Traditional Chinese medicine composition for clearing away heat and toxic materials as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention relates to the technical field of traditional Chinese medicine, and discloses a traditional Chinese medicine composition for clearing away heat and toxic materials as well as a preparation method and application thereof, and the traditional Chinese medicine composition comprises the following components in parts by weight: 10-30 parts of dandelion, 3-15 parts of trollflower, 5-30 parts of folium isatidis, 5-20 parts of radix puerariae and 3-15 parts of perilla leaf. The preparation method comprises the following steps: mixing dandelion, trollflower, folium isatidis, radix puerariae and perilla leaf medicinal materials, adding a solvent, decocting for 2-3 times, mixing decoction, concentrating, adding the solvent, stirring, standing, filtering, concentrating filtrate under reduced pressure, spray-drying concentrated solution, crushing obtained particles into dry extract powder, and adding auxiliary materials to prepare the required preparation. And carrying out quality control and packaging on the prepared granules, tablets, pills, capsules, decocted extracts, oral liquid and the like. The traditional Chinese medicine composition disclosed by the invention has relatively high drug effect and stability, and also has the effects of clearing away heat and toxic materials, resisting inflammation and the like.

Description

Technical Field

[0001] The invention relates to the technical field of traditional Chinese medicines, and in particular to a traditional Chinese medicine composition for clearing away heat and detoxifying, and a preparation method and application thereof. Background Art

[0002] In recent years, the frequent occurrence of seasonal influenza has easily led to diseases such as upper respiratory tract infection, pharyngitis and tonsillitis. The high incidence of these diseases has led to a significant decline in the quality of life of patients, especially for the elderly, children and individuals with low immunity. Therefore, how to effectively prevent and treat the above diseases has become an important topic in medical research.

[0003] As a traditional Chinese medicine, golden lotus is widely used in upper respiratory tract infection, pharyngitis and tonsillitis caused by wind-heat evil attacking the lungs, internal heat and toxicity, etc. due to its significant heat-clearing and detoxifying effects. However, the existing golden lotus single-prescription preparations have relatively single effects and limited scope of application, which cannot fully meet clinical needs.

[0004] Literature records that the traditional compound golden lotus decoction for clearing heat and detoxifying has many inconveniences in modern clinical application, such as inconvenient storage and transportation, easy deterioration; inconvenience for patients to take, especially for children and elderly patients; unstable dosage, and it is difficult for patients to accurately control the amount taken; there are potential risks for specific patient groups (such as diabetics, pregnant women, etc.).

[0005] In response to the drawbacks of current heat-clearing and detoxifying drugs, a Chinese medicine composition for clearing heat and detoxifying was invented. Not only was the drug efficacy further enhanced through scientific compound ratio design, but a variety of dosage forms were developed, which significantly improved the deficiencies in drug stability, ease of use, dosage control, etc., and improved patients' compliance. Summary of the invention

[0006] 1. Technical issues to be solved

[0007] In view of the deficiencies in the prior art, the present invention provides a traditional Chinese medicine composition for clearing away heat and detoxifying, and a preparation method and application thereof, which has high efficacy and stability, and has the effects of clearing away heat and detoxifying, anti-inflammatory and the like.

[0008] (II) Technical solution

[0009] To achieve the above purpose, the present invention provides the following technical scheme: a traditional Chinese medicine composition for clearing away heat and detoxifying, comprising the following components by weight: 10-30 parts by weight of dandelion, 3-15 parts by weight of trollius, 5-30 parts by weight of isatis indigotica, 5-20 parts by weight of kudzu root, and 3-15 parts of perilla leaf.

[0010] Furthermore, the preparation method of the traditional Chinese medicine composition for clearing away heat and detoxifying is as follows: combine the above-mentioned dandelion, trollius, isatis indigotica, kudzu root, and perilla leaf medicinal materials, add a solvent and boil them for 2-3 times, combine the decoctions, concentrate them, add a solvent, stir, let stand, filter, concentrate the filtrate under reduced pressure, spray-dry the concentrated solution, crush the obtained particles into dry extract powder, add auxiliary materials, and prepare the desired preparation; and perform quality control and packaging on the prepared granules, tablets, pills, capsules, decoctions, oral liquids, etc.

