Traditional Chinese medicine formula for treating anaphylactoid purpura

Abstract

The invention discloses a traditional Chinese medicine formula for treating anaphylactoid purpura, and relates to the technical field of traditional Chinese medicine prescriptions, and the traditional Chinese medicine formula comprises the following raw materials in parts by weight: 80-120 parts of folium isatidis, 80-120 parts of herba cepbalanoplosis segeti, 80-120 parts of cornu bubali, 80-120 parts of hairyvein agrimony, 80-120 parts of carbonized sanguisorba root, 80-120 parts of rehmannia, 80-120 parts of moutan bark, 80-120 parts of pseudo-ginseng, 80-120 parts of radix paeoniae alba, 80-120 parts of astragalus membranaceus, 80-120 parts of selaginella tamariscina and 80-120 parts of bighead atractylodes rhizome. Through the multi-target synergistic effect of removing heat to cool blood, astringing to stop bleeding and tonifying qi to strengthen superficies, the curative effect of anaphylactoid purpura is remarkably improved, and the traditional Chinese medicine composition is free of hormone dependence risk and especially suitable for long-term use by children and chronic patients; the dissolution rate of active ingredients is optimized by adopting a step-by-step extraction process, and the quality is controllable in combination with an HPLC fingerprint spectrum; the pharmaceutical composition is expanded to immune thrombocytopenia and other indications, and has safety, stability and clinical application flexibility.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine prescriptions, and specifically relates to a traditional Chinese medicine formula for treating allergic purpura. Background Art

[0002] Allergic purpura, also known as hemorrhagic capillary toxicosis, is a systemic hemorrhagic disease caused by microvascular abnormalities. Its basic lesion is extensive aseptic inflammatory reactions in capillaries and small arteries, leading to increased vascular wall permeability and exudative hemorrhage and edema. According to the lesion site and clinical manifestations, allergic purpura can be divided into multiple types such as simple type, joint type, abdominal type, renal type, and mixed type. In addition to purpura, the main symptoms can involve the skin, joints, gastrointestinal tract, and kidneys, presenting corresponding symptoms such as rashes, swelling, abdominal pain, joint swelling and pain, and nephritis. And 1 / 3 to 1 / 2 of the patients can develop nephritis, presenting proteinuria and hematuria, which can last for several months or years, having certain harmfulness. A small number of patients can lead to renal failure and even endanger life.

[0003] Currently, Western medicine treats allergic purpura with hormone hemostasis treatment. Due to long-term use of hormones, patients have symptoms such as buffalo hump, moon face, obesity, low immunity in children, and slow growth and development. Moreover, it cannot be cured and relapses frequently. Nearly 50% of the patients also develop purpuric nephropathy, causing great pain to the physical and mental health of the patients. Therefore, a traditional Chinese medicine formula for treating allergic purpura is designed to solve the negative impacts brought by hormones. Summary of the Invention

[0004] Aiming at the deficiencies of the prior art, the present invention provides a traditional Chinese medicine formula for treating allergic purpura, solving the technical problems raised in the above background art.

[0005] To achieve the above objectives, the present invention is realized through the following technical solutions: A traditional Chinese medicine formula for treating allergic purpura is composed of the following raw materials in parts by weight:

[0006] Isatis indigotica Fort. 80 - 120 parts, Cirsium setosum (Willd.) MB. 80 - 120 parts, Cornu Bubali 80 - 120 parts, Agrimonia pilosa Ledeb. 80 - 120 parts, Sanguisorba officinalis L. charcoal 80 - 120 parts, Rehmannia glutinosa Libosch. 80 - 120 parts, Cortex Moutan 80 - 120 parts, Panax notoginseng (Burk.) F. H. Chen 80 - 120 parts, Paeonia lactiflora Pall. 80 - 120 parts, Astragalus membranaceus (Fisch.) Bunge 80 - 120 parts, Selaginella tamariscina (Beauv.) Spring 80 - 120 parts, Atractylodes macrocephala Koidz. 80 - 120 parts.

[0007] Preferably, the parts by weight of the raw materials are:

[0008] Isatis indigotica Fort. 100 parts, Cirsium setosum (Willd.) MB. 100 parts, Cornu Bubali 100 parts, Agrimonia pilosa Ledeb. 100 parts, Sanguisorba officinalis L. charcoal 100 parts, Rehmannia glutinosa Libosch. 100 parts, Cortex Moutan 100 parts, Panax notoginseng (Burk.) F. H. Chen 100 parts, Paeonia lactiflora Pall. 100 parts, Astragalus membranaceus (Fisch.) Bunge 100 parts, Selaginella tamariscina (Beauv.) Spring 100 parts, Atractylodes macrocephala Koidz. 100 parts.

