Traditional Chinese medicine composition for conditioning qi-blood deficiency type constipation as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention relates to the technical field of traditional Chinese medicine, in particular to a traditional Chinese medicine composition for conditioning qi-blood deficiency type constipation, a preparation method and application. The traditional Chinese medicine composition is prepared from the following components in parts by weight: 12 to 24 parts of radix angelicae sinensis, 10 to 60 parts of radix astragali seu hedysari, 12 to 20 parts of herba cistanche, 10 to 30 parts of fructus cannabis, 10 to 24 parts of radix achyranthis bidentatae, 10 to 30 parts of radix rehmanniae, 12 to 30 parts of radix paeoniae alba, 4 to 10 parts of rhizoma coptidis and 6 to 20 parts of fructus aurantii. All the components of the traditional Chinese medicine composition are compounded to jointly achieve the effects of enriching blood, tonifying qi and relaxing bowel, the symptoms of patients with qi-blood deficiency type constipation can be remarkably improved, the curative effect is stable, and safety is good.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine, and specifically to a traditional Chinese medicine composition for conditioning constipation of qi and blood deficiency type, a preparation method and an application thereof. Background Art

[0002] Constipation generally refers to a disease syndrome characterized by difficult defecation, prolonged defecation time or defecation interval, dry and hard feces, or although the feces are soft, but the defecation is difficult and unsmooth due to the abnormal conduction function of the large intestine. From the perspective of traditional Chinese medicine syndrome differentiation and treatment, constipation can be mainly divided into the following six major syndrome types: heat constipation, qi constipation, cold constipation, qi deficiency constipation, blood deficiency constipation, and yin deficiency constipation. Each syndrome type has its unique etiology, pathogenesis, clinical manifestations and treatment characteristics.

[0003] Among them, constipation of qi and blood deficiency type is caused by both qi deficiency and blood deficiency. Qi deficiency will lead to weak propulsion of the intestine. Even if the feces are not dry and hard, it is still difficult to defecate. Blood deficiency may cause the intestine to lack moisture and lubrication, resulting in dry feces. It is stated in "Jingyue Quanshu. Secretion and Constipation": "For the syndrome of constipation, in general, the elderly, the weak, those with yin-viscera constitution, and those after childbirth, illness, excessive sweating, or excessive urination, or after blood loss, massive vomiting, or severe diarrhea, there are often those who suffer from dry constipation." And there is a relationship of mutual generation, mutual transformation and mutual influence between qi and blood. Deficiency of one side can aggravate the other side. Therefore, constipation of qi and blood deficiency type is common in those with weak constitutions, long-term illnesses, after childbirth or the elderly.

[0004] The treatment plan for constipation of qi and blood deficiency type generally starts from three aspects: taking traditional Chinese medicine, dietary conditioning and exercise massage, taking both the symptoms and the root causes into consideration. It is not recommended to use laxatives or glycerin suppositories to prevent dependence and resulting in habitual constipation. Most of the traditional Chinese medicines for treating constipation in the prior art contain purgatives (such as rhubarb, mirabilite, senna leaves, etc.), which are likely to damage healthy qi and are not suitable for people with qi and blood deficiency such as the elderly and parturients. A milder and more effective traditional Chinese medicine combination should be considered. Summary of the Invention

[0005] In order to solve the defects existing in the prior art, the present invention provides a traditional Chinese medicine composition for conditioning constipation of qi and blood deficiency type, a preparation method and an application thereof. The components of the traditional Chinese medicine composition are compounded to achieve the effects of tonifying qi and nourishing blood, and moistening the intestine and promoting defecation together, which can significantly improve the symptoms of patients with constipation of qi and blood deficiency type, with stable curative effect and good safety.

[0006] To achieve the above object, the present invention adopts the following technical solutions:

[0007] In the first aspect, the present invention provides a traditional Chinese medicine composition for conditioning constipation of qi and blood deficiency type. Calculated by weight, the components of the traditional Chinese medicine composition include: 12 - 24 parts of angelica sinensis, 10 - 60 parts of astragalus membranaceus, 12 - 20 parts of cistanche deserticola, 10 - 30 parts of cannabis seeds, 10 - 24 parts of achyranthes bidentata, 10 - 30 parts of rehmannia glutinosa, 12 - 30 parts of white peony root, 4 - 10 parts of coptis chinensis, 6 - 20 parts of fructus aurantii.

