A traditional Chinese medicine compound preparation for supplementing qi and nourishing yin, promoting blood circulation and dredging collaterals and application thereof

Abstract

This invention relates to the field of Traditional Chinese Medicine (TCM), specifically a compound TCM preparation for treating diabetic peripheral neuropathy with symptoms of both Qi and Yin deficiency and blood stasis. It consists of 12 TCM herbs: Coptis chinensis, Rehmannia glutinosa, Pueraria lobata, Panax ginseng, Paeonia lactiflora, Glycyrrhiza uralensis (processed), Morus alba twigs, raw chicken gizzard lining, Litchi chinensis seed, Lysimachia christinae, Curcuma zedoaria, and Corydalis yanhusuo. Based on the treatment principle of "tonifying Qi and nourishing Yin, promoting blood circulation and unblocking collaterals," this invention, through scientific formulation, aims to alleviate symptoms such as pain, numbness, and sensory abnormalities caused by diabetic peripheral neuropathy through synergistic effects via multiple pathways and targets. This invention improves blood circulation in the peripheral nerves and promotes nerve repair by regulating Qi and Yin and promoting blood circulation and removing blood stasis. It also holistically regulates the patient's constitution, exhibiting good safety and compliance.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine, specifically to a compound Chinese medicine preparation for treating diabetic peripheral neuropathy with symptoms of both qi and yin deficiency and blood stasis, which invigorates qi and nourishes yin, promotes blood circulation and unblocks collaterals, and its uses. Background Technology

[0002] Diabetic peripheral neuropathy (DPN) is a common chronic complication of diabetes, especially when high blood sugar is not effectively controlled over a long period, leading to gradual damage to nerve fibers due to metabolic disorders. DPN primarily manifests as damage to sensory, motor, and autonomic nerves. Patients typically experience symptoms such as numbness, pain, and decreased sensation in the limbs, and in severe cases, it can lead to ulcers, infections, and even amputation. The International Diabetes Federation (IDF) points out that with the continued rise in the global incidence of diabetes, the burden of diabetic complications on global healthcare systems and patients' quality of life is gradually increasing.

[0003] In modern medicine, diabetic peripheral neuropathy is primarily treated by controlling blood sugar levels to slow the progression of nerve damage, supplemented by symptomatic treatments such as antioxidants, neuroprotective agents, and analgesics. However, these therapies often cannot completely stop or reverse the progression of nerve damage, and long-term use of certain medications can lead to side effects such as gastrointestinal discomfort, hypoglycemia, and liver and kidney damage. These issues affect patient adherence to treatment and their quality of life. Therefore, finding a treatment plan with fewer side effects, stable efficacy, and the ability to fundamentally regulate the body's constitution has become an urgent priority.

[0004] Traditional Chinese medicine (TCM) considers diabetic peripheral neuropathy to fall under the category of "Xiao Ke Bi Zheng" (wasting and thirsting syndrome). According to TCM theory, the main pathogenesis of diabetic peripheral neuropathy is "deficiency of both Qi and Yin, and blood stasis obstructing the meridians." This means that prolonged illness damages Yin, further affecting the flow of Qi. Qi deficiency leads to blood stasis, obstructing the meridians and causing symptoms such as pain and numbness, ultimately resulting in insufficient blood supply to nerve endings and nerve damage. Diabetic patients often exhibit symptoms such as Qi deficiency and weakness, dry mouth and tongue, and numbness in the hands and feet. Blood stasis can even worsen pain and numbness. TCM treatment for diabetic peripheral neuropathy typically employs the principle of "tonifying Qi and nourishing Yin, activating blood and unblocking the meridians." By regulating overall Qi and blood, clearing the meridians, alleviating symptoms, repairing nerve function, regulating the overall internal environment, and improving the patient's constitution, TCM aims to alleviate symptoms and slow disease progression.

