Preparation Technology Research Of Shu Gan He Wei Dispersible Tablets

Objective: The Chronic Gastropathy is a common clinical disease. Its etiology is complexand has a long disease course. It is touching refractory or recurrent. So the patients is very painful.The Shu gan he wei prescription is derived from the clinical prescription Qing dan hewei prescription. It composes of medicinal materials such as Bupleurum, Codonopsis, Scutellaria.It has a good effect in the treatment of chronic gastropathy. As the traditional decoction, Shu ganhe wei Decoction is inconvenient to carry, to take and to storage. So we need to preparate thetraditional decoction into modern preparation. As a new dosage form, Dispersible Tablet developrapidly, and has advantages of convenient taking, fast absorption, and its biological utilizationrate is high. Therefore we preparate the prescription into Shu gan he wei dispersible tablet. Studyits preparation process and quality standard and preliminary stability. Thus provide a scientificbasis for the formulation and follow-up development.Methods:(1) Study of extraction technology Use the HPLC method to determine thecontent of saikosaponin a, saikosaponin d, paeoniflorin, baicalin in the alcohol extract liquid. Usethe Transfer rate of saikosaponin a, saikosaponin d, paeoniflorin, baicalin and the extract rate asthe index to select the alcohol extraction process of Bupleurum, Scutellaria and Radix PaeoniaeAlba by single factor test and orthogonal test design. Use the oil extraction rate as index toselect the supercritical CO2extraction process of dry Ginger oil by uniform experimentaldesign. Use the UV-visible spectrophotometry method to determinate the content ofpolysaccharide in the extract. Use the polysaccharide content and extract rate as index toselect the water extraction process of dry Ginger CO2supercritical extraction residue,Codonopsis, Atractylodes, cassia twig and licorice by orthogonal design.(2) The study of thedrying spray technology Use the powder ratio and powde moisture content and powder state asthe index to select the optimum extraction process parameters of concentrated liquid spray dryingby uniform experimental design.(3) The study of dry Ginger supercritical extract microcapsulepreparation preparate the dry Ginger supercritical extract microcapsule by spray dryingmethod. Use the drug loading and the encapsulation efficiency as index to select the optimizepreparation process conditions by uniform experimental design to the preparation.(4) The study of the forming process Use the dispersed evenly time as index to select filler, disintegrant type,the combination of different disintegrant types, the disintegrant adding method and drug loadingby single factor method. Use the central composite design and response surface method tooptimize the dosage of Aerosil, CCMC-Na, PVPP. Investigate tableting pressure by single factormethod. Use granulating conditions and grain characters as index to select the wetting agent. Usethe particles angle of repose as index to select the lubricant and ultimately determine the optimalprescription of Shu gan he wei dispersible tablets and the best preparation process.(5) The studyof quality standard To establish a qualitative identification method for Bupleurum, Scutellaria,Radix Paeoniae Alba, dry ginger, licorice, Codonopsis, Atractylodes and cassia twig in theprescription by the TLC method. To determine saikosaponin a, baicalin, paeoniflorin in theprescription by the HPLC method.(6) The study of the preliminary stability of Shu gan he weiDispersible Tablets Observe the samples for6months at room temperature and conductqualitative identification and content determination in the zeroth,the third and the sixth month.Results:(1) The optimum alcohol extraction process of Bupleurum, Scutellaria and RadixPaeoniae Alba: add8times amount of70%alcohol and extracting for3times, each time1hour.The optimum dry Ginger supercritical CO2extraction process: the extraction pressure is27Mpa,extraction temperature is35℃, extraction time is3hours and the oil rate is5.3%.The optimumwater extraction process of dry Ginger supercritical extraction residueCodonopsis, Atractylodes, cassia twig and licorice is decocting2times (10times,8times) andeach time2hours.(2) the best spray drying process of the medicine extracting concentrated liquid:inlet velocity is9.5ml/min and inlet air temperature is150℃and therelative density of the liquidis1.05.(3) The optimal process conditions for preparing dry Ginger supercritical extractmicrocapsule: the ratio of the medicine and the capsule material gum arabic is1:1.1and air inlettemperature is160℃and inlet velocity is8ml/min. The average encapsulation efficiency ofmicrocapsule prepared is66.44%and the drug loading is34.44%.(4) the best prescription of Shugan he wei Dispersible Tablets and its preparation: grinding45%drug and5%Aerosilevenly.Adding3%CCMC-Na and6%PVPP and mix uniformly.Then add MCC and mixuniformly. Use95%ethanol to made soft material and pelletize with24mesh sieve and oven drythem at50℃and finishing the particles. Add in the mixtures of3%CCMC-Na and6%PVPP anddry Ginger supercritical extract microcapsule and magnesium stearate, mixing, tabletting and thetablet hardness is30~40N.(5) The Shu gan he wei Dispersible Tablets preparated have yellowcolor. Its gas is micro fragrance. They taste bitter and slightly sweet. We have identifiedBupleurum, Scutellaria, Radix Paeoniae Alba, dry ginger and licorice and determinated thecontent of aikosaponin a, baicalin, paeoniflorin by the HPLC method.(6) the sample is table for at least6months at room temperature.Conclusion: Through the study of the Shu gan he wei Dispersible Tablets preparationprocess we can draw a conclusion that the preparation process is scientific and stable and it issuitable for industrial production. The quality standard established has strong specificity andgood reproducibility and it can control the quality of Shu gan he wei Dispersible Tabletsscientifically.