External traditional Chinese medicine formula for treating limb numbness and pain after stroke and preparation method of external traditional Chinese medicine formula

Abstract

The invention discloses an external traditional Chinese medicine formula for treating limb numbness and pain after stroke and a preparation method thereof, and relates to the technical field of traditional Chinese medicine preparations. The traditional Chinese medicine is characterized by being prepared from the following raw materials in parts by weight: 15-25 parts of long-noded pit viper, 10-20 parts of earthworm, 8-12 parts of safflower, 8-12 parts of ligusticum wallichii, 6-10 parts of cassia twig, 5-8 parts of radix aconiti preparata and 3-5 parts of rhizoma dioscoreae nipponicae. The long-noded pit viper and the earthworm are matched for use and combined for nerve repair, and by optimizing the formula proportion and the external administration route, the oral side effect is avoided, the curative effect is remarkably improved, and the adverse reaction risk is reduced.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine preparations, and specifically to an external traditional Chinese medicine formula for treating limb numbness and pain after stroke and its preparation method. Background Art

[0002] There are various causes of limb numbness and pain after stroke, mainly including damage to the areas of the brain that control sensation and movement caused by nerve injury, insufficient blood supply to the limbs caused by blood circulation disorders, stiffness and pain of muscles and joints due to long-term paralysis or limited movement, and chronic pain manifestations such as central pain syndrome. In addition, it may also involve compression of the spinothalamic tract, abnormal cerebral discharge, and psychological factors.

[0003] Limb numbness and pain after stroke are common clinical sequelae. Existing treatments mainly rely on oral medications or physical therapies, which have problems such as slow onset and large side effects. In the prior art, similar formulas such as "Qufeng Tongluo Decoction" contain ingredients such as Agkistrodon and Chuanxiong, but lack the design of external dosage forms. Oral administration has certain side effects and is not conducive to the health of patients. Summary of the Invention

[0004] The purpose of the present invention is to provide an external traditional Chinese medicine formula for treating limb numbness and pain after stroke and its preparation method to solve the problems raised in the above background art.

[0005] To achieve the above purpose, the present invention provides the following technical solution: An external traditional Chinese medicine formula for treating limb numbness and pain after stroke is made from the following raw materials in parts by weight: Agkistrodon: 15 - 25 parts, Pheretima: 10 - 20 parts, Flos Carthami: 8 - 12 parts, Chuanxiong Rhizoma: 8 - 12 parts, Ramulus Cinnamomi: 6 - 10 parts, Radix Aconiti Preparata: 5 - 8 parts, Dioscorea nipponica Makino: 3 - 5 parts.

[0006] Further, it is made from the following raw materials in parts by weight: Agkistrodon: 20 parts, Pheretima: 15 parts, Flos Carthami: 10 parts, Chuanxiong Rhizoma: 10 parts, Ramulus Cinnamomi: 8 parts, Radix Aconiti Preparata: 6 parts, Dioscorea nipponica Makino: 5 parts.

[0007] Compared with the prior art, the beneficial effects of the present invention are:

[0008] Agkistrodon is added to the traditional Chinese medicine formula for dispelling wind and dredging collaterals, specifically targeting meridian obstruction; Pheretima is added to enhance the effect of dredging collaterals and relieving pain, synergistically enhancing the effect with Agkistrodon. Moreover, the combination of Agkistrodon and Pheretima can enhance the repair ability of nerve endings; Flos Carthami, Chuanxiong Rhizoma, and Radix Aconiti Preparata are added. Flos Carthami promotes blood circulation and removes stasis, Chuanxiong Rhizoma promotes qi circulation and relieves pain, and Radix Aconiti Preparata warms the meridians and dispels cold. The three cooperate with Agkistrodon to dredge the meridians; Ramulus Cinnamomi and Dioscorea nipponica Makino are added. Ramulus Cinnamomi guides the medicine to reach the surface, and Dioscorea nipponica Makino promotes blood circulation and relieves pain, relaxes muscles and dredges collaterals. An external traditional Chinese medicine formula is prepared, significantly improving the curative effect and reducing the risk of adverse reactions. Detailed Embodiments

[0009] The technical solutions in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all embodiments. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts shall fall within the protection scope of the present invention.

