A Chinese medicine composition for treating constipation and its process

Abstract

The present invention relates to the field of traditional Chinese medicine, and relates to a traditional Chinese medicine composition for treating constipation and a process thereof. The traditional Chinese medicine composition contains the following traditional Chinese medicines in parts by weight: 27-89 parts of raw rhubarb, 22-65 parts of hemp seeds, 17-27 parts of bitter apricot kernels, 11-38 parts of magnolia bark, 7-18 parts of angelica sinensis, 7-18 parts of cistanche deserticola, 8-23 parts of raw atractylodes macrocephala, and 10-30 parts of stir-fried immature bitter oranges. Clinical trials have shown that the external-use powder of the present invention has an efficacy of over 90%. The traditional Chinese medicines of the present invention are all selected from natural Chinese herbal medicines, are easily available, have a simple preparation method, are low in cost, are easy to use, and can be industrially produced. The traditional Chinese medicine composition can effectively improve the quality of life of patients with constipation and has high social value.

Description

Technical Field

[0001] The present invention relates to the field of traditional Chinese medicine, and mainly relates to a traditional Chinese medicine composition for treating constipation and a process thereof. Background Art

[0002] Constipation is a common spleen and stomach symptom in traditional Chinese medicine. It was first documented in the Yellow Emperor's Classic of Internal Medicine. For example, the Lingshu Miscellaneous Diseases chapter discusses "abdominal distension, difficult defecation," and "inability to defecate" as typical symptoms of constipation. The Classic of Internal Medicine believes that constipation is closely related to the spleen and kidneys. The medical sage Zhang Zhongjing created Ma Ren Wan and clarified the pathogenesis and treatment of excessive stomach heat and spleen yin deficiency. The Treatise on Febrile Diseases, based on the Yangming meridian's heat syndrome, attributes the pathogenesis to heat stagnation and qi stagnation. It also developed purgative and yin-preserving formulas such as Da Chengqi Decoction, Xiao Chengqi Decoction, and Weiwei Chengqi Decoction. The Song Dynasty's Shengji Zonglu categorized constipation into wind, heat, cold, deficiency, and food stagnation based on etiology and pathogenesis. Liu Wansu of the Jin and Yuan dynasties first proposed the distinction between excess constipation and deficiency constipation. Later generations of physicians further enriched and summarized this distinction, accumulating a wealth of clinical experience in the treatment of constipation. Traditional Chinese medicine has strong advantages in treating constipation, and there are many methods such as oral administration of Chinese medicine, acupuncture, and external application. The clinical treatment based on syndrome differentiation often has relatively good results.

[0003] Constipation is a common symptom of difficulty in defecation or infrequent bowel movements, with dry, difficult stools. Constipation may cause discomfort such as bloating, abdominal pain, nausea, and loss of appetite. Medications for constipation mainly include the following types:

[0004] 1) Stool Softeners: These medications soften stool by increasing its moisture content, making it easier to pass. Common examples include polysaccharide effervescent tablets and liquid paraffin.

[0005] 2) Osmotic laxatives: Osmotic laxatives increase intestinal fluid content, promoting bowel movements and defecation. Common osmotic laxatives include lactulose and polyethylene glycol.

[0006] 3) Stimulant Laxatives: Stimulant laxatives stimulate bowel movements and defecation, helping to relieve constipation. Common stimulant laxatives include rhubarb, aloe vera, and senna.

[0007] 4) Rectal stimulants: These drugs work by directly stimulating the rectum, promoting bowel movements. Common rectal stimulants include glycerin suppositories and enteric-coated tablets.

[0008] 5) Prokinetic Agents: Prokinetic agents increase intestinal motility and promote bowel movements. Common prokinetic agents include mosapride and domperidone.

[0009] There are various forms of traditional Chinese medicine for treating constipation. For example, the marketed product Shouhui Tongbian Capsule pioneered the theory of "treating constipation with supplements." Summary of the Invention

[0010] Traditional Chinese medicines available in the prior art are unable to promote defecation without oral administration, making them particularly unsuitable for bedridden patients, patients with hemiplegia, or those with dysphagia. Therefore, the present invention provides a traditional Chinese medicine composition for treating constipation, which can effectively improve the quality of life of patients suffering from constipation and has high social value.

