Development Of Ganglouyuchuang Lotion And Preliminary Evaluation Of The Curative Effect

Objective:Crohn’s disease is a chronic inflammatory granulomatous disease of the gastrointestinal tract with an unknown etiology,the cause of the disease is varied,there are many complications of this disease,especially with anal fistula.At present,there is no medical treatment for the cures of anal fistula of Crohn’s disease,overoperation can lead to a variety of sequelae.Ganglouyuchuang lotion is prepared by four flavors:salvia miltiorrhiza,radix astragali,radix sanguisorbae and senecio,the purpose is to rinse the affected area of the anal fistula of Crohn’s disease,anti-inflammatory and anti-inflammatory,reducing the risk of aggravation and recurrence of anal fistula of Crohn’s disease.The subject optimize the preparation process of ganglouyuchaung lotion,research on its quality standards,and investigate the healing ability of the lotion.1.Preparation process research:Ganglouyuchuang lotion is preparation by water extraction and alcohol precipitation,research the preparation process by orthogonal test,use the content of Salvia miltiorrhizin as an index to optimum preparation process.2.Quality standard research:Research the quality standard of ganglouyuchuang lotion from the aspects of qualitative identification,content detection and the related examination of lotion.Qualitative identification by TLC for salvia miltiorrhiza,radix astragali,radix sanguisorbae and senecio in the lotion;determine the content of sodium danshensu by HPLC,establish the quality standard.3.Stability test study:in order to examine the stability of ganglouyuchuang lotion,according to the raw material drug and preparation stability test guidelines on the three batches of lotion(batch number 20150727,20150729,20150803)in accordance with the established quality standards traits,identification,examination,content determination was carried out 6 months of accelerated stability test and 12 months of long-term stability test.4.Study on the repair of bacterial infection wound:establish the model of skin incision in mice with staphylococcus aureus or escherichia coli infection,rinse the wound with ganglouyuchuang lotion,observe the wound shrinkage,carry out histopathological evaluation,judge is ganglouyuchuang lotion having any repair effect for bacterial infection wound or not.5.Clinical observation study:Choose 60 cases of patients operated by anal fistula of Crohn’s disease in department of general surgery,General Hospital of Nanjing Military Region,observe them for more than 1 year,conduct a comparison of the recurrence rate,to observe the clinical effect of ganglouyuchuang lotion.Results:1.Preparation process results:study by orthogonal test,the best preparation process of ganglouyuchuang lotion is:according to the proportion take salvia miltiorrhiza,radix astragali,radix sanguisorbae and senecio,soak overnight with 8 times the amount of water,decoct three times,2 h,1.5 h,1.5 h,respectively;combine the decoction and filter,concentrate the filtrate to the ratio of the medicinal materials to the concentrated liquid is 1:1.5,cool,add 2.5 times the amount of ethanol to stir well,cold storage and filter,filtrate recover ethanol to without alcohol;also take the borax with a proper amount of water to heat and stir to dissolve,add to the above solution,stir,set and filter,the filtrate add glycerin and proper water to volume,stir,separate packing,sterilize for 30 min at 100℃ then ganglouyuchuang lotion can be obtained.2.Establish quality standards:establish the method of TLC of salvia miltiorrhiza,radix astragali and radix sanguisorbae,establish the method of HPLC of sodium danshensu in lotion,every milliliter of Salvia miltiorrhiza containing sodium danshensu(C28H32O14)should not be less than 0.3mg,3.Stability test study:3 batch of ganglouyuchuang lotion were preserved for 6 months and 12 months under the condition of accelerated test and long-term test,all the indexes in this period are in accordance with the regulations,indicating that their stability is good.4.Study on the repair of bacterial infection wound:the study found that anal fistula lotion can promote healing of staphylococcus aureus or escherichia coli infected wounds,the shrinkage rate of the wound in mice using anus fistula guaiaci lotion was better.5.Clinical observation study:the observation shows that the clinical efficacy of ganglouyuchuang lotion is better,the healing time and recurrence rate of anal fistula of Crohn’s disease were greatly shortened.Therefore,the quality standard of ganglouyuchuang lotion has been preliminarily established,all the indicators are in accordance with the regulations,the lotion has a certain repair effect to staphylococcus aureus or escherichia coli infected wounds,and its clinical effect is also better,it can be preliminarily determined that ganglouyuchuang lotion has a good therapeutic effect on the anal fistula of Crohn’s disease.