[0010] Embodiment 1:

[0011] The present invention provides a technical solution: an external traditional Chinese medicine formula for treating limb numbness and pain after stroke, which is made of the following raw materials in parts by weight: Agkistrodon acutus: 20 parts, Pheretima aspergillum: 15 parts, Flos Carthami: 10 parts, Rhizoma Chuanxiong: 10 parts, Ramulus Cinnamomi: 8 parts, Radix Aconiti Lateralis Preparata: 6 parts, Dioscorea nipponica: 5 parts.

[0012] It should be noted that the above are only several given embodiments. During the research and development, the inventor conducted repeated experiments many times and obtained the same or similar results. The method is effective and feasible, the raw materials are rich, and it has good practical application value. The relevant research materials are as follows:

[0013] Objects of the experimental group and the control group:

[0014] 1. Source of cases: A total of 92 patients who visited the acupuncture department, rehabilitation department of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine and the traditional Chinese medicine general practice and rehabilitation ward of Jiaxing Road Sub-district Community Health Service Center in Hongkou District, Shanghai from January 2022 to May 2024 were selected in this study. They were divided into an experimental group and a control group by a randomized controlled study method, with 46 cases in each group.

[0015] 2. Diagnostic criteria: The diagnostic criteria for western medicine stroke refer to the diagnostic criteria for cerebral infarction and cerebral hemorrhage in "Diagnostic Guidelines for Various Cerebrovascular Diseases" adopted at the Fourth National Conference on Cerebrovascular Diseases; the diagnostic criteria for traditional Chinese medicine stroke refer to "Diagnostic Criteria and Efficacy Evaluation Standards for Stroke (Trial)".

[0016] 3. Inclusion criteria and exclusion criteria: The subjects must meet all the following criteria: ① Meet the diagnostic criteria for stroke; ② Diagnosed by CT or MRI imaging; ③ Aged between 45 and 75 years old; ④ Within 6 months after onset and with stable vital signs; ⑤ The National Institutes of Health Stroke Scale (NIHSS) assessment ≥ 3 points; ⑥ The patient himself or his relatives signed an informed consent form.

[0017] Exclusion criteria: ① Subarachnoid hemorrhage, transient ischemic attack; ② History of motor dysfunction, such as rheumatoid arthritis, joint deformity, etc.; ③ Pregnant women; ④ Presence of severe heart diseases, liver and kidney failure.

[0018] 4. Criteria for suspension and exclusion: ① Those who cannot adhere to the treatment or do not follow the treatment plan, and the reasons for suspension and exclusion and their relationship with the clinical research should be carefully recorded; ② Those who develop serious other complications or deteriorate during the treatment process.

[0019] And the comparison data of the experimental group and the control group are shown in Table 1 below:

[0020] Table 1: Comparison Table of Patient Data

[0021]

[0022] Intervention plan:

[0023] Method for the control group: Oral vitamin B1, 20 mg three times a day; Mecobalamin tablets, 500 μg three times a day.

[0024] Method for the experimental group: Agkistrodon acutus: 200 g, Pheretima aspergillum: 150 g, Flos Carthami: 100 g, Rhizoma Chuanxiong: 100 g, Ramulus Cinnamomi: 80 g, Radix Aconiti Lateralis Preparata: 60 g, Dioscorea nipponica: 50 g; Grind the medicinal materials into fine powder, mix with honey to form a paste, apply it externally to the affected area once a day, 6 - 8 hours each time.

[0025] Five times a week for 4 consecutive weeks.

[0026] Observation indicators:

[0027] (1) VAS score

[0028] The VAS score is divided into 10 points according to the degree of limb numbness sensation after stroke in patients. The score is proportional to the patient's numbness sensation. The more severe the patient's numbness sensation, the higher the score. The VAS scale is convenient and simple to operate and can intuitively reflect the patient's most real feelings, and is widely used to evaluate the treatment effect.

[0029] (2) Sensory disorder score

[0030] The patient's sensation is subdivided into pain sensation, temperature sensation, light touch sensation, etc. It can evaluate the patient's sensory disorder more comprehensively than the VAS scale. The total score is 42 points. The lower the score, the more severe the patient's sensory disorder. This table can more accurately reflect the degree of limb numbness in patients after stroke.

