Traditional Chinese medicine composition for treating diabetic peripheral neuropathy and preparation method thereof

Abstract

The invention discloses a traditional Chinese medicine composition for treating diabetic peripheral neuropathy and a preparation method thereof, and relates to the technical field of traditional Chinese medicine preparation. The traditional Chinese medicine composition comprises the following raw materials in parts by weight: 8-12 parts of astragalus membranaceus, 8-12 parts of ipomoea cairica, 8-12 parts of pericarpium zanthoxyli branches, 3-8 parts of euonymus alatus, 2-6 parts of earthworms, 2-6 parts of ligusticum wallichii, 2-6 parts of fructus crataegi cuneatae, 3-8 parts of parasitic loranthus, 2-4 parts of tetrapanax papyriferus, 2-6 parts of radix cyathulae, 2-6 parts of cassia twigs and 2-4 parts of liquorice. The traditional Chinese medicine composition for treating diabetic peripheral neuropathy is reasonable in formula, has the effects of reducing blood sugar, reducing traditional Chinese medicine syndrome scores and Toronto clinical scores and improving nerve conduction speed, and is remarkable and reliable in curative effect and good in safety.

Description

Technical Field

[0001] The invention relates to the technical field of Chinese medicine preparation, and in particular to a Chinese medicine composition for treating diabetic peripheral neuropathy and a preparation method thereof. Background Art

[0002] Diabetic peripheral neuropathy (DPN) is a common and most difficult to treat chronic complication in diabetic patients, with an incidence rate of about 60%-90% in diabetic patients. It can cause damage to the body's sensory nerves, resulting in limb numbness, pain, and paresthesia. In the late stage, it can also affect the motor nerves, leading to decreased muscle strength and even muscle atrophy and paralysis, seriously affecting the patient's quality of life.

[0003] The pathogenesis of DPN is relatively complex and has not yet been elucidated. It is generally believed to be related to oxidative stress, inflammatory response, vascular damage, abnormal neurotrophic factors, etc. At present, there is no specific drug for the treatment of DPN. Western medicine mainly controls blood sugar, improves microcirculation and nourishes nerves, but it can only improve the patient's clinical symptoms and cannot fundamentally reverse the pathological changes of peripheral nerves. The efficacy needs to be improved, and long-term use is prone to drug resistance.

[0004] Chinese herbal medicine is a treasure of our country, with the characteristics of high safety, no toxic side effects, and not easy to develop drug resistance. Traditional Chinese medicine believes that DPN is a syndrome of deficiency of the root and excess of the superficial symptoms. The root deficiency is the deficiency of qi, blood, yin, and yang, and the superficial symptoms are pathological products such as cold, phlegm, heat, blood stasis, and toxicity. The disease is located in the skin, muscles, and veins. It can be seen that the rational use of Chinese herbal medicine to treat DPN can achieve the effect of treating both the root and the superficial symptoms. Therefore, it is very meaningful to develop a Chinese medicine formula with reasonable compatibility and good efficacy for the treatment of DPN. Summary of the invention

[0005] In view of the above problems, the present invention provides a Chinese medicine composition for treating diabetic peripheral neuropathy and a preparation method thereof.

[0006] In order to achieve the above object, the technical solution adopted by the present invention is as follows: One object of the present invention is to provide a traditional Chinese medicine composition for treating diabetic peripheral neuropathy. The raw material formula and weight proportions of the traditional Chinese medicine composition are: 8-12 parts of astragalus, 8-12 parts of ivy-clawed golden dragon, 8-12 parts of Sichuan pepper branches, 3-8 parts of ghost arrow feathers, 2-6 parts of earthworms, 2-6 parts of chuanxiong, 2-6 parts of southern hawthorn, 3-8 parts of mistletoe, 2-4 parts of tongcao, 2-6 parts of chuanxiong, 2-6 parts of cassia twig, and 2-4 parts of licorice.

