Traditional Chinese medicine composition for treating irritable bowel syndrome and preparation method thereof

Abstract

The invention relates to a traditional Chinese medicine composition for treating irritable bowel syndrome and a preparation method thereof. The composition comprises a white peony root active component purified by macroporous resin, a pasty dried orange peel extract, a pasty licorice extract, an adhesive and the like, and also can be further added with bighead atractylodes rhizome, divaricate saposhnikovia root, fructus amomi and other components. The preparation method comprises the steps of white peony root powder preparation, ultrasonic extraction, macroporous resin purification, concentration and drying, auxiliary component preparation, mixing and granulation and the like. The purity of active ingredients of the radix paeoniae alba is improved through a purification process, the treatment effect on the irritable bowel syndrome is enhanced through the synergistic effect of all the ingredients, and the prepared granules are more stable in treatment effect on the irritable bowel syndrome and suitable for various people.

Description

TECHNICAL FIELD

[0001] The present application relates to a Chinese medicine composition for treating irritable bowel syndrome and a preparation method thereof. BACKGROUND

[0002] Irritable bowel syndrome (IBS) is a functional bowel disease characterized by abdominal pain, diarrhea, constipation or alternation of the two, and its pathogenesis involves abnormal intestinal motility, visceral hypersensitivity, intestinal flora imbalance, immune inflammatory response and psychological factors, which seriously affects the quality of life of patients.

[0003] Current western medicine treatment of IBS mainly focuses on symptomatic treatment, such as using antispasmodic drugs, antidiarrheal drugs, laxatives and antidepressants, etc., but there are obvious limitations: drug side effects are prominent; only temporary relief of symptoms, unable to fundamentally regulate intestinal function, and long-term use is prone to dependence.

[0004] For the long-term treatment and conditioning of IBS, it has been found that active ingredients such as paeoniflorin, paeoniflorin and total paeoniflorin in white peony root can relieve intestinal spasm, regulate immunity and improve intestinal microenvironment. However, white peony root contains low-activity ingredients such as sugars, tannins and amino acids, which are co-eluted with active ingredients during extraction, increasing the difficulty of purification and reducing the concentration of active ingredients, which seriously restricts the efficacy. Therefore, optimizing the extraction process to improve the concentration of active ingredients of white peony root is the key to improving its efficacy in treating IBS and has important research value. SUMMARY

[0005] The present application aims to provide a Chinese medicine composition for treating irritable bowel syndrome and a preparation method thereof, which solves the problem of low extraction purity of active ingredients and large impact on activity in the prior art. The specific composition ingredients and preparation process are as follows:

[0006] A Chinese medicine composition for treating irritable bowel syndrome, comprising the following ingredients by mass fraction: white peony root active ingredients purified by macroporous resin 5-15 parts, paste of dried tangerine or orange peel extract 10-20 parts, paste of licorice extract 3-8 parts, and adhesive 2-10 parts.

[0007] Further, the adaptability of the Chinese medicine composition to different physical populations can be improved by adding medicinal ingredients with synergistic effect. The composition comprises the following ingredients by mass fraction: white peony root active ingredients purified by macroporous resin 5-15 parts, paste of dried tangerine or orange peel extract 10-20 parts, white atractylodes 10-20 parts, wind-preventing 8-15 parts, sand 5-10 parts, paste of licorice extract 3-8 parts, and adhesive 2-8 parts.

[0008] A preparation method of a Chinese medicine composition for treating irritable bowel syndrome, comprising the following steps:

[0009] S1, preparing a white peony root powder mixture:

[0010] Take white peony root, wash, cut into slices, and dry in an oven at 60±5℃. After drying, crush and pass through an 80-mesh sieve to obtain white peony root powder. Add the obtained white peony root powder to an ethanol solution and soak for 30±5 min.

[0011] S2, ultrasonic-assisted extraction of filtrate:

[0012] Put the mixture into an ultrasonic extraction instrument. Collect the filtrate after extraction. Add ethanol solution to the residue, repeat the extraction under the same conditions, and combine the filtrates of the two times of extraction.

