Traditional Chinese medicine composition preparation, preparation method thereof and application of traditional Chinese medicine composition preparation in preparation of medicine for treating herpes zoster

Abstract

The invention discloses a traditional Chinese medicine composition preparation which mainly comprises the following components in parts by weight: 8-20 parts of notopterygium incisum, 8-20 parts of pericarpium citri reticulatae, 8-20 parts of flos carthami and 8-20 parts of ligusticum wallichii. The invention further discloses a preparation method of the traditional Chinese medicine composition preparation and application of the traditional Chinese medicine composition preparation in preparation of medicine for treating herpes zoster. The medicine for treating herpes zoster can effectively retain active ingredients, the compatibility of all the formulas is good, the medicine for treating herpes zoster is obtained under the synergistic interaction and interaction of all the formulas, and the medicine is convenient to take, quick in effect, short in treatment period, free of side effects, low in treatment cost, simple in preparation method and process, beneficial to production and suitable for popularization and application. Wide application prospects and large-scale popularization values are realized.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine, and more specifically, to a traditional Chinese medicine composition preparation and a preparation method thereof and an application thereof in preparing a medicine for treating herpes zoster. Background Art

[0002] The onset of herpes zoster is often caused by chickenpox in childhood, which causes the varicella-zoster virus to lurk in the body. When the resistance of adults decreases, the latent virus will transfer along the nerves to the skin in the area innervated by the nerves, replicate in large quantities, and produce blisters and other rashes. The virus causes inflammation and necrosis of the nerves, causing severe pain, which makes patients miserable. At present, antiviral drugs and analgesics are commonly used to relieve herpes symptoms, but they cannot cure herpes zoster. Traditional Chinese medicine believes that the early stage of herpes zoster is mainly due to damp heat obstruction and dampness and fire, and the later stage is mainly due to fire and heat damaging yin, qi stagnation and blood stasis or spleen deficiency and dysfunction, and the residual poison has not been cleared. In terms of treatment, there are many methods such as Chinese medicine compatibility or acupuncture, but most of the traditional Chinese medicine treatment plans have more formulas, poor compatibility effects, or long treatment cycles and slow onset. Repeated attacks bring a lot of pain to patients and also bring a high burden of treatment costs. How to safely, effectively, quickly treat herpes zoster without side effects is the key. Summary of the invention

[0003] The invention provides a Chinese medicine composition preparation and a preparation method thereof and application in preparing a medicine for treating herpes zoster. The Chinese medicine composition preparation can effectively retain active ingredients, and the compatibility between the various formulas is good. Under the synergistic enhancement and interaction of the various formulas, a medicine for treating herpes zoster is obtained. The medicine is convenient to use, has a rapid onset of effect, a short treatment cycle, no side effects, and a low treatment cost. The preparation method has a simple process, is conducive to production, and has broad application prospects and large-scale promotion value.

[0004] In order to achieve these purposes and other advantages according to the present invention, a Chinese medicine composition preparation is provided, which mainly comprises, by weight: 8-20 parts of Pteris ovata, 8-20 parts of dried tangerine peel, 8-20 parts of safflower, and 8-20 parts of Chuanxiong.

[0005] Preferably, the main ingredients, by weight, include: 10 parts of Pteris ovata, 15 parts of dried orange peel, 14 parts of safflower, and 14 parts of Ligusticum chuanxiong.

[0006] Preferably, the preparation includes aqueous solution, powder, cream, patch, tincture, film, ointment, gel, and aerosol.

[0007] Preferably, a pharmaceutical excipient is also included.

[0008] Preferably, the pharmaceutical excipients include one or more of preservatives, antioxidants, flavoring agents, aromatics, cosolvents, emulsifiers, solubilizers, osmotic pressure regulators, colorants, binders, fillers, disintegrants, lubricants, and bases.

[0009] The preparation method of the Chinese medicine composition preparation comprises the following steps: S1: Remove the stems and leaves of the above-mentioned fern by weight, leaving the roots, soak them in 2-15% acetic acid solution at a rate of 3 g: (8-10) mL for 5-10 days, and filter to obtain the first solution; S2: Soak the above-mentioned dried tangerine peel in 40-75% alcohol at a ratio of 1 g: (2-4) mL for 3-7 days, and filter to obtain a second solution; S3: Mix the above-mentioned safflower and chuanxiong in the proportions by weight, boil them with spring water at a ratio of 1 g:(2-4) mL for 20-40 min, cool and filter to obtain a third solution; S4: The first solution, the second solution and the third solution are mixed in a volume ratio of 6:3:1 to obtain a Chinese medicine composition extract.