[0011] Furthermore, the decoction is performed 2-3 times.

[0012] Furthermore, the auxiliary materials of the granules, tablets, pills and capsules include any one of starch, glutinous rice flour, lactose and sodium carboxymethyl cellulose.

[0013] Furthermore, the spray drying conditions are: inlet air temperature is 90-110°C, outlet air temperature is 60-90°C, material temperature is 60-90°C, atomization pressure is 0.2-0.5 MPa, and spray speed is 1-10 ml / s.

[0014] Furthermore, the solvent includes any one of water, ethanol, tetrahydrofuran, propylene glycol, toluene, and ethyl acetate.

[0015] Furthermore, the packaging of the traditional Chinese medicine composition for clearing away heat and detoxifying is in the form of single-dose independent packaging.

[0016] Furthermore, the application of the method in preparing a medicine having the effect of clearing away heat and detoxifying.

[0017] (III) Beneficial technical effects

[0018] 1. Diversification of dosage forms: Converting traditional decoctions into granules, tablets, pills, capsules, decoctions, etc. has greatly improved the convenience of drug use and patient compliance.

[0019] 2. Precise dosage and convenience: Modern dosage forms can accurately control dosage, avoiding the inconvenience of taking traditional decoctions and inaccurate dosage.

[0020] 3. Improved stability: Modern dosage forms improve the stability of drugs and avoid the problem of efficacy attenuation of traditional decoctions during storage and transportation.

[0021] 4. Improved extraction efficiency: The composite solvent system of water and ethanol combines the extraction capabilities of water-soluble and fat-soluble components, especially for the extraction of both water-soluble and fat-soluble components in Chinese medicinal materials.

[0022] 5. Improvement of comprehensive efficacy: Through compound design and modern dosage form development, the efficacy of drugs can be improved in many aspects and can better meet the needs of modern patients.

[0023] 6. Improve market adaptability: The present invention optimizes traditional Chinese medicine decoctions into modern multi-dosage forms, which meets the current society's requirements for high efficiency, convenience and safety of drugs, and improves the market adaptability of the product.

[0024] 7. Enhanced efficacy: Compared with the single preparation of Golden Lotus and the existing decoction, the compound composition achieves the synergistic effect of multiple components, significantly improving the comprehensive efficacy of clearing heat and detoxifying, anti-inflammatory and antiviral.

[0025] 8. Optimized storage conditions: Various dosage forms have a long shelf life and are easy to transport and store, overcoming the defect of traditional decoctions that are easy to deteriorate. DETAILED DESCRIPTION

[0026] Preparation of tablets:

[0027] Take the above-mentioned dried extract powder, add auxiliary materials (such as any one of lactose, starch, and sodium carboxymethyl cellulose), and use a tablet press to press and form tablets to ensure that the tablets have stable shape, accurate dosage, and are suitable for long-term storage. The tablets are subjected to quality tests in terms of hardness, disintegration time, solubility, etc. to ensure that they meet the drug quality standards.

[0028] Preparation of capsules:

[0029] Take the above-mentioned dried extract powder, add appropriate auxiliary materials (such as starch, microcrystalline cellulose) and mix evenly, and use a capsule filling machine to fill it into hard capsules or soft capsules. In order to improve the patient's taking experience, soft capsules can be selected to effectively mask the bitter taste of the drug.

[0030] Preparation of decoction:

[0031] The concentrate is mixed with auxiliary materials (such as honey or licorice extract) and prepared into a paste using low-temperature concentration technology. To avoid the inactivation of the active ingredients of the drug due to high temperature, the temperature of the entire process is controlled below 50°C. The resulting decoction can be packaged in appropriate amounts for patients to take as needed.

