Traditional Chinese medicine preparation for treating hand and foot numbness caused by diabetes as well as preparation method and application of traditional Chinese medicine preparation

Abstract

The invention discloses a traditional Chinese medicine preparation for treating hand and foot numbness caused by diabetes and a preparation method and application thereof, and belongs to the field of traditional Chinese medicine preparations. The traditional Chinese medicine preparation is prepared by the following method: (1) uniformly mixing 15-21 parts by weight of aleppo avens, 27-33 parts by weight of potentilla fruticosa and 2-12 parts by weight of pseudo-ginseng, crushing, and sieving with a 50-mesh sieve to obtain powder; (2) adding the powder obtained in the step (1) into an ethanol aqueous solution with the concentration of 48-52v / v% for dipping and extracting under the conditions that the material-liquid ratio is (1: 8)-(1: 12), the extraction temperature is 40-60 DEG C and the extraction time is 2-4 hours to obtain an extracting solution; (3) filtering the extracting solution obtained in the step (2), and removing ethanol and water from the filtrate to obtain a crude extract; (4) adding petroleum ether into the crude extract obtained in the step (3) for extraction, and removing petroleum ether to obtain a refined product at the lower layer; and (5) taking the refined product in the step (4), and performing spray drying to obtain finished medicinal powder. The traditional Chinese medicine preparation disclosed by the invention can cure hand and foot numbness caused by diabetes mellitus by reducing blood sugar content, dredging blood vessels, strengthening qi and nourishing blood.

Description

Technical Field

[0001] The present invention belongs to the field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine preparation for treating numbness of hands and feet caused by diabetes, its preparation method and application. Background Art

[0002] Diabetes is one of the most serious chronic diseases in the world, which is caused by congenital or acquired defects in insulin secretion and decreased responsiveness of the body to insulin secretion. These defects lead to elevated blood sugar levels, ultimately damaging the nervous and metabolic systems. Diabetics may experience numbness of hands and feet due to various factors such as metabolic abnormalities, vascular damage, oxidative stress, inflammation, and the accumulation of AGEs. Many patients often experience symptoms at night during sleep, waking up due to numbness, or feeling bloated, numb, and stiff in both hands after waking up in the morning, which can be relieved after a little activity.

[0003] Currently, the treatment methods for numbness of hands and feet caused by diabetes mostly focus on reducing blood sugar to relieve symptoms, and the targeted treatment methods are mostly analgesics. For this disease, the efficacy of using a single drug is limited. For example, existing hypoglycemic drugs (such as metformin and insulin) mainly control blood sugar, but have a weak effect on improving neuropathy; although some traditional Chinese medicines (such as astragalus membranaceus and salvia miltiorrhiza) can improve microcirculation, they cannot simultaneously take into account the three key aspects of hypoglycemic, promoting blood circulation, and analgesic when used alone; while combined medication lacks synergy, and existing compound preparations mostly use simple superposition (such as hypoglycemic drugs + blood-activating drugs), without systematically considering the interactions between drugs (such as enhancing efficacy and reducing toxicity); Western medicine analgesics (such as gabapentin) are prone to cause dizziness and drowsiness, while long-term use of traditional blood-activating traditional Chinese medicines (such as ligusticum wallichii) may increase the risk of bleeding. Summary of the Invention

[0004] To solve the above technical problems, the invention provides a traditional Chinese medicine preparation for treating numbness of hands and feet caused by diabetes, which is based on the pathogenesis chain of "glycotoxin-blood stasis-collateral damage", and can effectively treat numbness of hands and feet caused by diabetes through multiple aspects such as reducing blood sugar content in diabetics, improving blood vessel circulation, and reducing swelling and pain, with remarkable curative effects.

[0005] The present invention adopts the following technical solutions:

[0006] The first object of the present invention is to provide a traditional Chinese medicine preparation for treating numbness of hands and feet caused by diabetes, comprising the following raw materials in parts by weight: 15-21 parts of potentilla discolor, 27-33 parts of potentilla fruticosa, and 2-12 parts of notoginseng.

[0007] Preferably, the traditional Chinese medicine preparation for treating numbness of hands and feet caused by diabetes comprises the following raw materials in parts by weight: 18 parts of potentilla discolor, 30 parts of potentilla fruticosa, and 10 parts of notoginseng.

