Traditional Chinese medicine composition for treating diabetic peripheral neuropathy as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention discloses a traditional Chinese medicine composition for treating diabetic peripheral neuropathy. The traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 20-40 parts of astragalus membranaceus, 10-20 parts of angelica sinensis, 8-15 parts of cassia twig, 8-15 parts of red paeony root, 15-30 parts of caulis spatholobi, 5-10 parts of tetrapanax papyriferus, 3-6 parts of scorpio and 1-3 parts of centipede.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, and in particular to a traditional Chinese medicine composition for treating diabetic peripheral neuropathy, its preparation method, and its uses. Background Technology

[0002] Diabetic peripheral neuropathy (DPN) is one of the most common chronic complications of type 2 diabetes, with a high prevalence. It can cause limb pain, numbness, and paresthesia, and in severe cases, foot ulcers or even amputation, significantly reducing patients' quality of life. Current Western medicine treatments mainly involve controlling blood sugar, nourishing nerves (such as methylcobalamin), using antioxidants (such as alpha-lipoic acid), blocking aldose reductase activity (such as epalrestat), improving microcirculation (such as pancreatic kallikrein), and symptomatic pain relief. However, these methods suffer from significant individual differences in efficacy, drug resistance to some medications, and adverse reactions.

[0003] Traditional Chinese medicine (TCM) has accumulated rich experience in the prevention and treatment of diabetic neuropathy (DPN), believing that its pathogenesis is mostly due to "qi deficiency and blood stasis, and obstruction of the meridians." Treatment is primarily based on the principles of tonifying qi and promoting blood circulation, removing blood stasis and unblocking the meridians. Under this principle, many TCM compound formulas have been developed. Although existing formulas provide various treatment options, clinical practice still needs new TCM regimens with more significant efficacy, more comprehensive target action, and better improvement of nerve conduction function. Summary of the Invention

[0004] Therefore, this invention provides a traditional Chinese medicine composition for treating diabetic peripheral neuropathy, its preparation method and uses, which has a definite curative effect and can be used to treat type 2 diabetic peripheral neuropathy, solving the problems of insufficient efficacy and insignificant improvement in nerve conduction velocity of existing treatments.

[0005] To achieve the objectives of this invention, the following technical solution is adopted: A traditional Chinese medicine composition for treating diabetic peripheral neuropathy, wherein the traditional Chinese medicine composition is made from the following raw materials in parts by weight: Astragalus membranaceus 20-40 parts, Angelica sinensis 10-20 parts, Cinnamomum cassia 8-15 parts, Paeonia lactiflora 8-15 parts, Spatholobus suberectus 15-30 parts, Tetrapanax papyriferus 5-10 parts, Buthus martensii 3-6 parts, and Scolopendra subspinipes 1-3 parts.

[0006] The traditional Chinese medicine composition is made from the following raw materials in parts by weight: Astragalus membranaceus 30 parts, Angelica sinensis 15 parts, Cinnamomum cassia 10 parts, Paeonia lactiflora 10 parts, Spatholobus suberectus 20 parts, Tetrapanax papyriferus 6 parts, Buthus martensii 5 parts, and Scolopendra subspinipes 2 parts.

[0007] The preparation method of the traditional Chinese medicine composition includes the following steps: weigh each raw material according to the ratio, add water and decoct for 1.5 hours, filter out the decoction; add water to the residue again and decoct for 1 hour, filter out the decoction; combine the two decoctions.

[0008] The preparation method involves filtering and concentrating the combined decoction into a thick paste, mixing the thick paste with excipients, and granulating it using wet granulation technology to produce granules.

[0009] In the preparation method described above, the relative density of the viscous paste is 1.35-1.40.

[0010] The use of the traditional Chinese medicine composition described herein, or the traditional Chinese medicine composition prepared by the method described herein, in the preparation of a drug for treating diabetic peripheral neuropathy. Detailed Implementation

[0011] The specific embodiments of the present invention will be described in detail below. Obviously, the described embodiments are merely some, not all, of the embodiments of the present invention. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without creative effort are within the scope of protection of the present invention. The embodiments described are exemplary and are only used to explain the present invention, and should not be construed as limiting the present invention.

