Traditional Chinese medicine compound preparation for tonifying qi and yin and promoting blood circulation to remove meridian obstruction and application thereof

Abstract

The invention relates to the field of traditional Chinese medicines, in particular to a traditional Chinese medicine compound preparation for treating diabetic peripheral neuropathy caused by qi and yin impairment and blood stasis syndrome, which is prepared from 12 traditional Chinese medicinal materials, namely coptis chinensis, dried rehmannia root, kudzuvine root, ginseng, white paeony root, honey-fried licorice root, mulberry twig, raw endothelium corneum gigeriae galli, lychee seed, lysimachia christinae hance, curcuma zedoary and rhizoma corydalis. Based on the treatment principle of tonifying qi and yin, and promoting blood circulation to remove meridian obstruction, through scientific compatibility, the traditional Chinese medicine aims at relieving the symptoms such as pain, numbness and abnormal feeling caused by diabetic peripheral neuropathy through the synergistic effect of multiple ways and multiple target points. The traditional Chinese medicine composition can regulate and tonify qi and yin, promote blood circulation to remove blood stasis, improve blood circulation of peripheral nerves and promote neural restoration, can regulate the physique of a patient on the whole, and has good safety and compliance.

Description

Technical Field

[0001] The invention relates to the field of traditional Chinese medicine, and in particular to a Chinese medicinal compound preparation for invigorating qi and nourishing yin, promoting blood circulation and unblocking collaterals for treating diabetic peripheral neuropathy with both qi and yin damage and blood stasis syndrome, and its use. Background Art

[0002] Diabetic Peripheral Neuropathy (DPN) is one of the common chronic complications of diabetes. Especially when long-term high blood sugar is not effectively controlled, nerve fibers are gradually damaged due to metabolic disorders. DPN is mainly manifested as damage to sensory nerves, motor nerves and autonomic nerves. Patients usually experience symptoms such as numbness, pain and decreased sensation in the limbs. In severe cases, it may lead to ulcers, infections and even amputation. The International Diabetes Federation (IDF) pointed out that with the continued increase in the global incidence of diabetes, the burden of diabetic complications on the global medical system and the quality of life of patients is gradually increasing.

[0003] In the treatment system of modern medicine, diabetic peripheral neuropathy is mainly treated by controlling blood sugar to slow down the process of nerve damage, supplemented by symptomatic treatments such as antioxidants, neuroprotective drugs and analgesics. However, these therapies often cannot completely stop or reverse the progression of nerve damage, and due to the long-term use of certain drugs, patients may face the trouble of drug side effects, such as gastrointestinal discomfort, risk of hypoglycemia, and damage to liver and kidney function. These problems affect patients' treatment compliance and quality of life. Based on this, it is urgent to find a treatment plan with few side effects, stable efficacy and the ability to fundamentally regulate the physical constitution.

[0004] According to traditional Chinese medicine, diabetic peripheral neuropathy belongs to the category of "Xiaoke Bi syndrome". According to traditional Chinese medicine theory, the main pathogenesis of diabetic peripheral neuropathy is "injury to both qi and yin, blood stasis blocking the meridians", that is, long-term illness will damage yin, further affecting the movement of qi, qi deficiency will lead to blood stasis, blocking the meridians, and then causing symptoms such as pain and numbness, which will lead to insufficient blood supply to nerve endings and nerve damage. Diabetic patients often show symptoms such as qi deficiency, weakness, dry mouth, numbness of hands and feet, and even aggravation of pain and numbness caused by blood stasis. When treating diabetic peripheral neuropathy, traditional Chinese medicine usually adopts the treatment principle of "replenishing qi and nourishing yin, activating blood circulation and unblocking collaterals", by regulating the overall qi and blood, unblocking the meridians, relieving symptoms, repairing nerve function, regulating the overall internal environment, and improving the patient's physical condition, so as to achieve the purpose of relieving symptoms and delaying the development of the disease.

[0005] However, there has been no report on a traditional Chinese medicine compound preparation for invigorating qi and nourishing yin, promoting blood circulation and unblocking collaterals for treating diabetic peripheral neuropathy with both qi and yin damage and blood stasis syndrome. Summary of the invention

[0006] The present invention aims to provide a Chinese medicine composition and its compound preparation for invigorating qi and nourishing yin, promoting blood circulation and unblocking collaterals, especially a Chinese medicine composition for treating diabetic peripheral neuropathy. The present invention also provides the use of the Chinese medicine composition in preparing a drug for treating diabetic peripheral neuropathy.