[0008] The second object of the present invention is to provide a preparation method of a traditional Chinese medicine preparation for treating numbness of hands and feet caused by diabetes, and the preparation steps included are as follows:

[0009] (1) Mix the above-mentioned parts by weight of the raw medicinal materials evenly, then pulverize them and pass through a 50-mesh sieve to obtain powder;

[0010] (2) Add the powder obtained in step (1) to an ethanol aqueous solution for impregnation extraction to obtain an extract;

[0011] Preferably, the concentration of the ethanol aqueous solution is 48 - 52 v / v%;

[0012] Preferably, the ratio of material to liquid is 1:8 - 1:12;

[0013] Preferably, the extraction temperature is 40 - 60 °C and the extraction time is 2 - 4 h

[0014] (3) Take the extract obtained in step (2), filter it, and remove ethanol and water from the filtrate to obtain a crude extract;

[0015] (4) Take the crude extract obtained in step (3), add petroleum ether for extraction, remove the petroleum ether, and the lower layer is the refined product;

[0016] (5) Take the refined product obtained in step (4) and perform spray drying to obtain the finished medicine powder.

[0017] Furthermore, the finished medicine powder is further prepared into a preparation according to the conventional techniques in the art, including but not limited to any one of oral liquid, decoction, granule, pill, enema, capsule, suppository, freeze-dried powder.

[0018] The purpose of the third aspect of the present invention is to provide an application of the above-mentioned traditional Chinese medicine preparation of the present invention, and the traditional Chinese medicine preparation is used for preparing a medicine for treating numbness of hands and feet caused by diabetes.

[0019] The beneficial effects of the present invention are as follows: The present invention cures the numbness of hands and feet caused by diabetes by reducing the blood sugar value of diabetic patients and improving microvascular circulation, etc., and avoids the need for multiple drug combinations for patients to relieve pain. In the prior art, the treatment of numbness of hands and feet caused by diabetes mostly focuses on a single target (such as hypoglycemic or analgesic), while ignoring the pathological correlation of "glycemic toxicity - blood stasis - collateral damage". The present invention innovatively formulates the recipe: ① Potentilla fruticosa is used as the monarch drug to directly reduce blood sugar; ② Geum japonicum Thunb. is used as the minister drug to improve microcirculation, synergistically enhance blood sugar reduction and prevent vascular damage; ③ Panax notoginseng is used as the assistant drug to inhibit nerve inflammation and relieve numbness. Experiments have confirmed that the combination of the three drugs can effectively relieve the numbness condition. Detailed implementation mode

[0020] In order to make the purpose, technical solutions and advantages of the present invention clearer, the present invention will be further described in detail below with reference to 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.

[0021] Example:

[0022] Preparation of Traditional Chinese Medicine Preparation

[0023] A traditional Chinese medicine preparation for treating numbness in hands and feet caused by diabetes, the traditional Chinese medicine preparation is composed of raw materials in parts by weight shown in Table 1, and the specific preparation process is as follows, and the process parameters are shown in Table 2:

[0024] (1) Mix all the above-mentioned raw materials in parts by weight evenly, crush them, and pass through a sieve to obtain powder;

[0025] (2) Add the obtained powder to an ethanol aqueous solution with a corresponding concentration for impregnation extraction, the extraction temperature is 40-60 °C, and the extraction time is 2-4 h to obtain an extract;

[0026] (3) Take the extract described in step (2), filter it, and remove ethanol and water from the filtrate to obtain a crude extract;

[0027] (4) Take the crude extract described in step (3), add petroleum ether for extraction, remove the petroleum ether, and the lower layer is the refined product;

[0028] (5) Take the refined product described in step (4), and perform spray drying to obtain the finished powder for treating numbness in hands and feet caused by diabetes.

[0029] Table 1 Dosage of Traditional Chinese Medicine Raw Materials

[0030]

[0031] Table 2 Preparation Process of Traditional Chinese Medicine Composition

[0032]

[0033] After mixing the finished powder in step (5) with appropriate pharmaceutical excipients, it can be made into granule preparations for treating numbness in hands and feet caused by diabetes according to the conventional forming process or filled into capsule shells according to the conventional process to make capsules for treating numbness in hands and feet caused by diabetes.

[0034] Animal Model

[0035] Method: Use STZ (streptozotocin) to induce a diabetic rat model, and evaluate neuropathy (blood glucose, mechanical pain threshold, nerve conduction velocity) after observing for 12 weeks.

