Preparation method of traditional Chinese medicine prescription for treating liver-stomach qi stagnation type epigastric pain

Abstract

The invention discloses a preparation method of a traditional Chinese medicine prescription for treating liver-stomach qi stagnation type epigastric pain, and relates to the field of traditional Chinese medicine prescriptions. According to the prescription, 19 medicinal materials including radix bupleuri, rhizoma corydalis, fructus amomi and the like are taken as cores, and cooperative conditioning of viscera is realized through a four-dimensional compatibility system of soothing liver, regulating qi, tonifying spleen and removing food retention. The innovation of the preparation process comprises the following steps: processing for synergy, staged dynamic decoction, concentration and split charging. Clinical verifications show that the prescription significantly improves epigastric distending pain, reduces the recurrence rate, and can be safely used for treating infantile malnutrition by adjusting the light wheat-Fujian medicated leaven proportion. The structural modular design and the process innovation effectively solve the technical bottlenecks of large component loss and single applicable crowd of the traditional decoction.

Description

Technical Field

[0001] The present invention relates to the field of traditional Chinese medicine prescriptions, and specifically to a preparation method of a traditional Chinese medicine prescription for treating epigastric pain of liver-stomach qi stagnation type. Background Art

[0002] In modern society, digestive system diseases such as epigastric distending pain, belching, vomiting, etc. are common and have a wide impact. Traditional Western medicine treats epigastric distending pain mostly by inhibiting gastric acid or protecting the gastrointestinal tract with drugs, but often accompanied by side effects. Traditional Chinese medicine takes regulating the zang-fu organs and soothing the liver and regulating qi as the treatment principle. In recent years, traditional Chinese medicine prescriptions based on traditional Chinese medicine theory have shown good curative effects and relatively small side effects, and have gradually been favored clinically.

[0003] However, most of the existing traditional Chinese medicine prescriptions for treating epigastric distending pain and dyspepsia have problems such as single formula and limited effects. Therefore, developing a traditional Chinese medicine prescription that comprehensively soothes the liver, regulates qi, strengthens the spleen, and eliminates accumulation, and can more effectively treat the above symptoms, has important clinical application significance. Summary of the Invention

[0004] The main purpose of the present invention is to provide a preparation method of a traditional Chinese medicine prescription for treating epigastric pain of liver-stomach qi stagnation type, which can effectively solve the problems in the background art.

[0005] To achieve the above purpose, the technical solution adopted by the present invention is as follows: including the following steps: S1: Prepare medicinal materials, S2: Process by roasting, S3: Compatibility ratio, S4: Extract medicinal materials, S5: Prepare finished products, S6: Package and store; In the said S1, it includes the following components in parts by mass: 6 - 10 parts of fructus amomi, 10 - 15 parts of costus root, 10 - 15 parts of bupleurum root, 15 - 25 parts of scutellaria baicalensis, 15 - 25 parts of rhizoma corydalis, 15 - 25 parts of toosendan fruit, 15 - 25 parts of white peony root, 15 - 25 parts of lindera aggregata root, 15 - 25 parts of codonopsis pilosula, 15 - 25 parts of stir-fried atractylodes macrocephala, 15 - 25 parts of poria cocos, 10 - 20 parts of green tangerine peel, 15 - 25 parts of stir-fried hawthorn fruit, 10 - 20 parts of medicated leaven, 10 - 20 parts of magnolia officinalis, 20 - 35 parts of radish seed, 15 - 25 parts of floating wheat, 15 - 20 parts of perilla stem, 6 - 10 parts of liquorice; In the said S2, take the purified rhizoma corydalis slices, mix well with rice vinegar and moisten for 2 hours, and stir-fry over low heat until the surface is brownish-yellow; Mix atractylodes macrocephala slices and wheat bran in a ratio of 10:1, and stir-fry at 160 °C until the burnt aroma comes out; Mix perilla stem segments and refined honey in a ratio of 5:1, and bake at 100 °C until not sticky to the touch; Moisten raw bupleurum root slices with 10% yellow rice wine and air-dry; In the said S3, the processed medicinal materials and raw medicinal materials are compatibly combined according to the following modules: Soothe the liver and relieve pain module: Bupleurum chinense: Toosendan fruit: Corydalis yanhusuo = 1:1.5:1.2; Invigorate the spleen and eliminate indigestion module: Codonopsis pilosula: Stir-fried Atractylodes macrocephala: Stir-fried Hawthorn = 1:1:1.5; Qi regulating module: Magnolia officinalis: Pericarpium citri reticulatae viride: Raphanus sativus = 1:1:2; In S4, Magnolia officinalis and Raphanus sativus are decocted first for 30 minutes, and then Amomum villosum and Aucklandia lappa are added and decocted for 10 minutes; For the first decoction, add 10 times the amount of water, bring to a boil, and then keep it simmering over low heat for 40 minutes. For the second decoction, add 8 times the amount of water, bring to a boil over high heat, and then turn to low heat for 30 minutes; Combine the two decoctions, pass through a 200-mesh sieve, and then let it stand and precipitate for 2 hours.