[0007] The first aspect of the present invention provides a Chinese medicine composition for invigorating qi and nourishing yin, promoting blood circulation and unblocking collaterals for treating diabetic peripheral neuropathy, which is composed of the following raw materials in parts by weight:

[0008] 3-8 parts of coptis root, 10-15 parts of raw rehmannia root, 10-20 parts of kudzu root, 5-10 parts of ginseng, 8-12 parts of white peony root, 8-12 parts of roasted liquorice root, 10-15 parts of mulberry branch, 5-10 parts of raw chicken gizzard lining, 5-10 parts of litchi seed, 8-12 parts of desmodium, 8-12 parts of zedoaria, and 8-12 parts of corydalis.

[0009] Furthermore, the Chinese medicine composition for invigorating qi and nourishing yin, promoting blood circulation and unblocking collaterals is composed of the following raw materials in parts by weight:

[0010] 6 parts of coptis root, 12 parts of raw rehmannia root, 15 parts of kudzu root, 6 parts of ginseng, 9 parts of white peony root, 9 parts of roasted liquorice root, 15 parts of mulberry twig, 6 parts of chicken gizzard lining, 6 parts of litchi seed, 9 parts of moneywort, 9 parts of curcuma, 9 parts of corydalis.

[0011] The second aspect of the present invention provides a compound preparation with the above-mentioned Chinese medicine composition as an active ingredient, wherein the compound preparation is prepared into a common dosage form in pharmacy by conventional preparation methods in the art.

[0012] Furthermore, the compound preparation is a decoction, tablet, capsule, granule, pill, oral liquid or syrup.

[0013] Furthermore, the compound preparation also includes pharmaceutically acceptable excipients, such as starch, microcrystalline cellulose, lactose, etc.

[0014] Furthermore, the compound preparation can be prepared by the following method: (A) weighing the medicinal components, mixing them, and obtaining a mixture; (B) adding a pharmaceutically acceptable carrier or excipient to the mixture and preparing the compound preparation by a conventional preparation preparation method.

[0015] The third aspect of the present invention provides a use of the above-mentioned traditional Chinese medicine composition for invigorating qi and nourishing yin, promoting blood circulation and unblocking collaterals in the preparation of a drug for treating diabetic peripheral neuropathy.

[0016] The fourth aspect of the present invention provides a use of the compound preparation as described above in the preparation of a drug for treating diabetic peripheral neuropathy.

[0017] Furthermore, the diabetic peripheral neuropathy is diabetic peripheral neuropathy with both Qi and Yin damage and blood stasis.

[0018] Furthermore, the drug is suitable for treating symptoms such as pain, numbness and paresthesia caused by diabetic peripheral neuropathy.

[0019] The active ingredients in the compound preparation of the present invention can significantly improve clinical symptoms such as pain, numbness and paresthesia in patients with diabetic peripheral neuropathy through the mechanism of invigorating qi and nourishing yin, promoting blood circulation and removing blood stasis, and help repair damaged nerve function.

[0020] Furthermore, the compound preparation can:

[0021] a) Relieve pain caused by diabetic peripheral neuropathy;

[0022] b) Improve limb numbness;

[0023] c) Enhance blood circulation in nerve endings and promote recovery of nerve function.

[0024] The present invention is based on the theory of "replenishing qi and nourishing yin, promoting blood circulation and unblocking collaterals" in traditional Chinese medicine, and proposes a Chinese medicine compound preparation for treating diabetic peripheral neuropathy with both qi and yin injury and blood stasis syndrome. The preparation selects a variety of Chinese medicinal materials with the effects of replenishing qi and nourishing yin, promoting blood circulation and removing blood stasis, and unblocking collaterals and relieving pain, aiming to provide a safe and effective treatment plan for patients with diabetic peripheral neuropathy. Through multi-faceted synergistic effects, the patient's clinical symptoms are improved and nerve damage is repaired. Drugs such as ginseng and raw rehmannia can replenish qi and nourish yin, and improve the body's disease resistance; blood circulation and blood stasis-removing medicinal materials such as kudzu root, mulberry branch, and zedoaria can promote blood circulation and improve blood supply to nerve endings; drugs such as corydalis and litchi kernel can relieve pain and relieve pain caused by neuropathy.