[0008] Preferably, the components of the traditional Chinese medicine composition are as follows: 15 parts of Angelica sinensis, 15 parts of Astragalus membranaceus, 15 parts of Cistanche deserticola, 15 parts of Cannabis sativa seeds, 12 parts of Achyranthes bidentata, 12 parts of Rehmannia glutinosa, 12 parts of Paeonia lactiflora, 6 parts of Coptis chinensis, and 9 parts of Fructus Aurantii Immaturus.

[0009] In a second aspect, the present invention provides a traditional Chinese medicine preparation for regulating constipation of qi and blood deficiency type, which is prepared from the above traditional Chinese medicine composition and pharmaceutically acceptable excipients.

[0010] Preferably, the dosage form of the traditional Chinese medicine preparation is any one of granules, decoctions, powders, pills, solutions, and capsules.

[0011] Preferably, the preparation method of the granules comprises the following steps: mixing the components of the above traditional Chinese medicine composition, decocting with water, combining the decoction liquids, filtering, concentrating into an extract, drying and pulverizing, and adding excipients to obtain the granules.

[0012] Preferably, during the water decocting process, 6-10 times the amount of water is added, the decocting time is 30-90 min, and the number of decocting times is 1-3 times.

[0013] Preferably, the decocting is divided into two times. For the first time, 8 times the amount of water is added and decocted for 60 min, and for the second time, 6 times the amount of water is added and decocted for 30 min.

[0014] In a third aspect, the present invention provides a preparation method of a traditional Chinese medicine composition for regulating constipation of qi and blood deficiency type, which comprises mixing the components of the above traditional Chinese medicine composition to obtain the composition.

[0015] Preferably, the preparation method comprises the following steps: mixing the components of the above traditional Chinese medicine composition, decocting with water, combining the decoction liquids, filtering, concentrating into an extract, drying and pulverizing, and adding excipients to obtain the composition.

[0016] Preferably, during the water decocting process, 6-10 times the amount of water is added, the decocting time is 30-90 min, and the number of decocting times is 1-3 times.

[0017] Preferably, the decocting is divided into two times. For the first time, 8 times the amount of water is added and decocted for 60 min, and for the second time, 6 times the amount of water is added and decocted for 30 min.

[0018] Preferably, the relative density of the extract at 60-65 °C is 1.20-1.30.

[0019] In a fourth aspect, the present invention provides an application of the above traditional Chinese medicine composition in the preparation of a product for regulating constipation of qi and blood deficiency type.

[0020] Preferably, the symptoms of constipation of qi and blood deficiency type are difficult defecation, fatigue, pale complexion, palpitation, shortness of breath, pale tongue with white coating, and deep and thready pulse.

[0021] The beneficial effects of the present invention are as follows:

[0022] The components of the traditional Chinese medicine composition of the present invention are compounded according to the monarch, minister, assistant, and envoy principles and interact with each other. Cistanche deserticola warms the kidney and benefits essence, warms the waist and moistens the intestine, serving as the monarch drug; Angelica sinensis nourishes blood and moistens the intestine, nourishes blood and regulates intestinal dryness, Cannabis sativa seeds moisten the intestine and relieve constipation, Achyranthes bidentata strengthens the kidney and the waist, is good at descending, warms the kidney and guides qi, blood, and body fluids to the lower energizer, all serving as minister drugs; Rehmannia glutinosa nourishes yin and promotes the production of body fluids, nourishes the kidney water to relieve the dryness of yang drugs, prevents excessive warming and tonifying from damaging yin, Paeonia lactiflora nourishes blood and astringes yin, Coptis chinensis clears heat and dries dampness without damaging healthy qi, prevents dampness-heat from aggravating qi and blood deficiency, and counteracts the heat nature of warming and tonifying drugs, Astragalus membranaceus supplements qi and promotes the production of body fluids, sufficient qi promotes the conduction of the intestinal tract, and also prevents the qi-consuming effect of moistening drugs, all serving as assistant drugs; Aurantii Fructus Immaturus relaxes the intestine and descends qi, promotes qi movement and relieves distension, guides the power of various drugs directly to the large intestine to assist in relieving constipation, serving as the envoy drug. The combination of various drugs exerts the effects of nourishing blood and supplementing qi, moistening the intestine and relieving constipation, can significantly improve the symptoms of patients with qi and blood deficiency type constipation, and has stable curative effect and good safety. Specific embodiments

[0023] In order to enable those skilled in the art to better understand the technical solution of the invention, the present invention will be further described in detail below in conjunction with specific embodiments.