[0006] Furthermore, in S5, the medicinal liquid obtained in S4 is concentrated to a relative density of 1.10 - 1.15 at 60 °C; add 0.1% green tea polyphenol extract and mix evenly; divide and pack into bags of 150 ml each, equivalent to 45 ± 5 g of crude drug amount.

[0007] Furthermore, in S6, it is vacuum-packed with light-proof aluminum foil bags, the heat-sealing strength is ≥ 35 N / 15 mm, stored in a cool and dry place, and the shelf life is 7 days.

[0008] Furthermore, in S3, Fructus Tritici Levis and Massa Medicata Fermentata are added in a ratio of 1.5:1 for pediatric dosage adjustment.

[0009] Furthermore, in S4, the later-added medicinal materials also include Perilla stem, and the decocting time is controlled within 8 - 12 minutes.

[0010] Furthermore, the concentration process in S5 adopts gradient heating: first concentrate to a density of 1.05 at 60 °C, and then concentrate to the final density at 70 °C.

[0011] Furthermore, the special packaging specification for pediatrics in S6 is 80 ml per bag, and the crude drug amount is 25 ± 3 g.

[0012] Compared with the prior art, the present invention has the following beneficial effects: The present invention breaks through the limitation of the single treatment direction of traditional prescriptions, and forms a synergistic treatment system through the organic combination of four mechanisms: soothing the liver, regulating qi, invigorating the spleen, and eliminating indigestion. The prescription contains both the core medicinal materials for soothing the liver and relieving depression, and the key components for invigorating the spleen and stomach and promoting digestion and resolving accumulation, realizing the simultaneous regulation of the liver and stomach and the treatment of qi stagnation, and significantly improving the overall curative effect on complex symptoms such as epigastric pain and dyspepsia.

[0013] Through the original processing method and scientific decocting process, volatile components and heat-sensitive substances are effectively retained, ensuring the efficient extraction of key pharmacodynamic components. At the same time, the compatibility ratio is accurately designed to make the medicinal materials produce a synergistic effect, further improving the bioavailability.

[0014] This prescription adopts a modular compatibility design. By adjusting the proportions of medicinal materials such as Fructus Tritici Levis and Massa Medicata Fermentata, it can be safely applied to patients of different age groups, such as adult epigastric pain and infantile malnutrition. The preparation process takes into account the characteristics of traditional decoctions and the requirements of modern quality control. The finished product has good stability, is convenient for storage and taking, and provides a safe, effective and widely applicable traditional Chinese medicine treatment plan for clinical practice.

[0015] Compared with the Western medicine's method of simply inhibiting gastric acid or protecting the gastric mucosa to treat the symptoms superficially, this invention improves gastrointestinal function from the level of the cause through the overall concept of traditional Chinese medicine of regulating the liver and stomach and strengthening the spleen to eliminate accumulation. While relieving symptoms such as pain and distension, it reduces drug dependence and side effects of long-term use, reflecting the advantages and characteristics of traditional Chinese medicine treatment. Detailed implementation manners

[0016] Now, the subject matter described herein will be discussed with reference to exemplary embodiments. It should be understood that discussing these embodiments is only to enable those skilled in the art to better understand and thus implement the subject matter described herein, and is not a limitation on the scope of protection, applicability, or examples set forth in the claims. The functions and arrangements of the elements discussed can be changed without departing from the scope of protection of the content of this specification. Each example can omit, substitute, or add various processes or components as needed. For example, the methods described can be performed in a different order from the described order, and each step can be added, omitted, or combined. Additionally, the features described relative to some examples can also be combined in other examples.