[0025] This prescription uses ginseng and raw rehmannia as the main drugs, which can nourish qi and yin. Ginseng can greatly replenish vital energy, replenish spleen and produce body fluid; raw rehmannia nourishes yin and reduces fire, nourishes blood and yin, and complements ginseng to treat the basic pathogenesis of diabetic peripheral neuropathy with qi and yin injury and blood stasis syndrome. Coptis chinensis, white peony root and kudzu root are the assistant drugs. Coptis chinensis clears heat and dampness, purges fire and detoxifies, and is specially used to treat internal heat symptoms caused by qi and yin deficiency. White peony root nourishes blood and softens liver, relieves urgency and relieves pain; kudzu root promotes body fluid and quenches thirst, relaxes muscles and activates blood circulation. These drugs work together with the main drugs to regulate qi, blood, yin and yang. Mulberry branch, litchi seed, zedoaria and corydalis are used as adjuvant drugs. Mulberry branch can dispel rheumatism and dredge meridians; litchi seed warms the middle and dispels cold; zedoaria and corydalis can promote blood circulation and remove blood stasis, promote qi and relieve pain. Raw chicken gizzard lining and money grass help to promote digestion and resolve stagnation, promote diuresis and relieve stranguria. As a guiding drug, roasted licorice root can not only harmonize various medicines, but also replenish qi and nourish yin, relieve acute pain, and make the medicinal properties of the whole prescription tend to be mild.

[0026] Through the use of the compound preparation of the present invention, the patient's peripheral neuropathy symptoms such as pain and numbness can be significantly alleviated, blood circulation can be improved, and nerve function is gradually restored. This comprehensive treatment method is in line with the principle of "treating the root cause and treating the symptoms" in traditional Chinese medicine, which can not only effectively alleviate the existing symptoms of diabetic peripheral neuropathy, but also delay further deterioration of the disease through overall conditioning.

[0027] Compared with the prior art, the present invention has the advantages of:

[0028] 1. The Chinese medicine composition and compound preparation of the present invention can play a synergistic role in regulating blood sugar, improving microcirculation, repairing nerve damage, etc. through the combination of multiple Chinese medicine ingredients, and is not easy to produce obvious side effects, and has higher safety and compliance. It has the following advantages:

[0029] (1) Multi-component, multi-target, and multi-pathway synergistic effects: The multiple medicinal materials in the compound work synergistically to target multiple pathological links of diabetic peripheral neuropathy, including qi and yin deficiency, blood stasis, etc., and can effectively improve the condition.

[0030] (2) High safety: Compared with the long-term side effects of Western medicine, such as gastrointestinal discomfort and hypoglycemia, the ingredients of Chinese herbal compound preparations are natural and highly safe for long-term use.

[0031] (3) Dual conditioning of symptoms and constitution: It can not only significantly relieve symptoms such as nerve pain and numbness, but also regulate the overall constitution by replenishing qi and nourishing yin, unblocking meridians and activating blood circulation, helping patients improve their overall health, enhance their immune function, and prevent further development of complications.

[0032] 2. The Chinese medicine composition and compound preparation provided by the present invention can effectively improve the symptoms of diabetic peripheral neuropathy by regulating qi and yin, promoting blood circulation and unblocking collaterals, and clinical trials have confirmed that the compound preparation of the present invention has significant therapeutic effects.

[0033] 3. The medicinal materials in Chinese medicine formulas are all common traditional classic medicinal materials with clear pharmacological effects and high safety. They are widely available, low-cost, suitable for large-scale production, and highly safe to use with no obvious toxic side effects.

[0034] 4. The preparations of the present invention have various forms, which can meet the needs of different patients and are particularly suitable for long-term treatment.

[0035] In view of the high incidence and complexity of peripheral neuropathy in diabetic patients, the Chinese medicine compound preparation of the present invention provides a safe and effective treatment option, which is particularly suitable for long-term use. Compared with existing Western medicines, the Chinese medicine preparation of the present invention has the advantages of small side effects and high patient compliance. It can enhance the overall health level of patients while alleviating pain and improving nerve function, and has broad application prospects. Combined with modern pharmacological research, the compound preparation of the present invention can not only be used as a therapeutic drug for diabetic peripheral neuropathy, but also can be used to prevent and alleviate other complications of diabetes, such as diabetic cardiovascular and cerebrovascular diseases and diabetic foot, further broadening the scope of its clinical indications. DETAILED DESCRIPTION

[0036] The specific implementation methods provided by the present invention are described in detail below in conjunction with examples.