[0007] Another object of the present invention is to provide a method for preparing the above-mentioned Chinese medicine composition for treating diabetic peripheral neuropathy, which specifically comprises the following steps: S1: Take astragalus, five-clawed golden dragon, Sichuan pepper branch, ghost arrow feather, earthworm, chuanxiong, southern hawthorn, mistletoe, tongcao, Sichuan cyathula, cassia twig, and liquorice according to weight proportions, rinse with clean water, dry, mix, and obtain a drug mixture for later use; S2: crushing and sieving the drug mixture, sterilizing it to obtain drug powder; adding clean water to the drug powder, soaking it for a period of time, then boiling it for extraction, repeating the extraction 3 times, filtering it after the extraction to obtain a filtrate; decompressing and evaporating the filtrate to obtain a drug paste; S3: Mixing the thick medicinal paste with pharmaceutically acceptable excipients to prepare the Chinese medicine composition.

[0008] Furthermore, in step S2, the mass ratio of the drug powder to clean water is 1:8-10; the soaking time is 40-60 minutes, and the extraction time is 90-120 minutes.

[0009] Furthermore, in step S2, the relative density of the drug paste is 1.28-1.32 g / mL.

[0010] Furthermore, in step S3, the mass ratio of the drug paste to the pharmaceutically acceptable drug excipients is 1:0.2-0.6.

[0011] Furthermore, in step S3, the dosage form of the Chinese medicine composition is tablets, pills or granules.

[0012] According to traditional Chinese medicine, the cause of DPN is mainly related to emotional disorders, insufficient endowment, six exogenous pathogens, excessive labor and desire, and eating disorders. Its pathogenesis is that thirst lasts for a long time, and blood stasis is caused by deficiency. The basic pathogenesis is yin-blood deficiency, internal heat, and gradually the state of deficiency of vital energy such as qi and yin deficiency appears. Due to the deficiency of vital energy in the body, dysfunction of internal organs, and emotional stagnation, liver depression, spleen deficiency, and kidney deficiency occur, accompanied by pathological products such as blood stasis, phlegm, damp heat, cold and dampness. As the disease progresses, pathogens enter the collaterals, blood stasis leads to poor circulation of qi and blood, and the muscles, limbs, and meridians cannot be nourished, which eventually leads to symptoms such as numbness and pain. The Chinese medicine composition for treating diabetic peripheral neuropathy of the present invention is based on the theory of "monarch, minister, assistant and envoy" compatibility, with Astragalus, Ipomoea australis and Sichuan pepper as monarch medicines, which have the effects of invigorating qi, unblocking collaterals, warming the middle and relieving pain; with Herba Astragali, Pheretima, Rhizoma Chuanxiong and Crataegus Pinnatifida as adjuvants, which have the effects of promoting qi and blood circulation, unblocking collaterals and relieving pain; with Herba Visicae, Rhizoma Cyathulae, Rhizoma Anemarrhenae and Rhizoma Cinnamomi as adjuvants, which have the effects of nourishing liver and kidney, unblocking collaterals and relieving pain; with Radix Glycyrrhizae as an assistant medicine, which has the effects of invigorating spleen and invigorating qi and harmonizing medicinal properties. The pharmacological effects of each Chinese medicine raw material are as follows: Astragalus: sweet in taste, slightly warm in nature, enters the spleen and lung meridians, has the effects of strengthening the spleen and tonifying the middle, raising yang and lifting the sunken, benefiting the Wei and consolidating the exterior, promoting diuresis, expelling toxins and promoting tissue regeneration, and is used for spleen qi deficiency syndrome, lung qi deficiency syndrome, qi deficiency and spontaneous sweating syndrome, qi and blood deficiency, sores that are difficult to heal or ulcers that are difficult to heal, etc.

[0013] Five-clawed Golden Dragon: It tastes spicy and warm in nature. It enters the liver and kidney meridians. It has the effects of dispelling wind and dampness, setting bones and tendons, dispersing blood stasis and reducing swelling. It is used for rheumatism, arthralgia, fractures and tendon injuries, bruises, wet skin, burns from water or fire, and unknown swelling.

[0014] Sichuan pepper branches: warm in nature, enter the spleen, stomach, and kidney meridians, have the effects of warming the middle and relieving pain, killing insects and relieving itching, and are used to treat cold pain in the abdomen, vomiting and diarrhea, abdominal pain caused by insect accumulation, eczema and itching, etc.