[0013] S3, macroporous resin purification:

[0014] Pretreat the macroporous resin to remove impurities. Then, load the filtrate obtained in S2 into a resin column, control the loading flow rate, and then use distilled water and ethanol solution to elute in sequence, and collect the ethanol eluate.

[0015] S4, concentration and drying:

[0016] Concentrate the ethanol eluate to a paste under reduced pressure, dry it in a vacuum drying oven until the weight is constant, crush it, and obtain the active ingredients of white peony root.

[0017] S5, preparation of auxiliary ingredients:

[0018] Grind the dried tangerine peel and licorice root, sieve the powder, obtain the filtrate of dried tangerine peel and licorice root by water decoction, and prepare a paste by concentrating and drying the filtrate.

[0019] S6, mixing and granulation:

[0020] Mix the active ingredients of white peony root with the paste prepared in S5, add a binder to the mixture, and obtain granular material by wet granulation.

[0021] Further, in step S1, the concentration of the ethanol solution is 70%-80%, and the mass-volume ratio of white peony root powder to ethanol solution is 1:5. The concentration range of the ethanol solution can effectively dissolve the active ingredients such as paeoniflorin and albiflorin in white peony root, while avoiding excessive extraction of polysaccharide impurities by high-concentration ethanol.

[0022] Further, in step S3, the macroporous resin is AB-8 type macroporous resin, and the impurity removal pretreatment includes: soaking with 95% ethanol for 24 hours, washing with distilled water until there is no alcohol smell, soaking with 5% hydrochloric acid solution for 2 hours, washing with distilled water until neutral, soaking with 5% sodium hydroxide solution for 2 hours, and washing with distilled water until neutral. This pretreatment process can increase the adsorption capacity of the resin by 15%-20%, remove impurities in the resin, and ensure the stability of the purification effect.

[0023] Further, in step S3, the loading flow rate is 1 BV / h, the amount of distilled water is 2 BV, the elution flow rate is 2 BV / h, the concentration of the ethanol solution is 50%, and the elution flow rate is 1.5 BV / h.

[0024] Further, in step S5, the pericarpium citri reticulatae and licorice are crushed and passed through an 80-mesh sieve. The specific operation of the water decoction method is as follows: 10 times the amount of distilled water is added, soaked for 1 hour, heated to boiling and kept in a state of slight boiling, decocted twice, each time for 1.5 hours, and the two decoction liquids are combined as the filtrate. The first decoction can extract about 70% of the effective components, and the second decoction can further extract the remaining 30%. Combining the two decoction liquids as the filtrate can maximize the extraction of effective components from pericarpium citri reticulatae and licorice and ensure the efficacy of the auxiliary components.

[0025] Further, in step S6, the wet granulation process is as follows: the mixture is stirred with the binder to form soft material, which is suitable to be "hand-held into a ball, and light pressure to disperse". The soft material is then passed through an 18-mesh sieve to form granules, and the wet granules are dried in a 60°C oven until the moisture content is 3%-5%. After drying, the granules are passed through a 12-mesh sieve to form the final granules. The quality of the soft material is suitable to be "hand-held into a ball, and light pressure to disperse", which indicates that the moisture content of the material is moderate, ensuring the forming rate of the subsequent granulation.

[0026] The 18-mesh sieve is used for granulation, and the obtained granules have a diameter of about 1.0 mm, which not only meets the particle size requirements of the preparation, but also has good flowability.

[0027] Beneficial effects:

[0028] The ultrasonic-assisted extraction technology uses the cavitation effect of ultrasonic waves to form high-frequency micro-jets, which can efficiently break the cell wall of white peony root, with a cell wall breakage rate of more than 85%. Compared with the traditional water decoction extraction method, this technology can achieve sufficient dissolution of active ingredients in a shorter time, with a 40% reduction in extraction time and a significant improvement in production efficiency.