[0005] However, there are currently no reports on a traditional Chinese medicine compound preparation that invigorates qi and nourishes yin, promotes blood circulation and unblocks collaterals, and treats diabetic peripheral neuropathy with qi and yin deficiency and blood stasis syndrome. Summary of the Invention

[0006] The purpose of this invention is to provide a traditional Chinese medicine composition and its compound preparation that invigorates qi and nourishes yin, promotes blood circulation and unblocks collaterals, particularly a traditional Chinese medicine composition for treating diabetic peripheral neuropathy. This invention also provides the application of the aforementioned traditional Chinese medicine composition in the preparation of drugs for treating diabetic peripheral neuropathy.

[0007] In a first aspect, the present invention provides a traditional Chinese medicine composition for treating diabetic peripheral neuropathy that invigorates qi and nourishes yin, promotes blood circulation and unblocks collaterals, comprising the following raw materials in parts by weight:

[0008] Coptis chinensis 3-8 parts, Rehmannia glutinosa 10-15 parts, Pueraria lobata 10-20 parts, Panax ginseng 5-10 parts, Paeonia lactiflora 8-12 parts, Glycyrrhiza uralensis (processed) 8-12 parts, Morus alba twigs 10-15 parts, raw chicken gizzard lining 5-10 parts, Litchi chinensis seed 5-10 parts, Lysimachia christinae 8-12 parts, Curcuma zedoaria 8-12 parts, Corydalis yanhusuo 8-12 parts.

[0009] Furthermore, the aforementioned traditional 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] Coptis chinensis 6 parts, Rehmannia glutinosa 12 parts, Pueraria lobata 15 parts, Panax ginseng 6 parts, Paeonia lactiflora 9 parts, Glycyrrhiza uralensis (processed) 9 parts, Morus alba 15 parts, raw chicken gizzard 6 parts, Litchi chinensis seed 6 parts, Lysimachia christinae 9 parts, Curcuma zedoaria 9 parts, Corydalis yanhusuo 9 parts.

[0011] In a second aspect, the present invention provides a compound preparation using the above-described traditional Chinese medicine composition as the active ingredient, wherein the compound preparation is prepared into a commonly used dosage form in pharmaceuticals using 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 permissible excipients, such as starch, microcrystalline cellulose, lactose, etc.

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

[0015] In a third aspect, the present invention provides the application of the traditional Chinese medicine composition as described above, which invigorates qi and nourishes yin, and promotes blood circulation and unblocks collaterals, in the preparation of a drug for treating diabetic peripheral neuropathy.

[0016] In a fourth aspect, the present invention provides the use of the compound preparation described above in the preparation of a medicament for treating diabetic peripheral neuropathy.

[0017] Furthermore, the diabetic peripheral neuropathy described herein is a type of diabetic peripheral neuropathy characterized by deficiency of both Qi and Yin, along with blood stasis.

[0018] Furthermore, the medication described is suitable for 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 the clinical symptoms such as pain, numbness and abnormal sensation in patients with diabetic peripheral neuropathy through the mechanism of invigorating qi and nourishing yin, and promoting blood circulation and removing blood stasis, and help repair damaged nerve function.

[0020] Furthermore, the compound preparation can:

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

[0022] b) Improves limb numbness;

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

[0024] This invention, based on the traditional Chinese medicine theory of "tonifying Qi and nourishing Yin, promoting blood circulation and unblocking collaterals," proposes a compound traditional Chinese medicine preparation for treating diabetic peripheral neuropathy with Qi and Yin deficiency and blood stasis. The preparation carefully selects various Chinese medicinal herbs with the effects of tonifying 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 option for patients with diabetic peripheral neuropathy. Through the synergistic effect of multiple factors, it improves the patient's clinical symptoms and repairs nerve damage. Ginseng and Rehmannia glutinosa, among other herbs, can tonify Qi and nourish Yin, enhancing the body's disease resistance; Pueraria lobata, Morus alba twigs, and Curcuma zedoaria, among other herbs that promote blood circulation and remove blood stasis, can improve blood supply to nerve endings; Corydalis yanhusuo and Litchi chinensis seeds, among other herbs, can regulate Qi and relieve pain, alleviating the pain and discomfort caused by neuropathy.