[0009] Preferably, the active ingredients in the traditional Chinese medicine formula include paeonol, notoginsenoside R1, astragaloside IV, and paeoniflorin, wherein:

[0010] The content of paeonol ≥ 0.5 mg / g;

[0011] The content of notoginsenoside R1 ≥ 1.0 mg / g;

[0012] The content of astragaloside IV ≥ 0.8 mg / g;

[0013] The content of paeoniflorin ≥ 1.2 mg / g.

[0014] Preferably, it includes the following steps:

[0015] (1) Fractional extraction:

[0016] Extract buffalo horn, rehmannia root, moutan bark, and folium isatidis with 60% - 80% ethanol for 2 times, 1 - 2 hours each time. Combine the extraction solutions and concentrate to a clear paste with a relative density of 1.20 - 1.30, denoted as extract A;

[0017] Decoct agrimony and charred sanguisorba root with water for 2 times, 1 hour each time. Combine the decoction solutions and concentrate to a clear paste with a relative density of 1.10 - 1.15, denoted as extract B;

[0018] (2) Preparation of fine powder:

[0019] Crush cirsium setosum, notoginseng, white peony root, astragalus root, selaginella tamariscina, and atractylodes macrocephala through an 80 - 120 - mesh sieve to obtain a mixed fine powder; (3) Mixing and formulation:

[0020] Mix extract A, extract B, and the mixed fine powder in a weight ratio of 1:0.5:2, and add a binder to make pills, tablets, or granules.

[0021] Preferably,

[0022] In step (1), the pretreatment of buffalo horn is: crush buffalo horn to a particle size ≤ 2 mm and then extract it together with rehmannia root and moutan bark;

[0023] In step (3), the binder is honey or hydroxypropyl methylcellulose, and the dosage is 5% - 10% of the mixture.

[0024] Preferably, the application of the traditional Chinese medicine formula in the preparation of drugs for treating the following diseases:

[0025] Allergic purpura;

[0026] Immune thrombocytopenia:

[0027] Vasculitis - related cutaneous purpura.

[0028] Preferably, it further comprises a pharmaceutically acceptable excipient, wherein the excipient includes one or more of microcrystalline cellulose, lactose or magnesium stearate.

[0029] Preferably, the method comprises the following steps:

[0030] The contents of paeonol and astragaloside IV were determined by HPLC;

[0031] The characteristic spots of notoginsenoside R1 and Sanguisorba officinalis charcoal were identified by TLC.

[0032] Beneficial Effects

[0033] The present invention provides a Chinese medicine formula for treating allergic purpura. The present invention significantly improves the efficacy of allergic purpura through the multi-target synergistic effect of "clearing heat and cooling blood, astringing and stopping bleeding, and invigorating qi and consolidating the exterior", and has no risk of hormone dependence. The present invention is especially suitable for long-term use by children and chronic patients. The dissolution rate of the active ingredient is optimized by a step-by-step extraction process, and the quality is controlled by combining HPLC fingerprint, which is extended to indications such as immune thrombocytopenia, and has both safety, stability and flexibility in clinical application. DETAILED DESCRIPTION

[0034] The technical solutions in the embodiments of the present invention are described clearly and completely below. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of them. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0035] The present invention provides a technical solution: a traditional Chinese medicine formula for treating allergic purpura, which is composed of the following raw materials in parts by weight:

[0036] 80-120 parts of Folium Isatidis, 80-120 parts of Cirsium cyrtonema, 80-120 parts of Horn of Buffalo, 80-120 parts of Herba Agrimoniae, 80-120 parts of Carbonized Sanguisorba Officinalis, 80-120 parts of Rehmannia Glutinosa, 80-120 parts of Cortex Moutan, 80-120 parts of Notoginseng, 80-120 parts of White Peony, 80-120 parts of Astragalus, 80-120 parts of Selaginella, and 80-120 parts of Atractylodes.

[0037] This embodiment is further configured such that the weight portions of the raw materials are:

[0038] 100 parts of Folium Isatidis, 100 parts of Cirsium cyrtonema, 100 parts of Horn of Buffalo, 100 parts of Herba Agrimoniae, 100 parts of Carbonized Sanguisorba Officinalis, 100 parts of Rehmannia Glutinosa, 100 parts of Cortex Moutan, 100 parts of Radix Notoginseng, 100 parts of White Peony Roots, 100 parts of Radix Astragali, 100 parts of Selaginella, and 100 parts of Atractylodes Macrocephala.