[0029] At the same time, the active ingredients of white peony root are directionally enriched by combining macroporous resin dynamic adsorption and gradient elution technology: by precisely controlling the loading concentration, adsorption flow rate, and elution gradient, the specific adsorption and separation of core active ingredients such as paeoniflorin and albiflorin are realized. This process has high interception effect on low active ingredients such as sugars and tannins, significantly improving the purity of active ingredients and enhancing the directional treatment efficiency of the drug for irritable bowel syndrome.

[0030] On this basis, the physical qi-strengthening effect of the paste-like pericarpium citri reticulatae extract and the synergistic effect of the paste-like licorice extract with the high-purity white peony root active ingredients form a multi-target treatment system, which not only strengthens the core efficacy of relieving intestinal spasm and regulating the intestinal microenvironment, but also speeds up the improvement of symptoms such as abdominal pain and diarrhea, further improving the timeliness of the traditional Chinese medicine composition. BRIEF DESCRIPTION OF DRAWINGS

[0031] Figure 1 is a comparison chart of impurity residue detection in the active ingredient of Radix Paeoniae Alba purified by macroporous resin in Examples 1-3;

[0032] Figure 2 is a comparison chart of retention rate of total paeoniflorin in the active ingredient of Radix Paeoniae Alba purified by macroporous resin in Examples 1-3. DETAILED DESCRIPTION

[0033] In order to deepen the understanding of the present application, the present application will be further described in conjunction with the examples and drawings, which are only used to explain the present application and do not constitute a limitation on the protection scope of the present application.

[0034] Example 1:

[0035] A traditional Chinese medicine composition for treating irritable bowel syndrome, which is composed of the following components in mass parts: 5 parts of the active ingredient of Radix Paeoniae Alba purified by macroporous resin, 10 parts of paste-like Pericarpium Citri Reticulatae extract, 3 parts of paste-like Glycyrrhiza extract, and 6 parts of adhesive.

[0036] The preparation method is as follows:

[0037] S1, preparation of Radix Paeoniae Alba powder mixture: take Radix Paeoniae Alba medicinal materials, wash, slice, and dry in a 55℃ oven, crush and pass through an 80-mesh sieve; take the Radix Paeoniae Alba powder, add 70% ethanol solution, and the mass-volume ratio of Radix Paeoniae Alba powder to ethanol solution is 1:5, and soak for 25 min.

[0038] S2, ultrasonic-assisted extraction of filtrate: put the mixture into an ultrasonic extraction instrument, collect the filtrate after extraction; add 3 times the amount of 70% ethanol solution to the residue, repeat the extraction under the same conditions, and combine the two filtrates.

[0039] S3, macroporous resin purification: take AB-8 type macroporous resin, pretreat and load the column, and the pretreatment is as follows: 95% ethanol soaking for 24 h→distilled water washing until no alcohol smell→5% hydrochloric acid soaking for 2 h→distilled water washing until neutral→5% sodium hydroxide soaking for 2 h→distilled water washing until neutral.

[0040] Load the filtrate, the flow rate is 1 BV / h, first elute with 2 BV of distilled water at a flow rate of 2 BV / h, then elute with 50% ethanol solution at a flow rate of 1.5 BV / h, and collect the ethanol eluate.

[0041] S4, concentration and drying: concentrate the ethanol eluate to a paste at 45℃ under reduced pressure, dry in a vacuum drying box at 60℃ and a vacuum degree of 0.08 MPa to a constant weight, and crush to obtain the active ingredient of Radix Paeoniae Alba.

[0042] S5, preparation of auxiliary ingredients: the dried tangerine peel and licorice powder are crushed to pass through an 80-mesh sieve, soaked in 10 times the amount of distilled water for 1 h, heated to boiling and micro-boiled for 2 times, 1.5 h each time, and the filtrate is combined; the filtrate is concentrated and dried to a paste to obtain a paste-like dried tangerine peel extract and a paste-like licorice extract.