[0011] Specifically, the present invention solves the above technical problems through the following technical solutions:

[0012] A traditional Chinese medicine composition for treating constipation comprises the following traditional Chinese medicines in parts by weight: 27-89 parts of raw rhubarb, 22-65 parts of hemp seeds, 17-27 parts of bitter almonds, 11-38 parts of magnolia bark, 7-18 parts of angelica sinensis, 7-18 parts of cistanche deserticola, 8-23 parts of raw atractylodes macrocephala, and 10-30 parts of stir-fried immature bitter orange.

[0013] In a preferred embodiment of the present invention, the bitter almonds are stewed bitter almonds.

[0014] In a preferred embodiment of the present invention, the Magnolia officinalis is Magnolia officinalis Zingiber officinale.

[0015] In a preferred embodiment of the present invention, the Atractylodes macrocephala is raw Atractylodes macrocephala.

[0016] In a preferred embodiment of the present invention, the Citrus aurantium is stir-fried Citrus aurantium with bran.

[0017] Further, calculated by weight, calculated by weight, 27-89 parts of raw rhubarb, 22-65 parts of hemp seed, 17-27 parts of boiled bitter almonds, 11-38 parts of magnolia bark, 7-18 parts of angelica, 7-18 parts of cistanche, 8-23 parts of raw atractylodes, and 10-30 parts of fried aurantii with bran; further preferably, 52 parts of raw rhubarb, 44 parts of hemp seed, 19 parts of boiled bitter almonds, 20 parts of magnolia bark, 13 parts of angelica, 13 parts of cistanche, 16 parts of raw atractylodes, and 20 parts of fried aurantii with bran.

[0018] Furthermore, the dosage form prepared from the Chinese medicine composition is any clinically acceptable dosage form.

[0019] In a preferred embodiment of the present invention, the agent is a powder, more preferably a powder for external application.

[0020] Furthermore, the present invention provides a method for preparing the Chinese medicine composition, comprising the following steps:

[0021] 1) Grind raw rhubarb and hemp seeds into fine powder and set aside. Add 12-18 times boiling water to bitter almonds and blanch for 3-5 minutes. Remove and soak in cold water for 3-5 minutes. Rub off the skin and place in a 70-80°C oven to dry. Remove and remove to prepare the braised bitter almonds.

[0022] 2) Crush the bitter almonds and extract the volatile oil with 6-8 times the amount of water. The volatile oil, liquid medicine, and residue are set aside.

[0023] 3) Extract 1 / 2 of the fine powder from step 1) with the medicinal residue, Cistanche deserticola, and Angelica sinensis from step 2) twice with 75%-85% ethanol. Filter and concentrate the filtrate to obtain an extract A having a relative density of 1.15-1.24 at 50°C-60°C, which is set aside.

[0024] 4) Extract the decoction of Magnolia officinalis, Atractylodes macrocephala, and Fructus Aurantii immaturus from step 2) with 5-10 times the amount of water, perform extraction three times, centrifuge the decoction, filter, and concentrate the filtrate under reduced pressure to obtain an extract B with a relative density of 1.06-1.15, which is set aside;

[0025] 5) Combine Extract A, Extract B, and the volatile oil from step 2), then add the remaining half of the fine powder from step 1), mix well, dry, grind into a fine powder, and sieve.

[0026] Furthermore, the method comprises the following steps:

[0027] 1) Grind raw rhubarb and hemp seeds into fine powder and set aside. Add 15 times the volume of boiling water to bitter almonds and blanch for 4 minutes. Remove and soak in cold water for 4 minutes. Rub off the skin and place in a 75°C oven to dry. Remove and remove to obtain the braised bitter almonds.

[0028] 2) Crush the boiled bitter almonds and extract the volatile oil with 7 times the amount of water. The obtained bitter almond volatile oil, medicinal solution and medicinal residue are set aside.

[0029] 3) Take 1 / 2 of the fine powder from step 1) and the residue from step 2), Cistanche deserticola, and Angelica sinensis, and extract twice with 80% ethanol. Filter and concentrate the filtrate to obtain an extract A having a relative density of 1.20 at 55°C, which is set aside.

