Medicated diet composition for improving haemorrhoids and preparation method thereof

Abstract

The invention discloses a medicated diet composition for improving haemorrhoids and a preparation method thereof, and belongs to the field of traditional Chinese medicine, the medicated diet composition is specially used for qi deficiency and blood deficiency type haemorrhoids, and the medicated diet composition is prepared from the following raw materials in parts by mass: 15-30 parts of hairyvein agrimony, 50-80 parts of streaky pork, 15-30 parts of astragalus membranaceus, 10-20 parts of angelica sinensis, 6-10 parts of rhizoma cimicifugae, 100-150 parts of Chinese yam, 6-10 parts of pericarpium citri reticulatae and 10-15 parts of hawthorn. The traditional Chinese medicine composition realizes precise conditioning of homology of medicine and food, not only exerts the treatment effects of tonifying qi and lifting, nourishing blood and stopping bleeding through the medicinal materials, but also supplements nutrition and assists in improving the qi and blood deficiency state by means of food materials, solves the problem that patients of the type need long-term independent conditioning after conventional medicine treatment, and gives consideration to the synergistic effect of treatment and deficiency tonifying.

Description

TECHNICAL FIELD

[0001] The application discloses a medicinal diet composition for improving hemorrhoids and a preparation method thereof, and belongs to the field of traditional Chinese medicines. BACKGROUND

[0002] Hemorrhoids is a common anorectal disease caused by the varicosity, swelling or prolapse of the venous plexus around the anus, mainly manifested as hematochezia, anal pain, pruritus or prolapse of hemorrhoidal node, and is related to factors such as long sitting, constipation and spicy diet. According to traditional Chinese medicine, the occurrence of hemorrhoids is closely related to 'dampness-heat', 'blood stasis' and 'qi deficiency'. Dampness-heat descending to the anus leads to local qi-blood incoordination and meridian obstruction, resulting in swelling and pain; long-term qi-blood stasis aggravates varicose veins; qi deficiency and prolapse of hemorrhoidal node. Treatment emphasizes syndrome differentiation and treatment, mainly clearing heat and dampness, cooling blood to stop bleeding, promoting blood circulation to remove blood stasis and tonifying qi to lift and promote, and is often combined with internal administration and external washing and external application, taking into account local symptoms and overall conditioning.

[0003] In addition to the common dampness-heat descending type, there is also qi deficiency and blood deficiency type of hemorrhoids. Due to the deficiency of qi and blood, the patients of this type often need to spend a lot of time conditioning the body and supplementing qi and blood after conventional formula drug treatment. According to traditional Chinese medicine, 'food and medicine are homologous', and diet and medicine are mentioned together. In the treatment of diseases, in addition to taking medicine, medical diet therapy has a deep cultural and historical origin, and at present, there is still a lack of a medicinal diet composition for improving the above-mentioned qi deficiency and blood deficiency type of hemorrhoids. SUMMARY

[0004] The purpose of the present application is to provide a medicinal diet composition for improving hemorrhoids and a preparation method thereof.

[0005] The present application realizes the above-mentioned purpose through the following technical scheme. A medicinal diet composition for improving hemorrhoids comprises, by mass fraction, 15-30 parts of Agrimonia pilosa, 50-80 parts of five flower meat, 15-30 parts of Astragalus membranaceus, 10-20 parts of Angelica sinensis, 6-10 parts of Cimicifuga foetida, 100-150 parts of Dioscorea opposita, 6-10 parts of Citrus reticulata, and 10-15 parts of Crataegus pinnatifida.

[0006] The present application is aimed at qi deficiency and blood deficiency type of hemorrhoids, which is mainly manifested as obvious prolapse of hemorrhoidal node, repeated hematochezia, fatigue, shortness of breath, pale or yellowish complexion, dizziness, palpitation and numbness of hands and feet.