[0043] S6, mixing and granulation: the active ingredient of white peony root is mixed with the paste-like dried tangerine peel extract and the paste-like licorice extract, and a binder is added to stir into a soft material, which is then sieved through an 18-mesh sieve after achieving the effect of "hand-holding into a ball, and light pressing into a scattered state"; the wet granules are dried in an oven at 60°C to a moisture content of 3%, and then sieved through a 12-mesh sieve to obtain granules.

[0044] Example 2:

[0045] A traditional Chinese medicine composition for treating irritable bowel syndrome, which is composed of the following ingredients in mass parts: white peony root active ingredient purified by macroporous resin 10 parts, paste-like dried tangerine peel extract 15 parts, paste-like licorice extract 5 parts, atractylodes 15 parts, wind-preventing 12 parts, amomum villosum 8 parts, and binder 6 parts.

[0046] The preparation method is as in Example 1, with the difference that in S1, the drying temperature is 60°C, the ethanol concentration is 75%, and the soaking time is 30 min; in S6, the powder of atractylodes, wind-preventing, and amomum villosum (passed through an 80-mesh sieve) is mixed with other ingredients.

[0047] Example 3:

[0048] A traditional Chinese medicine composition for treating irritable bowel syndrome, which is composed of the following ingredients in mass parts: white peony root active ingredient purified by macroporous resin 15 parts, paste-like dried tangerine peel extract 20 parts, paste-like licorice extract 8 parts, atractylodes 20 parts, wind-preventing 15 parts, amomum villosum 10 parts, and binder 6 parts.

[0049] The preparation method is as in Example 1, with the difference that in S1, the drying temperature is 65°C, the ethanol concentration is 80%, and the soaking time is 35 min; in S6, the moisture content of the granules after drying is 5%.

[0050] Control group:

[0051] A traditional Chinese medicine composition for treating irritable bowel syndrome, which is composed of the following ingredients in mass parts: white peony root 35 parts, paste-like dried tangerine peel extract 15 parts, paste-like licorice extract 8 parts, atractylodes 20 parts, wind-preventing 15 parts, amomum villosum 10 parts, and binder 6 parts.

[0052] The white peony root is extracted by water decoction method, and the extracted active ingredient is mixed with the paste-like dried tangerine peel extract, the paste-like licorice extract, atractylodes, wind-preventing, amomum villosum, and the binder for granulation.

[0053] Embodiments 1-3 realize significant reduction of impurity residues and efficient reservation of active ingredients in white peony root by the combination process of "ultrasonic extraction + resin purification", shorten the extraction time, and solve the problem of "high impurities and low active ingredients" in the traditional process. Therefore, the total glucosides of paeonia lactiflora in white peony root can be further enriched, the total glucosides of paeonia lactiflora can regulate the contraction of intestinal smooth muscle, and can quickly relieve spastic abdominal pain. Secondly, the immune regulation function of the total glucosides of paeonia lactiflora is strengthened, and the ability to inhibit inflammatory factors such as tumor necrosis factor-α and interleukin-6 is improved after purification, which can effectively improve the intestinal chronic inflammatory microenvironment; finally, the substantial removal of impurities reduces the stimulation of sugars and tannins to the intestinal tract, reduces the risk of adverse reactions such as abdominal distension and diarrhea after taking medicine, and improves the long-term drug tolerance. It can be suitable for long-term treatment of irritable bowel syndrome in different populations.

[0054] Finally, it should be pointed out that the above embodiments are only used to illustrate the technical solutions of the present application and not to limit it. Although the present application has been described in detail with reference to the preferred embodiments, those skilled in the art should understand that the technical solutions of the present application can be modified or replaced by equivalents without departing from the purpose and scope of the present application, and they should be covered in the scope of the claims of the present application.

Claims

1. A Chinese medicine composition for treating irritable bowel syndrome, characterized in that: The invention comprises the following components in parts by mass: 5-15 parts of white peony root active ingredients purified by macroporous resin, 10-20 parts of pasty tangerine peel extract, 3-8 parts of pasty licorice extract and 2-10 parts of adhesive.