[0030] 4) Extracting the medicinal solution of Magnolia officinalis, Atractylodes macrocephala, and Fructus Aurantii immaturus (Fried with bran) from step 2) with water three times, adding 10 times the amount of water for the first extraction, 8 times the amount of water for the second extraction, and 5 times the amount of water for the third extraction. Each extraction is performed for 2 hours. The filtrates are combined, centrifuged, filtered, and the filtrate is concentrated under reduced pressure to obtain an extract B with a relative density of 1.11, which is set aside.

[0031] 5) Combine Extract A, Extract B, and the volatile oil from step 2), then add the remaining half of the fine powder from step 1), mix well, dry, grind into a fine powder, and sieve.

[0032] Furthermore, the present invention provides a pharmaceutical composition, which is a combination of the traditional Chinese medicine composition and a chemical drug for treating constipation.

[0033] The powder of the present invention is used for external application. Take an appropriate amount of the powder, mix it with 3-5% vinegar or sesame oil, and apply it to the navel. Each application lasts for 2 hours, and can be continued for 2 weeks.

[0034] This prescription combines the main, secondary, auxiliary, and guiding herbs, accurately targeting the underlying mechanism and demonstrating clear efficacy. Raw rhubarb and hemp seed serve as the main herbs, acting as purgatives, clearing away heat and purging fire, moistening the intestines, and promoting bowel movements. Simmered bitter almonds, raw white atractylodes, and magnolia bark serve as the auxiliary herbs, assisting the main herbs in achieving this purgative effect. Meanwhile, angelica and Cistanche deserticola serve as adjuvants, regulating qi and strengthening the spleen, promoting fluid circulation, reducing swelling, and nourishing the liver and kidneys. Citrus aurantium serves as the guiding herb, harmonizing the various herbs while guiding them directly to the affected area, promoting digestion and eliminating stagnation. Together, these herbs achieve a purgative effect.

[0035] Compared with the prior art, by processing amygdalin and the like, the preparation process and key parameters are optimized, and the pharmacological effect is more obvious. Clinical experiments show that the efficiency is more than 90%, indicating that the composition of the present invention can hit the mechanism. If a different prescription is used or the main drug is not included / replaced, even the auxiliary drug cannot play the role of the embodiment. The traditional Chinese medicine of the present invention is all made of natural Chinese herbal medicines, which are easy to obtain, simple to prepare, low in cost, easy to use, can be industrialized and produced on a large scale, and generate higher social value. Specific embodiments

[0037] The following describes in detail the specific embodiments of the present invention. However, the contents described are only preferred embodiments of the present invention and should not be considered to limit the scope of the present invention. All equivalent changes and improvements made within the scope of the present invention should still fall within the scope of the patent coverage of the present invention.

[0038] Example 1: A Chinese medicine powder for treating constipation, the dosage and preparation process are as follows:

[0039]

[0040] The method comprises the following steps:

[0041] 1) Grind raw rhubarb and hemp seeds into fine powder and set aside. Add 12 times the volume of boiling water to bitter almonds and blanch for 3 minutes. Remove and soak in cold water for 3 minutes. Rub off the skin and place in a 70°C oven to dry. Remove and remove to obtain the braised bitter almonds.

[0042] 2) Crush the boiled bitter almonds and extract the volatile oil with 6 times the amount of water. The obtained bitter almond volatile oil, medicinal solution, and medicinal residue are set aside.

[0043] 3) Take 1 / 2 of the fine powder from step 1), the medicinal residue from step 2), Cistanche deserticola, and Angelica sinensis, and extract twice with 75% ethanol. Filter and concentrate the filtrate to obtain an extract A having a relative density of 1.15 at 50°C, which is set aside.

[0044] 4) Extract the decoction of Magnolia officinalis, Atractylodes macrocephala, and Fructus Aurantii immaturus from step 2) with 5 times the amount of water, perform extraction three times, centrifuge the decoction, filter, and concentrate the filtrate under reduced pressure to obtain an extract B with a relative density of 1.06-, which is set aside;

[0045] 5) Combine Extract A, Extract B, and the volatile oil from step 2), then add the remaining half of the fine powder from step 1), mix well, dry, grind into a fine powder, and sieve.

