Qingli decoction traditional Chinese medicine composition as well as preparation method and application thereof

Abstract

The invention discloses a Qingli decoction traditional Chinese medicine composition as well as a preparation method and application thereof, and relates to the field of Qingli decoction, the Qingli decoction traditional Chinese medicine composition comprises the following raw materials in parts by weight: 15 parts of radix scrophulariae, 12 parts of radix ophiopogonis, 12 parts of lily, 8 parts of radix bupleuri, 12 parts of radix paeoniae alba, 7 parts of pericarpium citri reticulatae, 7 parts of semen brassicae, 12 parts of selfheal, 7 parts of caulis bambusae in taeniam, 12 parts of semen plantaginis, 7 parts of akebiaquinata, 7 parts of radix gentianae and 5 parts of rhizoma coptidis. According to the Qingli decoction traditional Chinese medicine composition as well as the preparation method and the application thereof, thirteen medicinal materials including radix scrophulariae, radix ophiopogonis and the like which have definite effects of clearing heat and causing diuresis are selected and combined through scientific compatibility and optimization principles. The medicinal materials cooperate with one another to jointly exert the effects of clearing away heat and toxic materials and inducing diuresis to reduce edema, and the traditional Chinese medicine is accurately used for treating the symptoms such as cough, excessive phlegm, swollen sore throat and difficult urination caused by lung heat and damp-heat downward flow. Through scientific compatibility, the problem that the curative effect difference between different batches or patients is large due to lack of scientific verification and optimization of a traditional compound is avoided, and the high efficiency and stability of the formula are ensured.

Description

A traditional Chinese medicine composition for clearing heat and detoxifying, its preparation method and application Technical Field

[0001] This invention relates to the technology of Qingli Decoction, specifically to a Qingli Decoction Chinese herbal composition, its preparation method, and its application. Background Technology

[0002] In traditional Chinese medicine theory, clearing heat and promoting diuresis are important principles for treating various diseases. With the accelerated pace of modern life and environmental changes, diseases caused by lung heat and damp-heat accumulation are increasingly common, with symptoms such as cough, excessive phlegm, sore throat, difficulty urinating, and edema frequently appearing, seriously affecting patients' quality of life. Although various heat-clearing and diuretic drugs exist on the market, most suffer from insignificant efficacy and significant side effects. Therefore, developing a traditional Chinese medicine composition for clearing heat and promoting diuresis with significant efficacy and minimal side effects is of great practical significance. Summary of the Invention

[0003] The purpose of this invention is to provide a Qingli Decoction traditional Chinese medicine composition, its preparation method, and its application, so as to solve the problems of insignificant efficacy and large side effects of existing drugs.

[0004] To achieve the above objectives, the present invention provides the following technical solution: a Qingli Decoction traditional Chinese medicine composition comprising the following raw materials in parts by weight: 10-20 parts of Scrophularia ningpoensis, 10-15 parts of Ophiopogon japonicus, 10-15 parts of Lilium brownii, 5-10 parts of Bupleurum chinense, 10-15 parts of Paeonia lactiflora, 5-10 parts of Citrus reticulata peel, 5-10 parts of Sinapis alba seed, 10-15 parts of Prunella vulgaris, 5-10 parts of Bambusa textilis, 10-15 parts of Plantago asiatica seed, 5-10 parts of Akebia trifoliata, 5-10 parts of Gentiana scabra, and 3-8 parts of Coptis chinensis.

[0005] Furthermore, the raw materials are in the following weight proportions: 15 parts of Scrophularia ningpoensis, 12 parts of Ophiopogon japonicus, 12 parts of lily bulb, 8 parts of Bupleurum chinense, 12 parts of Paeonia lactiflora, 7 parts of Citrus reticulata peel, 7 parts of Sinapis alba seed, 12 parts of Prunella vulgaris, 7 parts of Bambusa textilis, 12 parts of Plantago asiatica seed, 7 parts of Akebia quinata, 7 parts of Gentiana scabra, and 5 parts of Coptis chinensis.