[0010] Preferably, the method further comprises the following steps: S5: adding an excipient after freeze-drying the extract of the Chinese medicine composition, or directly adding an excipient to the extract of the Chinese medicine composition, to prepare a Chinese medicine composition preparation.

[0011] Preferably, the method comprises the following steps: S1: Remove the stems and leaves of the above-mentioned fern by weight, leaving the roots, soak them in 5% acetic acid solution at a ratio of 3 g:10 mL for 7 days, and filter to obtain the first solution; S2: The above-mentioned dried tangerine peels are soaked in 50% alcohol at a ratio of 1 g:2 mL for 3 days, and filtered to obtain a second solution; S3: Boil the above-mentioned safflower and chuanxiong in spring water at a ratio of 1 g:4 mL for 20 min, cool and filter to obtain a third solution; S4: The first solution, the second solution and the third solution are mixed in a volume ratio of 6:3:1 to prepare an aqueous solution.

[0012] Preferably, the method further comprises the following steps: S5: directly adding one or more of preservatives, antioxidants, flavoring agents, aromatics, cosolvents, emulsifiers, solubilizers, osmotic pressure regulators, and colorants to the extract of the traditional Chinese medicine composition to prepare an aqueous solution.

[0013] Application of the Chinese medicine composition preparation in preparing medicine for treating herpes zoster.

[0014] The present invention has at least the following beneficial effects: First, the present invention follows the prescription principle of "monarch, minister, assistant and envoy" in traditional Chinese medicine. The combination of fern, tangerine peel, safflower and chuanxiong has the effects of inhibiting bacteria and inflammation and soothing the skin, achieving the purpose of treating and preventing herpes zoster, with definite efficacy and no toxic side effects.

[0015] Second, the present invention is convenient to use, has a quick onset of effect, a short treatment cycle, and a low treatment cost. The preparation method is simple and easy to produce, and has broad application prospects and large-scale promotion value.

[0016] The main ingredients, assistant ingredients, and their properties and flavors are as follows: Tuber fern: It is the main drug, cool in nature and bitter in taste, and enters the spleen and kidney meridians. It has the effects of clearing away heat and detoxifying, reducing swelling and relieving pain, and inhibiting bacteria and inflammation. Tangerine peel: It is an auxiliary medicine, pungent, bitter and warm in nature, and it enters the spleen and lung meridians, and has the effect of regulating qi and strengthening the spleen; Safflower: It is an auxiliary drug, pungent and warm in nature, and it enters the heart and liver meridians. It has the effects of promoting blood circulation, dredge menstruation, removing blood stasis and relieving pain. Chuanxiong: As an auxiliary medicine, it is pungent and warm in nature. It enters the liver, gallbladder and pericardium meridians and has the effect of promoting qi and relieving pain.

[0017] The main drug, Tuberose, is cool in nature, so it is necessary to add warm compress drugs in the combination. Tangerine peel can promote skin absorption, which can enhance the effect of the main drug and can be used as the first choice of the auxiliary drug in this combination. In addition, safflower and Chuanxiong are both warm in nature, which can coordinate the main drug and have the effect of relieving pain and dispersing blood stasis. Chuanxiong also has the effect of guiding drugs, so it is used as an adjuvant and guiding drug in this combination.

[0018] Other advantages, objectives and features of the present invention will be embodied in part through the following description, and in part will be understood by those skilled in the art through study and practice of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Figure 1 A photograph of the affected part of a typical case 1 of the present invention; Figure 2 This is a photo of the affected part of typical case 2 of the present invention; Figure 3 It is the photograph of the affected part of typical case 3 of the present invention. DETAILED DESCRIPTION

[0020] The present invention is further described in detail below in conjunction with the accompanying drawings so that those skilled in the art can implement the invention with reference to the description.

[0021] It should be understood that the terms such as “having”, “including” and “comprising” used herein do not exclude the existence or addition of one or more other elements or combinations thereof.