[0046] Example 2: A Chinese medicine powder for treating constipation, the dosage and preparation process are as follows:

[0047]

[0048] The method comprises the following steps:

[0049] 1) Grind raw rhubarb and hemp seeds into fine powder and set aside. Add 18 times boiling water to bitter almonds and blanch for 5 minutes. Remove and soak in cold water for 5 minutes. Rub off the skin and place in an 80°C oven to dry. Remove and remove to obtain the braised bitter almonds.

[0050] 2) Crush the boiled bitter almonds and extract the volatile oil with 8 times the amount of water. The volatile oil, liquid medicine, and dregs of the bitter almonds are set aside.

[0051] 3) Take 1 / 2 of the fine powder from step 1) and the residue from step 2), Cistanche deserticola, and Angelica sinensis, extract twice with 85% ethanol, filter, and concentrate the filtrate to obtain an extract A having a relative density of 1.24 at 50°C-60°C, which is set aside;

[0052] 4) Extract the decoction of Magnolia officinalis, Atractylodes macrocephala, and Fructus Aurantii immaturus from step 2) with 5-10 times the amount of water three times. Centrifuge the decoction, filter, and concentrate the filtrate under reduced pressure to obtain an extract B with a relative density of 1.15, which is set aside.

[0053] 5) Combine Extract A, Extract B, and the volatile oil from step 2), then add the remaining half of the fine powder from step 1), mix well, dry, grind into a fine powder, and sieve.

[0054] Example 3: A Chinese medicine powder for treating constipation, the dosage and preparation process are as follows:

[0055]

[0056] The method comprises the following steps:

[0057] 1) Grind raw rhubarb and hemp seeds into fine powder and set aside. Add 15 times the volume of boiling water to bitter almonds and blanch for 4 minutes. Remove and soak in cold water for 4 minutes. Rub off the skin and place in a 75°C oven to dry. Remove and remove to obtain the braised bitter almonds.

[0058] 2) Crush the boiled bitter almonds and extract the volatile oil with 7 times the amount of water. The obtained bitter almond volatile oil, medicinal solution and medicinal residue are set aside.

[0059] 3) Take 1 / 2 of the fine powder from step 1) and the residue from step 2), Cistanche deserticola, and Angelica sinensis, and extract twice with 80% ethanol. Filter and concentrate the filtrate to obtain an extract A having a relative density of 1.20 at 55°C, which is set aside.

[0060] 4) Extracting the medicinal solution of Magnolia officinalis, Atractylodes macrocephala, and Fructus Aurantii immaturus (Fried with bran) from step 2) with water three times, adding 10 times the amount of water for the first extraction, 8 times the amount of water for the second extraction, and 5 times the amount of water for the third extraction. Each extraction is performed for 2 hours. The filtrates are combined, centrifuged, filtered, and the filtrate is concentrated under reduced pressure to obtain an extract B with a relative density of 1.11, which is set aside.

[0061] 5) Combine Extract A, Extract B, and the volatile oil from step 2), then add the remaining half of the fine powder from step 1), mix well, dry, grind into a fine powder, and sieve.

[0062] Example 4: A Chinese medicine powder for treating constipation, the dosage and preparation process are as follows:

[0063]

[0064] The method is the same as that of Example 3.

[0065] Example 5: A Chinese medicine powder for treating constipation, the dosage and preparation process are as follows:

[0066]

[0067] The method is the same as that in Example 3.

[0068] Comparative Example 1: A Chinese medicine powder for treating constipation, the dosage and preparation process are as follows:

[0069]

[0070] The method is the same as that of Example 3.

[0071] Comparative Example 2: A Chinese medicine powder for treating constipation, the dosage and preparation process are as follows:

[0072]

[0073] The method is the same as that of Example 3.

[0074] Comparative Example 3: A Chinese medicine powder for treating constipation, the dosage and preparation process are as follows:

[0075]

[0076] The method is the same as that of Example 3.

[0077] Comparative Example 4: A Chinese medicine powder for treating constipation, the dosage and preparation process are as follows:

[0078]

[0079] The method is the same as that of Example 3.

