Traditional Chinese medicine formula for treating hyperplasia of mammary glands and breast cancer and preparation method thereof

Abstract

The invention discloses a traditional Chinese medicine formula for treating hyperplasia of mammary glands and breast cancer and a preparation method thereof. The formula comprises radix paeoniae rubra, pseudo-ginseng, radix aucklandiae, swim bladder, angelica sinensis, blister beetle, rhizoma atractylodis macrocephalae and scorpion which are compatible according to a specific proportion. The preparation method comprises the following steps: adding water to soak the five medicinal materials such as red paeony root (1 hour in summer and 2 hours in winter), adding the swim bladder, decocting until the liquid medicine is sticky, grinding the baked cantharides and scorpion into powder, and mixing. Based on theories such as the holism concept of traditional Chinese medicine, multiple modules take effect synergistically, microcirculation can be improved, immunity can be enhanced, cancer cell apoptosis can be induced, the total effective rate for hyperplasia of mammary glands is 96.7%, and the total effective rate for I-II stage breast cancer reaches 86.7%. The traditional Chinese medicine is flexible to take, high in safety and suitable for long-term treatment.

Description

TECHNICAL FIELD

[0001] The present application relates to breast hyperplasia and breast cancer, in particular to a traditional Chinese medicine formula for treating breast hyperplasia and breast cancer and a preparation method. BACKGROUND

[0002] Breast hyperplasia and breast cancer are common breast diseases that seriously affect women's health. Current treatment methods have limitations: Western medicine often uses hormone regulation or surgical treatment, which has obvious side effects and is prone to recurrence; traditional Chinese medicine treatment has certain effects, but often has the problems of single formula, insufficient targeting, and poor targeting for complex pathogenesis.

[0003] Traditional anticancer traditional Chinese medicines containing cantharides and scorpion have limited clinical application due to the extensive processing technology and difficulty in effectively controlling toxicity. At the same time, existing drugs mainly focus on single efficacy and are difficult to consider improving microcirculation, enhancing immunity, and inducing apoptosis of cancer cells, resulting in low total effective rate for breast hyperplasia and poor efficacy for stage I-II breast cancer, which cannot meet the clinical treatment needs. Therefore, it is necessary to develop a traditional Chinese medicine formula with multiple modules, accurate efficacy, and high safety and a preparation method. SUMMARY

[0004] The technical problem to be solved by the present application is to overcome the defects of the above-mentioned technologies and provide a traditional Chinese medicine formula for treating breast hyperplasia and breast cancer and a preparation method.

[0005] To solve the above technical problems, the technical solution provided by the present application is a traditional Chinese medicine formula for treating breast hyperplasia and breast cancer and a preparation method, which is composed of the following raw materials by weight:

[0006] 5-15 parts of red peony root, 5-15 parts of Sanqi, 5-13 parts of costus, 10-50 parts of swim bladder, 10-25 parts of angelica, 0.02-0.08 parts of cantharides, 5-15 parts of atractylodes, and 0.5-3 parts of scorpion.

[0007] As an improvement, the weight of the red peony root is 8-12 parts.

[0008] As an improvement, the weight of the Sanqi is 8-12 parts.

[0009] As an improvement, the weight of the swim bladder is 20-40 parts.

[0010] As an improvement, the weight of the cantharides is 0.04-0.06 parts.

[0011] A preparation method of a traditional Chinese medicine formula for treating breast hyperplasia and breast cancer, comprising the following steps:

[0012] (1) Take red peony root, Sanqi, costus, angelica, and atractylodes, add 500-1500 ml of water, and soak for 1 hour in summer and 2 hours in winter;

[0013] (2) Take out the soaked red peony root, panax notoginseng, costus, angelica sinensis and atractylodes from step (1) and put them into fish maw, and decoct until the medicinal liquid is sticky;

[0014] (3) Roast and grind the cantharides and scorpion into powder;

[0015] (4) Mix the medicinal liquid obtained in step (2) with the powder obtained in step (3), and the formula is obtained.

[0016] As an improvement, in step (1), the amount of water is 800-1200 ml.

[0017] As an improvement, in step (2), the decocting until the medicinal liquid is sticky is specifically that the viscosity of the medicinal liquid reaches 500-1000 mPa·s.

[0018] As an improvement, in step (3), the roasting temperature is 60-80℃.

[0019] As an improvement, in step (3), the grinding into powder is passing through a 120-mesh sieve after grinding.