[0024] Angelica sinensis: This product is the dried root of the Umbelliferae plant Angelica sinensis (Oliv.) Diels. It is dug in late autumn, the fibrous roots and sediment are removed, and after the moisture evaporates slightly, it is bundled into small bundles, placed on a shed, and slowly smoked dry with smoke. It has the functions of nourishing blood and promoting blood circulation, regulating menstruation and relieving pain, and moistening the intestine and relieving constipation. In the present invention, it is an important drug for nourishing blood, can effectively improve the symptoms of blood deficiency, promote intestinal blood circulation, enhance intestinal function, moisten the intestine, and relieve constipation; it is rich in oil, has the effect of moistening and lubricating the intestine, and is beneficial to constipation caused by blood deficiency and intestinal dryness.

[0025] Astragalus membranaceus: This product is the dried root of the Leguminosae plant Astragalus membranaceus (Fisch.) Bge. var. mongholicus (Bge.) Hsiao or Astragalus membranaceus (Fisch.) Bge. It is dug in spring and autumn, the fibrous roots and root tips are removed, and then dried in the sun. It has the functions of supplementing qi and raising yang, securing the exterior and stopping sweating, promoting diuresis and alleviating edema, promoting the production of body fluids and nourishing blood, activating qi and dredging collaterals, expelling pus by supporting healthy qi, and promoting granulation for sore healing. In the present invention, it has the functions of supplementing qi and raising yang, strengthening the spleen and benefiting the lung, promoting diuresis and alleviating edema, and promoting granulation for sore healing, to improve the symptoms of qi deficiency, enhance the intestinal propulsion force, improve the weakness of defecation, and regulate the body fluid metabolism in the body.

[0026] Cistanche: This product is the dried fleshy stem with scale leaves of the plant Cistanche deserticola Y.C.Ma or Cistanche tubulosa (Schenk) Wight in the Orobanchaceae family. It is harvested when the seedlings just emerge in spring or before the frozen soil in autumn, removing the stem tips. Cut into sections and dried in the sun. It has the functions of warming the kidney yang, nourishing essence and blood, and moistening the intestines to promote defecation. In the present invention, it can warm the kidney yang, improve the symptoms of yang deficiency, and enhance the intestinal propulsion force; it can improve the symptoms of blood deficiency, moisten the intestines, and relieve constipation; it is rich in oil, has the effect of moistening dryness and lubricating the intestines, increases the intestinal lubrication degree, and promotes defecation.

[0027] Fructus Cannabis: This product is the dried ripe fruit of the plant Cannabis sativa L. in the Moraceae family. It is harvested when the fruit is ripe in autumn, removing impurities and dried in the sun. It has the function of lubricating the intestines to promote defecation. In the present invention, it has the effect of lubricating the intestines and promoting defecation; it contains rich nutritional components, can tonify qi and blood, and improve the weak constitution; it has a slight blood-activating effect and can improve the intestinal blood circulation.

[0028] Achyranthes Root: This product is the dried root of the plant Achyranthes bidentata Bl. in the Amaranthaceae family. It is harvested when the stems and leaves wither in winter, removing the fibrous roots and sediment, bundling them into small bundles, drying until dry and wrinkled, then cutting the top evenly and drying in the sun. It has the functions of removing blood stasis and dredging meridians, tonifying the liver and kidneys, strengthening tendons and bones, promoting diuresis and relieving stranguria, and guiding blood downward. In the present invention, it can nourish the liver and kidneys, improve the symptoms of deficiency, and enhance the body function; at the same time, it has the effect of guiding blood downward and guiding fire back to the origin, and can relieve the upper heat symptoms.

[0029] Radix Rehmanniae: This product is the fresh or dried tuberous root of the plant Rehmannia glutinosa Libosch. in the Scrophulariaceae family. It is harvested in autumn, removing the rhizome tip, fibrous roots and sediment, and slowly baking the Rehmannia until it is about 80% dry, commonly known as "Raw Rehmannia Root". It has the functions of clearing heat and cooling blood, nourishing yin and promoting fluid production. In the present invention, it is an important drug for nourishing yin, can significantly improve the symptoms of yin deficiency, moisten the intestines through nourishing yin, and relieve constipation; it has the effect of clearing heat, can relieve the symptoms of internal heat, and helps to improve the blood heat syndrome; it can promote the production of body fluid, relieve intestinal dryness, and has a good effect on constipation caused by fluid deficiency and intestinal dryness.

