Traditional Chinese medicine compound preparation for treating functional constipation and preparation method thereof

Abstract

The invention relates to the technical field of traditional Chinese medicine compositions, in particular to a traditional Chinese medicine compound preparation for treating functional constipation and a preparation method thereof. The traditional Chinese medicine compound preparation for treating functional constipation comprises the following components in parts by mass: 8-12 parts of betel nuts, 8-12 parts of lindera aggregata, 18-22 parts of immature bitter oranges, 25-35 parts of raw atractylodes macrocephala, 18-22 parts of semen raphani, 13-17 parts of trichosanthes kirilowii maxim and 18-22 parts of cistanche deserticola. According to the preparation, through the synergistic effect of multiple traditional Chinese medicines, overall regulation of liver-spleen disharmony type constipation is achieved, main symptoms such as defecation difficulty, abdominal distension and belching are relieved, and the multiple effects of tonifying the spleen, regulating qi, moistening the intestines, tonifying the kidney and the like are also achieved. The traditional Chinese medicine composition is scientific and reasonable in preparation process, effective components are fully extracted, the dosage form is suitable for modern clinical application, the traditional Chinese medicine composition has good safety and tolerance, and an effective and high-compliance traditional Chinese medicine treatment scheme is provided for patients with functional constipation.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of traditional Chinese medicine compositions, and particularly relates to a traditional Chinese medicine compound preparation for treating functional constipation and a preparation method thereof. BACKGROUND

[0002] Functional constipation is a common gastrointestinal dysfunction disease, which is mainly manifested as difficulty in defecation, reduced defecation frequency or a feeling of incomplete defecation, and has no clear organic lesion cause. The pathogenesis of the disease is complex, and is often related to multiple factors such as insufficient intestinal motility, abnormal visceral sensitivity, mental and psychological factors, and intestinal microecological imbalance. At present, the modern medical treatment mainly uses purgatives (such as osmotic laxatives, stimulant laxatives), prokinetic drugs or probiotic preparations, but long-term use is easy to lead to drug dependence, electrolyte disturbance and further damage to intestinal function, and the recurrence rate is high after drug withdrawal, which significantly affects the quality of life of patients.

[0003] In the theory of traditional Chinese medicine, functional constipation is mostly attributed to "constipation", "spleen constraint" and "yang knot", and it is believed that the pathogenesis is mainly related to abnormal transportation of the spleen and stomach, disorder of body fluid distribution and dysfunction of the intestinal tract. Traditional Chinese medicine treatment emphasizes syndrome differentiation and treatment, and often uses methods such as moistening the intestines to defecate, tonifying qi and nourishing yin, or warming yang and regulating qi, which has the characteristics of multiple targets and overall regulation. Although existing clinical commonly used prescriptions such as Mahaziren Pill and Huangqi Decoction have certain effects, they still have problems such as slow effect and fixed composition difficult to adapt to individual differences, and lack of compound preparations optimized for modern people's diet and rest characteristics, which limits their wide application.

[0004] In recent years, traditional Chinese medicine compound preparations have gradually attracted attention in the field of constipation treatment. They can synergistically enhance the effect of defecation, reduce adverse reactions, and have the comprehensive advantages of regulating intestinal flora and improving intestinal motility through the combination of multiple medicinal ingredients. However, existing preparations still have problems such as rough preparation process (such as low extraction efficiency, insufficient retention of effective components), single dosage form (such as mainly traditional decoction or pill), which are difficult to meet the needs of modern medicine. Therefore, it is of great clinical significance and application value to develop a traditional Chinese medicine compound preparation based on the optimization of classical prescriptions, with excellent preparation process and suitable for modern production. SUMMARY

[0005] The present application aims to provide a traditional Chinese medicine compound preparation for treating functional constipation and a preparation method thereof.

[0006] In order to achieve the above-mentioned application purpose, the present application provides the following technical solutions:

[0007] The application provides a traditional Chinese medicine compound preparation for treating functional constipation, which comprises the following components in parts by mass: Areca catechu 8-12 parts, Lindera aggregata 8-12 parts, Fructus Aurantii Immaturus 18-22 parts, Radix Pini 25-35 parts, Semen Raphani 18-22 parts, Trichosanthes kirilowii 13-17 parts and Cistanche 18-22 parts.

[0008] The application further provides a preparation method of the traditional Chinese medicine compound preparation for treating functional constipation.

[0009] (1) mixing Areca catechu, Lindera aggregata, Fructus Aurantii Immaturus, Radix Pini, Semen Raphani, Trichosanthes kirilowii and Cistanche to obtain material 1; mixing the material 1 with water, soaking, decocting and filtering to obtain filtrate and residue;

[0010] (2) mixing the residue with water, decocting and filtering to obtain decocted liquid;

[0011] (3) mixing the filtrate and the decocted liquid.

[0012] Preferably, the mass ratio of the material 1 to water in step (1) is 1:5-8.

[0013] Preferably, the soaking time in step (1) is 25-35 min.

[0014] Preferably, the decocting time in step (1) is 20-30 min.

[0015] Preferably, the mass ratio of the residue to water in step (2) is 1:2-3.