[0080] Comparative Example 5: A Chinese medicine powder for treating constipation, the dosage and preparation process are as follows:

[0081]

[0082] The method is the same as that of Example 3.

[0083] Comparative Example 6: A Chinese medicine powder for treating constipation, the dosage and preparation process are as follows:

[0084]

[0085] The method is the same as that in Example 3

[0086] Comparative Example 7: A Chinese medicine powder for treating constipation, the dosage and preparation process are as follows:

[0087]

[0088] The preparation process is:

[0089] 1) Grind raw rhubarb and hemp seeds into fine powder and set aside. Add 10 times the volume of boiling water to bitter almonds and blanch for 2 minutes. Remove and soak in cold water for 2 minutes. Rub off the skin and place in a 75°C oven to dry. Remove and remove to prepare the braised bitter almonds.

[0090] Steps 2), 3), and 4) are the same as in Example 3.

[0091] Comparative Example 8: A Chinese medicine powder for treating constipation, the dosage and preparation process are as follows:

[0092]

[0093] 1) Grind raw rhubarb and hemp seeds into fine powder and set aside. Add 15 times the volume of boiling water to bitter almonds and blanch for 4 minutes. Remove and soak in cold water for 4 minutes. Rub off the skin and place in a 75°C oven to dry. Remove and remove to obtain the braised bitter almonds.

[0094] 2) Crush the stewed bitter almonds and set aside;

[0095] Steps 3) and 4) are the same as in Example 3.

[0096] Comparative Example 9: A Chinese medicine powder for treating constipation, the dosage and preparation process are as follows:

[0097]

[0098] The method is the same as that of Example 3.

[0099] 1. The content of amygdalin in the above selected examples was tested as follows:

[0100] Chromatographic conditions and system suitability test: Octadecylsilane bonded silica gel was used as the filler; acetonitrile-0.1% phosphoric acid solution (8:92) was used as the mobile phase; the detection wavelength was 207 nm. The theoretical plate number calculated based on the amygdalin peak should be no less than 7000.

[0101] Preparation of reference solution: Take an appropriate amount of amygdalin reference substance, accurately weigh it, and add methanol to make a solution containing 40µg per 1mL.

[0102] Preparation of the test solution: Take 0.25 g of the powder of the embodiment of the present invention containing bitter almonds or stewed bitter almonds, accurately weigh it, place it in a stoppered conical flask, accurately add 100 mL of methanol, stopper it, weigh it, and ultrasonically treat it (power 250 W, frequency 50 kHz) for 30 minutes. Let it cool, weigh it again, make up the lost weight with methanol, shake it well, filter it, accurately measure 30 mL of the filtrate, place it in a 50 mL volumetric flask, add 50% methanol to dilute it to the scale, shake it well, filter it, and take the filtrate to obtain the product.

[0103] Determination method: Accurately pipette 10-20µl of reference solution and test solution respectively, inject into liquid chromatograph, and determine.

[0104] Accelerated experiment: The accelerated conditions were 40±2°C and 75±5% humidity. The amygdalin content of the above examples (parts) was tested at 0, 1, 2, and 36 months respectively.

[0105] Table 1 Amygdalin content in the examples (%)

[0106]

[0107] As can be seen in Table 1, using different preparation processes or replacing other types of Chinese medicinal materials will affect the content of amygdalin to a certain extent. The content of amygdalin in Comparative Example 9 is higher, even exceeding that of Examples 1, 2, and 5. The inventors conducted relevant clinical experiments on this. See the pharmacodynamics section for details.

[0108] 2. Clinical Pharmacodynamics Experiment

[0109] The cases in this study were derived from patients who visited Zhejiang Cancer Hospital from October 2020 to November 2021. A total of 126 patients who met the inclusion criteria were selected.

[0110] 1. Diagnostic criteria

[0111] 1.1 Western medicine diagnostic criteria

[0112] According to the 2016 Rome IV diagnostic criteria:

[0113] (1) The symptoms of constipation have occurred for more than six months, and the condition has recurred in the past three months, accompanied by the following

[0114] Two or more of the following:

[0115] ① Defecation is difficult and requires a lot of effort for a quarter or more of the time;

[0116] ② The stool is in the form of dry balls or lumps for more than a quarter of the time;

[0117] ③ Feeling of incomplete defecation for a quarter or more of the time;

[0118] ④ Feeling of anorectal obstruction or blockage during defecation for more than a quarter of the time;

[0119] ⑤ Manual defecation is required for a quarter or more of the time;

[0120] ⑥ The number of spontaneous bowel movements per week is less than 3 times.