[0022] It should be noted that the experimental methods described in the following embodiments are conventional methods unless otherwise specified, and the reagents and materials are commercially available unless otherwise specified, and should not be construed as limitations on the present invention.

[0023] The Chinese medicine composition preparation mainly comprises, by weight: 8-20 parts of fern, 8-20 parts of dried tangerine peel, 8-20 parts of safflower, and 8-20 parts of chuanxiong.

[0024] The preparation method of the Chinese medicine composition preparation comprises the following steps: S1: Remove the stems and leaves of the above-mentioned fern by weight, leaving the roots, soak in 2-15% acetic acid solution at 3g:(8-10) mL for 7 days, and filter to obtain the first solution; S2: Soak the above-mentioned dried tangerine peel in 40-75% alcohol at a ratio of 1 g:2 mL for 3 days, and filter to obtain a second solution; S3: Mix the above-mentioned safflower and chuanxiong in the proportions by weight, boil them with spring water at a ratio of 1 g:4 mL for 20 min, cool and filter to obtain a third solution; S4: mixing the first solution, the second solution, and the third solution in a volume ratio of 6:3:1 to obtain a Chinese medicine composition extract; S5: adding an excipient after freeze-drying the extract of the Chinese medicine composition, or directly adding an excipient to the extract of the Chinese medicine composition, to prepare a Chinese medicine composition preparation.

[0025] The Chinese medicine composition of the present invention can be used directly or in the form of a Chinese medicine composition preparation.

[0026] The Chinese medicine composition preparation contains a therapeutically effective amount of the Chinese medicine composition, and the rest is a pharmaceutically acceptable excipient that is non-toxic and inert to humans and animals.

[0027] Excipients are one or more selected from solid, semisolid and liquid diluents, fillers and pharmaceutical product adjuvants. The pharmaceutical preparation of the present invention is used in the form of a dosage per unit body weight. When the present invention is used for oral administration, it can be made into granules, mixtures, tablets, sustained-release tablets, controlled-release tablets, capsules, dripping pills, micropills, suspensions, emulsions, powders or granules (nano preparations), oral liquids, etc.; when the present invention is used for injection, it can be made into sterilized aqueous or oily solutions, sterile powder injections, liposomes or emulsions, etc.

[0028] The extract of the present invention is preferably administered to a patient in need of treatment in the form of external application.

[0029] For example, when preparing a plaster, the Chinese medicine composition is made into a fine powder and mixed with a suitable matrix to prepare a semi-solid or solid external preparation with a suitable consistency. Common matrices include vegetable oils, waxes, vaseline or animal fats. The preparation method of the plaster may include steps such as mixing and grinding to ensure that the active ingredients of the medicine can be evenly distributed in the matrix.

[0030] For example, when preparing a spray, ethanol, glycerol, water, propylene glycol or a mixture thereof is selected as a solvent; fatty acid sorbitan substances, polysorbate substances, polyoxyethylene fatty alcohol ether substances, polyoxyethylene-polyoxypropylene copolymers, polyethylene glycol substances, cyclodextrin substances, sodium lauryl sulfate, cetyltrimethylammonium bromide, or a mixture thereof is selected as a solubilizing agent; sodium lauryl sulfate, laurocaprol, lauric acid, sodium laurate, lecithin, oleic acid, poloxamer, phosphorylcholine, etc. or a mixture thereof is selected as an absorption enhancer.

[0031] For example, when preparing an aqueous solution, the solvent and dispersion medium are usually drinking water and a suitable organic solvent, and preservatives, dispersants, suspending agents, thickeners, cosolvents, wetting agents, buffers, emulsifiers, stabilizers, transdermal enhancers, etc. may be added.

[0032] There is no limitation on the excipients of the Chinese medicine composition preparation. The above is an illustrative description for the purpose of clarifying the preparation types in the specification.

[0033] The following example uses a ready-to-use aqueous solution of a Chinese medicine composition extract to more directly reflect the efficacy of the Chinese medicine composition preparation formula.

[0034] <Example 1> The Chinese medicine composition preparation mainly comprises, by weight: 10 parts of fern, 15 parts of dried orange peel, 14 parts of safflower, and 14 parts of chuanxiong.

