The background art comprises the following steps:
the complexity, the multiple points of the action and the comprehensive coordination of the components in the traditional Chinese medicine prescription are consistent with the complexity characteristics of body diseases, and the characteristics of syndrome differentiation and treatment of the traditional Chinese medicine are reflected. The compatibility of traditional Chinese medicines is mainly based on empirical summary, and verification of modern scientific methods is lacked. Therefore, the establishment of a prescription screening method aiming at a complex system of body diseases scientifically clarifies the independent action and the comprehensive action of each component in the prescription, and the development of the research on the Chinese medicines of the components is a main task of the compatibility research of the Chinese medicines.
At present, most of new traditional Chinese medicine research ideas still take classical formulas and clinical experience formulas as bases, and new traditional Chinese medicines are developed through pharmacodynamic research, clinical trial research and the like.
With the development of advanced science and technology, basic research of drug effect substances of traditional Chinese medicines, research of action mechanisms, compatibility research, in vivo and vitro pharmacological research, clinical trial research and the like are widely developed, and the method plays an important role in promoting the modernization and standardization of traditional Chinese medicines. At present, the comparative research of single decoction and mixed decoction of the traditional Chinese medicine decoction tablet, the research of prescription removal and addition and subtraction optimization, the application of network pharmacological theory, the research method of bioavailability, the research method of serum medicine chemistry of the traditional Chinese medicine, the application of molecule knockout technology, the research of improving bioavailability by nanometer technology and the like are reported. However, the compatibility research of the traditional Chinese medicine does not form a set of simple and effective screening method.
The invention content is as follows:
the invention aims to provide a screening method of a traditional Chinese medicine composition for treating qi stagnation type epigastric pain, which is used for selecting a formula, improving the scientificity of compatibility and overcoming the defect of low screening precision of the traditional formula
The screening method of the invention comprises the following steps:
1. the theory of effective prescription is proposed according to the theory of traditional Chinese medicine, and each effective component in the prescription is determined. A modern pharmacological method is applied, a pharmacological model screening system is designed for gastric acid, stomachache, gastrectasia and other qi stagnation type epigastric pain symptoms, and a new traditional Chinese medicine composition is screened by evaluating the contribution degree of each component in the pharmacological model screening system.
2. The screening method of the traditional Chinese medicine composition comprises the following steps:
2.1. the hypothesis of an effective formulation is presented: according to the theory of traditional Chinese medicine, the prescription capable of treating qi stagnation type epigastric pain is designed by screening traditional classical prescriptions, or by document retrieval and statistical analysis, or by experimental research and the like, and an effective prescription hypothesis is provided.
2.2. Determining effective components: effective components in the effective prescription for treating qi stagnation type epigastric pain diseases are determined through known effective parts and experimental research results.
2.3. Preparing an effective component: the components with definite content and controllable quality are obtained by extraction and purification.
2.4. Establishing a pharmacological model screening system: according to the qi stagnation type epigastric pain disease symptoms, related pharmacological models are designed aiming at gastric acid, stomachache, gastrectasia and the like to form a pharmacological model screening system.
2.5. Obtaining pharmacological test data according to the test result of the effective components in the pharmacological model screening system;
2.6. evaluating the contribution degree of the effective components in a pharmacological model screening system according to a contribution degree evaluation method;
2.7. optimizing to generate the Chinese medicinal composition with definite component composition, definite component proportion and definite medicinal effect according to the comprehensive contribution degree of each component in the contribution degree evaluation result;
2.8. the systematic pharmacodynamics verification of the preferred traditional Chinese medicine composition for the qi stagnation type epigastric pain is carried out.
3. The contribution degree evaluation method comprises component contribution degree and comprehensive contribution degree, and the specific calculation and evaluation method comprises the following steps:
3.1. "degree of contribution of components": refers to the ability of the component to contribute to the effect of the test model, denoted by S.
Wherein:
x: administration group index results; m: and (5) model group index result.
3.2. "comprehensive contribution degree": means the comprehensive ability of the component to act on the pharmacological model screening system, and sigma is used S And (4) showing.
3.3. Evaluation of contribution degree:
aiming at the single model comparison of the 'component contribution degree', the action direction and the target point of each component are determined. Example S A >S B Indicating that the A component has higher ability than the B component when acting on the model;
comparing the comprehensive contribution degree of disease symptoms, and determining the action ability of each component on the symptoms, such as Sigma S A >∑S B It means that the A component has a higher ability to act on the disease symptom than the B component. And the traditional Chinese medicine composition for treating qi stagnation type epigastric pain is screened according to the proportion of the comprehensive contribution degree.
The effective prescription hypothesis is provided by screening the traditional classic prescriptions or by literature search and statistical analysis according to the traditional Chinese medicine theory and designing the prescription for treating qi stagnation type epigastric pain.
The effective components are extracted from each single traditional Chinese medicine in the effective prescription hypothesis, and the extract with definite process standard and quality standard is obtained by the steps of extracting, separating, purifying, concentrating, drying and the like, the fingerprint features of the extract are definite, and the content indexes of the effective components or the effective component groups are definite.
The pharmacological model screening system is composed of animal test models of gastric emptying, small intestine propulsion, analgesia, anti-inflammation and the like and pharmacological test methods of smooth muscle spasmolysis in vitro experiments and the like, and is used as a screening system of a new traditional Chinese medicine composition for qi stagnation type epigastric pain.
The new traditional Chinese medicine composition is obtained according to the screening step of the screening method 2, and is a traditional Chinese medicine composition with definite components and proportions for treating qi stagnation type epigastric pain diseases.
The invention has the positive effects that: aiming at the screening research of the new composition for treating qi stagnation type epigastric pain, a new drug composition screening method taking contribution degree evaluation as the core is established, so that a new effective composition is obtained, and a referable method is provided for screening new drug compositions for other diseases. The composition obtained by screening with the method is as follows: 5 parts of total saikosaponin: 3 parts of total saponins of white peony root: 4 parts of fructus aurantii volatile oil: 4 parts of nutgrass galingale rhizome volatile oil: 2 parts of rhizoma corydalis total alkaloids: 3 parts of licorice total flavonoids.