[0020] The advantages of the present application compared with the prior art are that the present application follows the overall concept and syndrome differentiation and treatment theory of traditional Chinese medicine, and realizes the treatment of both symptoms and root causes by the synergy of multiple medicinal materials, reduces the recurrence rate, targets the local stagnation and phlegm toxin of the breast, and regulates the liver, spleen and kidney functions.

[0021] The formula multi-module synergy has a total effective rate of 96.7% on breast hyperplasia, and a rate of 86.7% on stage I-II breast cancer, and can improve microcirculation, enhance immunity, and induce apoptosis of cancer cells.

[0022] The scientific processing technology reduces the toxicity of cantharides and scorpion, retains the efficacy, has no serious adverse reactions in clinic, and is safer than traditional anticancer traditional Chinese medicines.

[0023] The preparation steps are simple, no complex equipment is needed, the raw materials are common and low in cost, and the medicine powder can be taken with honey water or rice, and has different doses for different people, and the patient compliance is high.

[0024] The formula of the supporting medicinal materials can enhance immunity, promote hematopoiesis, offset the damage of attacking drugs, protect the body functions, is suitable for long-term treatment, stabilizes the liver and kidney function indicators, and embodies the advantage of not damaging the body during anticancer treatment. DETAILED DESCRIPTION

[0025] In order to facilitate the understanding of the present application, the present application is described more comprehensively as follows. The traditional Chinese medicine formula for treating breast hyperplasia and breast cancer and the preparation method are composed of the following raw materials by weight:

[0026] Radix Paeoniae Rubra 5-15 parts, Panax Notoginseng 5-15 parts, Radix Aucklandiae 5-13 parts, Swallowwort 10-50 parts, Angelica 10-25 parts, Cantharis 0.02-0.08 parts, Rhizoma Atractylodis Macrocephalae 5-15 parts, Solpugid 0.5-3 parts.

[0027] As an improvement, the weight parts of the Radix Paeoniae Rubra are 8-12 parts.

[0028] As an improvement, the weight parts of the Panax Notoginseng are 8-12 parts.

[0029] As an improvement, the weight parts of the Swallowwort are 20-40 parts.

[0030] As an improvement, the weight parts of the Cantharis are 0.04-0.06 parts.

[0031] A preparation method of a traditional Chinese medicine formula for treating breast hyperplasia and breast cancer, comprising the following steps:

[0032] (1) taking Radix Paeoniae Rubra, Panax Notoginseng, Radix Aucklandiae, Angelica, Rhizoma Atractylodis Macrocephalae, adding 500-1500 ml of water, soaking for 1 hour in summer and 2 hours in winter;

[0033] (2) taking out the Radix Paeoniae Rubra, Panax Notoginseng, Radix Aucklandiae, Angelica and Rhizoma Atractylodis Macrocephalae soaked in step (1) and putting them into Swallowwort, decocting until the medicinal liquid is sticky;

[0034] (3) roasting and grinding Cantharis and Solpugid into powder;

[0035] (4) mixing the medicinal liquid obtained in step (2) and the powder obtained in step (3), and the traditional Chinese medicine formula is obtained.

[0036] As an improvement, in step (1), the amount of water is 800-1200 ml.

[0037] As an improvement, in step (2), the decocting until the medicinal liquid is sticky is that the viscosity of the medicinal liquid reaches 500-1000 mPa·s.

[0038] As an improvement, in step (3), the roasting temperature is 60-80 DEG C.

[0039] As an improvement, in step (3), the grinding into powder is that the powder is sieved through a 120-mesh sieve after grinding.

[0040] I. Theoretical basis of traditional Chinese medicine and logical design of formula:

[0041] The present application is based on the overall concept of traditional Chinese medicine, syndrome differentiation and treatment, and builds a treatment system for the core pathogenesis of breast hyperplasia and breast cancer. From the overall concept, the occurrence and development of breast diseases are closely related to the dysfunction of viscera, and the interaction of liver stagnation, spleen dysfunction and kidney yin deficiency leads to blood stasis, phlegm and toxin gathering in the breast collateral, so the overall goal of formula design is to "regulate viscera, unblock blood and disperse phlegm and toxin".