[0006] A method for preparing a traditional Chinese medicine composition for clearing heat and decoction includes the following steps:

[0007] Step 1: Wash and dry the following ingredients by weight: Scrophularia, Ophiopogon japonicus, Lilium brownii, Bupleurum chinense, Paeonia lactiflora, Citrus reticulata peel, Sinapis alba seed, Prunella vulgaris, Bambusa textilis, Plantago asiatica seed, Akebia trifoliata, Gentiana scabra, and Coptis chinensis.

[0008] Step 2: Mix the dried ingredients in the specified proportions, add 8-10 times the amount of water, and soak for 30-60 minutes;

[0009] Step 3: Heat the soaked mixture to a boil, maintain a simmer for 1-2 hours, and filter to obtain the first decoction;

[0010] Step 4: Add 5-7 times the amount of water to the dregs, heat again to a boil, maintain a simmer for 0.5-1 hour, and filter to obtain the second decoction.

[0011] Step 5: Combine the first and second decoctions and concentrate them into a clear extract with a relative density of 1.05-1.10 (60℃);

[0012] Step Six: Dry the paste to obtain dry paste powder, which is the Qingli Decoction herbal composition.

[0013] Furthermore, the drying process is vacuum drying or spray drying.

[0014] Furthermore, the concentration process in step five is carried out under reduced pressure to minimize the loss of active ingredients.

[0015] Furthermore, the application of the Qingli Decoction herbal composition in the preparation of heat-clearing drugs, which are used to treat symptoms of cough, excessive phlegm, and sore throat caused by lung heat.

[0016] Furthermore, the application of the Qingli Decoction herbal composition in the preparation of diuretic drugs, wherein the diuretic drugs are used to treat symptoms of dysuria and edema caused by damp-heat accumulation in the lower body.

[0017] Furthermore, the pharmaceutical preparation of the Qingli Decoction traditional Chinese medicine composition is an oral preparation, including granules, tablets, capsules, or oral liquid.

[0018] Compared with the prior art, the Qingli Decoction traditional Chinese medicine composition, its preparation method, and its application provided by the present invention have the following beneficial effects:

[0019] This invention abandons the traditional empirical approach of using traditional Chinese medicine formulas for clearing heat and promoting diuresis. Instead, it adopts a scientific approach based on formulation and optimization, carefully selecting thirteen herbs, including Scrophularia and Ophiopogon japonicus, which have clear heat-clearing and diuretic effects. These herbs work synergistically to clear heat, detoxify, promote diuresis, and reduce swelling, precisely targeting symptoms such as cough, excessive phlegm, sore throat, and difficulty urinating caused by lung heat and damp-heat accumulation. This scientific formulation avoids the problem of significant differences in efficacy between different batches or patients caused by the lack of scientific validation and optimization in traditional formulas, ensuring the high efficiency and stability of the formula. Simultaneously, the careful selection of herbs and precise dosage control effectively reduces the use of potentially risky components, lowering the probability of side effects and making the Qingli Tang (Clearing and Draining Decoction) herbal composition safer and more reliable in clinical application, providing patients with a better treatment option.

[0020] This invention introduces a standardized preparation process, encompassing precise steps such as cleaning, soaking, decocting, concentrating, and drying, with strict control over conditions at each step, such as soaking time, decoction time, and concentration ratio. This series of standardized operations ensures the product's therapeutic stability and quality controllability, solving the problem of uncontrollable product quality caused by the lack of unified standards in traditional preparation methods. Furthermore, the use of advanced vacuum drying or spray drying technologies further improves the product's purity and stability. Regarding ease of administration, the Qingli Tang herbal composition is formulated into various oral dosage forms such as granules and tablets, greatly improving patient convenience and compliance, contributing to enhanced therapeutic effects and improved quality of life, and possessing broad clinical application prospects and promotional value. Attached Figure Description

[0021] To more clearly illustrate the technical solutions in the embodiments of this application or the prior art, the drawings used in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments recorded in this invention. For those skilled in the art, other drawings can be obtained based on these drawings.

