Traditional Chinese medicine protective preparation for relieving exogenous and metabolic peripheral nerve injury

Abstract

The invention discloses a traditional Chinese medicine protection preparation for relieving exogenous and metabolic peripheral nerve injury, and relates to the technical field of medicines, the traditional Chinese medicine protection preparation is prepared from the following raw material medicines in parts by weight: 12-18g of angelica sinensis, 6-9g of cassia twig, 9-15g of radix paeoniae alba, 2-3g of asarum, 3-9g of tetrapanax papyriferus, 15-60g of astragalus membranaceus, 6-12g of radix bupleuri, 6-12g of immature bitter orange, 6-9g of jujube, 6-9g of ginger, 6-12g of cynanchum paniculatum, 6-12g of rhizoma corydalis, 6-9g of celandine, 6-12g of thunberg fritillary bulb, 12-30g of selfheal, 30-45g of caulis spatholobi, 15-45g of lycopodium clavatum and 6 A reasonable dosage interval is set for key medicines such as astragalus membranaceus and lycopodium clavatum in the prescription, and adaptive adjustment can be performed according to different syndromes of patients. The preparation provides a new medication choice for clinical prevention and treatment of peripheral nerve injury caused by chemotherapy, operations and metabolic diseases.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of medicine, in particular to a traditional Chinese medicine protective preparation for reducing exogenous and metabolic peripheral nerve injury. BACKGROUND

[0002] Peripheral nerve injury is a common complication of chemotherapy (such as oxaliplatin, taxol drugs), surgical trauma and metabolic disorders of diabetes, and the clinical manifestations are persistent numbness, tingling, sensory reduction and even dysfunction. The current western medicine treatment is mainly based on nerve nutrition drugs (such as mecobalamin and alpha-lipoic acid), but there are the following problems:

[0003] Inadequate efficacy: some patients have insufficient response to single drug therapy, especially the dose-dependent progression of neurotoxicity caused by chemotherapy, and existing means are difficult to block the injury process;

[0004] Long-term safety is questionable: some analgesics such as gabapentin can easily cause drowsiness, dizziness and other side effects, and neurotrophic agents need to be used for a long time and have limited structural repair effect on damaged nerves.

[0005] In view of the above problems, a traditional Chinese medicine compound preparation is designed, which takes into account multiple indications, has clear toxicity control standards and has definite efficacy, to solve the above technical problems. SUMMARY

[0006] In view of the deficiencies of the prior art, the present application provides a traditional Chinese medicine protective preparation for reducing exogenous and metabolic peripheral nerve injury, which solves the technical problems raised in the background art.

[0007] To achieve the above purpose, the present application realizes the following technical scheme: a traditional Chinese medicine protective preparation for reducing exogenous and metabolic peripheral nerve injury, which is composed of the following raw medicinal materials by weight: Angelica 12-18g, Ramulus Cinnamomi 6-9g, Radix Paeoniae Alba 9-15g, Asarum 2-3g, Herba Lycopi 3-9g, Radix Astragali 15-60g, Radix Bupleuri 6-12g, Fructus Aurantii 6-12g, Fructus Jujubae 6-9g, Rhizoma Zingiberis Recens 6-9g, Herba Coptidis 6-12g, Rhizoma Corydalis 6-12g, Chelidonium 6-9g, Fritillariae Thunbergii 6-12g, Prunella 12-30g, Caulis Spatholobi 30-45g, Herba Sedi 15-45g, and Radix Glycyrrhizae 6-9g.

[0008] Preferably, the preparation method is as follows:

[0009] The raw medicinal materials of claim 1 are decocted with water, filtered to obtain medicinal liquid, and then divided into daily doses of 1 dose each, which are taken twice a day in the morning and evening.

[0010] Preferably, the preferred amount of the raw medicinal materials is as follows:

[0011] Radix Astragali seu Hedysari 30-45g, Lycium Barbarum 35-40g, Rhizoma Sinodendri 25-35g;

[0012] The amount of Asarum is not more than 3g, and the amount of Chelidonium majus is not more than 9g.

[0013] Preferably, the toxic side effects include numbness, pain, paresthesia or skin peeling, and the patient has pale or pale red tongue, thin white fur and thin pulse.

[0014] Preferably, the application in the preparation of drugs for treating the following diseases:

[0015] (a) local pain, itching or numbness caused by peripheral nerve injury after surgery;

[0016] (b) peripheral needle-like pain, itching or paresthesia caused by peripheral nerve injury in diabetes.

[0017] Preferably, the patient is administered with the traditional Chinese medicine protective preparation according to any one of claims 1-3, 1 dose per day, decocted with water and taken twice a day, and the continuous administration is until the symptoms are relieved.