[0030] White Peony Root: This product is the dried root of the plant Paeonia lactiflora Pall. in the Ranunculaceae family. It is harvested in summer and autumn, washed, removing the head and tail and fine roots, boiled in boiling water and then removing the outer skin or removing the skin and then boiling again, and dried in the sun. It has the functions of nourishing blood and regulating menstruation, astringing yin and stopping sweating, soothing the liver and relieving pain, and suppressing liver yang. In the present invention, it is an important drug for nourishing blood, can significantly improve the symptoms of blood deficiency, moisten the intestines through nourishing blood, and relieve constipation; it has the effect of soothing the liver, relieves the stagnation of liver qi, and the pain-relieving effect helps to relieve the abdominal pain accompanied by constipation; it has the effect of suppressing liver yang and relieving the symptoms of hyperactive liver yang; it has the effect of regulating nutrient qi and defensive qi and improving the body function.

[0031] Coptis Rhizome: This product is the dried rhizome of Coptis chinensis Franch., Coptis deltoidea C.Y.Cheng et Hsiao, or Coptis teeta Wall. of the Ranunculaceae family. The above three are commonly known as "Weilian", "Yalian", and "Yunlian" respectively. It is harvested in autumn, the fibrous roots and sediment are removed, dried, and the remaining fibrous roots are knocked off. It has the effects of clearing heat and drying dampness, purging fire and detoxifying. In the present invention, it has a significant heat-clearing effect, can relieve internal heat symptoms, and its dampness-drying effect helps to improve damp-heat syndromes; it has a fire-purging effect, can relieve fire symptoms; it has a broad-spectrum antibacterial effect and can improve intestinal inflammation; it has a stomach-strengthening effect, can improve digestive function, promote appetite, and enhance nutrient absorption.

[0032] Fructus Aurantii Immaturus: This product is the dried immature fruit of Citrus aurantium L. of the Rutaceae family and its cultivated varieties. It is harvested in July when the pericarp is still green, cut transversely into two halves from the middle, and dried in the sun or by low-temperature drying. It has the effects of regulating qi and widening the middle-jiao, promoting qi movement and relieving distension. In the present invention, it has a qi-promoting effect, can relieve qi stagnation symptoms, and its middle-jiao widening effect helps to improve abdominal distension; it has a distension-relieving effect, can relieve abdominal fullness; it has a phlegm-resolving effect, can improve phlegm-damp syndromes, and helps to relieve food stagnation; it has a promoting gastrointestinal peristalsis effect and can improve intestinal function.

[0033] The present invention treats the above traditional Chinese medicine components according to syndrome differentiation and combines them rationally to achieve the effect of improving the symptoms of patients with qi and blood deficiency type constipation, with stable curative effect and good safety.

[0034] In the following examples of the present invention, the parts by weight are in grams.

[0035] Example 1

[0036] This example provides a traditional Chinese medicine composition for regulating qi and blood deficiency type constipation. By weight, the components of the composition are 15 parts of Angelica sinensis, 15 parts of Astragalus membranaceus, 15 parts of Cistanche deserticola, 15 parts of Cannabis sativa seed, 12 parts of Achyranthes bidentata, 12 parts of Rehmannia glutinosa, 12 parts of Paeonia lactiflora, 6 parts of Coptis Rhizome, and 9 parts of Fructus Aurantii Immaturus.

[0037] Example 2

[0038] This example provides a traditional Chinese medicine composition for regulating qi and blood deficiency type constipation. By weight, the components of the composition are 24 parts of Angelica sinensis, 60 parts of Astragalus membranaceus, 20 parts of Cistanche deserticola, 30 parts of Cannabis sativa seed, 24 parts of Achyranthes bidentata, 30 parts of Rehmannia glutinosa, 30 parts of Paeonia lactiflora, 10 parts of Coptis Rhizome, and 20 parts of Fructus Aurantii Immaturus.