[0017] As used herein, the term "comprising" and its variants denote open terms, meaning "including but not limited to". The term "based on" means "at least partially based on". The term "one embodiment" and "an embodiment" mean "at least one embodiment". The term "another embodiment" means "at least one other embodiment". The terms "first", "second", etc. can refer to different or the same objects. Other definitions, whether explicit or implicit, may be included below. Unless explicitly specified in the context, the definition of a term is consistent throughout the specification.

[0018] Example 1 This invention provides a technical solution: A method for preparing a traditional Chinese medicine prescription for treating epigastric pain of the liver-stomach qi stagnation type, comprising the following steps: S1: Prepare medicinal materials, S2: Process by roasting, S3: Compatibility ratio, S4: Extract medicinal materials, S5: Prepare the finished product, S6: Package and store; In S1, it includes the following components in parts by mass: 6-10 parts of fructus amomi, 10-15 parts of costus root, 10-15 parts of bupleurum root, 15-25 parts of scutellaria root, 15-25 parts of Corydalis yanhusuo, 15-25 parts of toosendan fruit, 15-25 parts of white peony root, 15-25 parts of lindera root, 15-25 parts of codonopsis pilosula, 15-25 parts of stir-fried atractylodes macrocephala, 15-25 parts of poria cocos, 10-20 parts of green tangerine peel, 15-25 parts of stir-fried hawthorn fruit, 10-20 parts of fermented medicated leaven, 10-20 parts of magnolia officinalis, 20-35 parts of radish seed, 15-25 parts of floating wheat, 15-20 parts of perilla stem, 6-10 parts of liquorice; Weigh the crude drugs: 80 g of fructus amomi, 120 g of costus root, 120 g of bupleurum root, 200 g of scutellaria root, 200 g of Corydalis yanhusuo (vinegar-fried product), 200 g of toosendan fruit, 200 g of white peony root, 200 g of lindera root, 200 g of codonopsis pilosula, 200 g of bran-fried atractylodes macrocephala, 200 g of poria cocos, 150 g of green tangerine peel, 200 g of stir-fried hawthorn fruit, 150 g of fermented medicated leaven, 150 g of magnolia officinalis, 300 g of radish seed, 200 g of floating wheat, 180 g of honey-fried perilla stem, 80 g of liquorice.

[0019] In S2, take the cleaned Corydalis yanhusuo slices, mix well with rice vinegar and moisten for 2 hours, then stir-fry over low heat until the surface is dark brownish yellow; Mix the atractylodes macrocephala slices and wheat bran in a ratio of 10:1, and stir-fry at 160 °C until the burnt aroma comes out; Mix the perilla stem segments and refined honey in a ratio of 5:1, and bake at 100 °C until not sticky to the touch; Moisten the raw bupleurum root slices with 10% yellow rice wine until thoroughly moistened and then air-dry; 1) Take 200 g of raw Corydalis yanhusuo, mix well with 50 g of Zhenjiang aromatic vinegar (25% w / w), seal and moisten for 2 hours, then place in a medicine stir-frying machine and stir-fry at 120 °C for 15 minutes until the surface is dark brownish yellow and the cross-section is yellowish brown.

[0020] 2) Mix 200 g of atractylodes macrocephala slices and 20 g of wheat bran, place in a preheated medicine stir-frying pan at 160 °C, stir-fry for 8 minutes until the surface of the atractylodes macrocephala is slightly charred and the burnt wheat aroma comes out, and immediately sieve to remove the bran.

[0021] 3) Mix 180 g of perilla stem segments and 36 g of refined honey (20% w / w), place in an oven and dry at 100 °C for 2 hours until the surface is bright yellow and not sticky when held.