[0015] Ghost Arrow Feather: bitter and pungent in taste, cold in nature, enters the liver and spleen meridians, has the effects of breaking blood and dredging menstruation, detoxifying and reducing swelling, and killing insects. It is used for lumps and masses, heart and abdominal pain, amenorrhea, dysmenorrhea, metrorrhagia, postpartum abdominal pain due to blood stasis, retained lochia, hernia, pain in the joints, sores, bruises, abdominal pain due to worm accumulation, burns, and snake bites.

[0016] Earthworm: salty in taste, cold in nature, enters the liver, spleen, and bladder meridians, has the effects of clearing away heat and calming the nerves, unblocking meridians, relieving asthma, and promoting diuresis. It is used for high fever and coma, epilepsy and convulsions, joint pain, limb numbness, hemiplegia, lung heat, cough and asthma, edema and oliguria.

[0017] Chuanxiong: spicy in taste, warm in nature, enters the liver, gallbladder, and pericardium meridians, has the effects of promoting blood circulation and qi, dispelling wind and relieving pain, and is used for irregular menstruation, amenorrhea, dysmenorrhea, abdominal pain due to masses, stabbing pain in the chest and flanks, swelling and pain due to falls, headache, and rheumatic pain.

[0018] Southern Hawthorn: slightly warm in nature, sour and sweet in taste, enters the spleen meridian, stomach meridian, and liver meridian. It has the effects of eliminating accumulation and stagnation, breaking up qi and dispersing blood stasis. It is used for meat stagnation, milk accumulation in children, abdominal distension and pain, dysentery, diarrhea, dysmenorrhea, postpartum abdominal pain due to blood stasis, hernia, and hyperlipidemia. The pharmacological effects show that it has the effects of lowering blood pressure, increasing coronary flow, and lowering blood lipids on the cardiovascular system.

[0019] Mulberry parasite: bitter, sweet, neutral in nature, enters the liver and kidney meridians, has the effects of removing rheumatism, nourishing the liver and kidney, strengthening the bones and tendons, and calming the fetus. It is used for rheumatic pain, soreness of the waist and knees, weakness of the bones and tendons, metrorrhagia, bleeding during pregnancy, restless fetal movement, and dizziness.

[0020] Tongcao: sweet, light, slightly cold, enters the lung and stomach meridians, has the effects of clearing heat and promoting diuresis, ventilating and promoting lactation, used for damp-heat stranguria, edema, oliguria, and lack of milk. "Shennong's Herbal Classic" records: It is mainly used to clear the nine orifices, blood vessels, and joints.

[0021] Sichuan Cyathula: Sweet, slightly bitter, neutral in nature, enters the liver and kidney meridians, has the effects of removing blood stasis, dredge meridians, open joints, promote urination and relieve stranguria, and guide blood (drug) downward. It is used for amenorrhea, retained placenta, traumatic injury, rheumatic pain, foot paralysis, tendon spasm, hematuria and stranguria.

[0022] Cinnamon twig: pungent in taste, hot in nature, enters the lung, heart, and bladder meridians, has the effects of sweating, warming and unblocking the meridians, and warming and supporting Yang Qi. It is used for colds, cold blood stagnation, various pains, phlegm, water retention, and palpitations.

[0023] Licorice: It is mild in nature, sweet in taste, and enters the heart meridian, stomach meridian, spleen meridian, and lung meridian. It has the effects of tonifying the spleen and replenishing qi, and harmonizing the properties of medicines.

[0024] Compared with the prior art, the present invention has the following beneficial effects: In the present invention, by adopting Chinese medicines with the effects of strengthening the spleen and replenishing qi, nourishing the liver and kidney, and unblocking meridians and relieving pain as raw materials, a Chinese medicine composition for treating diabetic peripheral neuropathy is prepared according to the Chinese medicine compatibility theory of "monarch, minister, assistant and messenger", and the drug compatibility is reasonable; the Chinese medicine composition for treating diabetic peripheral neuropathy of the present invention has the effects of lowering blood sugar, lowering the traditional Chinese medicine syndrome score and Toronto clinical score, and improving the nerve conduction velocity, and has significant and reliable therapeutic effect and good safety. DETAILED DESCRIPTION

[0025] In order to make the purpose and advantages of the present invention more clearly understood, the present invention is further described in detail below in conjunction with the embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not used to limit the present invention.