[0025] This formula uses ginseng and rehmannia as the principal herbs to invigorate qi and nourish yin. Ginseng greatly replenishes vital energy and strengthens the spleen to generate fluids; rehmannia nourishes yin and reduces fire, replenishes blood and nourishes yin, complementing ginseng to treat the basic pathogenesis of diabetic peripheral neuropathy with qi and yin deficiency and blood stasis. Coptis, white peony root, and kudzu root are the assistant herbs. Coptis clears heat and dries dampness, drains fire and detoxifies, specifically treating internal heat symptoms caused by qi and yin deficiency; white peony root nourishes blood and softens the liver, relieving spasms and pain; kudzu root promotes fluid production, quenches thirst, relaxes muscles and invigorates blood. These herbs work together with the principal herbs to regulate qi, blood, yin and yang. Mulberry twig, litchi seed, turmeric, and corydalis rhizome are the adjuvant herbs. Mulberry twig dispels wind and dampness and unblocks the meridians; litchi seed warms the middle and dispels cold; turmeric and corydalis rhizome invigorate blood, remove blood stasis, promote qi circulation and relieve pain. Raw chicken gizzard and lysimachia christinae assist in digestion, promote urination and relieve strangury. As an adjuvant, prepared licorice root not only harmonizes the effects of other herbs, but also replenishes qi and nourishes yin, relieves spasms and pain, making the overall medicinal properties of the formula more moderate.

[0026] Through the use of the compound preparation of this invention, patients' symptoms of peripheral neuropathy, such as pain and numbness, can be significantly relieved, blood circulation can be improved, and nerve function can be gradually restored. This comprehensive treatment approach conforms to the principle of "treating both the root cause and the symptoms" in traditional Chinese medicine. It can not only effectively relieve the existing symptoms of diabetic peripheral neuropathy, but also delay the further deterioration of the disease through overall conditioning.

[0027] Compared with the prior art, the advantages of this invention are:

[0028] 1. The traditional Chinese medicine composition and its compound preparation of the present invention, through the combination of multiple traditional Chinese medicine ingredients, can exert synergistic effects in regulating blood sugar, improving microcirculation, and repairing nerve damage, and are less likely to produce significant side effects, exhibiting higher safety and patient compliance. It has the following advantages:

[0029] (1) Synergistic effect of multiple components, multiple targets and multiple pathways: The compound has the synergistic effect of multiple medicinal materials, which target multiple pathological links of diabetic peripheral neuropathy, including qi and yin deficiency, blood stasis and collateral obstruction, 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 traditional Chinese medicine compound preparations are natural and have high safety for long-term use.

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

[0032] 2. The traditional 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 and promoting blood circulation. Clinical trials have confirmed that the compound preparation of the present invention has significant therapeutic effects.

[0033] 3. The medicinal materials in the Chinese medicine prescriptions are all common traditional classic medicinal materials with clear pharmacological effects and high safety. They are widely available, inexpensive, suitable for large-scale production, and have high safety in use with no obvious toxic side effects.

[0034] 4. The formulations of the present invention are diverse and can meet the needs of different patients, and are particularly suitable for long-term treatment.

[0035] Given the high incidence and complexity of peripheral neuropathy in diabetic patients, the traditional Chinese medicine compound preparation of this invention provides a safe and effective treatment option, particularly suitable for long-term use. Compared to existing Western medicines, the traditional Chinese medicine preparation of this invention has the advantages of fewer side effects and higher patient compliance. It can alleviate pain, improve nerve function, and enhance the overall health of patients, showing broad application prospects. Combined with modern pharmacological research, the compound preparation of this invention can not only be used as a treatment for diabetic peripheral neuropathy, but also for the prevention and relief of other complications of diabetes, such as diabetic cardiovascular and cerebrovascular diseases and diabetic foot, further broadening its clinical indications. Detailed Implementation

[0036] The specific implementation methods provided by the present invention will be described in detail below with reference to the embodiments.