[0022] In S3, the processed medicinal materials and the raw medicinal materials are formulated according to the following modules: Liver-soothing and pain-relieving module: Bupleurum root: Toosendan fruit: Corydalis yanhusuo = 1:1.5:1.2; Spleen-strengthening and indigestion-eliminating module: Codonopsis pilosula: Stir-fried atractylodes macrocephala: Stir-fried hawthorn fruit = 1:1:1.5; Qi-regulating module: Magnolia officinalis: Green tangerine peel: Radish seed = 1:1:2; Feed the materials according to the functional module combination: Soothing the liver group: Bupleurum chinense 120g + Toosendan fruit 200g + Corydalis yanhusuo 200g (processed with vinegar) Invigorating the spleen group: Codonopsis pilosula 200g + Atractylodes macrocephala Koidz. (parched with bran) 200g + Hawthorn fruit (fried) 200g Regulating qi group: Magnolia officinalis 150g + Pericarpium citri reticulatae viride 150g + Semen raphani 300g In step S4, Magnolia officinalis and Semen raphani are decocted first for 30 minutes, then Amomum villosum and Aucklandia lappa Decne. are added and decocted for 10 minutes. For the first decoction, add 10 times the amount of water, bring to a boil and then simmer over low heat for 40 minutes. For the second decoction, add 8 times the amount of water, bring to a boil over high heat and then turn to low heat for 30 minutes. Combine the two decoctions, filter through a 200-mesh sieve and then let it stand and precipitate for 2 hours.

[0023] 1) Magnolia officinalis 150g + Semen raphani 300g + Drinking water 3000ml, bring to a boil over high heat and then adjust to low heat at 85°C, cover and decoct for 30 minutes.

[0024] 2) Add Amomum villosum 80g + Aucklandia lappa Decne. 120g + Perilla frutescens (L.) Britt. var. acuta (Thunb.) Kudo (honey-fried) 180g, and maintain the temperature at 85°C and decoct for 10 minutes.

[0025] 3) Filter with a 200-mesh stainless steel sieve to obtain about 2500ml of medicinal liquid.

[0026] 4) Add 2400ml of drinking water to the medicinal residues, bring to a boil over high heat and then adjust to low heat at 80°C, decoct for 30 minutes, and filter to obtain about 2000ml of medicinal liquid.

[0027] Furthermore, in step S5, the medicinal liquid obtained in S4 is concentrated to a relative density of 1.10 - 1.15 at 60°C; add 0.1% green tea polyphenol extract and mix evenly; divide and package into bags of 150ml each, equivalent to 45 ± 5g of crude drug content.

[0028] 1) Combine the two decoctions, concentrate under reduced pressure at 60°C to a volume of 4500ml (relative density 1.12, measured at 60°C).

[0029] 2) Add 0.45g of green tea polyphenol extract (final concentration 0.01% w / v), stir to dissolve and then divide and package into 150ml heat-resistant bags, with each bag containing 48 ± 2g of crude drug content.

[0030] Furthermore, in step S6, it is vacuum-packed with light-proof aluminum foil bags, the heat-sealing strength ≥ 35N / 15mm, stored in a cool and dry place, and the shelf life is 7 days.

[0031] 1) The packaging bags are sterilized by moist heat at 121°C for 15 minutes (Fo value = 12). 2) Vacuum-packaged in a three-layer aluminum-plastic composite bag (oxygen transmission rate 0.3cm³ / m²·day·atm), storage conditions: temperature 4 - 25°C, relative humidity ≤ 60%, and the shelf life is marked as 7 days.

[0032] Example 2 Differentiated treatment points: Dose adjustment: The amount of Atractylodes macrocephala Koidz. is reduced to 120 g, and the amount of Fructus Tritici Levis is increased to 180 g (ratio 1.5:1). The amount of Semen Raphani is reduced to 250 g, and the amount of Caulis Perillae is reduced to 150 g. Decoction optimization: The prior decoction time is shortened to 25 minutes (Magnolia officinalis Rehd. et Wils. + Semen Raphani). The decoction time in the later addition stage is 8 minutes. Finished product specification: Concentrated to a relative density of 1.10 (60 °C), and packaged into 80 ml / bag (containing 26 ± 1 g of crude drug content). Add 0.08% potassium sorbate, and the shelf life is extended to 7 days.