[0022] Figure 1 is a flowchart of a Qingli Decoction traditional Chinese medicine composition of the present invention, its preparation method and application. Detailed Implementation

[0023] To enable those skilled in the art to better understand the technical solution of the present invention, the present invention will be further described in detail below with reference to the accompanying drawings.

[0024] Example 1

[0025] Ingredients: 15g Scrophularia, 12g Ophiopogon japonicus, 12g Lilium brownii, 8g Bupleurum chinense, 12g Paeonia lactiflora, 7g Citrus reticulata peel, 7g Sinapis alba seed, 12g Prunella vulgaris, 7g Bambusa textilis, 12g Plantago asiatica seed, 7g Akebia trifoliata, 7g Gentiana scabra, 5g Coptis chinensis.

[0026] Preparation method:

[0027] Step 1: Clean and dry the above raw materials respectively;

[0028] Step 2: Mix the dried ingredients in the specified proportions, add 9 times the amount of water, and soak for 45 minutes;

[0029] Step 3: Heat the soaked mixture to a boil, maintain a gentle boil and simmer for 1.5 hours, then filter to obtain the first decoction;

[0030] Step 4: Add 6 times the amount of water to the dregs, heat again to a boil, maintain a gentle boil and simmer for 0.75 hours, then filter to obtain the second decoction.

[0031] Step 5: Combine the first and second decoctions and concentrate under reduced pressure to obtain a clear extract with a relative density of 1.08 (60℃);

[0032] Step 6: Vacuum dry the paste to obtain dry paste powder, which is the Qingli Decoction herbal composition.

[0033] Example 2

[0034] Ingredients: 10g Scrophularia, 10g Ophiopogon japonicus, 10g Lilium brownii, 5g Bupleurum chinense, 10g Paeonia lactiflora, 5g Citrus reticulata peel, 5g Sinapis alba seed, 10g Prunella vulgaris, 5g Bambusa textilis, 10g Plantago asiatica seed, 5g Akebia trifoliata, 5g Gentiana scabra, 3g Coptis chinensis.

[0035] Preparation method:

[0036] Step 1: Clean and dry the above raw materials respectively;

[0037] Step 2: Mix the dried ingredients in the specified proportions, add 8 times the amount of water, and soak for 30 minutes;

[0038] Step 3: Heat the soaked mixture to a boil, maintain a simmer for 1 hour, and filter to obtain the first decoction.

[0039] Step 4: Add 5 times the amount of water to the dregs, heat again to a boil, maintain a gentle boil and simmer for 0.5 hours, then filter to obtain the second decoction.

[0040] Step 5: Combine the first and second decoctions and concentrate under reduced pressure to a clear extract with a relative density of 1.05 (60℃);

[0041] Step 6: Spray dry the ointment to obtain dry ointment powder, which is the Qingli Decoction herbal composition.

[0042] Example 3

[0043] Ingredients: 20g Scrophularia, 15g Ophiopogon japonicus, 15g Lilium brownii, 10g Bupleurum chinense, 15g Paeonia lactiflora, 10g Citrus reticulata peel, 10g Sinapis alba seed, 15g Prunella vulgaris, 10g Bambusa textilis, 15g Plantago asiatica seed, 10g Akebia trifoliata, 10g Gentiana scabra, 8g Coptis chinensis.

[0044] Preparation method:

[0045] Step 1: Clean and dry the above raw materials respectively;

[0046] Step 2: Mix the dried ingredients in the specified proportions, add 10 times the amount of water, and soak for 60 minutes;

[0047] Step 3: Heat the soaked mixture to a boil, maintain a simmer for 2 hours, and filter to obtain the first decoction.

[0048] Step 4: Add 7 times the amount of water to the dregs, heat again to a boil, maintain a gentle boil and simmer for 1 hour, then filter to obtain the second decoction.

[0049] Step 5: Combine the first and second decoctions and concentrate under reduced pressure to obtain a clear extract with a relative density of 1.10 (60℃);

[0050] Step 6: Vacuum dry the paste to obtain dry paste powder, which is the Qingli Decoction herbal composition.