[0037] Example 1: The traditional Chinese medicine composition of the present invention

[0038] Coptis chinensis 3 parts, Rehmannia glutinosa 10 parts, Pueraria lobata 10 parts, Panax ginseng 5 parts, Paeonia lactiflora 8 parts, Glycyrrhiza uralensis (processed) 8 parts, Morus alba 10 parts, raw chicken gizzard lining 5 parts, Litchi chinensis seed 5 parts, Lysimachia christinae 8 parts, Curcuma zedoaria 8 parts, Corydalis yanhusuo 8 parts.

[0039] Example 2: The traditional Chinese medicine composition of the present invention

[0040] Coptis chinensis 6 parts, Rehmannia glutinosa 12 parts, Pueraria lobata 15 parts, Panax ginseng 6 parts, Paeonia lactiflora 9 parts, Glycyrrhiza uralensis (processed) 9 parts, Morus alba 15 parts, raw chicken gizzard 6 parts, Litchi chinensis seed 6 parts, Lysimachia christinae 9 parts, Curcuma zedoaria 9 parts, Corydalis yanhusuo 9 parts.

[0041] Example 3: The traditional Chinese medicine composition of the present invention

[0042] Coptis chinensis 8 parts, Rehmannia glutinosa 15 parts, Pueraria lobata 20 parts, Panax ginseng 10 parts, Paeonia lactiflora 12 parts, Glycyrrhiza uralensis (processed) 12 parts, Morus alba twigs 12 parts, raw chicken gizzard lining 10 parts, Litchi chinensis kernels 10 parts, Lysimachia christinae 12 parts, Curcuma zedoaria 12 parts, Corydalis yanhusuo 12 parts.

[0043] Example 4: Preparation of decoction

[0044] Take any one of the Chinese herbal medicine compositions from Examples 1-3, add water and decoct twice, one hour each time, combine the decoctions, concentrate to an appropriate volume, and prepare a decoction.

[0045] Example 5: Preparation of tablets / capsules

[0046] Take any one of the traditional Chinese medicine compositions from Examples 1-5, grind it into a fine powder, decoct it, and concentrate it under reduced pressure to obtain an extract. Dry and pulverize the extract to make granules for capsules. Alternatively, add pharmaceutical excipients (starch or microcrystalline cellulose) and compress it into tablets or filled capsules.

[0047] Example 6: Preparation of Granules

[0048] Weigh any of the Chinese herbal medicines from Examples 1-5, grind them into a fine powder, decoct them, concentrate them under reduced pressure to obtain an extract, and dry and pulverize the extract to make granules.

[0049] Example 7: Preparation of pills / oral liquids / syrups

[0050] Weigh any of the Chinese herbal medicines from Examples 1-5, grind them into a fine powder, decoct them, take the supernatant, and concentrate it into a thick extract; add appropriate pharmaceutical excipients (white sugar, honey, benzopropionic acid or ethylparaben, etc.) to make pills, oral liquids or syrups.

[0051] Example 8: Clinical Study

[0052] 1. Experimental Methods

[0053] 1.1 Source of Cases

[0054] This clinical study included 104 patients with diabetic peripheral neuropathy (DPN) who presented with symptoms of both qi and yin deficiency and blood stasis. The cases were patients hospitalized in the Department of Endocrinology at Shuguang Hospital affiliated with Shanghai University of Traditional Chinese Medicine between January 2021 and June 2022.

[0055] 1.2 Diagnostic criteria

[0056] 1.2.1 Diagnostic criteria for diabetes

[0057] The diagnostic criteria for diabetes are based on the World Health Organization (WHO) diagnostic criteria for diabetes, which include the following:

[0058] The patient has typical symptoms of diabetes ("three highs and one low" - excessive thirst, excessive hunger, frequent urination, and unexplained weight loss), and fasting plasma glucose (FPG) ≥7.0 mmol / L, or random blood glucose ≥11.1 mmol / L.