[0032] Preparation of oral solution:

[0033] The concentrated liquid is diluted to an appropriate concentration, and auxiliary materials such as licorice and mint are added to improve the taste. It is then filtered and impurities are removed to obtain a clear and transparent oral liquid, which is finally packaged according to dosage for the convenience of daily use by patients.

[0034] Example 1

[0035] Take 10g of dandelion, 3g of trollius, 5g of isatis indigo leaf, 5g of kudzu root, and 3g of perilla leaf, mix them evenly according to the above proportions, add the above medicinal materials to solvent water 6 times the weight of the medicinal materials, and boil them under normal pressure for 1 hour; during the boiling process, keep boiling and stir at appropriate times to ensure that the effective ingredients of the medicinal materials are fully released, add the medicinal material residue to solvent water 5 times the weight of the medicinal materials; continue to boil for 1 hour to complete the second decoction, after the two decoctions are combined, filter and remove the residue to obtain a preliminary extract, and the two combined decoctions are subjected to reduced pressure concentration treatment, the temperature is controlled at 50°C, and concentrated to 1 / 4 of the volume of the medicinal liquid, and then the concentrate is sent to the spray In the drying tower, the spray drying conditions are set as: inlet air temperature 90°C, outlet air temperature 60°C, atomization pressure 0.2 MPa, and spray speed 1 ml / s. Finally, the dried extract powder is obtained, and the dried extract powder is mixed with the auxiliary material starch at a mass ratio of 1:0.5, and wet granulation is carried out. Qualified granules are obtained through particle screening to ensure that the particles are uniform and have good solubility. The active ingredient content of the granules is tested to ensure that it meets the drug quality standards. Finally, the granules are independently packaged in single doses using packaging materials that meet drug requirements to ensure the stability of the drug during transportation and storage.

[0036] Example 2

[0037] Take 30g of dandelion, 15g of trollius, 30g of isatis indigo leaf, 20g of kudzu root, and 15g of perilla leaf, mix them evenly according to the above proportions, add the above medicinal materials to solvent water 6 times the weight of the medicinal materials, and boil them under normal pressure for 1 hour; during the boiling process, keep boiling and stir at appropriate times to ensure that the effective ingredients of the medicinal materials are fully released, add the medicinal material residue to solvent water 5 times the weight of the medicinal materials; continue to boil for 1 hour to complete the second decoction, after the two decoctions are combined, filter and remove the residue to obtain a preliminary extract, and the two combined decoctions are subjected to reduced pressure concentration treatment, the temperature is controlled at 70°C, and concentrated to 1 / 4 of the volume of the medicinal liquid, and then the concentrate is sent to a spray In the spray drying tower, the spray drying conditions are set as: inlet air temperature 110°C, outlet air temperature 90°C, atomization pressure 0.5 MPa, and spray speed 10 ml / s. Finally, the dried extract powder is obtained, and the dried extract powder is mixed with the auxiliary material starch at a mass ratio of 1:0.6, and wet granulation is carried out. Qualified granules are obtained through particle screening to ensure that the particles are uniform and have good solubility. The active ingredient content of the granules is tested to ensure that it meets the drug quality standards. Finally, the granules are independently packaged in single doses using packaging materials that meet drug requirements to ensure the stability of the drug during transportation and storage.

[0038] Example 3

[0039] Take 30g of dandelion, 12g of trollius, 20g of isatis indigo leaf, 15g of kudzu root, and 12g of perilla leaf, mix them evenly according to the above proportions, add the above medicinal materials to solvent water 6 times the weight of the medicinal materials, and boil them under normal pressure for 1 hour; during the boiling process, keep boiling and stir at appropriate times to ensure that the effective ingredients of the medicinal materials are fully released, add the medicinal material residue to solvent water 5 times the weight of the medicinal materials; continue to boil for 1 hour to complete the second decoction, after the two decoctions are combined, filter and remove the residue to obtain a preliminary extract, and the two combined decoctions are subjected to reduced pressure concentration treatment, the temperature is controlled at 60°C, and concentrated to 1 / 4 of the volume of the medicinal liquid, and then the concentrate is sent to a spray In the spray drying tower, the spray drying conditions are set as: inlet air temperature 95°C, outlet air temperature 70°C, atomization pressure 0.3 MPa, and spray speed 5 ml / s. Finally, the dried extract powder is obtained, and the dried extract powder is mixed with the auxiliary material starch at a mass ratio of 1:0.55, and wet granulation is carried out. Qualified granules are obtained through particle screening to ensure that the particles are uniform and have good solubility. The active ingredient content of the granules is tested to ensure that it meets the drug quality standards. Finally, the granules are independently packaged in single doses using packaging materials that meet drug requirements to ensure the stability of the drug during transportation and storage.