[0042] In the aspect of syndrome differentiation and treatment, breast hyperplasia and breast cancer belong to the category of "rufous mass" and "breast rock", and the core syndrome type is qi stagnation and blood stasis and phlegm and blood stasis. The present formula is aimed at the syndrome type, and red peony root, sanchi ginseng, costus root, and fish maw are used to activate blood and resolve stasis, dredge qi and resolve stagnation, and soften and resolve mass, so as to achieve the effect of "qi flow and blood flow, and stasis dispersion and phlegm resolution", and realize accurate treatment of "syndrome differentiation and treatment".

[0043] Spleen balance, from the root, to improve the pathological basis of breast disease.

[0044] II. Formula composition and dosage range:

[0045] The traditional Chinese medicine formula in the present application is composed of the following raw materials in parts by weight:

[0046] Red peony root 5-15 parts;

[0047] Sanchi ginseng 5-15 parts;

[0048] Costus root 5-13 parts;

[0049] Fish maw 10-50 parts;

[0050] Angelica 10-25 parts;

[0051] Canton 0.02-0.08 parts;

[0052] White atractylodes 5-15 parts;

[0053] Scorpion 0.5-3 parts;

[0054] The above dosage is determined by clinical optimization, wherein canton and scorpion are toxic medicinal materials, and the upper limit is strictly limited to ensure the safety of medication; fish maw is the core medicinal material for softening and resolving mass, and the dosage range covers 10-50 parts, which can be adjusted according to the size of the mass and the course of the disease, and reflects the flexibility of "treatment according to disease".

[0055] III. Preparation method and processing technology:

[0056] Pre-treatment of medicinal materials:

[0057] Select red peony root, sanchi ginseng, costus root, angelica and white atractylodes decoction pieces that meet the standards of Chinese Pharmacopoeia, and remove impurities; fish maw is soaked in clean water until it is softened, cut into 1-2 cm small pieces; canton is removed from head, foot and wing (to reduce toxicity), and scorpion is rinsed with clean water to remove mud and sand, and dried for use.

[0058] Soaking process:

[0059] Take red peony root, sanchi, costus, angelica, and atractylodes, add 500-1500 milliliters of purified water (preferably 800-1200 milliliters), soak for 1 hour in summer (room temperature 25-30°C) and 2 hours in winter (room temperature 5-10°C). The purpose of processing: through differential time control, ensure that the medicinal materials are fully water-absorbed in a low-temperature environment, and avoid the early loss of effective components in a high-temperature environment, laying the foundation for subsequent decoction.

[0060] Decoction and concentration:

[0061] Move the soaked medicinal materials and medicinal liquid into a sand pot, add cut fish maw, and simmer on low heat until the medicinal liquid is sticky (viscosity 500-1000 mPa·s). The purpose of processing: fish maw is rich in collagen, and long-term simmering to stickiness can promote the full dissolution of its effective components, enhance the softening and resolving effects, and form a sticky matrix for subsequent mixing with powder.

[0062] Processing of toxic medicinal materials:

[0063] Banmao and quanchi use low-temperature roasting method: place in a ceramic container, roast at a constant temperature of 60-80°C (moisture content ≤5%), and crush to 120 mesh after roasting. The purpose of processing: high temperature of 60-80°C can destroy part of the toxic groups of cantharidin and scorpion toxin (attenuation), while retaining their anticancer activity; ultrafine grinding (120 mesh) can improve the dissolution of the drug and enhance the bioavailability.

[0064] Finished product preparation:

[0065] Mix the sticky medicinal liquid after decoction with banmao and quanchi powder, stir evenly, and dry below 60°C, then crush to 80 mesh to obtain the finished product powder.

[0066] Four, pharmacological analysis:

[0067] Blood-activating and stasis-removing module: red peony root contains paeoniflorin, which can inhibit platelet aggregation and improve local microcirculation of the breast; sanchi contains notoginsenosides, which can inhibit tumor cell proliferation and induce apoptosis, and the two can work together to remove blood stasis and obstacles for subsequent treatment.

[0068] Qi-regulating and phlegm-resolving module: costus contains volatile oil (such as costunolide), which can improve liver stagnation by regulating the autonomic nervous system and indirectly relieve breast pain; fish maw contains various essential amino acids, which can promote tissue repair and soften and shrink the hyperplastic mass, directly attacking the core of the lesion.

[0069] Strengthening the body resistance module: angelica contains ferulic acid, which can promote hematopoietic function and enhance immune cell activity; atractylodes contains atractylodes lactone, which can inhibit tumor angiogenesis and improve the body's tolerance, and the two form a protective barrier of "qi and blood supplementation" to prevent damage to the healthy qi by attacking drugs.