[0012] Example 1: Traditional Chinese Medicine Composition A traditional Chinese medicine composition for treating diabetic peripheral neuropathy, the composition being made from the following raw materials: Astragalus membranaceus, Angelica sinensis, Cinnamomum cassia, Paeonia lactiflora, Spatholobus suberectus, Tetrapanax papyriferus, Buthus martensii, and Scolopendra subspinipes.

[0013] The weight ratio of each raw material (1 gram per part) is as follows: Astragalus membranaceus 20-40 parts, Angelica sinensis 10-20 parts, Cinnamomum cassia 8-15 parts, Paeonia lactiflora 8-15 parts, Spatholobus suberectus 15-30 parts, Tetrapanax papyriferus 5-10 parts, Buthus martensii 3-6 parts, Scolopendra subspinipes 1-3 parts.

[0014] Preferably, the weight parts of each raw material are: 30 parts of Astragalus membranaceus, 15 parts of Angelica sinensis, 10 parts of Cinnamomum cassia, 10 parts of Paeonia lactiflora, 20 parts of Spatholobus suberectus, 6 parts of Tetrapanax papyriferus, 5 parts of Buthus martensii, and 2 parts of Scolopendra subspinipes.

[0015] Based on traditional Chinese medicine theory, this invention creatively constructs a three-dimensional treatment method for DPN that addresses the root cause of the disease (Qi deficiency as the root cause and blood stasis and meridian obstruction as the symptoms) by "tonifying Qi and nourishing blood to treat the root cause, promoting blood circulation and relaxing muscles to treat the symptoms, and using insect-based medicines to dispel wind and unblock meridians to relieve pain."

[0016] Fang Zhong: Astragalus and Angelica sinensis are the principal herbs, forming the classic "Astragalus-Angelica sinensis pair," which together greatly replenish vital energy, nourish blood and promote blood circulation, targeting the root cause of the disease "qi deficiency and blood stasis."

[0017] Cinnamon twig, red peony root, and chicken blood vine are the assistant herbs. Cinnamon twig warms and unblocks the meridians, assisting astragalus in promoting the circulation of qi and blood; red peony root clears heat, cools the blood, disperses blood stasis, and relieves pain; chicken blood vine invigorates blood, nourishes blood, relaxes muscles and tendons. The combination of these three herbs enhances the effects of invigorating blood, removing blood stasis, and unblocking the meridians. The antioxidant properties of chicken blood vine help alleviate oxidative stress damage caused by DPN.

[0018] Scorpion, centipede, and tetrapanax papyriferus are used as adjuvant herbs. Scorpion and centipede are insect-based medicines, known for their penetrating and dispersing properties, particularly effective in dispelling wind, clearing the channels, relieving spasms, and alleviating pain. They are especially beneficial for "stubborn numbness and pain" caused by long-term illness and deep-seated obstruction in the channels. Modern research suggests that the active ingredients derived from scorpion have neuroprotective potential. Tetrapanax papyriferus clears heat and promotes diuresis, and in this formula, it also has the unique function of guiding other herbs into the channels to relieve pain.

[0019] This invention focuses on invigorating Qi and promoting blood circulation, dispelling wind and unblocking the meridians. Building upon this foundation, it emphasizes the use of insect-based medicines (scorpion and centipede) to "search out" deeply hidden pathogens, resulting in a strong effect in unblocking the meridians and relieving pain. It also invigorates Qi and nourishes Yin, detoxifies and removes blood stasis. The emphasis is on simultaneously replenishing both Qi and Yin, while also clearing damp-heat and toxins. The treatment method directly targets the key pathological link of "meridian obstruction," which leads to numbness and pain, resulting in a stronger effect in unblocking the meridians.

[0020] The core formula consists of Astragalus and Angelica sinensis, Cinnamomum cassia and Paeonia lactiflora, Scorpion / Scolopendra subspinipes, and Tetrapanax papyriferus. This forms a complete chain of "tonifying Qi and nourishing blood, promoting blood circulation and removing blood stasis, warming and unblocking the meridians, dispelling wind and unblocking collaterals, and guiding the medicine into the collaterals." The innovative introduction of the "Scorpion-Scolopendra subspinipes" insect pair, along with Tetrapanax papyriferus as a guide, is a significant difference in the formula's structure.