[0040] Example 4

[0041] Take 22g of dandelion, 14g of trollius, 18g of isatis indigo leaf, 16g of kudzu root, and 12g of perilla leaf, mix them evenly according to the above proportions, add the above medicinal materials to solvent water 6 times the weight of the medicinal materials, and boil them under normal pressure for 1 hour; during the boiling process, keep boiling and stir at appropriate times to ensure that the effective ingredients of the medicinal materials are fully released, add the medicinal material residue to solvent water 5 times the weight of the medicinal materials; continue to boil for 1 hour to complete the second decoction, after the two decoctions are combined, filter and remove the residue to obtain a preliminary extract, and the two combined decoctions are subjected to reduced pressure concentration treatment, the temperature is controlled at 55°C, and concentrated to 1 / 4 of the volume of the medicinal liquid, and then the concentrate is sent to a spray In the spray drying tower, the spray drying conditions are set as: inlet air temperature 105°C, outlet air temperature 85°C, atomization pressure 0.2 MPa, and spray speed 8 ml / s. Finally, the dried extract powder is obtained, and the dried extract powder is mixed with the auxiliary material starch at a mass ratio of 1:0.57, and wet granulation is carried out. Qualified granules are obtained through particle screening to ensure that the particles are uniform and have good solubility. The active ingredient content of the granules is tested to ensure that it meets the drug quality standards. Finally, the granules are independently packaged in single doses using packaging materials that meet drug requirements to ensure the stability of the drug during transportation and storage.

[0042] Example 5

[0043] Take 14g of dandelion, 11g of trollius, 10g of isatis indigo leaf, 14g of kudzu root, and 9g of perilla leaf, mix them evenly according to the above proportions, add the above medicinal materials to solvent water 6 times the weight of the medicinal materials, and boil them under normal pressure for 1 hour; during the boiling process, keep boiling and stir at appropriate times to ensure that the effective ingredients of the medicinal materials are fully released, add the medicinal material residue to solvent water 5 times the weight of the medicinal materials; continue to boil for 1 hour to complete the second decoction, after the two decoctions are combined, filter and remove the residue to obtain a preliminary extract, and the two combined decoctions are subjected to reduced pressure concentration treatment, the temperature is controlled at 64°C, and concentrated to 1 / 4 of the volume of the medicinal liquid, and then the concentrate is sent to a spray In the spray drying tower, the spray drying conditions are set as: inlet air temperature 92°C, outlet air temperature 80°C, atomization pressure 0.5 MPa, and spray speed 9 ml / s. Finally, the dried extract powder is obtained, and the dried extract powder is mixed with the auxiliary material starch at a mass ratio of 1:0.53, and wet granulation is carried out. Qualified granules are obtained through particle screening to ensure that the particles are uniform and have good solubility. The active ingredient content of the granules is tested to ensure that it meets the drug quality standards. Finally, the granules are independently packaged in single doses using packaging materials that meet drug requirements to ensure the stability of the drug during transportation and storage.