[0121] (2) Without the use of laxatives to assist defecation, loose stools rarely occur.

[0122] (3) Exclude constipation caused by organic intestinal lesions and drug factors.

[0123] 1.2. Standards of TCM Syndrome Differentiation:

[0124] With reference to the consensus opinion of TCM diagnosis and treatment experts on constipation (2017) and the TCM disease diagnosis and treatment standard, the

[0125] The diagnostic criteria for damp-heat stagnation syndrome are as follows:

[0126] Main symptoms: Decreased bowel movement, sticky and uncomfortable bowel movements, and a feeling of incomplete bowel movements;

[0127] Strain; prolonged bowel movement.

[0128] Secondary symptoms: bad breath, abdominal distension, heaviness in limbs, fever, irritability, nausea and vomiting.

[0129] Tongue and pulse: The tongue is reddish, the tongue coating is greasy and yellow, and the pulse is weak and rapid.

[0130] If the main symptoms meet 1 or more, and the secondary symptoms meet 2 or more, combined with the tongue and pulse, the diagnosis can be made.

[0131] Constipation due to damp-heat stagnation.

[0132] 1.3. Case inclusion criteria:

[0133] 1. Meet the FC Western medicine diagnostic criteria;

[0134] 2. The patient is diagnosed as damp-heat stagnation type according to TCM syndrome differentiation;

[0135] 3. Aged between 18 and 80 years old;

[0136] 4. No medication to assist defecation was used in the past week;

[0137] 5. Voluntarily participate in this clinical study, voluntarily enroll, and sign the informed consent.

[0138] 1.4. Case Exclusion Criteria

[0139] 1. Patients with complex TCM symptoms and multiple concurrent symptoms;

[0140] 2. Patients diagnosed with organic lesions of the colon or rectum;

[0141] 3. Pregnant and lactating women;

[0142] 4. Those with a history of mental illness;

[0143] 5. Patients with severe lesions in other organs.

[0144] (V) Case exclusion and dropout criteria

[0145] 1. Those who take other medications that may cause abnormal bowel movements during the study;

[0146] 2. Patients who fail to take medication and perform acupoint application according to doctor's instructions;

[0147] 3. Patients who are allergic to or intolerant of the drugs used in this study;

[0148] 4. Patients who request to withdraw from this study due to personal reasons;

[0149] 5. Patients lost to follow-up.

[0150] 2. Research Methods

[0151] 2.1 Trial Grouping

[0152] 126 patients were randomly divided into 6 groups, 21 cases in each group, specifically Example 5, Comparative Example 1, Comparative Example 4, Comparative Example 5, Comparative Example 9, and a blank control group. There were no significant differences in age, gender, condition, or cycle among the groups (P>0.05).

[0153] 2.2 Usage and Dosage

[0154] For external use: Take an appropriate amount of the powder, mix it with 3-5% vinegar, and apply it to the navel. Apply for 2 hours at a time and continue for 2 weeks.

[0155] 2.3 Observation indicators

[0156] 2.3.1. Evaluation of TCM symptom efficacy

[0157] Clinical symptoms of FC were categorized according to their relevance to defecation. Symptoms directly related to defecation were designated as primary symptoms, and any accompanying symptoms other than defecation were designated as secondary symptoms. All Traditional Chinese Medicine (TCM) symptoms were assigned scores of 0, 3, 5, or 7, corresponding to severity levels of none, mild, moderate, or severe. Before treatment and two weeks after treatment, participants completed the TCM Primary and Secondary Symptom Score Sheets under the guidance of a physician, and the total score was calculated. TCM tongue and pulse assessments were not included in the observations for this trial.

[0158] (1) Evaluation index of TCM main symptoms and efficacy: The TCM main symptoms scoring standard refers to the “Evaluation of Constipation Symptoms and Efficacy”.