[0021] Number of medicinal ingredients: 8. The formula is more refined while ensuring efficacy.

[0022] Efficacy and Features: It excels at clearing blockages and relieving pain, and improving nerve conduction. Clinical data shows a significant effect on increasing nerve conduction velocity. It is also effective in improving symptoms and regulating the body's metabolic function. This invention has a greater advantage in improving objective electrophysiological indicators (nerve conduction velocity), providing a different therapeutic focus.

[0023] Example 2: Preparation of a Traditional Chinese Medicine Composition (Decoction) Weigh out 30g of Astragalus membranaceus, 15g of Angelica sinensis, 10g of Cinnamomum cassia, 10g of Paeonia lactiflora, 20g of Spatholobus suberectus, 6g of Tetrapanax papyriferus, 5g of Buthus martensii, and 2g of Scolopendra subspinipes.

[0024] After cleaning and mixing the above-mentioned medicinal materials, add 10 times the weight of the total medicinal materials in drinking water (approximately 980 mL), soak for 30 minutes, bring to a boil over high heat, then simmer over low heat for 1.5 hours, and filter out the liquid. Add 8 times the weight of the total medicinal materials in water to the dregs again, decoct for 1 hour, and filter out the liquid. Combine the two decoctions, filter through a 200-mesh sieve, and concentrate the filtrate under reduced pressure at 60°C to approximately 150 mL to obtain the decoction.

[0025] Example 3: Preparation of Traditional Chinese Medicine Composition (Granules) Aqueous decoction was prepared according to the proportions and decoction method of Example 2 and filtered. The combined filtrates were concentrated to a thick paste with a relative density of 1.35-1.40 (60°C). The thick paste was mixed with appropriate amounts of dextrin, soluble starch and other excipients, granulated using wet granulation technology, dried, sized, and packaged into individual bags.

[0026] Experimental example: 1. Subjects: 104 patients meeting the diagnostic criteria for type 2 diabetic peripheral neuropathy admitted to Fenyang Traditional Chinese Medicine Hospital, Shanxi Province, from June 2023 to May 2025 were randomly divided into a Traditional Chinese Medicine group (treatment group using the drugs of this invention) and a Western Medicine group (epalrestat tablet control group), with 52 patients in each group. There were no statistically significant differences between the two groups in terms of age, gender, disease duration, etc. (P>0.05), making them comparable. All patients received basic routine diabetes treatment (blood glucose control, dietary and exercise guidance).

[0027] 2. Treatment methods: All patients received standard treatment, including blood glucose control with hypoglycemic agents, dietary and exercise guidance, and intravenous infusion of alpha-lipoic acid 600mg + 250ml normal saline once daily for two weeks.

[0028] Western medicine group: Oral epalrestat tablets, 50mg each time, 3 times a day.

[0029] Traditional Chinese Medicine Group: Take the decoction prepared by the method in Example 2 of this invention orally, one dose per day, divided into two administrations.

[0030] Treatment duration: Both groups received continuous treatment for 4 weeks.

[0031] 3. Observation indicators and results: Four weeks after treatment, the efficacy indicators of the two groups of patients were compared, and the key results are summarized below: Comparison of key clinical efficacy indicators (after 4 weeks of treatment) I. Main therapeutic indicators 1. Total score of TCM syndrome The score in the Traditional Chinese Medicine group decreased from (22.37±2.87) to (9.47±2.06). Western medicine group: score decreased from (22.55±2.89) to (10.94±2.19). Intergroup comparison: The score of the Traditional Chinese Medicine group was significantly lower than that of the Western Medicine group (P<0.05). 2. Sensory conduction velocity (SCV) of the posterior tibial nerve The speed of the Traditional Chinese Medicine group increased from (28.56±2.45) m / s to (35.94±3.37) m / s. Western medicine group: increased from (28.17±2.38) m / s to (32.07±3.11) m / s Intergroup comparison: The SCV in the Traditional Chinese Medicine group was significantly higher than that in the Western Medicine group (P<0.001). 3. Common peroneal nerve motor conduction velocity (MCV) The speed of the Traditional Chinese Medicine group increased from (30.22±3.24) m / s to (41.76±4.31) m / s. Western medicine group: increased from (30.68±3.37) m / s to (38.52±3.95) m / s Intergroup comparison: The MCV of the TCM group was significantly higher than that of the Western medicine group (P<0.001). II. Secondary therapeutic indicators Improved blood rheology After treatment, the levels of indicators such as whole blood viscosity (low shear) and erythrocyte sedimentation rate (ESR) in the TCM group were significantly lower than those in the Western medicine group (P<0.05).