[0007] Astragalus is slightly warm in nature and sweet in taste, and can replenish qi and raise yang. Cimicifuga is slightly cold in nature and pungent and sweet in taste, and can raise yang and lift prolapse. The two together can improve the relaxation of anal tissue caused by qi deficiency and prolapse, thereby reducing hemorrhoid prolapse. Agrimonia is neutral in nature and bitter and astringent in taste, and can astringe and stop bleeding, reduce inflammation and replenish deficiency. Angelica is warm in nature and sweet and pungent in taste, and can nourish blood and promote blood circulation. Tangerine peel is warm in nature and bitter and pungent in taste, and can regulate qi and strengthen the spleen, dry dampness and resolve phlegm, and resolve the greasy feeling of qi-tonifying and blood-nourishing drugs such as astragalus and angelica. Pork belly is neutral in nature and sweet and salty in taste. When consumed in moderation, it can replenish deficiency and moisten dryness, supplement nutrition, help improve blood deficiency, and gently lubricate the intestines. Hawthorn is slightly warm in nature and sour and sweet in taste, and can promote digestion, resolve food stagnation, promote qi circulation and disperse blood stasis. When combined with tangerine peel, it can resolve the greasiness of pork belly.

[0008] The raw materials for this formula come from the following sources:

[0009] Agrimony: The dried aerial parts of Agrimony, a plant in the Rosaceae family;

[0010] Astragalus: The dried root of Astragalus membranaceus, a legume.

[0011] Angelica sinensis: the dried root of Angelica sinensis, a plant belonging to the Apiaceae family;

[0012] Cimicifuga: The dried rhizome of Cimicifuga, a plant in the Ranunculaceae family;

[0013] Yam: The dried rhizome of Dioscorea opposita, a plant in the Dioscoreaceae family;

[0014] Dried tangerine peel: the dried, mature peel of the tangerine fruit and its cultivated varieties, belonging to the Rutaceae family;

[0015] Hawthorn: The dried, ripe fruit of the hawthorn plant, belonging to the Rosaceae family.

[0016] In the medicinal diet composition of the present invention, the pork belly should be fresh and odorless, and the ratio of fat to lean meat should be about 1:3. This can not only moisturize dryness and replenish deficiency, but also avoid excessive oil from aggravating the burden on the spleen and stomach and generating damp heat.

[0017] In some embodiments, the medicinal diet composition for improving hemorrhoids comprises, by weight, the following ingredients: 30 parts Agrimonia pilosa, 80 parts pork belly, 30 parts Astragalus membranaceus, 20 parts Angelica sinensis, 10 parts Cimicifuga foetida, 150 parts Dioscorea opposita, 10 parts Citrus reticulata peel, and 15 parts Crataegus pinnatifida.

[0018] In some embodiments, the medicinal diet composition for improving hemorrhoids comprises, by weight, the following ingredients: 15 parts Agrimonia pilosa, 50 parts pork belly, 15 parts Astragalus membranaceus, 10 parts Angelica sinensis, 6 parts Cimicifuga foetida, 100 parts Dioscorea opposita, 6 parts Citrus reticulata peel, and 10 parts Crataegus pinnatifida.

[0019] In some implementations, food-acceptable seasonings or medically acceptable excipients may also be added.

[0020] The application also provides a preparation method of the above-mentioned medicinal diet composition for improving hemorrhoids, comprising the following steps: cutting five flower meat into small pieces, boiling in cold water, adding ginger and a little cooking wine, removing floating scum, washing with warm water, quickly washing Xianhe grass, Huangqi, Danggui, Shengma and Chenpi with clean water; removing the core of hawthorn; peeling yam and cutting into pieces, adding clean water into a sand pot, putting all medicinal materials and blanched five flower meat, boiling with a large fire and then simmering with a small fire for 30 minutes, adding yam pieces and continuing to simmer with a small fire for 20-25 minutes, until yam is soft and five flower meat is cooked, adding a little seasoning before taking out.