[0159] It is formulated based on the "Evaluation of Defecation", which includes five aspects: degree of defecation difficulty, frequency of defecation, time of defecation, frequency of defecation and feeling of incomplete defecation.

[0160] 2.3.2. Based on the Bristol stool consistency classification (type 1 corresponds to 1 point, type 2 corresponds to 2 points, and so on), add the stool consistency scores of all spontaneous bowel movements in the previous week and divide the sum by the total number of spontaneous bowel movements in the week to calculate the average score.

[0161] 2.3.3. Effectiveness evaluation

[0162] (1) Establishment of efficacy evaluation standards

[0163] Formulate efficacy evaluation standards based on the Guiding Principles for Clinical Research of New Chinese Medicines:

[0164] ① Cured: Within the observation range, the patient's bowel movements are basically normal, the secondary symptoms of traditional Chinese medicine have basically disappeared, and the total TCM

[0165] The total score of physical symptom efficacy is reduced by ≥95% compared with before treatment;

[0166] ② Markedly effective: After treatment, the total score of TCM symptom efficacy decreased by ≥70% compared with that before treatment;

[0167] ③ Effective: The total score of TCM overall symptom efficacy after treatment is reduced by ≥30% compared with that before treatment;

[0168] ④ Ineffective: The patient's bowel movements have basically not changed significantly compared to before treatment, or the main symptoms and secondary symptoms of traditional Chinese medicine appear.

[0169] In the case of worsening symptoms, the total score of TCM overall symptom efficacy after treatment decreased by <30% compared with that before treatment.

[0170] (2) Effective rate = (cured cases + markedly effective cases + effective cases) ÷ total number of cases studied × 100%. See Table 2 for details.

[0171] 2.3.4. Constipation self-rating

[0172] Stool consistency, rectal symptoms, and abdominal symptoms are the primary criteria, categorized as none, mild, moderate, severe, or very severe (scored 0-5 points, respectively). Stool consistency assesses stool consistency and volume; rectal symptoms are categorized as frequency, straining, bleeding, and burning; and abdominal symptoms include stomach pain, abdominal cramping, and abdominal distension.

[0173] 2.3.5. Weekly bowel movement frequency

[0174] Each group of patients counted the number of bowel movements per week by themselves.

[0175] 3. Data Statistics

[0176] GRAPHAD PRISM 6.0 statistical software was used. The inter-group comparison method was one-way variance method, and P < 0.05 was considered statistically significant.

[0177] 4. Results

[0178] Figure 1 Comparison of the total scores of the main symptoms of traditional Chinese medicine before and after treatment shows that there was no significant difference between the groups before treatment. After 2 weeks of treatment, it can be seen that compared with the blank control group, both the comparative examples and the experimental examples had significant differences, indicating that the embodiments of the present invention all have therapeutic effects, and the therapeutic effect of Example 5 is the most significant, with significant differences compared with other comparative examples.

[0179] Figure 2 It can be seen from the number of complete spontaneous bowel movements per week that there was no significant difference between the groups before treatment. After 2 weeks of treatment, it can be seen that the Example 5 group had significant differences compared with the other groups and the blank control group.

[0180] Figure 3It can be seen from the Constipation Symptom Self-Assessment Scale that there was no significant difference between the groups before treatment. After 2 weeks of treatment, it can be seen that compared with the blank control group, the control group and the experimental example all had significant differences, indicating that the embodiments of the present invention all have therapeutic effects, and the therapeutic effect of Example 5 is the most significant, with significant differences compared with other control groups.

[0181] Figure 4 It can be seen from the Bristol stool shape score that after 2 weeks of treatment, the stool shape has been significantly improved. Example 5 has the highest score and is the most satisfactory to patients.

[0182] Table 2 Evaluation of therapeutic effects of each group

[0183]

[0184] As can be seen from Table 1, the effective rate of Example 5 group reached more than 90%. Using different prescriptions or excluding / replacing the main drug, or even the auxiliary drug could not play the role of the example. The content of amygdalin in the control group 9 was the highest, but the clinical effect was not the best. The inventors speculated that the effect of the preparation may have promoted the absorption of the skin, or the interaction with other Chinese medicines reduced the effect of bitter almonds.