[0031] Statistical data:

[0032] Analyze with the statistical software SPSS 23.0. Enter the scores into the database. Use t-tests including independent samples t-test and paired t-test (obeying the normal distribution) or non-parametric rank sum tests including two independent samples Wilcoxon rank sum test and sign rank sum test (not obeying the normal distribution). When P < 0.05, it indicates that the difference is significant.

[0033] Experimental results:

[0034] The comparison of VAS between the two groups of patients before and after treatment is shown in Table 2 below. Before treatment, there was no statistically significant difference in VAS scores between the two groups, and the groups were comparable. After treatment, within-group comparison showed that the VAS scores of both groups increased significantly compared with those before treatment. Between-group comparison showed that the degree of reduction in VAS scores in the experimental group was better than that in the control group (P<0.05).

[0035] The comparison of sensory disturbance scores between the two groups of patients before and after treatment is shown in Table 2. Before treatment, there was no statistically significant difference in sensory disturbance scores between the two groups, and the groups were comparable. After treatment, within-group comparison showed that the sensory disturbance scores of both groups increased significantly compared with those before treatment. Between-group comparison showed that the degree of improvement in sensory disturbance scores in the experimental group was better than that in the control group (P<0.05).

[0036] Table 2: Comparison of VAS and sensory disturbance scores before and after treatment

[0037]

[0038] It should be noted that compared with before treatment in this group, *P<0.05; compared with the control group at the same time, △P<0.05. During the research process, no accidents such as falls and injuries, discomfort such as fainting during acupuncture, and related adverse reactions occurred in the two groups of patients, and no cases dropped out halfway.

[0039] Example 2:

[0040] The difference from Example 1 is that the drug ratio in the experimental group is different. In this example, the drug formula is: Agkistrodon: 150g, Pheretima: 100g, Flos Carthami: 80g, Rhizoma Chuanxiong: 80g, Ramulus Cinnamomi: 60g, Radix Aconiti Lateralis Preparata: 50g, Dioscorea Nipponica: 30g.

[0041] Example 3:

[0042] The difference from Example 1 is that the drug ratio in the experimental group is different. In this example, the drug formula is: Agkistrodon: 250g, Pheretima: 200g, Flos Carthami: 120g, Rhizoma Chuanxiong: 120g, Ramulus Cinnamomi: 100g, Radix Aconiti Lateralis Preparata: 80g, Dioscorea Nipponica: 50g.

[0043] Through the comparison of the experimental results: All three examples can improve limb numbness and pain after stroke, and Example 1 has the best effect.

[0044] Although the embodiments of the present invention have been shown and described, for those of ordinary skill in the art, it can be understood that various changes, modifications, substitutions and variations can be made to these embodiments without departing from the principles and spirit of the present invention. The scope of the present invention is defined by the appended embodiments and their equivalents.

Claims

1. An external Chinese medicine formula for treating limb numbness and pain after stroke, characterized in that: It is made from the following raw materials in parts by weight: Agkistrodon acutus: 15 - 25 parts, Pheretima aspergillum: 10 - 20 parts, Carthamus tinctorius: 8 - 12 parts, Ligusticum chuanxiong: 8 - 12 parts, Ramulus cinnamomi: 6 - 10 parts, Radix aconiti preparata: 5 - 8 parts, Dioscorea nipponica: 3 - 5 parts.

2. The external traditional Chinese medicine formula for treating limb numbness and pain after stroke according to claim 1, characterized in that: It is made from the following raw materials in parts by weight: Agkistrodon acutus: 20 parts, Pheretima aspergillum: 15 parts, Carthamus tinctorius: 10 parts, Ligusticum chuanxiong: 10 parts, Ramulus cinnamomi: 8 parts, Radix aconiti preparata: 6 parts, Dioscorea nipponica: 5 parts.

3. A preparation method of an external-use traditional Chinese medicine formula for treating limb numbness and pain after stroke, characterized in that: An external traditional Chinese medicine prescription for treating numbness and pain of limbs after stroke described in claim 1 is used.

4. Application of an external-use traditional Chinese medicine prescription for treating limb numbness and pain after stroke, characterized in that: An external traditional Chinese medicine prescription for treating numbness and pain of limbs after stroke described in claim 1 is applied to treat numbness and pain of limbs after stroke.

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