[0039] Example 3

[0040] This embodiment provides a traditional Chinese medicine composition for regulating constipation of qi and blood deficiency type. Calculated by weight parts, the components of the composition are 12 parts of Angelica sinensis, 10 parts of Astragalus membranaceus, 12 parts of Cistanche deserticola, 10 parts of Cannabis sativa seed, 10 parts of Achyranthes bidentata, 10 parts of Rehmannia glutinosa, 12 parts of Paeonia lactiflora, 4 parts of Coptis chinensis, and 6 parts of Aurantii Fructus Immaturus.

[0041] Example 4

[0042] Traditional Chinese medicine granule preparation

[0043] The preparation method of the granule preparation is as follows: Mix the compositions described in any one of Examples 1 to 3, decoct with water, combine the decoction liquids, filter, concentrate the filtrate to an extract with a relative density of 1.20 - 1.30 (60 - 65 °C), dry, pulverize into dry extract powder, add appropriate amounts of β-cyclodextrin and stevioside, use water and a small amount of ethanol as wetting agents, mix evenly, make into granules, and dry.

[0044] Taking the composition of Example 1 as an example, an orthogonal test analysis was carried out on the preparation parameters of the granule preparation, which is specifically as follows:

[0045] 1. Header design

[0046] The design of the orthogonal test factor level table is shown in Table 1.

[0047] Table 1. Orthogonal test factor level table

[0048]

[0049] 2. Experimental results

[0050] The experimental results are shown in Table 2:

[0051] Table 2. Orthogonal test intuitive analysis

[0052]

[0053] Note: 1. The flavonoid content is the proportion of flavonoids contained in the extract in the total amount of medicinal materials. 2. Comprehensive weighted scoring formula: Comprehensive score = 40% × (dry extract rate / maximum dry extract rate) + 60% × (total flavonoid content / maximum total flavonoid content). 3. Ki represents the sum of comprehensive scores at the corresponding levels of the corresponding factors.

[0054] 3. Variance analysis

[0055] Table 3. Variance analysis results

[0056]

[0057] 4. Experimental conclusion

[0058] It can be seen from the intuitive analysis in Table 2 that after comprehensively scoring the paste yield and total flavonoid content, the order of the influence of each factor on the result is C > B > A. The different levels of each factor are in turn A2 > A1 > A3, B3 > B2 > B1, C3 > C2 > C1, and the optimal factor combination is A2B3C3. In summary, the paste yield and total flavonoid content are the highest when the combination is A2B3C3, that is, the water addition is 8 times, decocting for 90 minutes, and decocting 3 times.

[0059] It can be seen from the variance analysis in Table 3 that the influence of the water addition amount on the comprehensive score result is not significant (P > 0.05). Therefore, considering the production cost in the optimization experiment, the water addition amount can be changed to 6 times during the second decoction; the influence of the decocting time on the comprehensive score result is significant (P < 0.05), but from the intuitive analysis, the K values of 60 minutes and 90 minutes do not differ much. Considering the production cost, the decocting time can be changed to 60 minutes; the influence of the number of decoctions on the comprehensive score result is significant (P < 0.05), but decocting 3 times is time-consuming and costly in industry. Therefore, it is recommended to optimize it to 2 times.

[0060] In summary, the optimal conditions for the orthogonal experiment of the preparation method of the traditional Chinese medicine composition granule preparation for qi and blood deficiency type constipation in the present invention are water addition 8 times, decocting for 90 minutes, and decocting 3 times. Considering the production cost factor, it can be optimized to: adding 8 times the amount of water for the first decoction for 60 minutes, and adding 6 times the amount of water for the second decoction for 30 minutes.

[0061] Example 5

[0062] Traditional Chinese medicine decoction

[0063] The preparation method of the traditional Chinese medicine preparation includes: taking the traditional Chinese medicine compositions described in Examples 1 to 3, decocting with water respectively, and filtering to obtain the traditional Chinese medicine decoction.

[0064] Example 6

[0065] Traditional Chinese medicine powder

[0066] The preparation method of the traditional Chinese medicine preparation includes: taking the components of the traditional Chinese medicine compositions in Examples 1 to 3, pulverizing and mixing to obtain the traditional Chinese medicine powder.

[0067] Example 7

[0068] Traditional Chinese medicine pills

[0069] The preparation method of the traditional Chinese medicine preparation includes: taking the components of the traditional Chinese medicine compositions in Examples 1 to 3, pulverizing, adding a binder to make spherical pills to obtain the traditional Chinese medicine pills; the binder is water.