[0016] Preferably, the decocting time in step (2) is 5-10 min.

[0017] Compared with the prior art, the application has the following beneficial effects:

[0018] The traditional Chinese medicine compound preparation for treating functional constipation provided by the application is mainly used for treating constipation caused by liver and spleen imbalance, and the symptoms are as follows: difficult defecation, incomplete defecation, uncomfortable after defecation, gurgling sound of the intestines, abdominal distention and pain, belching, poor appetite, yellow urine, poor sleep, pale red tongue, greasy or yellowish greasy fur and slippery pulse. The western medicine diagnosis is functional constipation or constipation type irritable bowel syndrome. The following is the explanation of the prescription: Lindera aggregata and Lignum Aquilariae Resinatum can regulate qi and relieve stagnation, and the two drugs have pungent smell and can enter liver and spleen; Areca catechu, Fructus Aurantii Immaturus and Semen Raphani can break qi and remove stagnation; Radix Pini is good at invigorating the spleen and promoting defecation; Trichosanthes kirilowii can clear heat, reduce phlegm, moisten the intestines and promote defecation; and Cistanche can tonify the kidney and promote defecation.

[0019] The preparation realizes the overall regulation on constipation caused by liver and spleen imbalance through the synergistic effect of multiple Chinese medicines, not only relieves the main symptoms such as defecation difficulty, abdominal distension, belching and the like, but also takes into account multiple effects such as invigorating the spleen, regulating qi, moistening the intestines and tonifying the kidney. The preparation process is scientific and reasonable, the extraction of effective components is sufficient, the dosage form is suitable for modern clinical application, and the preparation has good safety and tolerability, thereby providing an effective and highly compliant Chinese medicine treatment scheme for patients with functional constipation. DETAILED DESCRIPTION

[0020] The technical solutions provided by the present application will be described in detail below in combination with the embodiments, but they should not be understood as limiting the protection scope of the present application.

[0021] Example 1

[0022] A preparation method of a Chinese medicine compound preparation for treating functional constipation, the steps are as follows:

[0023] (1) 12 parts of Areca catechu, 12 parts of Lindera aggregata, 22 parts of Fructus Aurantii Immaturus, 35 parts of Radix Paeoniae Alba, 22 parts of Semen Raphani, 17 parts of Trichosanthes kirilowii and 22 parts of Cistanche deserticola are mixed to obtain material 1; the material 1 is mixed with water at a mass ratio of 1:5 for 27 min of soaking, 20 min of decoction, and then filtered to obtain a filtrate and a residue;

[0024] (2) the residue is mixed with water at a mass ratio of 1:2 for 5 min of decoction, and then filtered to obtain a decoction liquid;

[0025] (3) the filtrate and the decoction liquid are mixed.

[0026] Example 2

[0027] A preparation method of a Chinese medicine compound preparation for treating functional constipation, the steps are as follows:

[0028] (1) 8 parts of Areca catechu, 8 parts of Lindera aggregata, 18 parts of Fructus Aurantii Immaturus, 25 parts of Radix Paeoniae Alba, 18 parts of Semen Raphani, 13 parts of Trichosanthes kirilowii and 18 parts of Cistanche deserticola are mixed to obtain material 1; the material 1 is mixed with water at a mass ratio of 1:8 for 33 min of soaking, 30 min of decoction, and then filtered to obtain a filtrate and a residue;

[0029] (2) the residue is mixed with water at a mass ratio of 1:3 for 10 min of decoction, and then filtered to obtain a decoction liquid;

[0030] (3) the filtrate and the decoction liquid are mixed.

[0031] Example 3

[0032] A preparation method of a Chinese medicine compound preparation for treating functional constipation, the steps are as follows:

[0033] (1) Mix 9 parts of areca nut, 9 parts of Lindera root, 21 parts of immature bitter orange, 33 parts of raw Atractylodes macrocephala, 19 parts of radish seed, 14 parts of Trichosanthes fruit and 19 parts of Cistanche deserticola to obtain material 1; mix material 1 with water at a mass ratio of 1:6 and soak for 27 minutes, decoct for 23 minutes, and filter to obtain filtrate and residue;

[0034] (2) Mix the filter residue with water at a mass ratio of 1:3 and boil for 6 minutes, then filter to obtain the decoction.

[0035] (3) Simply mix the filtrate and the decoction.

[0036] Example 4

[0037] A method for preparing a traditional Chinese medicine compound for treating functional constipation, comprising the following steps:

[0038] (1) Mix 11 parts of areca nut, 11 parts of Lindera root, 19 parts of immature bitter orange, 26 parts of raw Atractylodes macrocephala, 21 parts of radish seed, 16 parts of Trichosanthes fruit and 19 parts of Cistanche deserticola to obtain material 1; mix material 1 with water at a mass ratio of 1:7 and soak for 29 minutes, decoct for 28 minutes, and filter to obtain filtrate and residue;

[0039] (2) Mix the filter residue with water at a mass ratio of 1:3 and boil for 9 minutes, then filter to obtain the decoction.

[0040] (3) Simply mix the filtrate and the decoction.