[0039] This embodiment is further configured such that the active ingredients in the traditional Chinese medicine formula include paeonol, notoginsenoside R1, astragaloside IV, and paeoniflorin, wherein:

[0040] The content of paeonol ≥ 0.5 mg / g;

[0041] The content of notoginsenoside R1 ≥ 1.0 mg / g;

[0042] The content of astragaloside IV ≥ 0.8 mg / g;

[0043] The content of paeoniflorin ≥ 1.2 mg / g.

[0044] This embodiment is further configured to include the following steps:

[0045] (1) Fractional extraction:

[0046] Extract buffalo horn, rehmannia root, moutan bark, and folium isatidis with 60% - 80% ethanol twice, each time for 1 - 2 hours, combine the extracts, and concentrate to a clear paste with a relative density of 1.20 - 1.30, denoted as extract A;

[0047] Decoct agrimony and charred sanguisorba root twice with water, each time for 1 hour, combine the decoctions, and concentrate to a clear paste with a relative density of 1.10 - 1.15, denoted as extract B;

[0048] (2) Preparation of fine powder:

[0049] Crush cirsium setosum, notoginseng, white peony root, astragalus root, selaginella, and atractylodes macrocephala through an 80 - 120 - mesh sieve to obtain a mixed fine powder; (3) Mixing and formulation:

[0050] Mix extract A, extract B, and the mixed fine powder in a weight ratio of 1:0.5:2, and add a binder to make pills, tablets, or granules.

[0051] This embodiment is further configured as:

[0052] In step (1), the pretreatment of buffalo horn is: crush the buffalo horn to a particle size ≤ 2 mm and then extract it together with rehmannia root and moutan bark;

[0053] In step (3), the binder is honey or hydroxypropyl methylcellulose, and the dosage is 5% - 10% of the mixture.

[0054] This embodiment is further configured for the application of the traditional Chinese medicine formula in the preparation of drugs for treating the following diseases: allergic purpura;

[0055] Immune thrombocytopenia:

[0056] Vasculitis - related cutaneous purpura.

[0057] This embodiment is further configured to further include pharmaceutically acceptable excipients, and the excipients include one or more of microcrystalline cellulose, lactose or magnesium stearate.

[0058] This embodiment is further configured to include the following steps:

[0059] Determine the contents of paeonol and astragaloside IV by HPLC method;

[0060] Identify the characteristic spots of notoginsenoside R1 and charred sanguisorba root by TLC method.

[0061] Its detailed connection means are well-known techniques in the art. The following mainly introduces the working principle and process, and the specific work is as follows.

[0062] Example: Pretreatment:

[0063] Crush buffalo horn to a particle size of ≤2 mm (using a high-speed crusher, rotation speed 2000 r / min, time 5 minutes); pass charred sanguisorba root through a 40-mesh sieve to remove impurities.

[0064] Stepwise extraction:

[0065] Ethanol extract (heat-clearing and blood-cooling component):

[0066] Mix buffalo horn, rehmannia root, moutan bark and isatis leaf, add 8 times the amount of 70% ethanol (v / v), reflux and extract at 80 °C for 2 times, 1.5 hours each time, combine the filtrates, concentrate under reduced pressure (vacuum degree -0.08 MPa, temperature 60 °C) to a clear paste with a relative density of 1.25, and spray dry (inlet air temperature 180 °C, outlet air temperature 90 °C) to obtain dry extract powder.

[0067] Water extract (hemostatic component):

[0068] Decoct agrimony and charred sanguisorba root with water for 2 times (10 times the amount of water, 1 hour each time), combine the decoctions, concentrate at 60 °C to a clear paste with a relative density of 1.12, and freeze dry (-40 °C pre-freezing, vacuum degree 10 Pa) to obtain freeze-dried powder.

[0069] Fine powder preparation:

[0070] Crush thistle, notoginseng, white peony root, astragalus root, selaginella, and atractylodes macrocephala respectively through a 100-mesh sieve and mix evenly.

[0071] Pill making:

[0072] Mix the dry extract powder of the ethanol extract, the freeze-dried powder of the water extract and the fine powder in a weight ratio of 1:0.5:2, add 10% honey (w / w) as a binder to make soft materials (humidity 25%), and use a full-automatic pill making machine (aperture 2 mm) to make concentrated pills with a diameter of 3 mm, and dry at 60 °C with hot air until the water content ≤8% to obtain the finished product.