[0032] Serum factor regulation Endothelin-1 (ET-1): The level in the TCM group decreased to (32.16±3.35) pg / mL, while that in the Western medicine group decreased to (35.17±3.58) pg / mL. The level in the TCM group was even lower (P<0.001).

[0033] Nitric oxide (NO): The concentration in the TCM group increased to (4.02±0.61) μmol / L, while that in the Western medicine group increased to (3.42±0.57) μmol / L. The concentration in the TCM group was even higher (P<0.001).

[0034] Propylene glycol (MDA): The level decreased to (3.34±1.03) mmol / L in the TCM group and (4.11±1.08) mmol / L in the Western medicine group, with the TCM group showing the lowest level (P<0.001).

[0035] III. Safety Indicators Incidence of adverse reactions: In the Traditional Chinese Medicine group, 2 cases of diarrhea and 1 case of dizziness occurred; in the Western Medicine group, 2 cases of nausea and vomiting, 3 cases of diarrhea, 1 case of drowsiness, and 1 case of dizziness occurred. There was no statistically significant difference in the incidence of adverse reactions between the two groups (P=0.183), and all were mild and did not affect treatment.

[0036] Conclusion: The above clinical data fully demonstrate that the traditional Chinese medicine composition provided by the present invention shows a superior trend in efficacy compared with the classic Western medicine epalrestat in improving the clinical symptoms of patients with type 2 diabetic peripheral neuropathy, increasing nerve conduction velocity, improving blood rheology, regulating oxidative stress and endothelial function-related serum factors, and has good safety.

[0037] The above are merely preferred embodiments of the present invention and are not intended to limit the present invention in any way. Although the present invention has been disclosed above with reference to preferred embodiments, it is not intended to limit the present invention. Any person skilled in the art can make some modifications or alterations to the above-disclosed technical content to create equivalent embodiments without departing from the scope of the present invention. Any simple modifications, equivalent changes and alterations made to the above embodiments based on the technical essence of the present invention without departing from the scope of the present invention shall still fall within the scope of the present invention.

Claims

1. A traditional Chinese medicine composition for treating diabetic peripheral neuropathy, characterized in that: The traditional Chinese medicine composition is made from the following raw materials in parts by weight: Astragalus membranaceus 20-40 parts, Angelica sinensis 10-20 parts, Cinnamomum cassia 8-15 parts, Paeonia lactiflora 8-15 parts, Spatholobus suberectus 15-30 parts, Tetrapanax papyriferus 5-10 parts, Buthus martensii 3-6 parts, and Scolopendra subspinipes 1-3 parts.

2. The traditional Chinese medicine composition according to claim 1, characterized in that: The traditional Chinese medicine composition is made from the following raw materials in parts by weight: Astragalus membranaceus 30 parts, Angelica sinensis 15 parts, Cinnamomum cassia 10 parts, Paeonia lactiflora 10 parts, Spatholobus suberectus 20 parts, Tetrapanax papyriferus 6 parts, Buthus martensii 5 parts, and Scolopendra subspinipes 2 parts.

3. A method for preparing the traditional Chinese medicine composition as described in claim 1 or 2, characterized in that... The process includes the following steps: weigh each raw material according to the ratio, add water and decoct for 1.5 hours, then filter out the liquid; add water to the dregs again and decoct for 1 hour, then filter out the liquid; combine the two decoctions.

4. The preparation method according to claim 3, characterized in that, The combined decoction was filtered and concentrated into a thick paste. The thick paste was then mixed with excipients and granulated using wet granulation technology to produce granules.

5. The preparation method according to claim 4, characterized in that: The relative density of the thick paste is 1.35-1.

40.

6. The use of the traditional Chinese medicine composition according to any one of claims 1 to 2 or the traditional Chinese medicine composition prepared by the preparation method according to any one of claims 4 to 5 in the preparation of a medicament for treating diabetic peripheral neuropathy.