2. A Chinese medicine composition for treating irritable bowel syndrome according to claim 1, characterized in that: The invention comprises the following components by mass: 5-15 parts of macroporous resin purified white peony root active ingredients, 10-20 parts of paste tangerine peel extract, 10-20 parts of atractylodes macrocephala, 8-15 parts of siler, 5-10 parts of amomum villosum, 3-8 parts of paste licorice extract and 2-8 parts of adhesive.

3. A method for preparing a Chinese medicine composition for treating irritable bowel syndrome, characterized in that: The following steps are involved: S1. Preparation of white peony root powder mixture: Wash and slice white peony root, dry it in an oven at 60±5°C, crush it, and pass it through an 80-mesh sieve to obtain white peony powder. Add the obtained white peony powder to the ethanol solution and soak it for 30±5 minutes. S2, ultrasonic-assisted extraction filtrate: The mixture was placed in an ultrasonic extractor, and the filtrate was collected after extraction. The filtrate was added with ethanol solution and the extraction was repeated once under the same conditions. The two filtrates were combined. S3. Macroporous resin purification: The macroporous resin is pretreated to remove impurities, and the filtrate obtained in S2 is then loaded onto the resin column. The loading flow rate is controlled, and distilled water and ethanol solutions are used for elution in sequence, and the ethanol eluate is collected; S4, Concentration and Drying: The ethanol eluate was concentrated under reduced pressure to a paste, dried in a vacuum drying oven to a constant weight, and crushed to obtain the active ingredient of white peony root; S5. Preparation of auxiliary components: Crush tangerine peel and licorice to obtain powder, sieve it, use water decoction to obtain tangerine peel and licorice filtrate, concentrate and dry the filtrate to prepare a paste; S6, mixing and granulation: The white peony root active substance is mixed with the paste prepared in S5, a binder is added to the mixture, and a granular material is obtained through a wet granulation step.

4. The method for preparing a Chinese medicine composition for treating irritable bowel syndrome according to claim 3, characterized in that In step S1, the concentration of the ethanol solution is 70%-80%, and the mass volume ratio of white peony powder to ethanol solution is 1:

5.

5. The method for preparing a Chinese medicine composition for treating irritable bowel syndrome according to claim 3, characterized in that In step S3, the macroporous resin is an AB-8 type macroporous resin, and the impurity removal pretreatment includes: soaking in 95% ethanol for 24 hours, washing with distilled water until there is no alcohol smell, soaking in 5% hydrochloric acid solution for 2 hours, washing with distilled water until neutral, soaking in 5% sodium hydroxide solution for 2 hours, washing with distilled water until neutral.

6. The method for preparing a Chinese medicine composition for treating irritable bowel syndrome according to claim 3, characterized in that In step S3, the loading flow rate is 1 BV / h, the amount of distilled water is 2 BV, the elution flow rate is 2 BV / h, the concentration of the ethanol solution is 50%, and the elution flow rate is 1.5 BV / h.

7. The method for preparing a Chinese medicine composition for treating irritable bowel syndrome according to claim 3, characterized in that In step S5, tangerine peel and licorice are crushed and passed through an 80-mesh sieve. The specific operation of the water decoction method is as follows: add 10 times the amount of distilled water, soak for 1 hour, heat to boiling and keep it in a slightly boiling state, decoct twice, each time for 1.5 hours, and combine the two decoctions as the filtrate.

8. The method for preparing a Chinese medicine composition for treating irritable bowel syndrome according to claim 3, characterized in that In step S6, the wet granulation step is specifically as follows: the mixed material is stirred with the binder to form a soft material, the soft material is preferably formed into a ball by hand and falls apart when lightly pressed, granulated through an 18-mesh sieve, and the wet granules are placed in a 60°C oven to dry to a moisture content of 3%-5%, and after drying, granulated through a 12-mesh sieve.

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