[0041] Example 5

[0042] A method for preparing a traditional Chinese medicine compound for treating functional constipation, comprising the following steps:

[0043] (1) Mix 10 parts of areca nut, 10 parts of Lindera root, 20 parts of immature bitter orange, 30 parts of raw Atractylodes macrocephala, 20 parts of radish seed, 15 parts of Trichosanthes fruit and 20 parts of Cistanche deserticola to obtain material 1; mix material 1 with water at a mass ratio of 1:6 and soak for 30 minutes, decoct for 25 minutes, and filter to obtain filtrate and residue;

[0044] (2) Mix the filter residue with water at a mass ratio of 1:3 and boil for 8 minutes, then filter to obtain the decoction.

[0045] (3) Simply mix the filtrate and the decoction.

[0046] Experimental Example 1

[0047] Sixty-two patients with functional constipation who visited the Department of Gastroenterology at the Affiliated Hospital of Shaanxi University of Traditional Chinese Medicine from April 2021 to January 2022 were selected as the study subjects and randomly divided into an experimental group (n=31) and a control group (n=31) using a random number table. In the experimental group, there were 15 males and 16 females, aged 43–85 years, with a mean age of (60.31±10.27) years. In the control group, there were 14 males and 17 females, aged 42–84 years, with a mean age of (61.12±10.42) years. There were no statistically significant differences in general characteristics between the two groups (P>0.05), indicating comparability.

[0048] Inclusion criteria: ① Meets the diagnostic criteria for constipation in Traditional Chinese Medicine Internal Medicine; syndrome type is liver-spleen disharmony; ② Functional constipation or constipation-predominant irritable bowel syndrome; ③ Age 18-70 years; ④ Gender not limited. Exclusion criteria: ① Constipation caused by intestinal or systemic organic lesions such as colon tumors; ② Accompanied by serious underlying diseases; ③ Accompanied by mental illness; ④ Pregnant or lactating women; ⑤ Allergic to lactulose and traditional Chinese medicine decoctions.

[0049] Patients in the experimental group were treated with the Wu Mo Tong Bian Fang (prepared according to the method in Example 5), 150ml twice daily. Patients in the control group were treated with lactulose oral solution, starting at 30ml daily and maintaining at 15ml daily, once daily after breakfast. Both groups underwent one course of treatment, lasting 4 weeks.

[0050] Clinical efficacy evaluation criteria: Cured: Normal bowel movements (defecation once every 2 days, with smooth and easy stool); Significantly effective: Symptoms are significantly improved, bowel movement interval and stool consistency are close to normal; or stool is slightly dry but bowel movement interval is within 72 hours, and most other symptoms disappear; Effective: Bowel movement interval is shortened by 1 day, or stool dryness is improved, and other symptoms are improved; Ineffective: Constipation and other symptoms are not improved.

[0051] Treatment results: Experimental group: 10 cases were cured, 11 cases showed significant improvement, 7 cases were effective, and 3 cases were ineffective, with a total effective rate of 90.32%; Control group: 6 cases were cured, 8 cases showed significant improvement, 6 cases were effective, and 11 cases were ineffective, with a total effective rate of 64.52%.

[0052] This invention, through clinical trials, found that the total effective rate of patients treated with this preparation (experimental group) reached 90.32%, significantly higher than that of the control group treated with lactulose oral solution (total effective rate 64.52%). The experimental group was superior to the control group in terms of the number of cured, significantly effective, and effective cases, indicating that this compound preparation has significant advantages in improving constipation symptoms and increasing the frequency and quality of bowel movements.

[0053] The above description is only a preferred embodiment of the present invention. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine compound preparation for treating functional constipation, characterized in that, The components include the following parts by weight: 8-12 parts of areca nut, 8-12 parts of Lindera root, 18-22 parts of immature bitter orange, 25-35 parts of raw Atractylodes macrocephala, 18-22 parts of radish seed, 13-17 parts of Trichosanthes fruit, and 18-22 parts of Cistanche deserticola.

2. The method for preparing a traditional Chinese medicine compound preparation for treating functional constipation as described in claim 1, characterized in that, Includes the following steps: (1) Mix areca nut, Lindera root, immature bitter orange, raw Atractylodes macrocephala, radish seed, Trichosanthes fruit and Cistanche deserticola to obtain material 1; mix material 1 with water, soak, decoct, and filter to obtain filtrate and residue; (2) The filter residue is mixed with water and boiled, and then filtered to obtain the decoction; (3) Simply mix the filtrate and the decoction.

3. The preparation method according to claim 2, characterized in that, The mass ratio of material 1 to water in step (1) is 1:5 to 8.

4. The preparation method according to claim 2, characterized in that, The soaking time in step (1) is 25 to 35 minutes.

5. The preparation method according to claim 2, characterized in that, The simmering time in step (1) is 20 to 30 minutes.

6. The preparation method according to claim 2, characterized in that, The mass ratio of filter residue to water in step (2) is 1:2 to 3.

7. The preparation method according to claim 2, characterized in that, The simmering time in step (2) is 5 to 10 minutes.