[0021] Compared with the prior art, the application has the following beneficial effects:

[0022] 1. The medicinal diet composition is specially used for treating hemorrhoids of qi deficiency and blood deficiency, realizes precise conditioning of the same origin of medicine and food, plays the therapeutic effect of tonifying qi, ascending and tonifying blood and stopping bleeding through medicinal materials, and supplements nutrition and assists in improving the state of deficiency of qi and blood through food materials, solves the problem that patients of this type need long-term conditioning alone after conventional drug treatment, and takes into account the synergistic effect of treatment and deficiency.

[0023] 2. The medicinal diet composition of the application enhances the effects of ascending, fixing, stopping bleeding and tonifying blood through the synergistic effect of Xianhe grass, Huangqi, Shengma and Danggui, and realizes supplementing without stagnation, treatment and nourishment through the combination of five flower meat, Chenpi and hawthorn, the deficiency and dryness tonifying effect of five flower meat, and the effective resolution of the greasy nature of five flower meat, avoiding the promotion of dampness and heat, and overcoming the limitations of single drug or dietary conditioning. DETAILED DESCRIPTION

[0024] The technical solutions in the embodiments of the application will be clearly and completely described below with reference to the embodiments of the application. Based on the embodiments of the application, all other embodiments obtained by those skilled in the art without creative labor fall within the scope of protection of the application, and the embodiments are only used to better explain the content of the application and do not limit the scope of protection of the application. The process steps not disclosed in the embodiments are prior art, and the following raw materials are commercially available unless otherwise specified.

[0025] Embodiment 1

[0026] The medicinal diet composition for improving hemorrhoids of the embodiment comprises, by mass fraction, Xianhe grass 30 g, five flower meat 80 g, Huangqi 30 g, Danggui 20 g, Shengma 10 g, yam 150 g, Chenpi 10 g and hawthorn 15 g.

[0027] The preparation method comprises the following steps:

[0028] Pork belly is cut into small pieces, cold water is added into a pot, ginger and a little cooking wine are added, and the water is boiled and the scum is removed, the pork belly is taken out and washed with warm water, Xianhe grass, Huangqi, Danggui, Shengma, and Chenpi are quickly washed with clean water, hawthorn is pitted, yam is peeled and cut into pieces, clean water is added into a sand pot, all the medicinal materials and the blanched pork belly are added, the water is boiled with a large fire and then the heat is turned to small, yam pieces are added after 20 minutes, the heat is kept small for 15-20 minutes, until yam is soft and the pork belly is cooked, a little seasoning is added before the pot is taken out.

[0029] Example 2

[0030] The medicinal diet composition for improving hemorrhoids in this example comprises, in mass parts, Xianhe grass 15 g, pork belly 50 g, Huangqi 15 g, Danggui 10 g, Shengma 6 g, yam 100 g, Chenpi 6 g, and hawthorn 10 g.

[0031] The preparation method comprises the following steps:

[0032] Pork belly is cut into small pieces, cold water is added into a pot, ginger and a little cooking wine are added, and the water is boiled and the scum is removed, the pork belly is taken out and washed with warm water, Xianhe grass, Huangqi, Danggui, Shengma, and Chenpi are quickly washed with clean water, hawthorn is pitted, yam is peeled and cut into pieces, clean water is added into a sand pot, all the medicinal materials and the blanched pork belly are added, the water is boiled with a large fire and then the heat is turned to small, yam pieces are added after 20 minutes, the heat is kept small for 15-20 minutes, until yam is soft and the pork belly is cooked, a little seasoning is added before the pot is taken out.

[0033] Next, to illustrate the treatment effect of the medicinal diet composition of the present application on hemorrhoids of qi deficiency and blood deficiency type, the medicinal diet prepared in Examples 1-2 is used for clinical trials.

[0034] I. Diagnostic criteria and inclusion and exclusion criteria

[0035] (I) Diagnostic criteria

[0036] 1. Western medicine diagnostic criteria

[0037] Referring to the "Hemorrhoids Clinical Diagnosis and Treatment Guidelines", hemorrhoids is a kind of anorectal disease caused by the varicosity and swelling or prolapse of the anorectal venous plexus, mainly manifested as blood in stool, prolapse of hemorrhoidal node, and anal pain or itching; and the clinical types are internal hemorrhoids, external hemorrhoids or mixed hemorrhoids.