[0059] Diabetes can be diagnosed if a patient has no typical symptoms but has a fasting plasma glucose (FPG) ≥7.0 mmol / L, or a 2-hour postprandial glucose (2hPG) ≥11.1 mmol / L in an oral glucose tolerance test (OGTT). Meeting any one of these criteria and repeating the tests will confirm a diagnosis of diabetes.

[0060] 1.2.2 DPN Diagnostic Criteria

[0061] The diagnosis of diabetic peripheral neuropathy (DPN) is based on the diagnostic criteria for DPN 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 occurs at or after the diagnosis of diabetes;

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

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

[0066] 1.2.3 Traditional Chinese Medicine Diagnostic Criteria

[0067] Referring to the "Guidelines for Clinical Diagnosis and Treatment of Diabetic Peripheral Neuropathy in Traditional Chinese Medicine (2016 Edition)" regarding the syndrome of blood stasis in DPN, the main symptoms include numbness and pain in the limbs, and secondary symptoms include tingling in the extremities, which worsens especially in the lower limbs and at night. The tongue and pulse are characterized by a dark tongue, a thin white coating, and a wiry and hesitant pulse.

[0068] 1.3 Inclusion Criteria

[0069] Ages 18-75;

[0070] Meets the above diagnostic criteria for diabetes and has a history of the disease for more than 1 year;

[0071] Glycated hemoglobin (HbA1c) was between 7.0% and 11.0%.

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

[0073] Informed consent has been signed.

[0074] 1.4 Exclusion Criteria

[0075] Neuropathies caused by other etiologies, such as cervical and lumbar spine diseases, cerebral infarction, etc.

[0076] Pregnant or breastfeeding women;

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

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

[0079] Those suffering from severe complications of the heart, liver, kidneys, or other serious diseases.

[0080] 1.5 Treatment Methods

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

[0082] Control group: Basic treatment + thioctic acid tablets (0.3g / tablet), once daily, taken in the morning.

[0083] Basic treatment includes a reasonable diet, exercise therapy, and diabetes education, which should be carried out according to the "Guidelines for the Prevention and Treatment of Type 2 Diabetes in China (2017 Edition)" based on the individual patient's situation. Blood glucose control and treatment plans for chronic complications (such as hypertension and dyslipidemia) should be developed according to the guidelines.

[0084] 1.6 Observation Indicators

[0085] 1.6.1 General Indicators

[0086] During the initial consultation, record the patient's age, body mass index (BMI), duration of diabetes, systolic blood pressure, diastolic blood pressure, and other general clinical data.

[0087] 1.6.2 Main therapeutic indicators

[0088] Glucose metabolism indicators: fasting plasma glucose (FPG), 2-hour postprandial plasma glucose (2hPG), and glycated hemoglobin (HbA1c).

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

[0090] Traditional Chinese Medicine (TCM) syndrome scoring: Record the patient's TCM symptoms, including numbness, tingling, and loss of sensation in the limbs. 1 point is awarded for each symptom, with a total score of 17 points.

[0091] 1.6.3 Secondary efficacy indicators

[0092] Visual analog scale (VAS): Used to assess a patient's subjective perception of pain, scored from 0 to 10, where 0 indicates no pain and 10 indicates severe pain.

[0093] Ankle-brachial index (ABI): Measured using a Doppler flow meter.

[0094] Vibration sensing threshold (VPT): Detects the sensation of vibration 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 were measured before and after treatment. If any adverse events (such as gastrointestinal discomfort) occurred during the trial, medication was immediately discontinued and recorded.

[0100] 1.8 Statistical Methods

[0101] SPSS 24.0 statistical software was used for analysis. All statistical results were analyzed using two-tailed tests, and P < 0.05 was considered statistically significant. Quantitative data were expressed as mean ± standard deviation (Mean ± SD). Paired t-tests were used for within-group comparisons, and independent samples t-tests were used for between-group comparisons.