[0070] Example 8

[0071] Traditional Chinese medicine oral liquid

[0072] The traditional Chinese medicine oral liquid is prepared from the traditional Chinese medicine composition components in Examples 1 to 3 and pharmaceutically acceptable excipients.

[0073] Example 9

[0074] Traditional Chinese medicine concentrated oral liquid

[0075] The traditional Chinese medicine concentrated oral liquid is prepared from the traditional Chinese medicine composition components in Examples 1 to 3 and pharmaceutically acceptable excipients.

[0076] Example 10

[0077] Traditional Chinese medicine capsules

[0078] The traditional Chinese medicine capsules are prepared from the traditional Chinese medicine composition components in Examples 1 to 3 and pharmaceutically acceptable excipients.

[0079] Control group 1

[0080] This example provides a traditional Chinese medicine composition. Calculated by weight, the components are 30 parts of Angelica sinensis, 15 parts of Astragalus membranaceus, 24 parts of Cistanche deserticola, 15 parts of Cannabis sativa L. seeds, 12 parts of Achyranthes bidentata, 12 parts of Rehmannia glutinosa, 9 parts of Paeonia lactiflora, 3 parts of Coptis chinensis, and 9 parts of Aurantii Fructus Immaturus.

[0081] Control group 2

[0082] This example provides a traditional Chinese medicine composition. Calculated by weight, the components are 15 parts of Angelica sinensis, 15 parts of Astragalus membranaceus, 15 parts of Cistanche deserticola, 15 parts of Cannabis sativa L. seeds, 12 parts of Achyranthes bidentata, 12 parts of Rehmannia glutinosa, and 9 parts of Aurantii Fructus Immaturus.

[0083] Effect example 1

[0084] The therapeutic effect of the traditional Chinese medicine composition of the present invention is illustrated below through clinical data.

[0085] I. Inclusion of research subjects

[0086] 1. Case inclusion criteria

[0087] ① Defecation less than 3 times a week, difficult defecation, long defecation time each time, excluding dry and few feces like sheep dung, and the feeling of incomplete defecation after defecation.

[0088] ② Physically weak, with symptoms such as dizziness and insomnia.

[0089] ③ Fatigue accompanied by pale complexion, palpitation accompanied by shortness of breath (syndrome differentiation: qi and blood deficiency syndrome).

[0090] ④ Pale tongue, white coating, and deep and thready pulse.

[0091] ⑤ Voluntarily participate and complete the consent form.

[0092] Those who meet the above conditions can be included in the group.

[0093] 2. Exclusion Criteria

[0094] ① In the early stage of intestinal obstruction, paralytic ileus.

[0095] ② There is a mass in the abdomen, which may be colon tumor, abdominal tumor, or sigmoid colon spasm.

[0096] ③ Intestinal tuberculosis or abdominal tuberculosis.

[0097] ④ Those who have used antibiotics within the past 3 months.

[0098] ⑤ Those with severe psychological or emotional disorders or those determined by other doctors to be unfit to participate in this study.

[0099] 3. Withdrawal Criteria

[0100] ① Patients with poor compliance or those who voluntarily request to withdraw from this clinical trial.

[0101] ② Those who experience serious adverse events and should withdraw from the clinical trial according to the doctor's judgment.

[0102] ③ Those who do not take medicine as prescribed, have an insufficient treatment course, or have incomplete case report filling.

[0103] 4. Exclusion Criteria

[0104] ① Those who fail to complete the clinical trial, affecting the judgment of efficacy and safety.

[0105] ② During the drug administration process, patients participate in other clinical trials or use combined medications and treatment methods outside the specified scope, especially those with a greater impact on the test results, affecting the judgment of efficacy and safety.

[0106] According to the above criteria, a total of 120 patients meeting the diagnostic criteria were included in the observational study. The patients were from Zhongjiang County Traditional Chinese Medicine Hospital and were randomly divided into three groups. Among them, 4 patients dropped out due to reasons such as transfer for treatment and hospital relocation:

[0107] Group Number of cases Number of male patients / Number of female patients Age (years, X±S) Disease duration (years, X±S) Group A 39 14 / 25 53.2±8.5 2.1±1.2 Group B 37 14 / 23 54.1±9.0 2.3±1.4 Group C 40 16 / 24 52.8±8.7 2.0±1.1

[0108] Analysis and comparison: There were no statistically significant differences in gender, age, and disease course among the three groups (P > 0.05).