[0038] The severity of the disease is divided into degrees I-IV according to the above guidelines combined with symptoms, degree I: blood in stool, dripping blood or jetting blood, blood after defecation can stop by itself, no prolapse of hemorrhoidal node; degree II: often with blood in stool, prolapse of hemorrhoidal node during defecation, which can be returned by itself after defecation; degree III: occasionally with blood in stool, prolapse of hemorrhoidal node during defecation or standing for a long time, coughing, straining, or weight bearing, which needs to be returned by hand; degree IV: occasionally with blood in stool, prolapse of hemorrhoidal node which cannot be returned or returned again after prolapse.

[0039] 2. TCM syndrome diagnostic criteria

[0040] Qi deficiency and blood deficiency type: obvious prolapse of hemorrhoidal node, needing hand to hold back or unable to hold back after defecation; pale red or dark red blood in stool, little and persistent; accompanied by lassitude, shortness of breath, pale or yellowish complexion, dizziness, palpitation, numbness of hands and feet; tender tongue, thin white fur, and weak pulse.

[0041] (II) Inclusion criteria

[0042] 1. Meet the above Western medicine hemorrhoid diagnostic criteria, and TCM syndrome differentiation is Qi deficiency and blood deficiency type;

[0043] 2. Clinical classification is Ⅱ-Ⅲ degree internal hemorrhoids or mixed hemorrhoids;

[0044] 3. Hemorrhoidal node prolapse and repeated blood in stool are the main symptoms;

[0045] 4. The patient or his legal representative signs the informed consent form.

[0046] (III) Exclusion criteria

[0047] 1. Allergic constitution or allergic to any component of the medicinal diet composition of the invention;

[0048] 2. Combined with anal fissure, perianal abscess, anal fistula, rectal polyp, rectal cancer and other anorectal diseases that affect symptom judgment;

[0049] 3. Pregnant or lactating women;

[0050] 4. Combined with severe underlying diseases or acute exacerbation of chronic diseases;

[0051] 5. Received hemorrhoid surgery or sclerosing agent injection treatment within the past 1 month;

[0052] 6. Participated in or is currently participating in other clinical trials within 1 month before this study;

[0053] 7. Cannot complete follow-up or dietary control.

[0054] II. Case source and grouping

[0055] The cases come from Qi deficiency and blood deficiency type hemorrhoid patients in Hutou Town, Guanqiao Town, Fengcheng Town, and Penglaie Town of Anxi County, Fujian Province.

[0056] The experiment is based on an observational research design, with an experimental group: control group = 2:1 design; with a two-sided alpha = 0.05, beta = 0.10, i.e. at a 0.05 test level, with a 90% confidence level, 362 cases are needed in the experimental group and 181 cases in the control group; considering a 15% loss rate, therefore 416 cases are needed in the experimental group and 210 cases in the control group, a total of 626 samples are needed.

[0057] III. Observation indicators and time points

[0058] (1)General conditions, including age, gender, height, weight, medical history, onset time, dietary preferences, exercise habits, etc., were collected at the first observation.

[0059] (2) Clinical symptoms and signs: including the degree of prolapse of hemorrhoids, blood in stool, anal distension, fatigue, dizziness, etc.; 1 time per week during treatment, for a total of 4 weeks.

[0060] (3) Hemorrhoid symptom score sheet, as shown in Table 1, 1 time per week during treatment. The treatment period is 4 weeks, and patients whose symptoms disappear can end follow-up early.

[0061] (4) Treatment plan, including whether to use other hemorrhoid drugs, etc.

[0062] (5) Post-medication conditions (such as abdominal distension, appetite changes, etc.), 1 time per week during treatment.