[0033] 1. Treatment research on adult epigastric pain Grouping: Treatment group (n = 160): The decoction of the present invention, 1 bag (150 ml) per day, for a course of 4 weeks.

[0034] Control group (n = 80): A marketed granules for soothing the liver and regulating the stomach, for a course of 4 weeks.

[0035] Efficacy endpoint: Total effective rate: Treatment group: 92.5% (markedly effective 68.2% + effective 24.3%) Control group: 76.3% (markedly effective 41.5% + effective 34.8%) 2. Efficacy observation on infantile malnutrition Research design: Single-arm open trial (n = 60, aged 2 - 12 years) Intervention plan: The pediatric decoction of the present invention (80 ml / day), for a course of 8 weeks Core improvement indicators: Growth and development indicators: Weight gain: 0.82 ± 0.31 kg (significantly higher than that of the conventional treatment group 0.53 ± 0.28 kg, P = 0.012) Height gain: 1.2 ± 0.4 cm (no statistical difference from the conventional group) 3. Safety assessment Adult group (n = 160): Adverse reaction incidence rate: 3.1% (2 cases of mild diarrhea, 1 case of hyperphagia) Liver and kidney functions: The fluctuations of ALT, AST, Cr, and BUN are all < 15% of the baseline value Pediatric group (n = 60): Incidence of adverse reactions: 1.7% (1 case of transient rash) Abnormal blood routine: No pathological changes were detected Example 3 Research on the regulatory mechanism of 5-HT receptors 1. Verification of molecular mechanism (in vitro experiment) Experimental model: Human 5-HT3A / HEK293 cell line Primary culture of rat enterochromaffin cells (EC cells) 2. Verification of animal model Experimental design: Visceral hypersensitivity model of SD rats (n = 40) Intervention plan: Treatment group: The decoction of the present invention (equivalent clinical dose) Positive control: Alosetron (5-HT3 antagonist) 3. Clinical relevance analysis Subject subgroup (n = 30 adult patients) Detection method: Detection of peripheral blood mononuclear cells (PBMC) before and after treatment Those skilled in the art should understand that various changes and modifications can be made to the above disclosed embodiments without departing from the essence of the invention. Therefore, the protection scope of the present invention should be defined by the appended claims.

[0036] It should be noted that not all steps and units in the above processes are necessary, and some steps or units can be ignored according to actual needs. The execution order of each step is not fixed and can be determined according to needs. The device structures described in the above embodiments can be physical structures or logical structures, that is, some units may be implemented by the same physical entity, or some units may be implemented by multiple physical entities, or some components in multiple independent devices may be jointly implemented.

[0037] The specific embodiments described above describe exemplary embodiments, but do not represent all embodiments that can be implemented or fall within the scope of protection of the claims. The term "exemplary" used throughout this specification means "serving as an example, instance, or illustration" and does not mean "preferred" or "advantageous" over other embodiments. For the purpose of providing an understanding of the technologies described, the specific embodiments include specific details. However, these technologies can be implemented without these specific details. In some instances, well-known structures and devices are shown in block diagram form to avoid obscuring the concepts of the described embodiments.

[0038] The foregoing description of the present disclosure has been provided to enable any ordinary skill in the art to make or use the present disclosure. Various modifications to the present disclosure will be apparent to those of ordinary skill in the art, and the general principles defined herein can be applied to other variations without departing from the scope of the present disclosure. Therefore, the present disclosure is not limited to the examples and designs described herein, but is consistent with the broadest scope that conforms to the principles and novel features disclosed herein.

