraction technology researchThe technology route was designed according to the clinical efficacy,prescription drug and drug effective component properties of prescription.(1)The volatile oil in Cinnamon,Syzygium aromaticum,Angelica sinensis,was extracted by the steam distillation,single factor experiment design were used to optimize extracting process of medicinal materials with indexes of volatile oil sufficient,the result of the extraction process is soak medicinal materials forl h,add 10 times water extract 6 h.(2)The main factors of influence extraction process were water addtion,extracting time,extraction times,take the above factors as an testing factors,the extraction process was optimized with orthogonal experiment,paeoniflorin and extraction amount were choosed for index,the optimized extraction processwas as follows:radix paeoniae alba,cinnamon,Angelica sinensis and other medical material was extracting 3 times,adding 10 times amount of water and 1 hours for each time.(3)With extraction amount and anointed rate for the index,according to the main factors of influence extraction process that multiple solvent,extracting time,extraction times,take the orthogonal test,the optimized extraction processwas as follows:poria and datesr was extracting 3 times,adding 8 times amount of water and 1 hours for each time.(4)Take honokiol,magnolol and a solid rate as index,for the main influence of the extraction technology of radix curcumaeand and magnoliae officinalis were alcohol concentration,solvent extraction time,extraction times,by orthogonal experiment design,the best extraction process is:add 8 times of 65%ethano,extracting three times,each time for 2 hours.(5)Ethanol-extraction liquid was concentrated under reduced pressure in 60℃,the water extraction of reclaims alcohol and Chinese-date was concentrated to 1.2g/mL under reduced pressure,and centrifuge for 30min with the rotate speed of 8000r/min,take the supernatan concentrated and reserveed.Take paeoniflorin as index to optimise alcohol precipitation of the water-extraction,the result is:concentrated the medicine liquid to the relative density of 1.10-1.15,and add 95%ethanol to make alcohol concentration 70%,storage for 12 hours in cold,vacuum filtration,recovery ethanol in reduced pressure,extractum spare;With the index of the content of paeoniflorin,honokiol,magnolol and moisture capacity optimizing vacuum drying process:extractum relative density 1.25-1.30(60℃),temperature is 75 ℃,degree of vacuum is-0.1Mpa,drying 24hs,quickly broken as take out.3 Molding technology studyTake extract powder as raw material,Optimization the pressure prescription,the preparation preparation technology is:extract powder(pass 100 mesh screen),10%microcrystalline cellulose,5%calcium sulfate,4%sodium carboxy methyl starch,1%superfine silica powder,spray into the naphtha blending,tabletting directly,make film-coating.4 Quality Standards studyIn order to make the quality of the product controllability,this article describes the TLC and regular project check of Gui Po tablets.Establish a method for the determination,HPLC method was used for the determination of paeoniflorin,honokiol and magnolol in the preparation.Developed standards(draft)of the preparation.According to the determination results of three batches product test,Temporary prescribe that the content of honokiol shall not be less than 0.469mg,the content of magnolol shall not be less thanl.28mg,the content of paeoniflorin shall not be less than 1.28mg.5 Stability studyIn order to investigate the stability of drugs and determine the validity,this subject with reference to the established quality standards,the accelerated test of the preparation has been carried out for 3 months,carry out a preliminary study of stability of Characters,identification,moisture content,disintegration time,microbial limit and content.Carry out the test of a three-month investigation to three batches test products retained in room temperature for 0,1,2,3 months.Prove that all targets were within the acceptable range,indicating that the tablet is essentially stable under the conditions of this packaging. |
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