[0037] Embodiment 1: Chinese medicine composition of the present invention

[0038] 3 parts of coptis root, 10 parts of raw rehmannia root, 10 parts of kudzu root, 5 parts of ginseng, 8 parts of white peony root, 8 parts of roasted liquorice root, 10 parts of mulberry twig, 5 parts of chicken gizzard lining, 5 parts of litchi seed, 8 parts of moneywort, 8 parts of curcuma, 8 parts of corydalis.

[0039] Embodiment 2: Chinese medicine composition of the present invention

[0040] 6 parts of coptis root, 12 parts of raw rehmannia root, 15 parts of kudzu root, 6 parts of ginseng, 9 parts of white peony root, 9 parts of roasted liquorice root, 15 parts of mulberry twig, 6 parts of chicken gizzard lining, 6 parts of litchi seed, 9 parts of moneywort, 9 parts of curcuma, 9 parts of corydalis.

[0041] Embodiment 3: Chinese medicine composition of the present invention

[0042] 8 parts of Coptidis Rhizoma, 15 parts of Radix Rehmanniae, 20 parts of Radix Puerariae, 10 parts of Radix Ginseng, 12 parts of White Peony Root, 12 parts of Radix Glycyrrhizae Preparata, 12 parts of Ramulus Mori, 10 parts of Chicken Gizzard Stone Endothelial Gizzard, 10 parts of Semen Litchi, 12 parts of Herba Lysimachiae, 12 parts of Rhizoma Curcumae, and 12 parts of Rhizoma Corydalis.

[0043] Example 4: Preparation of decoction

[0044] Take any of the Chinese medicine composition materials of Examples 1-3, add water and boil twice, each time for 1 hour, combine the medicinal liquids, concentrate to an appropriate volume, and prepare a decoction.

[0045] Example 5: Preparation of tablets / capsules

[0046] Take any of the Chinese medicine composition materials of Examples 1-5, grind them into powder, decoct them, and concentrate them under reduced pressure to obtain an extract, dry and crush the extract to make granules for capsules, or add pharmaceutical excipients (starch or microcrystalline cellulose), press them into tablets or fill them into capsules.

[0047] Example 6: Preparation of granules

[0048] Weigh the medicinal materials of any one of the Chinese medicine compositions of Examples 1-5, grind them into powder, decoct them, and concentrate them under reduced pressure to obtain an extract, which is then dried and crushed to prepare granules.

[0049] Example 7: Preparation of pills / oral liquid / syrup

[0050] Weigh any of the Chinese medicine compositions of Examples 1-5, grind them into powder, decoct them, take the supernatant, and concentrate it into a thick extract; add appropriate pharmaceutical excipients (such as sugar, honey, benzopropionic acid or ethylparaben) to prepare pills, oral liquids or syrups.

[0051] Example 8: Clinical study

[0052] 1. Experimental Methods

[0053] 1.1 Case source

[0054] A total of 104 patients with diabetic peripheral neuropathy (DPN) with both Qi and Yin damage and blood stasis syndrome were included in this clinical study. The cases were patients hospitalized in the Department of Endocrinology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine from January 2021 to June 2022.

[0055] 1.2 Diagnostic criteria

[0056] 1.2.1 Diagnostic criteria for diabetes

[0057] The diagnostic criteria for diabetes refer to the diabetes diagnostic criteria published by the World Health Organization (WHO), including the following:

[0058] There are typical symptoms of diabetes ("three mores and one less" - thirst, frequent hunger, frequent urination and unexplained weight loss), and fasting blood glucose (FPG) ≥ 7.0mmol / L, or blood glucose ≥ 11.1mmol / L at any time.

[0059] No typical symptoms, but FPG ≥ 7.0mmol / L, or in the glucose tolerance test (OGTT), 2 hours postprandial blood glucose (2hPG) ≥ 11.1mmol / L. If any of the above conditions are met and repeated tests meet the standards, diabetes can be diagnosed.

[0060] 1.2.2 Diagnostic criteria for DPN

[0061] The diagnosis of diabetic peripheral neuropathy is based on the DPN diagnostic criteria in the "Guidelines for the Prevention and Treatment of Type 2 Diabetes in China (2017 Edition)", including:

[0062] History of diabetes diagnosis;

[0063] peripheral neuropathy that develops at or after the time of diabetes diagnosis;

[0064] Clinical symptoms and signs are consistent with DPN, such as pain, numbness, paresthesia, etc.