[0051] Comparison Example

[0052] Existing technical solution content:

[0053] 1. Formula composition:

[0054] Traditional Chinese medicine formulas for clearing heat and promoting diuresis typically include the following herbs (taking a common combination as an example): honeysuckle 15g, forsythia 10g, scutellaria 10g, poria 15g, alisma 10g, talc 15g, and licorice 6g. This formula aims to clear heat and detoxify through honeysuckle and forsythia, clear lung heat through scutellaria, promote diuresis and reduce swelling through poria, alisma, and talc, and harmonize the effects of the other herbs through licorice.

[0055] 2. Preparation method:

[0056] Cleaning and soaking: Weigh the above-mentioned medicinal materials according to the proportion, clean them to remove impurities, and then add enough water to soak for 30 minutes to 1 hour to allow the medicinal materials to fully absorb water and swell.

[0057] Decoction: Place the soaked herbs and soaking liquid in a decoction pot, heat to a boil, then reduce to a simmer and cook for 1-1.5 hours. Stir occasionally to prevent the herbs from sticking to the pot or burning.

[0058] Filtration and Concentration: After decoction, filter the liquid through gauze or a filter to remove the dregs. The filtrate can be further heated and concentrated to the desired concentration, but traditional methods often do not emphasize specific concentration ratios or condition control.

[0059] Formulation: Depending on clinical needs, the concentrated drug solution can be taken directly or further processed into traditional dosage forms such as pills or powders. However, traditional preparation methods are relatively crude in terms of formulation, lacking the refined processing of modern formulation technology.

[0060] 3. Existing problems:

[0061] Unstable efficacy: Because traditional compound prescriptions are mostly based on empirical compatibility and lack scientific verification and optimization, there are large differences in efficacy between different batches or different patients.

[0062] Significant side effects: Some traditional heat-clearing and diuretic compound formulas may contain ingredients that pose potential risks to specific groups (such as pregnant women, children, and those with impaired liver and kidney function), and the dosage control is not precise enough, which can easily lead to side effects.

[0063] Inconvenient to take: Traditional dosage forms such as pills and powders have problems such as large dosage and poor taste, which affect patient compliance.

[0064] Lack of standardization: Traditional preparation methods lack unified standards in terms of medicinal material processing, decoction conditions, and concentration ratios, making it difficult to control product quality.

[0065] The effects of a Qingli Decoction traditional Chinese medicine composition, its preparation method, and its application in Examples 1 to 3 were compared with those in a control example, and the results are shown in the table below:

[0066] Comparison Item Example 1 Example 2 Example 3 Control Example (Traditional Chinese Medicine Compound for Clearing Heat and Promoting Diuresis) Formula Scientific Compatibility Scientifically formulated, clearly defined combination of herbs with heat-clearing and diuretic effects Same as Example 1 Same as Example 1 Based on empirical compatibility, lacking scientific verification and optimization Preparation Process Standardization Cleaning, soaking, decocting, concentrating, and drying processes, precise condition control Same as Example 1 Same as Example 1 The preparation process is rough, lacking unified standards and condition control Efficacy Stability Significant and stable efficacy, with obvious improvement in symptoms of lung heat and damp-heat accumulation Same as Example 1 Same as Example 1 Efficacy is unstable, with large differences between different batches or patients Side Effect Control Selected herbs, precise dosage, few side effects Same as Example 1 Same as Example 1 May contain potentially risky components, imprecise dosage control, easily leading to side effects Convenience of Use Can be made into granules, tablets, and other oral preparations, convenient to take Same as Example 1 Same as Example 1 Traditional dosage forms have large dosages, poor taste, and low compliance Quality Control Ensures stable product quality through precise control of preparation conditions Same as Example 1 Same as Example 1 Lack of standardization, product quality is difficult to control surface

[0067] As can be seen from the table above, Examples 1 to 3 have many beneficial effects compared to the control example:

[0068] The Qingli Decoction herbal compositions and their preparation methods in Examples 1 to 3 demonstrate significant beneficial effects compared to the traditional heat-clearing and diuretic herbal formulas in the control examples. Firstly, the examples, through scientific formulation and optimization, carefully selected medicinal materials with clear heat-clearing and diuretic effects, ensuring the scientific validity and effectiveness of the formula. Secondly, the examples employed standardized preparation processes, including precise cleaning, soaking, decoction, concentration, and drying procedures, effectively controlling preparation conditions and improving the efficacy stability and quality controllability of the product. Furthermore, the examples emphasized side effect control; by carefully selecting medicinal materials and precisely controlling dosage, the use of potentially risky components was reduced, lowering the probability of side effects. Finally, the examples provided various oral formulations, such as granules and tablets, greatly improving patient convenience and compliance. In summary, the examples are superior to the control examples in terms of scientific formulation, preparation process, efficacy stability, side effect control, and ease of use, demonstrating significant clinical application value.

[0069] Application examples

[0070] Application scenario: A patient suffers from lung heat cough due to long-term smoking, with copious and thick yellow phlegm, accompanied by symptoms such as sore throat and dark urine.

[0071] Treatment regimen: Administer granules made from the Qingli Decoction herbal composition prepared in Example 1, 5g each time, 3 times a day, dissolved in warm water, for 7 consecutive days.

[0072] Treatment efficacy: After 3 days of treatment, the patient's cough symptoms were significantly reduced, and the amount of sputum decreased and became thinner; after 5 days, the sore throat symptoms disappeared, and urination returned to normal; after 7 consecutive days of treatment, all symptoms disappeared, and the patient recovered. This indicates that the Qingli Decoction herbal composition has significant efficacy in treating symptoms such as cough, excessive sputum, sore throat, and difficulty urinating caused by lung heat.

[0073] In summary, the Qingli Decoction traditional Chinese medicine composition and its preparation method of the present invention are innovative research and developments that address the shortcomings of traditional heat-clearing and diuretic traditional Chinese medicine compound prescriptions in terms of scientific formulation, preparation process, efficacy stability, side effect control, and ease of administration.

[0074] In terms of formulation design, this invention abandons the traditional experience-based approach to compound prescriptions, instead adopting a scientific and optimized approach. It carefully selects a combination of herbs with clear heat-clearing and diuretic effects, including Scrophularia, Ophiopogon japonicus, Lilium brownii, Bupleurum chinense, Paeonia lactiflora, Citrus reticulata peel, Sinapis alba seed, Prunella vulgaris, Bambusa textilis, Plantago asiatica seed, Akebia trifoliata, Gentiana scabra, and Coptis chinensis. These herbs work synergistically to clear heat, detoxify, promote diuresis, and reduce swelling, effectively addressing various symptoms caused by lung heat and damp-heat accumulation.

[0075] In terms of preparation process, this invention introduces a standardized operating procedure, including precise steps such as cleaning, soaking, decocting, concentration, and drying. By strictly controlling the conditions of each step, such as soaking time, decoction time, and concentration ratio, the therapeutic stability and quality controllability of the product are ensured. Simultaneously, this invention also employs advanced drying technologies, such as vacuum drying or spray drying, further improving the purity and stability of the product.

[0076] Regarding side effect control, this invention effectively reduces the use of potentially risky ingredients and lowers the probability of side effects by carefully selecting medicinal materials and precisely controlling dosage. This makes the Qingli Decoction herbal composition safer and more reliable in clinical applications.

[0077] Furthermore, this invention also emphasizes the convenience of product administration. By formulating the Qingli Tang herbal composition into various oral dosage forms such as granules and tablets, the convenience and compliance of patients are greatly improved. This helps to enhance the treatment effect and quality of life for patients.

[0078] In practical applications, the Qingli Decoction herbal composition has demonstrated significant clinical efficacy. As described in the application example, a patient suffering from lung heat and cough due to long-term smoking experienced significant symptom improvement and ultimately recovered after taking granules made from the Qingli Decoction herbal composition prepared in Example 1. This fully demonstrates the effectiveness and practicality of this invention in clearing heat, promoting diuresis, and treating lung heat-related symptoms. Therefore, the Qingli Decoction herbal composition and its preparation method of this invention have broad clinical application prospects and promotional value.