[0102] 2. Results

[0103] (1) Comparison of glucose metabolism indicators

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

[0105] Table 1. Glucose metabolism indicators

[0106]

[0107] (2) Comparison of neurological symptom scores

[0108] As shown in Table 2, the TCSS and UENS scores in the treatment group decreased significantly after treatment (P<0.05), showing a significant difference compared with the control group.

[0109] Table 2. Neuropathic 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 had a significant effect on improving the symptoms of DPN.

[0113] Table 3. Traditional Chinese Medicine Syndrome Scoring

[0114]

[0115] (4) Safety evaluation

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

[0117] 3. Conclusion:

[0118] The traditional Chinese medicine compound preparation of this invention has a significant therapeutic effect on diabetic peripheral neuropathy. Research results show that patients in the treatment group experienced significant improvements in glucose metabolism, neuropathy symptoms, and TCM syndromes, with good safety profile.

[0119] The preferred embodiments of the present invention have been described in detail above, but the present invention is not limited to the embodiments described. Those skilled in the art can make various equivalent modifications or substitutions without departing from the spirit of the present invention, and these equivalent modifications or substitutions are all included within the scope defined by the claims of this application.

Claims

1. A traditional Chinese medicine composition for invigorating qi and nourishing yin, promoting blood circulation and unblocking collaterals, characterized in that, It is composed of the following raw materials in parts by weight: Coptis chinensis 3-8 parts, Rehmannia glutinosa 10-15 parts, Pueraria lobata 10-20 parts, Panax ginseng 5-10 parts, Paeonia lactiflora 8-12 parts, Glycyrrhiza uralensis (processed) 8-12 parts, Morus alba twigs 10-15 parts, chicken gizzard lining 5-10 parts, Litchi chinensis seed 5-10 parts, Lysimachia christinae 8-12 parts, Curcuma zedoaria 8-12 parts, Corydalis yanhusuo 8-12 parts.

2. The traditional Chinese medicine composition for invigorating qi and nourishing yin, promoting blood circulation and unblocking collaterals according to claim 1, characterized in that, It is composed of the following raw materials in parts by weight: Coptis chinensis 6 parts, Rehmannia glutinosa 12 parts, Pueraria lobata 15 parts, Panax ginseng 6 parts, Paeonia lactiflora 9 parts, Glycyrrhiza uralensis (processed) 9 parts, Morus alba 15 parts, raw chicken gizzard lining 6 parts, Litchi chinensis seed 6 parts, Lysimachia christinae 9 parts, Curcuma zedoaria 9 parts, Corydalis yanhusuo 9 parts.

3. A compound preparation using the traditional Chinese medicine composition for invigorating qi and nourishing yin, promoting blood circulation and unblocking collaterals as described in claim 1 or 2 as an active ingredient, characterized in that, The compound preparation described herein is prepared using conventional methods in the field to form a commonly used dosage form in pharmaceuticals.

4. The compound preparation according to claim 3, characterized in that, The compound preparations mentioned are decoctions, tablets, capsules, granules, pills, oral liquids, or syrups.

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

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

7. The use of a traditional Chinese medicine composition as described in claim 1 or 2, which invigorates qi and nourishes yin, promotes blood circulation and unblocks collaterals, in the preparation of a drug for treating diabetic peripheral neuropathy.

8. The application according to claim 7, characterized in that, The diabetic peripheral neuropathy described herein is a type of diabetic peripheral neuropathy characterized by deficiency of both Qi and Yin, along with blood stasis.

9. The application according to claim 7, characterized in that, The medication described is suitable for the symptoms of pain, numbness, and paresthesia caused by diabetic peripheral neuropathy.

10. The use of a compound preparation as described in any one of claims 3-6 in the preparation of a medicament for treating diabetic peripheral neuropathy.

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