[0065] In the clinical examination, at least one of the tests (ankle reflex, pinprick pain, vibration sensation, pressure sensation, temperature sensation) is abnormal. If there are no symptoms, at least two tests must be abnormal.

[0066] 1.2.3 TCM Syndrome Differentiation Standards

[0067] Refer to the DPN blood stasis syndrome in the TCM Clinical Diagnosis and Treatment Guidelines for Diabetic Peripheral Neuropathy (2016 Edition). The main symptoms include numbness and pain in the limbs, and secondary symptoms include tingling in the extremities, especially in the lower limbs and at night. The tongue and pulse are dark, thin white fur, and stringy pulse.

[0068] 1.3 Inclusion criteria

[0069] Aged 18-75;

[0070] Meet the above-mentioned diagnostic criteria for diabetes and have a history of more than 1 year;

[0071] Glycated hemoglobin (HbA1c) is between 7.0% and 11.0%;

[0072] TCSS score>5 points indicates the presence of diabetic peripheral neuropathy;

[0073] The informed consent form has been signed.

[0074] 1.4 Exclusion criteria

[0075] Neuropathy caused by other causes, such as cervical and lumbar spine disease, cerebral infarction, etc.

[0076] Pregnant or breastfeeding women;

[0077] Those who have had diabetic ketoacidosis or severe hypoglycemia in the past 3 months;

[0078] Those who have used lipoic acid or other DPN-related drugs;

[0079] Those with serious complications such as heart, liver, kidney or other serious diseases.

[0080] 1.5 Treatment

[0081] Treatment group: basic treatment + Chinese herbal compound preparation of the present invention (prepared into tablets or capsules according to the methods of Example 2 and Example 5), 3 capsules each time, twice a day, orally, for continuous treatment for 12 weeks.

[0082] Control group: basic treatment + lipoic acid tablets (0.3 g / tablet), once a day, in the morning.

[0083] Basic treatment includes a proper diet, exercise therapy and diabetes education, which is carried out according to the individual conditions of the patient in accordance with the Guidelines for the Prevention and Treatment of Type 2 Diabetes in China (2017 Edition). Treatment plans for blood sugar control and chronic complications (such as hypertension and dyslipidemia) are formulated according to the guidelines.

[0084] 1.6 Observation indicators

[0085] 1.6.1 General indicators

[0086] At the initial visit, general clinical data such as the patient's age, body mass index (BMI), duration of diabetes, systolic blood pressure, and diastolic blood pressure were recorded.

[0087] 1.6.2 Main efficacy indicators

[0088] Carbohydrate metabolism indicators: fasting blood glucose (FPG), 2-hour postprandial blood glucose (2hPG), and glycosylated hemoglobin (HbA1c).

[0089] Neuropathy score: including Toronto Clinical Neuropathy Score (TCSS) and Utah Neurological Symptom Score (UENS). Scoring items include dorsalis pedis artery blood flow, vibration sensation, ankle reflex, etc. TCSS score>5 points indicates the presence of DPN.

[0090] TCM syndrome scoring: Record the patient's TCM symptoms, including limb numbness, tingling, loss of sensation, etc. If the symptom occurs, 1 point is recorded, and the total score is 17 points.

[0091] 1.6.3 Secondary efficacy indicators

[0092] Visual Analog Scale (VAS): It is used to assess the patient's subjective feeling of pain and is divided into 0-10 points, with 0 indicating no pain and 10 indicating severe pain.

[0093] Ankle-brachial index (ABI): measured using a Doppler blood flow detector.

[0094] Vibration Perception Threshold (VPT): Vibration sensation is detected using a vibration sensor.

[0095] 1.6.4 Glucose and lipid metabolism indicators

[0096] Glucose metabolism: FPG, 2hPG, HbA1c;

[0097] Lipid metabolism: total cholesterol (TC), triglycerides (TG), high-density lipoprotein (HDL), low-density lipoprotein (LDL).

[0098] 1.7 Safety Evaluation

[0099] Safety indicators include alanine aminotransferase (ALT), blood urea nitrogen (BUN), and creatinine (SCr). Liver and kidney function of patients were tested before and after treatment. If adverse events (such as gastrointestinal discomfort) occurred during the trial, medication was stopped immediately and recorded.

[0100] 1.8 Statistical methods

[0101] SPSS 24.0 statistical software was used for analysis. All statistical results were tested on two sides, and P < 0.05 indicated that the difference was statistically significant. Measurement data were expressed as mean ± standard deviation (Mean ± SD), and paired t-test was used for intra-group comparison, and independent sample t-test was used for inter-group comparison.