[0073] It should be noted that in this article, relational terms such as first and second are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any actual relationship or order between these entities or operations.

Claims

1. A traditional Chinese medicine formula for treating anaphylactoid purpura, characterized in that, It consists of the following raw materials in parts by weight: 80 - 120 parts of Folium Isatidis, 80 - 120 parts of Herba Cirsii, 80 - 120 parts of Cornu Bubali, 80 - 120 parts of Herba Agrimoniae, 80 - 120 parts of Carbonized Sanguisorbae Radix, 80 - 120 parts of Rehmanniae Radix, 80 - 120 parts of Cortex Moutan, 80 - 120 parts of Notoginseng Radix et Rhizoma, 80 - 120 parts of Paeoniae Radix Alba, 80 - 120 parts of Astragali Radix, 80 - 120 parts of Selaginella tamariscina, 80 - 120 parts of Atractylodis Macrocephalae Rhizoma.

2. The Chinese medicine formula for treating allergic purpura according to claim 1, wherein , the parts by weight of the raw materials are: 100 parts of Folium Isatidis, 100 parts of Herba Cirsii, 100 parts of Cornu Bubali, 100 parts of Herba Agrimoniae, 100 parts of Carbonized Sanguisorbae Radix, 100 parts of Rehmanniae Radix, 100 parts of Cortex Moutan, 100 parts of Notoginseng Radix et Rhizoma, 100 parts of Paeoniae Radix Alba, 100 parts of Astragali Radix, 100 parts of Selaginella tamariscina, 100 parts of Atractylodis Macrocephalae Rhizoma.

3. A traditional Chinese medicine formula for treating anaphylactoid purpura according to claim 1, characterized in that , the active ingredients in the traditional Chinese medicine formula include paeonol, notoginsenoside R1, astragaloside IV and paeoniflorin, among which: the content of paeonol ≥ 0.5mg / g; the content of notoginsenoside R1 ≥ 1.0mg / g; the content of astragaloside IV ≥ 0.8mg / g; the content of paeoniflorin ≥ 1.2mg / g.

4. A traditional Chinese medicine formula for treating anaphylactoid purpura according to claim 1, characterized in that , including the following steps: (1) Separate extraction: Extract Cornu Bubali, Rehmanniae Radix, Cortex Moutan and Folium Isatidis with 60% - 80% ethanol for 2 times, 1 - 2 hours each time, combine the extraction solutions, and concentrate to a clear paste with a relative density of 1.20 - 1.30, denoted as extract A; Decoct Herba Agrimoniae and Carbonized Sanguisorbae Radix with water for 2 times, 1 hour each time, combine the decoction solutions, and concentrate to a clear paste with a relative density of 1.10 - 1.15, denoted as extract B; (2) Preparation of fine powder: Crush Herba Cirsii, Notoginseng Radix et Rhizoma, Paeoniae Radix Alba, Astragali Radix, Selaginella tamariscina and Atractylodis Macrocephalae Rhizoma through an 80 - 120 - mesh sieve to obtain a mixed fine powder; (3) Mixing and preparation: Mix extract A, extract B and the mixed fine powder in a weight ratio of 1:0.5:2, and add a binder to make pills, tablets or granules.

5. The preparation method according to claim 4, characterized in that: In step (1), the pretreatment of Cornu Bubali is: crush Cornu Bubali to a particle size ≤ 2mm and then extract it together with Rehmanniae Radix and Cortex Moutan; In step (3), the binder is honey or hydroxypropyl methylcellulose, and the dosage is 5% - 10% of the mixture.

6. The application of the traditional Chinese medicine formula according to any one of claims 1 - 3 in the preparation of drugs for treating the following diseases: Allergic purpura; Immune thrombocytopenia: Vasculitis - related cutaneous purpura.

7. The traditional Chinese medicine formula according to any one of claims 1-3, characterized in that , further comprising pharmaceutically acceptable excipients, and the excipients include one or more of microcrystalline cellulose, lactose or magnesium stearate.

8. A quality inspection method for quality control of the traditional Chinese medicine composition according to any one of claims 1-3, characterized in that Including the following steps: Determine the contents of paeonol and astragaloside IV by HPLC method; Identify the characteristic spots of notoginsenoside R1 and Carbonized Sanguisorbae Radix by TLC method.