Claims

1. A Chinese medicine composition for external use for treating constipation, characterized in that: The Chinese medicine composition is prepared from the following Chinese medicinal materials in parts by weight: 27-89 parts of raw rhubarb, 22-65 parts of hemp seeds, 17-27 parts of boiled bitter almonds, 11-38 parts of ginger magnolia bark, 7-18 parts of angelica, 7-18 parts of cistanche deserticola, 8-23 parts of raw atractylodes, and 10-30 parts of stir-fried immature bitter oranges. The preparation method of the Chinese medicine composition comprises the following steps: 1) Grind raw rhubarb and hemp seeds into fine powder and set aside. Add 12-18 times boiling water to bitter almonds and blanch for 3-5 minutes. Remove and soak in cold water for 3-5 minutes. Rub off the skin and place in a 70-80°C oven to dry. Remove and remove to prepare the braised bitter almonds. 2) Crush the bitter almonds and extract the volatile oil with 6-8 times the amount of water. The volatile oil, liquid medicine, and residue are set aside. 3) Extract 1 / 2 of the fine powder from step 1) with the medicinal residue, Cistanche deserticola, and Angelica sinensis from step 2) twice with 75%-85% ethanol. Filter and concentrate the filtrate to obtain an extract A having a relative density of 1.15-1.24 at 50°C-60°C, which is set aside. 4) Mix the medicinal solutions of Magnolia officinalis, Atractylodes macrocephala, stir-fried Citrus aurantium immaturum with bran, and step 2) and extract with 5-10 times the amount of water. Extract three times. Centrifuge the decoction, filter, and concentrate the filtrate under reduced pressure to obtain an extract B with a relative density of 1.06-1.15, which is set aside. 5) Combine Extract A, Extract B, and the volatile oil from step 2), then add the remaining half of the fine powder from step 1), mix well, dry, grind into a fine powder, and sieve.

2. The Chinese medicine composition according to claim 1, characterized in that The Chinese medicine composition is prepared from the following Chinese medicinal materials in parts by weight: 52 parts of raw rhubarb, 44 parts of hemp seeds, 19 parts of boiled bitter almonds, 20 parts of ginger magnolia bark, 13 parts of angelica, 13 parts of cistanche deserticola, 16 parts of raw atractylodes, and 20 parts of stir-fried immature bitter oranges.

3. The Chinese medicine composition according to any one of claims 1-2, characterized in that The dosage form of the Chinese medicine composition is powder.

4. The Chinese medicine composition according to claim 3, characterized in that The powder is mixed with 3-5% concentration of vinegar or sesame oil and applied to the navel.

5. The Chinese medicine composition according to claim 1, characterized in that The preparation method of the Chinese medicine composition comprises the following steps: 1) Grind raw rhubarb and hemp seeds into fine powder and set aside. Add 15 times the volume of boiling water to bitter almonds and blanch for 4 minutes. Remove and soak in cold water for 4 minutes. Rub off the skin and place in a 75°C oven to dry. Remove and remove to obtain the braised bitter almonds. 2) Crush the boiled bitter almonds and extract the volatile oil with 7 times the amount of water. The obtained bitter almond volatile oil, medicinal solution and medicinal residue are set aside. 3) Take 1 / 2 of the fine powder from step 1) and the residue from step 2), Cistanche deserticola, and Angelica sinensis, and extract twice with 80% ethanol. Filter and concentrate the filtrate to obtain an extract A having a relative density of 1.20 at 55°C, which is set aside. 4) Mix the ginger magnolia bark, raw white atractylodes, stir-fried bitter orange immature fruit, and the medicinal solution from step 2) and extract with water. Extract three times, adding 10 times the amount of water for the first extraction, 8 times the amount of water for the second extraction, and 5 times the amount of water for the third extraction. Decoction for 2 hours each time. Combine the filtrates, centrifuge, filter, and concentrate the filtrate under reduced pressure to obtain an extract B with a relative density of 1.11, which is set aside. 5) Combine Extract A, Extract B, and the volatile oil from step 2), then add the remaining half of the fine powder from step 1), mix well, dry, grind into a fine powder, and sieve.

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