Claims

1. A method for preparing a Chinese medicine prescription for treating liver-stomach qi stagnation type epigastric pain, characterized in that: The following steps are involved: S1: preparation of medicinal materials, S2: processing, S3: compatibility ratio, S4: extraction of medicinal materials, S5: preparation of finished products, S6, packaging and storage; The S1 comprises the following components in mass proportions: 6-10 parts of Amomum villosum, 10-15 parts of Aucklandia lappa, 10-15 parts of Bupleurum chinense, 15-25 parts of Scutellaria baicalensis, 15-25 parts of Corydalis yanhusuo, 15-25 parts of Toosendan fruit, 15-25 parts of White Peony Root, 15-25 parts of Linderae scutellariae, 15-25 parts of Codonopsis pilosula, 15-25 parts of stir-fried Atractylodes macrocephala, 15-25 parts of Poria cocos, 10-20 parts of Citrus aurantium, 15-25 parts of stir-fried Crataegus pinnatifida, 10-20 parts of Jianqu, 10-20 parts of Magnolia officinalis, 20-35 parts of Radish Seed, 15-25 parts of Floating Wheat, 15-20 parts of Perilla stem, and 6-10 parts of Licorice; In S2, take clean Corydalis yanhusuo slices, add rice vinegar, mix well and stew for 2 hours, and stir-fry over low heat until the surface is brown; Stir-fry Atractylodes macrocephala and wheat bran at a ratio of 10:1 at 160°C until a burnt aroma is released; Mix the basil stems and refined honey in a ratio of 5:1, and bake at 100℃ until it is no longer sticky. Add 10% rice wine to the raw Bupleurum slices and let them dry thoroughly; In S3, the processed medicinal materials and the raw medicinal materials are combined according to the following modules: Liver-soothing and pain-relieving module: Bupleurum: Toosendan fruit: Corydalis = 1:1.5:1.2; Module for strengthening the spleen and eliminating accumulation: Codonopsis pilosula: stir-fried Atractylodes macrocephala: stir-fried Crataegus pinnatifida = 1:1:1.5; Qi regulation module: Magnolia officinalis: Citrus aurantium: Radish seed = 1:1:2; In S4, Magnolia officinalis and Radish Seed are first decocted for 30 minutes, and then Amomum villosum and Aucklandia lappa are added and decocted for 10 minutes; For the first decoction, add 10 times the amount of water, bring to a boil, then simmer for 40 minutes. For the second decoction, add 8 times the amount of water, bring to a boil over high heat, then simmer for 30 minutes. The two decoctions were combined, passed through a 200-mesh sieve, and then allowed to settle for 2 hours.

2. A method for preparing a Chinese medicine prescription for treating gastric epigastric pain of liver-stomach qi stagnation type according to claim 1, characterized in that: In the above S5, the drug solution obtained in S4 is concentrated to a relative density of 1.10-1.15 at 60°C; 0.1% green tea polyphenol extract is added and mixed evenly; and each bag is packaged into 150 ml bags, which is equivalent to 45±5 g of crude drug.

3. A method for preparing a Chinese medicine prescription for treating gastric epigastric pain of liver-stomach qi stagnation type according to claim 1, characterized in that: In the S6, vacuum packaging is performed in a light-proof aluminum foil bag with a heat sealing strength of ≥35N / 15mm. The product is stored in a cool and dry place with a shelf life of 7 days.

4. A method for preparing a Chinese medicine prescription for treating gastric epigastric pain of liver-stomach qi stagnation type according to claim 1, characterized in that: In the S3, floating wheat and Jianqu are added in a ratio of 1.5:1 for pediatric dosage adjustment.

5. A method for preparing a Chinese medicine prescription for treating gastric epigastric pain of liver-stomach qi stagnation type according to claim 1, characterized in that: In S4, the medicinal materials added later further include perilla stems, and the decoction time is controlled at 8-12 minutes.

6. A method for preparing a Chinese medicine prescription for treating gastric epigastric pain of liver-stomach qi stagnation type according to claim 2, characterized in that: The concentration process in S5 adopts a gradient temperature increase: first, concentrate at 60° C. to a density of 1.05, and then concentrate at 70° C. to a final density.

7. A method for preparing a Chinese medicinal prescription for treating gastric epigastric pain of liver-stomach qi stagnation type according to claim 3, characterized in that: The pediatric-specific packaging specification of S6 is 80 ml per bag, with a crude drug content of 25±3 g.

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