[0018] Beneficial effects

[0019] The present application provides a kind of traditional Chinese medicine protective preparation for reducing exogenous and metabolic peripheral nerve injury, the composition of the present application considers the function of promoting blood circulation and relieving pain and dredging collaterals and relieving pain, and clinical observation can see that the symptoms such as numbness and pain of hands and feet are improved;Through the synergistic effect of Radix Astragali seu Hedysari, Lycium Barbarum and other drugs, it is helpful to promote the recovery of nerve function;The design of preparation pays attention to safety, and the process and dosage of Asarum and Chelidonium majus and other medicinal materials are optimized, so that the overall safety meets the standard requirements;The reasonable dosage range of key drugs such as Radix Astragali seu Hedysari and Rhizoma Sinodendri in the prescription can be adjusted adaptively according to different patient's symptoms. The preparation provides a new drug selection for clinical prevention and treatment of peripheral nerve injury caused by chemotherapy, surgery and metabolic diseases. DETAILED DESCRIPTION

[0020] The technical solutions in the embodiments of the present application will be described below in a clear and complete manner. Obviously, the described embodiments are only a part of the embodiments of the present application, rather than all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative labor fall within the scope of protection of the present application.

[0021] The present application provides a technical solution: a traditional Chinese medicine protective preparation for reducing exogenous and metabolic peripheral nerve injury, comprising the following raw medicinal materials by weight:

[0022] Angelica 12-18g, cassia twig 6-9g, white peony root 9-15g, asarum 2-3g, common horsegentian 3-9g, milkvetch 15-60g, bupleurum 6-12g, citron fruit 6-12g, jujube 6-9g, ginger 6-9g, long-jointed sophora 6-12g, rhizoma corydalis 6-9g, fritillaria 6-12g, prunella vulgaris 12-30g, caulis bonneti 30-45g, stretchy grass 15-45g, licorice 6-9g.

[0023] The preparation method of the embodiment is further provided.

[0024] The raw medicine of claim 1 is decocted with water, filtered to obtain medicine liquid, and then divided into daily doses of 1 dose each, which is taken twice a day.

[0025] The preferred amount of the raw medicine is further provided in the embodiment.

[0026] Milkvetch 30-45g, caulis bonneti 35-40g, stretchy grass 25-35g;

[0027] The amount of asarum is not more than 3g, and the amount of rhizoma corydalis is not more than 9g.

[0028] The embodiment is further provided that the toxic side effects include numbness, pain, paresthesia or skin peeling, and the patient has pale or pale red tongue, thin white fur, and thin pulse.

[0029] The embodiment is further provided for the application in the preparation of medicines for treating the following diseases:

[0030] (a) local pain, itching or numbness of the wound caused by peripheral nerve injury after surgery;

[0031] (b) limb peripheral pinprick-like pain, itching or paresthesia caused by peripheral nerve injury in diabetes.

[0032] The embodiment is further provided that the patient is administered with the traditional Chinese medicine protective preparation of any one of claims 1-3, 1 dose per day, decocted with water and taken twice a day, and the administration is continued until the symptoms are relieved.

[0033] The detailed connection means is a technology known in the art, and the working principle and process are mainly introduced below. The specific work is as follows.

[0034] Embodiment 1: preparation of the preparation

[0035] Raw material ratio (single dose)

[0036] Angelica 15 g, Ramulus cinnamomi 8 g, Radix paeoniae alba 12 g, Asarum 2.5 g, Radix et rhizoma polygalae 6 g, Radix astragali 40 g, Radix bupleuri 9 g, Fructus aurantii immaturus 9 g, Fructus jujubae 8 g, Rhizoma zedoariae 8 g, Radix et rhizoma aconiti 9 g, Radix et rhizoma chuanxiong 9 g, Radix et rhizoma notopterygii 7 g, Rhizoma bletillae 9 g, Prunella vulgaris 20 g, Caulis Spatholobi 38 g, Herba arisaematis 30 g, Radix glycyrrhizae 8 g

[0037] Preparation method

[0038] Pre-treatment: Put the above decoction pieces into a decoction container, add 8 times the amount of cold water (about 2000 ml) and soak for 40 minutes;

[0039] Decoction:

[0040] First decoction: After boiling with strong fire, change to medium heat and decoct for 30 minutes, filter out the medicinal liquid;

[0041] Second decoction: Add 5 times the amount of water (about 1250 ml) to the residue, decoct with medium heat for 25 minutes, and filter;

[0042] Combine and concentrate: Combine the two filtrates and concentrate to 400 ml (equivalent to crude drug concentration 1 g / ml);

[0043] Dispensing: Dispense 200 ml per bag as morning and evening doses, and store in cold storage (4°C).