[0102] 2. Results

[0103] (1) Comparison of glucose metabolism indicators

[0104] As shown in Table 1, compared with the control group, FPG and HbA1c in the treatment group were significantly improved (P<0.05), while there was no significant difference in 2hPG.

[0105] Table 1. Glucose metabolism indicators

[0106]

[0107] (2) Comparison of neuropathy symptom scores

[0108] As shown in Table 2, the TCSS scores and UENS scores of the treatment group decreased significantly after treatment (P<0.05), which was significantly different from those of the control group.

[0109] Table 2. Neuropathy symptom scores

[0110]

[0111] (3) Comparison of TCM syndrome scores

[0112] As shown in Table 3, the TCM syndrome scores of the treatment group decreased significantly, indicating that TCM syndrome differentiation and treatment was effective in improving the symptoms of DPN.

[0113] Table 3. TCM syndrome scores

[0114]

[0115] (4) Safety evaluation

[0116] There was no significant difference in the liver and kidney function indicators between the two groups before and after treatment, indicating that the Chinese medicine compound preparation of the present invention has good safety.

[0117] 3. Conclusion:

[0118] The Chinese medicine compound preparation of the present invention has a significant therapeutic effect on diabetic peripheral neuropathy. The research results show that the sugar metabolism, neuropathy symptoms and TCM syndromes of the patients in the treatment group are significantly improved, and the safety is good.

[0119] The preferred embodiments of the present invention have been specifically described above, but the present invention is not limited to the embodiments. Those skilled in the art may make various equivalent modifications or substitutions without violating the spirit of the present invention. These equivalent modifications or substitutions are all included in the scope defined by the claims of this application.

Claims

1. A Chinese medicine composition for invigorating qi and nourishing yin, promoting blood circulation and unblocking collaterals, characterized in that: The invention is composed of the following raw materials in parts by weight: 3-8 parts of coptis root, 10-15 parts of raw rehmannia root, 10-20 parts of kudzu root, 5-10 parts of ginseng, 8-12 parts of white peony root, 8-12 parts of roasted liquorice root, 10-15 parts of mulberry branch, 5-10 parts of raw chicken gizzard lining, 5-10 parts of litchi seed, 8-12 parts of desmodium herb, 8-12 parts of zedoaria, and 8-12 parts of corydalis.

2. The Chinese medicine composition for invigorating qi and nourishing yin, promoting blood circulation and unblocking collaterals according to claim 1, characterized in that: The invention is composed of the following raw materials in parts by weight: 6 parts of coptis root, 12 parts of raw rehmannia root, 15 parts of kudzu root, 6 parts of ginseng, 9 parts of white peony root, 9 parts of roasted liquorice root, 15 parts of mulberry branch, 6 parts of raw chicken gizzard lining, 6 parts of litchi seed, 9 parts of moneywort, 9 parts of curcuma 9 parts and corydalis 9 parts.

3. A compound preparation with the Chinese medicine composition for replenishing qi and nourishing yin, promoting blood circulation and unblocking collaterals as claimed in claim 1 or 2 as an active ingredient, characterized in that: The compound preparation is prepared into a common dosage form in pharmacy by conventional preparation methods in the art.

4. The compound preparation according to claim 3, characterized in that: The compound preparation is a decoction, tablet, capsule, granule, pill, oral liquid or syrup.

5. The compound preparation according to claim 3, characterized in that: The compound preparation also includes pharmaceutically acceptable excipients.

6. The compound preparation according to claim 5, characterized in that: The compound preparation can be prepared by the following method: (A) weighing the medicinal components, mixing them, and obtaining a mixture; (B) adding a pharmaceutically acceptable carrier or excipient to the mixture and preparing the compound preparation by a conventional preparation method.

7. Use of the Chinese medicinal composition for invigorating qi and nourishing yin, promoting blood circulation and unblocking collaterals as claimed in claim 1 or 2 in the preparation of a drug for treating diabetic peripheral neuropathy.

8. The use according to claim 7, characterized in that: The diabetic peripheral neuropathy is diabetic peripheral neuropathy with both Qi and Yin damage and blood stasis.

9. The use according to claim 7, characterized in that: The medicine is suitable for treating pain, numbness and paresthesia symptoms caused by diabetic peripheral neuropathy.

10. Use of the compound preparation according to any one of claims 3 to 6 in the preparation of a drug for treating diabetic peripheral neuropathy.

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