[0070] Detoxification Anti-cancer Module: Cantharides contains cantharidin (reduced toxicity by baking), which can specifically inhibit DNA synthesis of cancer cells; scorpion contains scorpion venom protein, which can block tumor cell migration channel and relieve cancer pain, both of which constitute the core strength of targeted anti-cancer.

[0071] The whole prescription realizes the unity of local treatment and systemic regulation through the compatibility art of "activating blood without damaging blood, promoting qi without consuming qi, and resisting cancer without damaging the normal".

[0072] Five, data verification:

[0073] Clinical verification scheme: 120 cases of breast hyperplasia patients (aged 25-50 years old), 60 cases of breast cancer stage I-II patients (aged 35-65 years old) were selected, all of which met the western diagnostic criteria and TCM "Qi stagnation and blood stasis" syndrome differentiation criteria.

[0074] Dosage: 2-3g of drug powder each time, 2 times a day, honey water or with meals, 3 months as a course of treatment.

[0075] Efficacy criteria:

[0076] Breast hyperplasia: cure (lump and pain disappeared), marked effect (lump shrinkage ≥ 50%), effective (lump shrinkage 20%-50%), ineffective (not up to the above standard).

[0077] Breast cancer: complete remission (lesion disappeared), partial remission (lesion shrinkage ≥ 30%), stable (lesion change < 30%), progression (lesion enlargement).

[0078] Results:

[0079] Breast hyperplasia group: 86 cases were cured (71.7%), 22 cases were markedly effective (18.3%), 8 cases were effective (6.7%), and 4 cases were ineffective (3.3%), with a total effective rate of 96.7%.

[0080] Breast cancer group: 12 cases were completely relieved (20.0%), 30 cases were partially relieved (50.0%), 10 cases were stable (16.7%), and 8 cases were progressive (13.3%), with a total effective rate of 86.7%.

[0081] Safety: All subjects' liver and kidney function indicators were within the normal range during treatment, only 3 cases had mild gastrointestinal discomfort (relieved after adjusting to take after meals), and there were no serious adverse reactions.

[0082] Six, taking instructions and precautions:

[0083] Usage and dosage: adults, 2-3g each time, 2 times a day; weak, 1.5-2g each time, 2 times a day for people over 65 years old.

[0084] Administration: take with honey water (honey can moderate the nature of the drug) or with rice (reduce gastrointestinal irritation).

[0085] Contraindications: pregnant women, lactating women are prohibited; patients with liver and kidney dysfunction should be used with caution; patients allergic to the ingredients of the formula are prohibited.

[0086] Course management: 1-2 courses for continuous use for breast hyperplasia, 3-6 courses for continuous use for breast cancer, and monthly review of blood routine, liver and kidney function, and lesion changes during the period.

[0087] The present application provides a safe and effective traditional Chinese medicine regimen for the treatment of breast hyperplasia and breast cancer by guiding the formula design with traditional Chinese medicine theory, combining standardized processing technology and clinical verification data, and embodies the organic integration of traditional medicine and modern technology.

[0088] In line with traditional Chinese medicine theory, overall conditioning is achieved.

[0089] The present application strictly follows the overall concept of traditional Chinese medicine and treatment based on syndrome differentiation, and through the synergistic effect of multiple medicinal materials, it not only targets the local stasis, phlegm and toxin of the breast for targeted treatment, but also regulates the functions of liver, spleen, kidney and other viscera, improves the pathological state of blood imbalance and phlegm production from the root, and achieves "treatment of both symptoms and root cause". Compared with single-component chemical drugs, it can effectively reduce the recurrence rate of diseases, and embodies the advantages of traditional Chinese medicine "prevention of disease".

[0090] Multiple target synergistic effect, wide treatment range:

[0091] The four modules of activating blood and resolving stasis, promoting qi and resolving masses, strengthening the body resistance and detoxifying and resisting cancer in the formula work synergistically, not only have significant effect on the qi stagnation and blood stasis type of breast hyperplasia (total effective rate 96.7%), but also can inhibit the proliferation and metastasis of breast cancer cells, and the total effective rate of stage I-Ⅱ breast cancer is 86.7%. Its mechanism of action covers multiple aspects such as improving microcirculation, enhancing immune function, and inducing tumor cell apoptosis, solving the problem of insufficient targeting of traditional single therapy.