[0079] The foregoing has only described certain exemplary embodiments of the present invention by way of illustration. Undoubtedly, those skilled in the art can modify the described embodiments in various ways without departing from the spirit and scope of the present invention. Therefore, the foregoing drawings and descriptions are illustrative in nature and should not be construed as limiting the scope of protection of the claims of the present invention.

Claims

1. A traditional Chinese medicine composition for clearing heat and purging, characterized in that, The ingredients contain the following parts by weight: Scrophularia ningpoensis 10-20 parts, Ophiopogon japonicus 10-15 parts, Lilium brownii 10-15 parts, Bupleurum chinense 5-10 parts, Paeonia lactiflora 10-15 parts, Citrus reticulata 5-10 parts, Sinapis alba 5-10 parts, Prunella vulgaris 10-15 parts, Bambusa textilis 5-10 parts, Plantago asiatica 10-15 parts, Akebia trifoliata 5-10 parts, Gentiana scabra 5-10 parts, and Coptis chinensis 3-8 parts.

2. The herbal composition for clearing heat and decoction according to claim 1, characterized in that, The raw materials are in the following weight proportions: 15 parts of Scrophularia ningpoensis, 12 parts of Ophiopogon japonicus, 12 parts of lily bulb, 8 parts of Bupleurum chinense, 12 parts of Paeonia lactiflora, 7 parts of Citrus reticulata peel, 7 parts of Sinapis alba seed, 12 parts of Prunella vulgaris, 7 parts of Bambusa textilis, 12 parts of Plantago asiatica seed, 7 parts of Akebia trifoliata, 7 parts of Gentiana scabra, and 5 parts of Coptis chinensis.

3. The method for preparing a Qingli Decoction herbal composition according to claim 1, characterized in that, Includes the following steps: Step Step 1: Wash and dry the following ingredients by weight: Scrophularia, Ophiopogon japonicus, Lilium brownii, Bupleurum chinense, Paeonia lactiflora, Citrus reticulata peel, Sinapis alba seed, Prunella vulgaris, Bambusa textilis, Plantago asiatica seed, Akebia trifoliata, Gentiana scabra, and Coptis chinensis. Step 2: Mix the dried ingredients according to the specified proportions, add 8-10 times the amount of water, and soak for 30-60 minutes. Step 3: Heat the soaked mixture to a boil, maintain a gentle boil, and simmer for 1-2 hours. Filter to obtain the first decoction. Step 4: Add 5-7 times the amount of water to the dregs, heat again to a boil, maintain a gentle boil, and simmer for 0.5-1 hour. Filter to obtain the second decoction. Step 5: Combine the first and second decoctions and concentrate to a clear paste with a relative density of 1.05-1.

10. Step 6: Dry the clear paste to obtain a dry powder, which is the Qingli Decoction herbal composition.

4. The method for preparing a Qingli Decoction herbal composition according to claim 3, characterized in that, The drying process is either vacuum drying or spray drying.

5. The method for preparing a Qingli Decoction herbal composition according to claim 3, characterized in that, The concentration process in step five is carried out under reduced pressure to minimize the loss of active ingredients.

6. The use of the Qingli Decoction traditional Chinese medicine composition as described in claim 1 or 2 in the preparation of heat-clearing drugs.

7. The application according to claim 6, characterized in that, The heat-clearing medicine is used to treat symptoms such as cough, excessive phlegm, and sore throat caused by lung heat.

8. The use of the Qingli Decoction traditional Chinese medicine composition as described in claim 1 or 2 in the preparation of diuretic drugs.

9. The application according to claim 8, characterized in that, The diuretic drug is used to treat symptoms of urinary difficulty and edema caused by damp-heat accumulation in the lower body.

10. A pharmaceutical preparation comprising the Qingli Decoction traditional Chinese medicine composition as described in claim 1 or 2, characterized in that, The pharmaceutical preparation is an oral preparation, including granules, tablets, capsules, or oral liquids.

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