| Compound Danshen preparation composed of Salvia miltiorrhiza,Radix Notoginseng and Borneol can therapy angina pectoris.The main active components of Danshen are water-soluble salvianolic acids(Sals) and liposoluble tanshinones(Tans).Tanshinone have many roles of anti-atherosclerosis, reduce the myocardial infarct size, reducing myocardial oxygen consumption, and anti-arrhythmic effect. Salvianolic acid have many roles of expansion to increase coronary blood flow, anti-angina, anti-lipid peroxidation and free radical scavenging effects. Modern research shows that two types of chemical constituents of Danshen, including cardio-and cerebro-vascular and blood systems are a significant and extensive pharmacological effects, but have different emphases, and two types of active ingredients after the combined effect significantly stronger than a single component. At present, the preparations containing Danshen mainly:①Water-soluble components of preparations:the main varieties are Danshen injection, Danshen powder injections, as well as Compound Danshen Dropping Pill, etc;②fat-soluble components of preparations: the main types of drugs have Tanshinone tablets, Tanshinone Shuxin Capsule, etc;③both fat-soluble components and water-soluble components to the One particular type of agent-based Danshen:Danshen preparation of such formulations is the subject of a compound preparation mainly used for coronary heart disease and cerebrovascular disease, the main varieties have compound Danshen Tablets, Dan Qi Tablets, and so on. The former two types of agents reflects only contain one type of Danshen chemical composition,but neglect the other chemical constituents. Production process is not the only problem, the most important thing is not contains two types of active ingredients at the same time. On the one hand, waste a large number of Materia Medica, on the other hand, a serious impact on the clinical efficacy of Danshen. The third type of agents is difficult to play a role in the rapid treatment. At the same time, the extraction of existing formulations is mainly water extract, aqueous alcohol extract or a combination with the alcohol extract. From time to time in the recovery of residual ethanol, and in the process of extraction and concentration loss of more active ingredients, culminating in the preparation of low content of active ingredients. In this paper, two different methods were extracted from the Tans and Sals, And then refined Tans and compatibility with Borneol filling in the A cavity of self-developed spray devices; In addition, refined Sals and compatibility with PNS filling in the cavity B. Danshen oral spray with two types of effective parts has developed, Identified compound Danshen spray preparation process, and initial established the corresponding quality standards.1. The fat-soluble and water-soluble active ingredients of Danshen herbs were set up by HPLC method, the extraction methods of medicinal herbs were evaluated.2. Orthogonal design was used for studying the effect of 3 factors(Extraction temperature, extraction pressure and ethanol concentration) to estracting technical of fat-soluble part of Danshen,with the content of TanshinoneⅡA and extrace yiele as evaluation indexes to potimize the extracting technical.The best technical is at the pressure of 15 Mpa with 95% ethanol,at 35℃. The refining technical was concentrate at 60℃,and the concentrate was dried with a low pressure,its yield was 2.1% (tanshinoneⅡA containing 12.7%).Orthogonal design was also used for studying the effect of 3 factors(water volume,time and times) to extracing technical of water-soluble part of Danshen,with the content of Salvianolic acid B and extrace yield as evaluation indexes to optimize the extracting technical.The best technical was adding 8 times water refluxing for 8 times,2minutes each time.The refining technical is make the percolate which using HAC tune PH= 3, after chromatography on polyamide mixed to Polyamide column chromatography,wash the mixture with water when its molisch reaction is negative,then wash the mixture with 60% alcohol and 5 times volume of percolate,reclaim alcohol from the washed alcohol,and the concentrate was dried with a low pressure at 60℃,its yield was 5.8%(Salvianolic acid B containing 46.8%).3. In order to enhance the active ingredient solubility and stability of the Danshen spray, screened the corresponding accessories, and finally identified the formula. In order to set up quality standards,thin layer chromatography was performed to identify the ingredients of the spraying preparation,and a quantitative method was prevented for determination of TanshinoneⅡA and Salvianolic acid B by HPLC. the initial stability of Danshen spray studied on 3 months(40℃), the indicators are in line with the requirements. Description this product is stable. |
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