[0109] II. Drug Administration Plan

[0110] The compositions of Example 1, Control Group 1, and Control Group 2 were selected for drug administration. Among them, the composition of Control Group 1 was administered to Group A patients, the composition of Control Group 2 was administered to Group B patients, and the composition of Example 1 was administered to Group C patients. All three groups were decocted in water for oral administration. Each dose was decocted for 2 days, administered 3 times a day, and taken continuously for 4 weeks.

[0111] III. Efficacy Evaluation Criteria

[0112] 1. Observation Indicators and Judgment Criteria

[0113] Total effective rate: The efficacy was judged as markedly effective, effective, and ineffective with reference to the "Guiding Principles for Clinical Research of New Chinese Medicines" and the "Rome IV Diagnostic Criteria for Functional Constipation". Markedly effective: Constipation was basically controlled after treatment, and defecation became normal 2 - 4 weeks after medication, and the conditions of fatigue accompanied by pale complexion and palpitation accompanied by shortness of breath were significantly improved. Effective: The symptoms of constipation were significantly improved, and the conditions of fatigue accompanied by pale complexion and palpitation accompanied by shortness of breath were improved. Ineffective: The symptoms of constipation were not improved, and the conditions of fatigue accompanied by pale complexion and palpitation accompanied by shortness of breath were even aggravated. Total effective rate = (markedly effective + effective) / total number of cases.

[0114] TCM syndrome score: Main symptoms: Difficult defecation; Sub - symptoms: Fatigue, pale complexion; Palpitation, shortness of breath; Pale tongue with white coating, deep and thready pulse (each item is scored 0 - 3 points, total score 0 - 12 points).

[0115] Time to improve constipation: The time from the start of treatment to the first normal defecation (Bristol score 4 - 5 points).

[0116] 2. Statistical methods

[0117] Measurement data: For normal distribution, paired t - test (mean ± standard deviation) was used, and for non - normal distribution, Wilcoxon signed - rank sum test (median [M(QL~QU)]) was used.

[0118] Count data: Paired chi - square test (number of cases, percentage).

[0119] Significance level: α = 0.05 (SPSS 22.0).

[0120] IV. Experimental results

[0121] 1. Evaluation of total effective rate

[0122]

[0123]

[0124] 2. Changes in TCM syndrome scores

[0125]

[0126] 3. Time to improve constipation of qi and blood deficiency type

[0127]

[0128] As can be seen above, the total effective rate of Group C is the best, significantly higher than that of Group B (P<0.05), and there is no significant difference from Group A. However, the improvement of traditional Chinese medicine syndrome scores in Group C is better, and the time for improving constipation of qi and blood deficiency type in Group C is the shortest. This shows that the various components in the traditional Chinese medicine composition of the present invention complement each other, and when used together, they can nourish qi and blood, moisten the intestines and relieve constipation, and can significantly improve the symptoms of patients with constipation of qi and blood deficiency type, with stable curative effect and good safety. Compared with the present invention, the composition of Group B does not include Paeonia lactiflora and Coptis chinensis, resulting in insufficient power of nourishing blood and moistening dryness and lack of effect of clearing heat and preventing stagnation in the prescription, making it difficult to demonstrate the overall curative effect. Compared with Group C, in Group A, the dosage of traditional Chinese medicine flavors such as Angelica sinensis and Cistanche deserticola in the prescription is too large, while the dosage of the combination of Paeonia lactiflora and Coptis chinensis is insufficient, resulting in excessive warming and tonifying, aggravated dampness and heat, and thus poor effect.

[0129] Effect Example 2

[0130] The traditional Chinese medicine composition for regulating constipation of qi and blood deficiency type in Example 1 was made into a decoction. Each dose was decocted for 2 days, administered 3 times a day, and taken continuously for 1 week (1 course of treatment).

[0131] 442 patients who met the diagnostic criteria for constipation of qi and blood deficiency type (main symptoms: difficult defecation; secondary symptoms: fatigue, pale complexion; palpitation, shortness of breath; pale tongue with white coating, deep and thready pulse) and sought medical treatment in Zhongjiang County Traditional Chinese Medicine Hospital from 2019 to 2024 were screened for clinical observation. It was found that defecation could be improved within 1 week, and the effective rate reached 96%. 3 cases had mild diarrhea (0.6%), and there were no other adverse reactions.