[0044] Key control point: Asarum and Radix et rhizoma chuanxiong are added at the end (added in the last 10 minutes) to avoid excessive dissolution of toxic ingredients.

[0045] Example 2: Clinical application of neurotoxicity after chemotherapy

[0046] Case selection

[0047] Inclusion criteria:

[0048] Patients with colorectal cancer who have completed oxaliplatin chemotherapy for ≥4 cycles;

[0049] Developed NCI-CTCAE grade 2 or above peripheral neurotoxicity (numbness / pain / hypoesthesia of hands and feet);

[0050] TCM syndrome differentiation: pale red tongue, thin white fur, and thin pulse.

[0051] Exclusion criteria:

[0052] Combined with diabetes or traumatic nerve injury;

[0053] Currently using neurotrophic drugs.

[0054] Treatment regimen

[0055] Test group (n = 30): orally take the preparation of Example 1, 1 dose per day (morning and evening), for 28 consecutive days;

[0056] Control group (n=30): Mecobalamin tablets 0.5mg tid.

[0057] Efficacy evaluation

[0058]

[0059] Example 4: Postoperative nerve repair application

[0060] Special scene adaptation

[0061] Postoperative 3 days formula adjustment:

[0062] Remove Zhishi (to avoid affecting blood coagulation);

[0063] Add Olibanum 6g, Myrrh 6g (enhance local anti-inflammatory analgesic);

[0064] After decoction, the residue is applied around the wound (2 times a day, 30 minutes each time).

[0065] Efficacy observation

[0066] Patients (n=20) after modified radical mastectomy for breast cancer, intractable stabbing pain with ant-like sensation in the surgical area: oral administration of

[0067] After 7 days of external application: pain VAS score decreased from 6.8±1.2 to 3.1±0.9; 14 days later, the improvement rate of paresthesia was 90%, and there was no delay in wound healing

[0068] It should be noted that in this text, relational terms such as first and second are used merely to distinguish one entity or action from another entity or action without necessarily requiring or implying any such actual relationship or order between such entities or actions.

Claims

1. A traditional Chinese medicine protective preparation for alleviating exogenous and metabolic peripheral nerve damage, characterized in that, Composed of the following parts by weight of active pharmaceutical ingredient: Angelica sinensis 12-18g, Cinnamomum cassia 6-9g, Paeonia lactiflora 9-15g, Asarum heterotropoides 2-3g, Tetrapanax papyriferus 3-9g, Astragalus membranaceus 15-60g, Bupleurum chinense 6-12g, Citrus aurantium 6-12g, Ziziphus jujuba 6-9g, Zingiber officinale 6-9g, Cynanchum paniculatum 6-12g, Corydalis yanhusuo 6-12g, Celastrus orbiculatus 6-9g, Fritillaria thunbergii 6-12g, Prunella vulgaris 12-30g, Spatholobus suberectus 30-45g, Lycopodium clavatum 15-45g, Glycyrrhiza uralensis 6-9g.

2. The traditional Chinese medicine protective preparation for reducing exogenous and metabolic peripheral nerve damage according to claim 1, characterized in that... Its preparation method is as follows: The active pharmaceutical ingredient described in claim 1 is decocted with water, filtered to obtain a medicinal liquid, and then packaged into a daily dose, which is taken twice a day, in the morning and evening.

3. The traditional Chinese medicine protective preparation for reducing exogenous and metabolic peripheral nerve damage according to claim 1, characterized in that... The preferred dosage of the active pharmaceutical ingredient is as follows: Astragalus membranaceus 30-45g, Spatholobus suberectus 35-40g, Lycopodium clavatum 25-35g; The dosage of Asarum should not exceed 3g, and the dosage of Celandine should not exceed 9g.

4. A traditional Chinese medicine protective preparation for reducing exogenous and metabolic peripheral nerve damage according to claims 1-3, characterized in that... The adverse reactions include numbness, pain, paresthesia or skin peeling in the hands and feet, and the patient's tongue is pale or pale red, with a thin white coating and a thready pulse.

5. The use of the traditional Chinese medicine protective preparation according to any one of claims 1-3 in the preparation of drugs for treating the following diseases: (a) Local pain, itching, or numbness at the wound site caused by peripheral nerve damage after surgery; (b) peripheral nerve damage in diabetes causing needle-like pain, itching or abnormal sensations in the extremities.

6. The traditional Chinese medicine protective preparation for reducing exogenous and metabolic peripheral nerve damage according to claim 1, characterized in that... The traditional Chinese medicine protective preparation according to any one of claims 1-3 is administered to the patient, one dose per day, decocted in water and taken twice a day, morning and evening, until the symptoms are relieved.

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