Development Of "Bunao Decoction" Oral Liquid Of Recipe Of Famous Chinese Physician Wei Changchun

Objective:Identify the source of the Chinese herbal medicines and extracts in the prescriptions and establish the quality standards.The orthogonal test is designed to optimize the water extraction and alcohol precipitation conditions,and the preparation of the Bunao Oral Liquid is determined by optimizing the compatibility of the pharmaceutical excipients.Qualitative and quantitative quality standards for Bunao Oral Liquid were established.The stability of Bunao Oral Liquid was investigated.The effect of Bunao Oral Liquid on mice's sleep was studied and efficacy tests were conducted.Methods:(1).The content of polysaccharides in three extracts of Huangjing,Yuzhu and Juemingzi was determined by phenol-concentrated sulfuric acid method,and the content of alcohol-soluble extracts was determined.The content of ferulic acid was determined by high performance liquid chromatography(HPLC).The qualitative identification was performed by thin layer chromatography(TLC).The determination of moisture content,total ash content and acid-insoluble ash content were determined by Pharmacopoeia method.(2).Taking the total polysaccharide content as an index,orthogonal experiments were designed by selecting three factors,namely the amount of water added,the volume ratio of ethanol,and the time of alcohol precipitation,and a standard curve was drawn to select the best water extraction and alcohol precipitation conditions.(3).The qualitative identification standard for medicinal materials was established by TLC.The content of total polysaccharides and ferulic acid were used as indexes to establish the standards for determination of the content.(4).The high temperature test and accelerated test were used to investigate the stability of Bunao Oral Liquid.(5).Through the direct sleep test of mice,prolonging the sleep time test of pentobarbital sodium mice,hypnotic test of subthreshold dose of pentobarbital sodium in mice,and sleep latency test of mice with pentobarbital sodium,the effect of Bunao Oral Liquid on experimental animals,and the effect of sleep deprivation on the inducible nitric oxide synthase(iNOS)in the brain of rats these five tests,the effect of Bunao Oral Liquid on sleep in experimental animals was investigated.Results:(1).The experimental results show that the extracts used in this project and Chuanxiong original herbs comply with the relevant provisions of Pharmacopoeia.(2).The optimum conditions of water-ethanol precipitation were as follows: the amount of water was 20 times the mass of the extract,the volume ratio of ethanol was 60 % and the alcohol precipitation time was24 hours.Choose 1 % poloxamer 188 as surfactant and the time of high-speed stirring is 15 min.Select high-sweetness and low calory stevioside as the main flavor,and mannitol aided seasoning.The commonly used potassium sorbate was chosen as preservatives at 0.1 %.The solution preparation is sterile.(3).Bunao oral liquid was prepared according to the above preferred process,which was a brown transparent liquid with a slight odor of Chinese traditional medicine.It is sweet and slightly astringent,and has no precipitate or suspended matter.Relative density of oral liquid is more than1.16.The pH value is in the range of 4.5 to 6.5.The original medicine qualitative identification meets the relevant regulations.The polysaccharide content of the oral solution was determined to be 131 mg/mL by phenol-concentrated sulfuric acid method,and the content of ferulic acid was 0.197 mg/mL in the oral liquid by high performance liquid chromatography.(4).The results of the high temperature test,the accelerated test and the normal temperature retention sample test showed that the oral liquid sample did not precipitate and precipitate,and the appearance properties were stable.The original decoction began to show granular precipitation and turbidity on the fifth day of the high-temperature test,and began to appear granular precipitates and turbidity in the third month of the accelerated test and normal temperature retention sample test.In the high temperature test,the polysaccharide content and ferulic acid content of the oral liquid on the 10 th day were 102.80% and 99.42% compared with 0th day respectively.The content of the original decoction was 76.24% and85.78% compared with the 0th day.In the accelerated test,the polysaccharide content and ferulic acid content of the oral liquid on the 6th month were 98.93% and 99.07% compared with 0th day respectively.The content of the original decoction was 65.56% and 81.23% compared with the 0th day.In the normal temperature retention sample test,the polysaccharide content and ferulic acid content of the oral liquid on the12 th month were 96.51% and 97.88% compared with 0th day respectively.The content of the original decoction was 41.35% and 64.48%compared with the 0th day.It can be seen that oral liquid samples are superior to the original decoction in terms of stability and retention of active ingredients.(5).Animal experiments showed that Bunao Oral Liquid could significantly prolong the sleep time of mice injected with pentobarbital sodium,significantly increase the sleep rate of mice injected with subliminal dose of pentobarbital sodium,significantly shorten the sleep latency time of mice injected with pentobarbital sodium,and significantly reduce iNOS activity in the forebrain tissue of sleep deprived rats.Conclusion:This topic optimizes the process,prepares a Bunao Oral Liquid,establishes quality standards,and conducts pharmacodynamic studies.Compared with the original decoction,the oral liquid has the advantages of convenient storage,transportation,and administration,improved quality standards,good stability,long-term retention of ingredients,long effective period,and soothing and improving sleep efficacy.It laid the foundation for further pilot study and industrialization.