[0063] Table 1 Hemorrhoid symptom score sheet

[0064]

[0065] Four, treatment plan

[0066] 1. Conventional treatment plan: symptomatic treatment according to the "Hemorrhoid Clinical Diagnosis and Treatment Guidelines", including external use of compound chitosan ester suppository, keeping the stool unobstructed, etc.

[0067] 2. Medicinal diet treatment plan: the experimental group patients are additionally given the medicinal diet composition of the application on the basis of conventional treatment.

[0068] Medicinal diet composition preparation: take 15-30 parts of Herba Agrimoniae, 50-80 parts of pork belly, 15-30 parts of Radix Astragali, 10-20 parts of Angelica sinensis, 6-10 parts of Rhizoma Coptidis, 100-150 parts of Dioscorea, 6-10 parts of Pericarpium Citri Reticulatae, and 10-15 parts of Fructus Crataegi; cut the pork belly into pieces and blanch it in water to remove floating scum, quickly rinse the medicinal materials, remove the core of the Fructus Crataegi, and cut the Dioscorea into pieces; add water to a sand pot, put in the medicinal materials and pork belly, boil with a large fire and then simmer with a small fire for 30 minutes, add the Dioscorea and simmer for another 20-25 minutes, and add salt for seasoning; 1 dose per day, taken twice a day, and continuously taken for 4 weeks.

[0069] The control group patients only adopt the conventional treatment plan, and the experimental group patients adopt the TCM syndrome differentiation treatment plan. According to the actual treatment plan received by the patients, the groups are divided, and the efficacy indicators are compared, with the time when the hemorrhoid symptom score is reduced to ≤3 points as the main efficacy indicator.

[0070] Five, test results

[0071] A total of 702 patients were followed up, and 89 patients with qi deficiency and blood deficiency syndrome, 23 patients with other anorectal diseases, and 34 patients lost to follow-up were excluded. Finally, 556 patients were included, including 198 patients in the control group and 358 patients in the experimental group.

[0072] 1. Baseline analysis

[0073] The baseline data of the patients are shown in Table 2.

[0074] Table 2 Comparison of baseline data between the control group and the experimental group

[0075]

[0076] As shown in Table 2, the two groups of patients were balanced and comparable in terms of age, gender, degree of hemorrhoids, and baseline symptom scores (all P>0.05).

[0077] 2. Comparison between the two groups before and after propensity score matching

[0078] According to age, gender, degree of hemorrhoids, disease duration, and baseline symptom scores, propensity score matching was performed. After matching, there were 180 patients in each group, and the baseline data of the two groups were balanced and comparable (all SMD<0.1).

[0079] 3. Comparison of outcomes after matching

[0080] Regression analysis after propensity score matching of the two groups is shown in Table 3.

[0081] Table 3 Regression analysis after propensity score matching of the two groups

[0082] Outcome HR(95%CI) P value Symptom relief(score≤3) 1.56(1.21,1.99) 0.001

[0083] Note: HR: hazard ratio, HR>1 indicates that the experimental group has a higher probability of symptom relief compared to the control group.

[0084] As shown in Table 3, the risk of symptom relief in the experimental group was 1.56 times that of the control group, and the difference was statistically significant (P=0.001).

[0085] 4. Comparison of secondary indicators between the two groups after matching

[0086] The results of the comparison of secondary indicators between the two groups after propensity score matching are shown in Table 4.

[0087] Table 4 Comparison of secondary indicators between the two groups after matching

[0088]

[0089] As shown in Table 4, the symptom relief rates at weeks 2 and 4 and the improvement rates of fatigue in the experimental group were significantly higher than those in the control group (all P<0.01).

[0090] 6. Conclusion

[0091] Taking the medicinal diet composition of the present application can significantly improve the symptom relief speed of patients with qi deficiency and blood deficiency type hemorrhoids, and the symptom relief risk of the experimental group is 1.56 times that of the control group; after 2 weeks and 4 weeks of treatment, the symptom relief rate and fatigue improvement rate of the experimental group are significantly higher than those of the control group, indicating that the medicinal diet composition can effectively improve the prolapse, hematochezia and general deficiency symptoms of qi deficiency and blood deficiency type hemorrhoids, and has the advantage of "treating hemorrhoids and tonifying deficiency".