[0026] The instruments, reagents, materials, etc. involved in the following examples, unless otherwise specified, are all conventional instruments, reagents, materials, etc. in the prior art and can be obtained through regular commercial channels. The experimental methods, detection methods, etc. involved in the following examples, unless otherwise specified, are all conventional experimental methods, detection methods, etc. in the prior art.

[0027] Example 1 The present embodiment provides a traditional Chinese medicine composition for treating diabetic peripheral neuropathy. The raw material formula and weight proportions of the traditional Chinese medicine composition are: 8 parts of astragalus, 8 parts of ixora chinensis, 8 parts of Sichuan pepper branches, 3 parts of ghost arrow feathers, 2 parts of earthworms, 2 parts of chuanxiong, 2 parts of southern hawthorn, 3 parts of mistletoe, 2 parts of tongcao, 2 parts of cyathula, 2 parts of cassia twig, and 2 parts of licorice.

[0028] The preparation method of the above-mentioned Chinese medicine composition specifically comprises the following steps: S1: Take astragalus, five-clawed golden dragon, Sichuan pepper branch, ghost arrow feather, earthworm, chuanxiong, southern hawthorn, mistletoe, tongcao, Sichuan cyathula, cassia twig, and liquorice according to weight proportions, rinse with clean water, dry, mix, and obtain a drug mixture for later use; S2: crush the drug mixture through an 80-mesh sieve and sterilize to obtain drug powder; add 8-10 times the weight of clean water to the drug powder, soak for 40 minutes, then boil and extract for 90 minutes, repeat the extraction 3 times, filter after the extraction to obtain a filtrate; evaporate and concentrate the filtrate under reduced pressure to obtain a drug paste with a relative density of 1.28 g / mL; S3: Mixing the thick medicinal paste with pharmaceutically acceptable excipients in a mass ratio of 1:0.2 to prepare a Chinese medicine composition in the form of tablets.

[0029] Example 2 The present embodiment provides a traditional Chinese medicine composition for treating diabetic peripheral neuropathy. The raw material formula and weight proportions of the traditional Chinese medicine composition are: 10 parts of astragalus, 10 parts of cinnamon bark, 10 parts of Sichuan pepper branch, 5 parts of ghost arrow feather, 4 parts of earthworm, 4 parts of chuanxiong, 4 parts of southern hawthorn, 5 parts of mistletoe, 3 parts of tongcao, 4 parts of Sichuan cyathula, 4 parts of cassia twig, and 3 parts of licorice.

[0030] The preparation method of the above-mentioned Chinese medicine composition specifically comprises the following steps: S1: Take astragalus, five-clawed golden dragon, Sichuan pepper branch, ghost arrow feather, earthworm, chuanxiong, southern hawthorn, mistletoe, tongcao, Sichuan cyathula, cassia twig, and liquorice according to weight proportions, rinse with clean water, dry, mix, and obtain a drug mixture for later use; S2: The drug mixture was crushed and passed through an 80-mesh sieve, sterilized, and obtained drug powder; 9 times the weight of clean water was added to the drug powder, first soaked for 50 minutes, then boiled and extracted for 110 minutes, and the extraction was repeated 3 times. After the extraction, the filtrate was filtered to obtain a filtrate; the filtrate was evaporated and concentrated under reduced pressure to obtain a drug paste with a relative density of 1.30 g / mL; S3: Mixing the thick medicinal paste with pharmaceutically acceptable excipients in a mass ratio of 1:0.4 to prepare a Chinese medicine composition in the form of pills.

[0031] Example 3 The present embodiment provides a traditional Chinese medicine composition for treating diabetic peripheral neuropathy. The raw material formula and weight proportions of the traditional Chinese medicine composition are: 12 parts of astragalus, 12 parts of ixora chinensis, 12 parts of Sichuan pepper branches, 8 parts of ghost arrow feathers, 6 parts of earthworms, 6 parts of chuanxiong, 6 parts of southern hawthorn, 8 parts of mistletoe, 4 parts of tongcao, 6 parts of cyathula, 6 parts of cassia twig, and 4 parts of licorice.

