| Shuanghuanglian prescription is composed of honeysuckle,Scutellaria,forsythia.Now there are mainly oral liquid,tablets,injections and other dosage forms in the market.The bioavailability of oral liquid is higher than other forms,however,it is unstable,easy to precipitate after a long set,and also hard to carry with physically.Although the general tablet is more stable than the oral liquid,it is inconvenient to use,especially for children and patients with difficulty swallowing.The use of injections is inconvenience,and there are relatively more adverse reactions.Therefore,this study will make Shuanghuanglian soluble tablets.After solubilizing the soluble tablet into water,it will turn into a clear solution,and then take it orally.At the same time,it has the advantages of both oral liquid and tablet.Not only solves the problem of inconvenience,but also provides a better preparation for the elderly,children and patients with difficulty swallowing.The focus of this study is to screen the suitable formulation and preparation method.Soluble tablet requirement is soluble in water and turns into clear solution,which requires the materials and the main drugs used can be dissolved in water.However,the preparation of tablets in commonly used disintegrants are generally sparingly soluble in water,and water-soluble effervescent disintegrating agent cannot be used as soluble tablet's disintegrating agent.The soluble tablets in the strict sense are corroded,and then dissolved.If adding effervescent disintegrating agent into effervescent tablets,it may lead to dangers such as suffocation when these tablets are taken improperly.Therefore,the difficulty of this research is through the experiment,the prescription screening,and ultimately to prepare a qualified soluble tabletsof Shuanghuanglian.Objective: First the quality of honeysuckle extract,Scutellaria baicalensis extract and Forsythia Extract were detected to determine compliance with the provisions of raw materials.And then prepared a qualified soluble tablets of Shuanghuanglian.,and establish quality standards.Methods:1 The quality detection of honeysuckle,Scutellaria baicalensis extract,forsythia extract:Using HPLC determination of chlorogenic acid content in honeysuckle extract,the content of Baicalin in Scutellaria extract,Forsythia Extract of phillyrin and forsythiaside A content.Determination of moisture content of raw materials.Determination of the dissolution and clarification time of raw materials.2 The prepared extracts of Scutellaria baicalensis honeysuckle and Forsythia suspensa were mixed with appropriate excipients,and the Shuanghuanglian soluble tablets were prepared by method of dry pressing.In this experiment,the filler is mannitol,the solid dispersion carrier is polyethylene glycol 20,000,and the base required for salt formation of baicalin is sodium bicarbonate.Through the single factor experiment,the best prescription was selected according to the effect of tablet and the time of dissolution.3 studied on the quality control of Shuanghuanglian soluble tablets:Established the method of determination the contents of chlorogenic acid,baicalin and forsythin in Shuanghuanglian dissolved tablets by HPLC.According to the best process preparation prescription,three batches of Shuanghuanglian dissolved tablets were prepared.The content of baicalin,chlorogenic acid and the content of forsythin were determined,and the difference of tablet weight,hardness,friability in each batch was also determined at the same time.Results:1 Qulity inspection results on raw materialsContent measurement results: The concentration of chlorogenic acid was between7.70 × 10-3g.L-1 and 4.64 × 10-2g.L-1,which was good.The linear range was A= 4.11×104c-8714?R2=0.999?,and the detected content of chlorogenic acid in honeysuckle extract was 10.05%.The concentrationof Baicalin's was between 1.12×10-2g.L-1 and 6.71×10-2g.L-1 which was good.The linear range was A=4.19×104c-4983?R2=0.999?,and the detected content of baicalin in scutellaria baicalensis extract was 86.25%.The concentration of Forsythinextract was between 5.40 × 10-3g.L-1and3.25 ×10-2g.L-1which was good.The regression equation was A=9.27×104c-5936?R2=1.000?.The concentration of Forsythiaside A was between 1.98 ×10-1g.L-1 and 1.19 g.L-1 which was good,and the regression equation was A=4.55×104c-5936(?R2=1.000?.The content of Forsythin in Forsythia suspense extract was 2.17%,and the content of Forsythiaside A was 6.13%.The determination results of raw material moisture: the water content was3.56%,3.22%,and 3.91% in honeysuckle extract,scutellaria baicalensis extract,and fructus forsythiae extract respectively.The raw material is dissolved in water clarification time: the extract of honeysuckle and Forsythia Extract dissolved in water clarification time respectively: 16 "and 11",water insoluble extracts,this is because the baicalin is almost insoluble in water,which accounted for 86.25% of Scutellaria baicalensis extract.Therefore,in the subsequent preparation of soluble when considering baicalin and alkali soluble salt soluble tablet made of,made to dissolve in water after clarification.2 By single-factor optimization with the melting time as the index,The optimal recipe of Shuanghuanglian soluble tablets was determined as followed,Honeysuckle extract: 11%,Forsythia suspense extract: 15%,scutellaria extract:12%,mannitol: 43.5%,sodium bicarbonate: 12%,PEG20000: 6.5%.Firstly,mixture the prescription amount of honeysuckle extract and Forsythia extract together,and then put it into the permelted PEG20000 and mix them,after cooling,the amount of prescription Scutellaria extract,mannitol and sodium bicarbonate mixed evenly.Powder direct compression method was used to prepared soluble tablets.3 The HPLC method was established for the content determination of baicalin,chlorogenic acid and forsythin in Shuanghuanglian soluble tablets.The detection wavelength was 235 nm,and the moving phases are acetonitrile and0.1% of formic acid.The method was proved validated in methodology,besides,the auxiliary materials and solvents had no interference.So,this method was sensitive,simple and accurate for Shuanghuanglian soluble quality control.Conclusion: The prescription and preparation process of the Shuanghuanglian soluble tablet is simple and feasible,and has good reproducibility,dissolves rapidly in the warm water,the active ingredient dissolves quickly,and at the same time,the taste is suitable and can improve the patient's compliance.The method of detection of content and melting time was established,which provided a guarantee for the quality control of this preparation. |
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