Research Of New Chinese Traditional Medicine Baobeizike Oral Solution

Baobei Relieving a Cough Oral Solution which is Chinese Traditional Medicine compound preparation is made from nine kinds of medical materials such as milkvetch , manchurian lilae bark , bulbus fritillariae unibracteatae and so on ,and it has been used as many-year clinic proved recipe ,and it also has the efficacy of qingfei and expectorant , relieving a cough and smoothing asthma . It can play an important role in curing acute bronchitis, and chronic bronchitis acute outbreak. According to the relative rule and regulation of the new medicine research ,we have completed the medicine clinic researches ,such as including the technics of the dose sort selection , preparation , quality research work , leechdom standard , stability , pharmacology , toxicology and so on . The results are as follows :1 Pharmaceutical ResearchThe medicine was originally taken as the soup , and the soup was non-proprietary Chinese medicines reagent , which is taken and schlepped inconveniently ,and after we do the researches ,we choose the oral solution taken conveniently of absorbing rapidly , and working swiftly . Through the researches of naphtha extraction , water frying technics , alcohol precipitation technics , alcohol precipitation technics pharmacodynamics validation , preparation molding technics and three batches mid-term production , the result of the technics choice confirms the present optimum preparation technics , to guarantee to bring forward the available composition of prescription Chinese traditional medicine materials . In the sample quality standard , we respectively establish the TLC discrimination of main medicine materials , such as milkvetch ,manchurian lilae bark , tatarian aster and ephedra , and the method is demonstrative strongly , and negative comparison has no interference ;the check-up item regulation is that the comparative density is no less than 1.02,PH is 6.0-8.0 , and others should accord with each item of compound dose regulation ;the content determination item is about the main astragaloside IV content of milkvetch measured by patina scanning ,and the limitation is determined by the astragaloside IV(C41H68014)each milkvetch ,no less than 0.31mg .The quality standard can control the pharmacy quality .To guarantee the quality of the medicine storage and the use course , and the clinic curative effect and to determine the medicine use term ,we did the preliminary stable research about the medicine ,and the results show that the sample can be stable to the light and heat ;at the room temperature ,we left the sample for three months , and each indication accorded with the regulation ,without any obvious changes ,which shows the principium stability of Baobei Relieving a Cough Oral Solution is very good .2 Pharmacology and Toxicology Researches1 Main Pharmacodynamics TestThe clinically recommended dose of the sample is 60ml/day?adult(containing raw medicine 28.8g/60ml),the animal dose is 5 , 10 ,15ml/kg(containing raw medicine 2.4 , 4.8 , 7.2g/kg) , which is respectively 5 times , 10 times , 15 times of clinically recommended dose . Relieving a cough , expectorant , and smoothing asthma , in the test Chuanbei Qingfei Tangjiang was used as the positively comparative medicine ;in the immunity test AL tonic capsules was chosen ; in the antibacterial and body outer antibacterial test , Sheganliyan Oral Solution was chosen . The dose is as the same as the clinic dose .The test results about relieving a cough, expectorant , and smoothing asthma show the high , middle doses of the sample can decrease the coughing times to two kinds of coughing animals models caused by 12.5% ammonia 5% citrate ,whose latent period has the prolonging trend , however, compared with the comparison team ,there are no obvious differences ;mice phenol red method and capillary sputum volume method ,the high , middle doses of the sample can obviously have the role in expectorant ;the coughing test of 0.1% histamine and 2% egg protein shows,the medicine can obviously prolong asthma latent period .The high , middle doses teams of Baobei Relieving a Cough Oral Solution can obviously strengthen mice reticuloendothelial system phagocytosis function ;and they can increase mice hemolysin antibodies production and peripheral blood T lymphocytes percent,which indicates the medicine can strengthen animal humoral immunity , and cell immunity function .Baobei Relieving a Cough Oral Solution can evidently restrain small mice ears turgidity caused by dimethylbenzene, capillary vessel permeability and the mice agar granuloma increase.Baobei Relieving a Cough Oral Solution can obviously prolong the small mice bathing death time ,but it has little function on the anti-hypoxia .The test results about body outer antibacterial of the sample show that it has the antibacterial function on the staph ylococcus aureus escherichia coli, bstreptococcus,streptococcus pneumoniae to different extent .2 Tests about Acute Toxicity and Long-term Toxicity Tests about acute toxicity :the medicine does not measure LD50 ,the largest dose is 120ml/kg , which is 120 times of recommending clinic dose,which suggests the medicine has little toxicity .Tests about long-term toxicity : make three kinds of dose teams of 60,40,20ml/kg,administration period is 30 days,and the results shows it has no influence on the big mice weight,and the check-up indications are in the normal range such as viscera body ratio,hematology indicators,blood biochemical indicators, histopathologic examination and so on ,without obvious toxicity,and it is indicated that the medicine has little toxicity in the long-term .Above all , through the research results about its clinic pharmacy , pharmacology , and toxicology , show that the composition , the confirmed dose sort , and preparation technics of Baobei Relieving a Cough Oral Solution can be available .Though the research results of clinic pharmacy , pharmacology , and toxicology , show the medicine composition , and dose kind can be confirmed ,and preparation technics can be available ,and quality standard can control medicine quality ,and after it is reviewed , the principium stability of the medicine is good . The research results of pharmacodynamics shows the medicine relieves a cough obviously , has expectorant , and smooths asthma ;it strengthens animal humour immunity and cell immunity function ;it has anti-inflammatory function ;And it has the roles of the body outer antibacterial and dealing with stress .The test results of acute toxicity and long-term toxicity indicate the medicine toxicity is low.Baobei Relieving a Cough Oral Solution composition ,accords with the preparation principles of Chinese pharmacology,and after it has been taken clinically for twenty years,which proves it is the available medicine to cure acute bronchitis , chronic bronchitis and acute paroxysm .The medicine has the innovation below:1 Manchurian lilae bark can have the roles in qingfei expectorant , relieving a cough and smoothing asthma ,and high doses milkvetch ,can play part in yiqi gubiao tuodu ,and one side is that fuzheng quxie is to make manchurian quxia out ,and the other side is that the spleen is kept good through yiqi gubiao ,to prevent the waixie from inbreaking and interdict the production origin of phlegm .The pathogeny and disease mechanism discussion about acute bronchitis,chronic bronchitis and acute paroxysm corresponds with that above;which breaks the single treatment demonstration , and the single routine about relieving a cough applied in the ancient Chinese traditional medicine treating the disease;2 The complete attacking and filling , chill and fever was used together , smooth and dryness ,and the medicine is nature and sapor kind of mild dose ,and therefore it is used in chill , fever , dryness , and wet phlegm ;3 The medicine materials of the sample pass the lung, whose efficacy is about relieving a cough . In all, the clinic research results about Baobei Relieving a Cough Oral Solution show the medicine safe, available, stable, and its quality can be controlled. It will become safe and dependable Chinese traditional medicine compound preparation with good curative effect in clinic.