[0044] Example 6

[0045] Take 13g of dandelion, 15g of trollius, 25g of isatis indigo leaf, 16g of kudzu root, and 10g of perilla leaf, mix them evenly according to the above proportions, add the above medicinal materials to solvent water 6 times the weight of the medicinal materials, and decoct them under normal pressure for 1 hour; during the decoction process, keep boiling and stir at appropriate times to ensure that the effective ingredients of the medicinal materials are fully released, add the medicinal material residue to solvent water 5 times the weight of the medicinal materials; continue to decoct for 1 hour, complete three decoctions, after the two decoctions are combined, filter and remove the residue to obtain a preliminary extract, and the two combined decoctions are subjected to reduced pressure concentration treatment, the temperature is controlled at 60°C, and concentrated to 1 / 4 of the volume of the medicinal liquid, and then the concentrate is sent to a spray In the spray drying tower, the spray drying conditions are set as: inlet air temperature 100°C, outlet air temperature 75°C, atomization pressure 0.4 MPa, and spray speed 6 ml / s. Finally, the dried extract powder is obtained, and the dried extract powder is mixed with the auxiliary material starch at a mass ratio of 1:0.57, and wet granulation is carried out. Qualified granules are obtained through particle screening to ensure that the particles are uniform and have good solubility. The active ingredient content of the granules is tested to ensure that it meets the drug quality standards. Finally, the granules are independently packaged in single doses using packaging materials that meet drug requirements to ensure the stability of the drug during transportation and storage.

[0046] The preferred embodiments of the present invention disclosed above are only used to help illustrate the present invention. The preferred embodiments do not describe all the details in detail, nor do they limit the invention to the specific implementation methods described. Obviously, many modifications and changes can be made according to the content of this specification. This specification selects and specifically describes these embodiments in order to better explain the principles and practical applications of the present invention, so that those skilled in the art can understand and use the present invention well. The present invention is limited only by the claims and their full scope and equivalents.

Claims

1. A Chinese medicine composition for clearing away heat and detoxifying, characterized in that: The invention comprises the following components by weight: 10-30 parts by weight of dandelion, 3-15 parts by weight of golden lotus, 5-30 parts by weight of isatis indigofera, 5-20 parts by weight of kudzu root and 3-15 parts of perilla leaf.

2. The method for preparing the Chinese medicine composition for clearing away heat and detoxifying according to claim 1, characterized in that: The preparation method of the traditional Chinese medicine composition for clearing away heat and detoxifying is as follows: combining the above-mentioned dandelion, trollius, isatis indigo leaf, kudzu root and perilla leaf medicinal materials, adding a solvent and boiling for 2-3 times, combining the decoctions, concentrating, adding a solvent, stirring, standing, filtering, concentrating the filtrate under reduced pressure, spray-drying the concentrated solution, crushing the obtained particles into dry extract powder, adding auxiliary materials, and preparing the required preparation; and performing quality control and packaging on the prepared granules, tablets, pills, capsules, decoctions, oral liquids and the like.

3. The method for preparing the Chinese medicine composition for clearing away heat and detoxifying according to claim 2, characterized in that: The decoction times are 2-3 times.

4. The method for preparing the Chinese medicine composition for clearing away heat and detoxifying according to claim 2, characterized in that: The auxiliary materials of the granules, tablets, pills and capsules include any one of starch, glutinous rice flour, lactose and sodium carboxymethyl cellulose.

5. The method for preparing the Chinese medicine composition for clearing away heat and detoxifying according to claim 2, characterized in that: The spray drying conditions are: air inlet temperature 90-110°C, air outlet temperature 60-90°C, material temperature 60-90°C, atomization pressure 0.2-0.5 MPa, and spray speed 1-10 ml / s.

6. The method for preparing the Chinese medicine composition for clearing away heat and detoxifying according to claim 2, characterized in that: The solvent includes any one of water, ethanol, tetrahydrofuran, propylene glycol, toluene and ethyl acetate.

7. The method for preparing the Chinese medicine composition for clearing away heat and detoxifying according to claim 2, characterized in that: The packaging of the traditional Chinese medicine composition for clearing away heat and detoxifying is in the form of single-dose independent packaging.

8. A Chinese medicine composition for clearing away heat and detoxifying according to any one of claims 1 to 7, characterized in that: The application of the invention in preparing medicines with heat-clearing and detoxifying effects.