[0032] The preparation method of the above-mentioned Chinese medicine composition specifically comprises the following steps: S1: Take astragalus, five-clawed golden dragon, Sichuan pepper branch, ghost arrow feather, earthworm, chuanxiong, southern hawthorn, mistletoe, tongcao, Sichuan cyathula, cassia twig, and liquorice according to weight proportions, rinse with clean water, dry, mix, and obtain a drug mixture for later use; S2: The drug mixture is crushed through an 80-mesh sieve and sterilized to obtain drug powder; 10 times the weight of clean water is added to the drug powder, first soaked for 60 minutes, then boiled and extracted for 120 minutes, and the extraction is repeated 3 times. After the extraction is completed, the filtrate is filtered to obtain a filtrate; the filtrate is evaporated and concentrated under reduced pressure to obtain a drug paste with a relative density of 1.32 g / mL; S3: Mixing the thick medicinal paste with pharmaceutically acceptable excipients in a mass ratio of 1:0.6 to prepare a granular Chinese medicine composition.

[0033] A clinical trial was conducted using the Chinese medicine composition for treating diabetic peripheral neuropathy of Example 2. The specific process and test results of the clinical trial are as follows: 1. Diagnostic criteria: (1) Western medicine diagnostic criteria: Diagnostic criteria for type 2 diabetes: refer to the "Guidelines for the Prevention and Treatment of Type 2 Diabetes in China" (2020 edition), fasting blood glucose ≥ 7.0mmol / L and (or) 2h postprandial blood glucose ≥ 11.1mmol / L. (2) Traditional Chinese medicine diagnostic criteria: refer to the "Guidelines for Clinical Diagnosis and Treatment of Diabetic Peripheral Neuropathy in Traditional Chinese Medicine (2016 edition)" issued by the Diabetes Branch of the Chinese Association of Traditional Chinese Medicine.

[0034] 2. Inclusion criteria: ① Meet the diagnostic criteria for DPN; ② Age 20-65 years old, regardless of gender; ③ Those who sign the informed consent form and agree to receive this treatment are included.

[0035] 3. Exclusion criteria: ① Patients whose condition is in the acute exacerbation stage or have complications; ② Pregnant or lactating women; ③ Those who are allergic to this drug; ④ Those who do not meet the above inclusion criteria.

[0036] 4. Experimental subjects: According to the inclusion and exclusion criteria, 133 qualified cases were screened from DPN patients who visited Shaanxi Provincial Hospital of Traditional Chinese Medicine from 2021 to 2024. According to the principles of open and parallel control, the patients were randomly divided into two groups: 68 cases in the treatment group and 65 cases in the control group. There was no statistical difference in the clinical data such as age, gender, and disease course of the two groups of experimental subjects, and they were comparable.

[0037] 5. Treatment (intervention) methods: (1) Control group: Orally administered methylcobalamin tablets (Jiangxi Qingfeng Pharmaceutical Co., Ltd.), 0.5 g / time, 3 times a day.

[0038] (2) Treatment group: The subjects were given the Chinese medicine composition for treating diabetic peripheral neuropathy prepared in Example 2, 15 g per day, divided into 3 doses, orally taken half an hour before meals.

[0039] The two groups of patients were given intervention treatment according to the above method, with a treatment course of 1 month.

[0040] 6. Indicator monitoring (1) The fasting blood glucose and 2-hour postprandial blood glucose of patients were tested on days 0, 14, and 30 respectively. The 2-hour postprandial blood glucose was uniformly set as 75 g of anhydrous glucose dissolved in 200 mL of water, which the patient was required to drink within 5 minutes. The blood glucose value was measured 2 hours after the patient drank the first sip of the sugar water.