[0035] The method for preparing a Chinese medicine aqueous composition for treating herpes zoster comprises the following steps: S1: Remove the stems and leaves of the above-mentioned fern by weight, leaving the roots, soak them in 5% acetic acid solution at a mass (g) to volume (ml) ratio of 3 g:10 mL for 7 days, and filter to obtain the first solution; S2: The above-mentioned dried tangerine peels are soaked in 52% alcohol for 3 days at a mass (g) to volume (ml) ratio of 1 g:2 mL, and filtered to obtain a second solution; S3: Mix the above-mentioned safflower and chuanxiong in the proportions by weight, boil them with spring water for 20 min at a mass (g) to volume (ml) ratio of 1 g:4 mL, cool and filter to obtain a third solution; S4: The first solution, the second solution and the third solution are mixed in a volume ratio of 6:3:1 to prepare an aqueous solution.

[0036] <Clinical Trials> 1.1 Case criteria The diagnostic criteria of Western medicine refer to the relevant standards of herpes zoster in the "Clinical Disease Diagnosis Based on Cure and Improvement Standards", "Dermatology and Venereology", and "Chinese Herpes Zoster Diagnosis and Treatment Expert Consensus (2022 Edition)": Pre-herpes symptoms such as local skin burning and pain appear before herpes, which may be accompanied by hyperalgesia; followed by skin erythema and clustered herpes, distributed along the nerves, rarely passing the midline; herpes are clustered and not fused, there may be erythema at the bottom of the blister, and occasionally larger blisters can be seen, etc. Neuralgia is one of the characteristics of this disease. A total of 43 patients met the criteria. The method of use is to apply it to the affected area of ​​the skin, 3 to 5 times a day depending on the severity of the patient, and the effect is best when the applicator is dried and then dressed.

[0037] 1.2 Indicator judgment 1.2.1 Criteria for evaluating therapeutic efficacy According to the Diagnostic Standards for Symptoms in Traditional Chinese Medicine, the efficacy evaluation criteria are formulated as follows: ① Significantly effective: herpes subsides, skin lesions disappear completely, and pain disappears; ② Effective: the color of herpes becomes lighter than before, some dry scabs form, the range is ≥30%, and the symptoms and pain of skin lesions are significantly improved; ③ Ineffective: the range of herpes subsides <30%, and the symptoms and pain of skin lesions are not significantly improved. Total effective rate (%) = (number of markedly effective cases + number of effective cases) / total number of cases × 100%.

[0038] 1.2.2 Evaluation of safety indicators The evaluation index is the occurrence of skin allergic symptoms (such as rash, itching, and pain).

[0039] 1.3 Test results Among all the patients who participated in the test, 5 cases were markedly effective, 38 cases were effective, and 0 cases were ineffective, with a total effective rate of 100%. There was no allergic reaction during use in all patients, and no adverse drug reactions occurred during the treatment period, indicating that the drug of the present invention has good safety. The drug of the present invention is a Chinese medicine extraction preparation, and the ingredients used include daily edible condiments such as alcohol and rice vinegar, which are non-toxic.

[0040] <Typical Cases> Typical case 1: Patient Long Mouhua, male, 56 years old, had transparent small blisters on the outer side of the left thigh, accompanied by local ulceration and suppuration, and unbearable pain. Figure 1 A. The pharmaceutical preparation of Example 1 of the present invention was applied to the affected area. After 3 days of use, the wound had no pus formation, gradually healed, and began to form a scab. Figure 1 B. After that, the patient was cured after taking the medicine for 7 consecutive days, and there was no recurrence in the follow-up for more than one year after the end of treatment.

[0041] Typical case 2: Patient Wu Mouju, female, 55 years old, had severe itching under the right shoulder blade, with yellow transparent continuous ribbon-like blisters, and unbearable pain. Figure 2A. The pharmaceutical preparation of Example 1 of the present invention was applied to the affected area. After 4 days of use, the blisters on the affected area formed scabs, the pain disappeared, and the affected area gradually healed. Figure 2 B. After that, the patient was cured after taking the medicine for 7 consecutive days, and there was no recurrence in the follow-up for more than two years after the end of treatment.