[0092] Scientific processing technology, high safety:

[0093] Through the low-temperature roasting at 60-80℃ and ultrafine grinding process of cantharis and scorpion, the anticancer activity is retained while the toxicity is significantly reduced; the fish maw is treated by decocting to sticky, which maximizes the extraction of effective ingredients and avoids impurity residues. Clinical verification shows that there is no serious adverse reaction in the subjects, only 3 cases of mild gastrointestinal discomfort, and it can be relieved by adjusting the administration method, and the safety is better than that of traditional anticancer traditional Chinese medicine containing toxic ingredients.

[0094] Simple preparation method, easy to promote:

[0095] The preparation process of the application only involves conventional steps such as soaking, decocting, roasting, and crushing, does not need complex equipment, is suitable for small and medium-sized pharmaceutical enterprises or medical institutions for batch production, the raw materials are all common traditional Chinese medicinal materials, the source is stable, the cost is relatively low, and the application is convenient for popularization and application in primary medical scenes.

[0096] The taking mode is flexible, and the patient compliance is high.

[0097] The finished medicine powder can be taken with honey water or rice, which reduces the stimulation of the medicine on the gastrointestinal tract and simplifies the taking process; different dosages are formulated for different groups of people (adults, the weak, and the elderly), which further improves the convenience of taking medicine. Compared with the bitter taste and inconvenience of taking the traditional decoction, the application significantly improves the long-term medication compliance of patients.

[0098] Both the strengthening of healthy qi and the elimination of pathogenic factors are considered, and the function of the body is protected.

[0099] The tonifying medicinal materials such as angelica and atractylodes in the formula can enhance the immune function and promote hematopoiesis, offset the damage of the toxic drugs such as cantharis and scorpion to the body, and solve the drawback of the traditional anticancer traditional Chinese medicine that eliminates pathogenic factors and damages healthy qi. Clinical data show that the liver and kidney function indexes of the subjects are stable during the treatment, which reflects the advantage of “anti-cancer without damaging healthy qi”, and the application is especially suitable for chronic breast disease patients who need long-term treatment.

[0100] If a person skilled in the art is inspired by the application and designs a similar structure and embodiment without departing from the purpose of the application, the design should belong to the protection scope of the application.

Claims

1. A traditional Chinese medicine formula for treating breast hyperplasia and breast cancer, characterized in that: It consists of the following raw materials in parts by weight: Red peony root 5-15 parts, Panax notoginseng 5-15 parts, Costus root 5-13 parts, fish maw 10-50 parts, Angelica sinensis 10-25 parts, blister beetle 0.02-0.08 parts, Atractylodes macrocephala 5-15 parts, scorpion 0.5-3 parts.

2. The traditional Chinese medicine formula according to claim 1, characterized in that: The weight of the red peony root is 8-12 parts.

3. The traditional Chinese medicine formula according to claim 1, characterized in that: The weight of the Panax notoginseng is 8-12 parts.

4. The traditional Chinese medicine formula according to claim 1, characterized in that: The swim bladder is in the form of 20-40 parts by weight.

5. The traditional Chinese medicine formula according to claim 1, characterized in that: The weight of the blister beetle is 0.04-0.06 parts.

6. A method for preparing a traditional Chinese medicine formula for treating breast hyperplasia and breast cancer, characterized in that: Includes the following steps: (1) Take red peony root, Panax notoginseng, costus root, angelica root, and atractylodes macrocephala, add 500-1500 ml of water, soak for 1 hour in summer and 2 hours in winter; (2) Take out the soaked red peony root, Panax notoginseng, costus root, angelica root and atractylodes macrocephala in step (1), put them into the fish maw, and simmer until the medicinal liquid becomes sticky; (3) Dry the blister beetle and scorpion and grind them into powder; (4) Mix the liquid obtained in step (2) with the powder obtained in step (3) to obtain the final product.

7. The preparation method according to claim 6, characterized in that: In step (1), the amount of water used is 800-1200 ml.

8. The preparation method according to claim 6, characterized in that: In step (2), the step of decocting until the medicinal liquid becomes viscous specifically means that the viscosity of the medicinal liquid reaches 500-1000 mPa·s.

9. The preparation method according to claim 6, characterized in that: In step (3), the drying temperature is 60-80℃.

10. The preparation method according to claim 6, characterized in that: In step (3), the grinding into powder means grinding and then passing it through a 120-mesh sieve.