[0041] (2) TCM syndrome scoring: This was developed with reference to the TCM Diagnosis and Treatment Program for 95 Diseases in 22 Specialties (Combined Edition). The scoring criteria for each major symptom are: 0 for none, 2 for mild, 4 for moderate, and 6 for severe; the scoring criteria for each minor symptom are: 0 for none, 1 for mild, 2 for moderate, and 3 for severe. Records were taken once before and after treatment.

[0042] (3) Toronto Clinical Scale (TCSS): Symptom score: 1 point for each symptom, 0 point for each symptom; Reflex score: 2 points for each side’s absent reflex, 1 point for each side’s decreased reflex, 0 point for each side’s normal reflex, and 4 points for the highest score; Sensation score: 1 point for each abnormality, 0 point for no abnormality; The highest total score is 19 points. Record once before and after treatment.

[0043] (4) Nerve conduction velocity: The sensory conduction velocity (SCV) of the median nerve and superficial peroneal nerve and the motor conduction velocity (MCV) of the median nerve, tibial nerve and common peroneal nerve were recorded. Methods: The Danish Alpine Biomed Aps-KEYPOINT 6Ch.Amplifier electromyography / evoked potential instrument was used. The instrument was placed in a constant temperature electromyography room with the room temperature maintained at 22-25℃. The subject's body temperature was required to be normal. The examination was performed once before and after treatment.

[0044] (5) Safety check: Liver function (ALT, AST) and renal function (CR, BUN) were tested once before and after treatment. Closely observe and record the patient's response to treatment at any time. If adverse reactions occur, relevant treatment measures should be taken immediately and recorded.

[0045] 7. Statistical analysis The experimental data were analyzed and processed using SPSS 22.0 software and expressed as mean ± standard deviation. The measurement data were analyzed using t test and the count data were analyzed using X-test. 2 Inspection and rank data were analyzed using Ridit.

[0046] 8. Results (1) Comparison of blood sugar The comparison results of fasting blood glucose values ​​and 2-hour postprandial blood glucose values ​​of patients before and after treatment are shown in Table 1.

[0047] Table 1

[0048] Note: * For comparison with day 0, P < 0.05; #Compared with the control group, P<0.05.

[0049] As can be seen from Table 1, the fasting blood glucose value and 2-hour postprandial blood glucose value of the patients in the treatment group after treatment (30 days) were significantly lower than those before the start of treatment (0 days). At the same time, the 2-hour postprandial blood glucose value of the patients in the treatment group detected on the 30th day was significantly lower than the 2-hour postprandial blood glucose value of the patients in the control group during the same period, indicating that the Chinese medicine composition for treating diabetic peripheral neuropathy of this embodiment has the effect of lowering the blood glucose of DPN patients.

[0050] (2) Comparison of TCM syndrome scores The comparison results of TCM syndrome scores of patients before and after treatment are shown in Table 2.

[0051] Table 2

[0052] Note: * For comparison with day 0, P < 0.05; # Compared with the control group, P<0.05.

[0053] As can be seen from Table 2, the TCM syndrome score of the patients in the treatment group after treatment (30d) was significantly lower than that before treatment (0d). At the same time, the TCM syndrome score of the patients in the treatment group on the 30th day was significantly lower than that of the patients in the control group during the same period, indicating that the Chinese medicine composition for treating diabetic peripheral neuropathy of this embodiment has the effect of reducing the TCM syndrome score.

[0054] (3) Comparison of TCSS scores The comparison results of TCSS scores of patients before and after treatment are shown in Table 3.

[0055] Table 3

[0056] Note: * For comparison with day 0, P < 0.05; # Compared with the control group, P<0.05.

[0057] As can be seen from Table 3, the TCSS score of the patients in the treatment group after treatment (30d) was significantly lower than that before treatment (0d). At the same time, the TCSS score of the patients in the treatment group on the 30th day was significantly lower than that of the patients in the control group during the same period, indicating that the Chinese medicine composition for treating diabetic peripheral neuropathy of this embodiment has the effect of reducing the Toronto clinical score.

[0058] Nerve conduction velocity comparison The comparison results of nerve conduction velocity of patients before and after treatment are shown in Table 4.

[0059] Table 4

[0060] Note: * For comparison with day 0, P < 0.05; # Compared with the control group, P<0.05.