[0042] Typical case 3: Patient Yin Mounan, male, 61 years old, had obvious granular transparent blisters on the right back of his right armpit, with unbearable pain and local burning. Figure 3 A. The pharmaceutical preparation of Example 1 of the present invention was applied to the affected area. After 17 days of use, the blisters on the affected area disappeared and the epidermal scabs were obviously restored. Figure 3 B. No recurrence was found in the three-year follow-up.

[0043] The number of devices and processing scales described here are used to simplify the description of the present invention. Applications, modifications and variations of the present invention will be obvious to those skilled in the art.

[0044] Although the embodiments of the present invention have been disclosed as above, they are not limited to the applications listed in the specification and the implementation modes, and they can be fully applied to various fields suitable for the present invention. For those familiar with the art, additional modifications can be easily implemented. Therefore, without departing from the general concept defined by the claims and the scope of equivalents, the present invention is not limited to the specific details and the illustrations shown and described herein.

Claims

1. A Chinese medicine composition preparation, characterized in that: The invention mainly comprises, by weight, 8-20 parts of fern fern, 8-20 parts of dried orange peel, 8-20 parts of safflower, and 8-20 parts of chuanxiong.

2. The Chinese medicine composition preparation according to claim 1, characterized in that: Calculated by weight, the main ingredients include: 10 parts of fern, 15 parts of dried orange peel, 14 parts of safflower, and 14 parts of chuanxiong.

3. The Chinese medicine composition preparation according to claim 1 or 2, characterized in that: Preparations include aqueous solutions, powders, pastes, patches, tinctures, coatings, ointments, gels, and aerosols.

4. The Chinese medicine composition preparation according to claim 3, characterized in that: Pharmaceutical excipients are also included.

5. The Chinese medicine composition preparation according to claim 4, characterized in that: Pharmaceutical excipients include one or more of preservatives, antioxidants, flavoring agents, aromatics, solubilizers, emulsifiers, solubilizers, osmotic pressure regulators, colorants, binders, fillers, disintegrants, lubricants, and bases.

6. A method for preparing a Chinese medicine composition preparation, characterized in that: The following steps are involved: S1: Remove the stems and leaves of the above-mentioned fern by weight, leaving the roots, soak them in 2-15% acetic acid solution at a ratio of 3g:(8-10) mL for 5-10 days, and filter to obtain the first solution; S2: Soak the above-mentioned dried tangerine peel in 40-75% alcohol at a ratio of 1 g: (2-4) mL for 3-7 days, and filter to obtain a second solution; S3: Mix the above-mentioned safflower and chuanxiong in the proportions by weight, boil them with spring water at a ratio of 1 g:(2-4) mL for 20-40 min, cool and filter to obtain a third solution; S4: The first solution, the second solution and the third solution are mixed in a volume ratio of 6:3:1 to obtain a Chinese medicine composition extract.

7. The method for preparing the Chinese medicine composition preparation according to claim 6, characterized in that: The following steps are also included: S5: adding an excipient after freeze-drying the extract of the Chinese medicine composition, or directly adding an excipient to the extract of the Chinese medicine composition, to prepare a Chinese medicine composition preparation.

8. A method for preparing a Chinese medicine aqueous composition for treating herpes zoster, characterized in that: The following steps are involved: S1: Remove the stems and leaves of the above-mentioned fern by weight, leaving the roots, soak them in 5% acetic acid solution at a ratio of 3 g:10 mL for 7 days, and filter to obtain the first solution; S2: soak the above-mentioned dried tangerine peel in 50% alcohol at a ratio of 1 g:2 mL for 3 days, and filter to obtain a second solution; S3: Boil the above-mentioned safflower and chuanxiong in spring water at a ratio of 1 g:4 mL for 20 min, cool and filter to obtain a third solution; S4: The first solution, the second solution and the third solution are mixed in a volume ratio of 6:3:1 to prepare an aqueous solution.

9. The method for preparing the aqueous Chinese medicine composition for treating herpes zoster according to claim 8, characterized in that: The following steps are also included: S5: directly adding one or more of preservatives, antioxidants, flavoring agents, aromatics, cosolvents, emulsifiers, solubilizers, osmotic pressure regulators, and colorants to the extract of the traditional Chinese medicine composition to prepare an aqueous solution.

10. Use of the Chinese medicine composition preparation according to any one of claims 1 to 5 in the preparation of a medicament for treating herpes zoster.

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