[0132] Typical Cases

[0133] Case 1: Ms. Wang, 36 years old. The patient had suffered from constipation of qi and blood deficiency type for two years after childbirth. During this period, she had tried water-soluble dietary fiber many times with effectiveness, but the condition recurred after discontinuation and the effect gradually decreased. She often had palpitation and shortness of breath. After seeking medical treatment, she was given the traditional Chinese medicine composition of Example 1 of the present invention. Her condition improved significantly and her stools were normal after one week. After continuing to take the medicine for 3 weeks, there was no recurrence.

[0134] Case 2: Mr. Xue, 59 years old. He had suffered from constipation of qi and blood deficiency type for 3 years. He had difficulty defecating, sweating and shortness of breath when going to the toilet, accompanied by pale face, palpitation, mental fatigue and weakness. He was given the traditional Chinese medicine composition of Example 1 of the present invention. His defecation improved after four days. After taking the medicine for 3 weeks, his defecation basically returned to normal. After continuing to take the medicine for 3 weeks to consolidate the curative effect, there was no recurrence.

[0135] Case 3: Mr. Xu, 74 years old. He had constipation and poor qi and blood, accompanied by dizziness and insomnia for many years. He was given the traditional Chinese medicine composition of Example 1 of the present invention. His defecation was smooth the next day. After continuing to take the medicine for 3 weeks, his defecation remained normal, and the symptoms of dizziness and insomnia improved. There was no recurrence of constipation.

[0136] The above are only the preferred embodiments of the present invention. It should be noted that the above preferred embodiments should not be construed as limiting the present invention, and the protection scope of the present invention should be subject to the scope defined by the claims. For those of ordinary skill in the art, without departing from the spirit and scope of the present invention, several improvements and modifications can be made, and these improvements and modifications should also be regarded as within the protection scope of the present invention.

Claims

1. A Chinese medicine composition for regulating constipation caused by deficiency of both qi and blood, characterized in that: In parts by weight, the components of the Chinese medicine composition include: 12 to 24 parts of angelica sinensis, 10 to 60 parts of astragalus, 12 to 20 parts of cistanche deserticola, 10 to 30 parts of hemp seed, 10 to 24 parts of achyranthes bidentata, 10 to 30 parts of rehmannia root, 12 to 30 parts of white peony root, 4 to 10 parts of coptis chinensis, and 6 to 20 parts of fructus aurantii.

2. The Chinese medicine composition according to claim 1, characterized in that: The components of the Chinese medicine composition are: 15 parts of angelica sinensis, 15 parts of astragalus, 15 parts of cistanche deserticola, 15 parts of hemp seeds, 12 parts of achyranthes bidentata, 12 parts of rehmannia root, 12 parts of white peony root, 6 parts of coptis chinensis and 9 parts of aurantium.

3. A Chinese medicine preparation for regulating constipation caused by deficiency of both qi and blood, characterized in that: The traditional Chinese medicine preparation is made from the traditional Chinese medicine composition according to claim 1 or 2 and pharmaceutically acceptable excipients.

4. The Chinese medicine preparation according to claim 3, characterized in that: The dosage form of the traditional Chinese medicine preparation is any one of granules, decoctions, powders, pills, solutions and capsules.

5. A method for preparing a Chinese medicine composition for regulating constipation due to deficiency of both qi and blood, characterized in that: The method comprises mixing the components of the Chinese medicine composition according to claim 1 or 2.

6. The preparation method according to claim 5, characterized in that: The preparation method comprises the following steps: mixing the components of the traditional Chinese medicine composition, boiling with water, combining the decoctions, filtering, concentrating into an extract, drying and crushing, and adding auxiliary materials to obtain the extract.

7. The preparation method according to claim 6, characterized in that: During the decoction process, 6 to 10 times of water is added, the decoction time is 30 to 90 minutes, and the decoction times are 1 to 3 times.

8. The preparation method according to claim 7, characterized in that: The decoction is divided into two decoctions, the first time adding 8 times the amount of water and decocting for 60 minutes, the second time adding 6 times the amount of water and decocting for 30 minutes.

9. Use of the Chinese medicine composition according to claim 1 or 2 in preparing a product for regulating constipation of qi and blood deficiency type.

10. The use according to claim 9, characterized in that: The symptoms of Qi and blood deficiency type constipation are difficulty in defecation, fatigue, pale complexion, palpitations, shortness of breath, pale tongue with white coating, and deep and thin pulse.

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