[0061] As can be seen from Table 4, the median nerve SCV, superficial peroneal nerve SCV, median nerve MCV, peroneal nerve MCV and common peroneal nerve MCV of the patients in the treatment group after treatment (30d) were significantly lower than those before the start of treatment (0d). At the same time, the median nerve SCV, superficial peroneal nerve SCV, peroneal nerve MCV and common peroneal nerve MCV of the patients in the treatment group after treatment (30d) were significantly higher than those in the control group, indicating that the Chinese medicine composition for treating diabetic peripheral neuropathy of this embodiment can improve the electromyography nerve conduction velocity of patients with diabetic peripheral neuropathy, and the effect is better than that of simple oral methylcobalamin tablets.

[0062] Safety evaluation During the intervention period, the liver function (ALT, AST) and renal function (CR, BUN) of patients in the treatment group and the control group were within the normal range, the vital signs of the patients were stable, and no adverse reactions occurred.

[0063] In some embodiments of the present invention, clinical trials were conducted using the Chinese medicine compositions for treating diabetic peripheral neuropathy of Examples 1 and 3, and the same experimental results as those of the Chinese medicine composition of Example 2 were obtained (having the efficacy of lowering blood sugar in DPN patients, lowering TCM syndrome scores, lowering Toronto clinical scores, and improving electromyography nerve conduction velocity in patients).

[0064] Based on the above results, it can be seen that the Chinese medicine composition for treating diabetic peripheral neuropathy of Examples 1-3 has the effects of lowering blood sugar, reducing TCM syndrome scores and Toronto clinical scores, and increasing nerve conduction velocity, and has significant and reliable efficacy and good safety.

[0065] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims

1. A Chinese medicine composition for treating diabetic peripheral neuropathy, characterized in that: The raw material formula and weight proportions of the traditional Chinese medicine composition are: 8-12 parts of astragalus, 8-12 parts of ivy clawed golden dragon, 8-12 parts of Sichuan pepper branches, 3-8 parts of ghost arrow feathers, 2-6 parts of earthworms, 2-6 parts of chuanxiong, 2-6 parts of southern hawthorn, 3-8 parts of mistletoe, 2-4 parts of tongcao, 2-6 parts of Sichuan cyathula, 2-6 parts of cassia twig, and 2-4 parts of liquorice.

2. A method for preparing a Chinese medicine composition for treating diabetic peripheral neuropathy as claimed in claim 1, characterized in that: The specific steps include: S1: Take astragalus, five-clawed golden dragon, Sichuan pepper branch, ghost arrow feather, earthworm, chuanxiong, southern hawthorn, mistletoe, tongcao, Sichuan cyathula, cassia twig, and liquorice according to weight proportions, rinse with clean water, dry, mix, and obtain a drug mixture for later use; S2: crushing and sieving the drug mixture, sterilizing it to obtain drug powder; adding clean water to the drug powder, soaking it for a period of time, then boiling it for extraction, repeating the extraction 3 times, filtering it after the extraction to obtain a filtrate; decompressing and evaporating the filtrate to obtain a drug paste; S3: Mixing the thick medicinal paste with pharmaceutically acceptable excipients to prepare the Chinese medicine composition.

3. A method for preparing a Chinese medicine composition for treating diabetic peripheral neuropathy according to claim 2, characterized in that: In step S2, the mass ratio of the drug powder to clean water is 1:8-10; the soaking time is 40-60 minutes, and the extraction time is 90-120 minutes.

4. A method for preparing a Chinese medicine composition for treating diabetic peripheral neuropathy according to claim 2, characterized in that: In the step S2, the relative density of the thick paste of the medicine is 1.28-1.32 g / mL.

5. The method for preparing a Chinese medicine composition for treating diabetic peripheral neuropathy according to claim 2, characterized in that: In step S3, the mass ratio of the drug paste to the pharmaceutically acceptable drug excipients is 1:0.2-0.

6.

6. The method for preparing a Chinese medicine composition for treating diabetic peripheral neuropathy according to claim 2, characterized in that: In step S3, the dosage form of the Chinese medicine composition is tablets, pills or granules.

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