Study On Preparation Process And Quality Standard Of Compound Pingyou Granules

Verruca plana is a skin disease caused by infecting human papilloma virus?HPV?,clinical manifestations of pale brown or normal skin color flat papules,skin lesions for the tip to the size of soybeans,the surface is smooth and hard.The course of verruca plana is slow,easy to relapse,the side effects are serious by long-term treatment of western medicine.Compound Pingyou soup is based on traditional Chinese medicine theory and a large number of clinical practice experience,a total of ten herbs composition from honeysuckle,forsythia,gardenia,rehmannia root,angelica,yam,tuckahoe,Schizonepeta,cicada and licorice,with the effect of clearing heat and cooling blood,nourishing blood and expelling wind,for the treatment of verruca plana curative effect is good.There are many shortcomings of the original decoction,patient compliance is poor.This project proposed according to the requirement of new drug research and development of traditional Chinese medicine,developed the Compound Pingyou soup into granules,and provide basis for the further development of six kinds of traditional Chinese medicine.In this thesis,the water extraction,alcohol precipitation and preparation process of Compound Pingyou Granules were optimized.In the water extraction,the chlorogenic acid content and the dry paste yield were taken as the index,the amount of water,decocting time,decocting times were taken as the factors by using the L₉?3⁴?orthogonal test,and the optimum water extraction process was as follows:adding 10 times the amount of water for the first time,the second and the third with 8 times the amount of water,decocting 3 times,each time 1h.In the alcohol precipitation,the chlorogenic acid content and the dry paste yield were taken as the index,the relative density of the liquid,alcohol concentration,alcohol precipitation time were taken as factors by using the L₉?3⁴?orthogonal test,and the optimum alcohol precipitation process was as follows:the relative density of the liquid is1.05,the concentration of alcohol is 50%,alcohol precipitation time is 24h.In the preparation process,the factors such as the type of excipients,the dosage of excipients and the concentration of wetting agent were investigated,and the optimum preparation process was that the dry powder and dextrin evenly mixed according to the proportion of 1:1,sprayed with 80%ethanol as wetting agent,wet granulation,and wet granules were dried at60?.In this thesis,the quality standard of Compound Pingyou Granules were also studied.By using the thin layer chromatography,honeysuckle,forsythia,angelica and yam in Compound Pingyou Granules were identified,the results showed that the samples of 4herbs were all the same color spots in the same position as the reference or control materials,while the negative control had no interference.And the particle size,moisture content,solubility and volume difference of Compound Pingyou Granules were examined,the results were in line with the Chinese Pharmacopoeia.By the high performance liquid chromatography,the content of chlorogenic acid were determined,and the corresponding methodology were investigated,the results showed that the methodology to determine the contents were in line with the requirements.In order to investigate the preliminary stability of Compound Pingyou Granules,long-term tests and accelerated tests were conducted of 3 batches of samples.The results showed there were no obvious changes in the indexes of 3 batches of samples,which indicated that the compound Pingyou granule were stable for 6 months under long-term test and accelerated test.