[0092] It is apparent to those skilled in the art that the present application is not limited to the details of the foregoing exemplary embodiments, but can be implemented in other concrete forms without departing from the spirit or essential characteristics of the present application. Therefore, the embodiments should be considered in all respects as illustrative and not restrictive, and the scope of the present application is defined by the appended claims rather than the above description, and it is intended to encompass all changes falling within the meaning and scope of the equivalent elements of the claims. Any mark in the claims should not be considered as limiting the involved claims.

[0093] In addition, it should be understood that although the present specification is described in terms of embodiments, not every embodiment contains only one independent technical solution, and the description manner of the specification is only for the sake of clarity, and those skilled in the art should consider the specification as a whole, and the technical solutions in each embodiment can also be properly combined to form other embodiments that those skilled in the art can understand.

Claims

1. A medicinal diet composition for improving hemorrhoids, characterized by comprising: The raw material composition of the application is as follows in terms of mass parts: Herba Agrimoniae 15-30 parts, pork belly 50-80 parts, Radix Astragali 15-30 parts, Radix Angelicae Sinensis 10-20 parts, Cimicifugae 6-10 parts, Dioscoreae 100-150 parts, Pericarpium Citri Reticulatae 6-10 parts, and Fructus Crataegi 10-15 parts. ​ 2. The medicinal diet composition for improving hemorrhoids according to claim 1, characterized in that: The raw material composition of the application is as follows in terms of mass parts: Herba Agrimoniae 30 parts, pork belly 80 parts, Radix Astragali 30 parts, Radix Angelicae Sinensis 20 parts, Cimicifugae 10 parts, Dioscoreae 150 parts, Pericarpium Citri Reticulatae 10 parts, and Fructus Crataegi 15 parts.

3. The medicinal diet composition for improving hemorrhoids according to claim 1, wherein the medicinal diet composition for improving hemorrhoids is a medicinal diet composition for improving hemorrhoids, which comprises the following ingredients: The raw material composition of the application is as follows in terms of mass parts: Herba Agrimoniae 15 parts, pork belly 50 parts, Radix Astragali 15 parts, Radix Angelicae Sinensis 10 parts, Cimicifugae 6 parts, Dioscoreae 100 parts, Pericarpium Citri Reticulatae 6 parts, and Fructus Crataegi 10 parts. ​ 4. A medicinal diet composition for improving hemorrhoids according to any one of claims 1 to 3, and a method of preparing the same, characterized by: The pork belly is required to be fresh and without peculiar smell, and the fat-to-meat ratio is selected to be about 1:

3.

5. A medicinal diet composition for improving hemorrhoids according to any one of claims 1 to 3, and a method of preparing the same, characterized by comprising: Food acceptable flavoring or medically acceptable adjuvant can also be added.

6. A process for the preparation of a pharmaceutical diet composition for the management of hemorrhoids as claimed in any one of claims 1 to 4, wherein: The method comprises the following steps: The pork belly is cut into small pieces, and then boiled in cold water with ginger and a small amount of cooking wine, and the scum is removed. The pork belly is then washed with warm water. The Herba Agrimoniae, Radix Astragali, Radix Angelicae Sinensis, Cimicifugae, and Pericarpium Citri Reticulatae are washed quickly with clean water. The Fructus Crataegi is pitted. The Dioscoreae is peeled and cut into pieces. All the medicinal materials and the boiled pork belly are added into a sand pot, and then boiled with a large fire. After boiling, the fire is turned to small and the pork belly is stewed for 30 minutes. The Dioscoreae pieces are added and the pork belly is further stewed for 20-25 minutes until the Dioscoreae is soft and the pork belly is cooked. A small amount of seasoning is added before the pork belly is taken out of the pot.

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