[0036] Grouping: Model group, Potentilla fruticosa single drug group, Geum japonicum Thunb. single drug group, Panax notoginseng single drug group, Preparation No. 5 of the traditional Chinese medicine preparation of the present invention.

[0037] The results are shown in Table 3:

[0038] Table 3 Results of Drug Administration in Animal Experiments

[0039] Detection indicators Model group Potentilla fruticosa single drug Geum japonicum Thunb. single drug Notoginseng single drug The preparation of the present invention Blood glucose (mmol / L) 25.6±3.2 18.4±2.1 22.1±2.8 24.3±3.0 15.2±1.8 Mechanical pain threshold (g) 4.2±0.5 5.1±0.6 5.8±0.7 7.3±0.9 9.5±1.1 Nerve conduction velocity (m / s) 28.4±3.1 32.7±3.5 35.2±4.0 36.8±4.2 42.6±4.8

[0040] Conclusion: The hypoglycemic effect of the traditional Chinese medicine preparation of the present invention is better than that of Potentilla fruticosa L. alone. Its analgesic and nerve repair effects are significantly stronger than those of single drugs and the model group.

[0041] Clinical effects of patients

[0042] Patient Yuan XX (Test Example 1), female, 61 years old, with a 12-year history of diabetes. Due to the continuous increase in blood glucose levels without decline, she suffered from numbness in hands and feet for 2 years. According to the dosage of one dose of the preparation in Serial No. ① of Table 1 for the traditional Chinese medicine preparation per day, each dose was taken three times before meals, and 30 doses were continuously taken as one course of treatment. The recovery of the disease was evaluated from the sensory perception of numbness in hands and feet and blood glucose indicators. The specific sensory evaluation indicators for numbness in hands and feet are shown in Table 4, and the treatment results are shown in Table 5. According to the treatment results, after 2 courses of treatment, the blood glucose level returned to normal, and the symptoms of numbness in hands and feet completely disappeared, achieving complete cure.

[0043] Table 4 Sensory evaluation indicators for numbness in hands and feet

[0044]

[0045] Table 5 Treatment results of Test Example 1

[0046]

[0047]

[0048] Meanwhile, according to the feedback of Test Example 1, there were no adverse reactions.

[0049] Patient Zhou XX (Test Example 2), male, 62 years old, with an 8-year history of diabetes. Due to the continuous increase in blood glucose levels without decline, he suffered from numbness in hands and feet for 1 year. According to the dosage of one dose of the preparation in Serial No. ② of Table 1 for the traditional Chinese medicine preparation per day, each dose was taken three times before meals, and 40 doses were continuously taken as one course of treatment. The recovery of the disease was evaluated from the sensory perception of numbness in hands and feet and blood glucose indicators. The treatment results are shown in Table 6. According to the treatment results, after 1 course of treatment, the blood glucose level returned to normal, and the symptoms of numbness in hands and feet completely disappeared, achieving complete cure.

[0050] Table 6 Treatment results of Test Example 2

[0051] Medication cycle Not taking medicine Half a course of treatment (20 doses) 1 course of treatment (40 doses) Blood glucose value (mmol / L) 16.5 10.3 5.4 Condition of numbness in hands and feet 4 3 1

[0052] Meanwhile, according to the feedback of Test Example 2, there were no adverse reactions.

[0053] Patient Liu (Test Example 3), male, 70 years old, has a history of diabetes for 20 years. He has numbness of hands and feet for 3 years due to elevated blood sugar levels that have not decreased. According to the Chinese medicine preparation table 1, serial number ③ preparation is prepared in one dose per day, each dose is taken three times before meals, and 50 doses are taken continuously as a course of treatment. After 2 courses of treatment, the blood sugar level returns to normal, the symptoms of numbness of hands and feet completely disappear, and complete recovery is achieved. The recovery of the symptoms is evaluated from the numbness of hands and feet senses and blood sugar indicators, and the treatment results are shown in Table 7. According to the treatment results, the blood sugar level returns to normal after 2 courses of treatment, the symptoms of numbness of hands and feet completely disappear, and complete recovery is achieved.

[0054] Table 7 Treatment results of test example 3

[0055] Medication cycle Not taking medicine 1 course of treatment (50 doses) 2 courses of treatment (100 doses) Blood glucose value (mmol / L) 14.5 8.3 5.0 Condition of numbness in hands and feet 4 3 1

[0056] Meanwhile, according to the reaction of Test Example 3, no adverse reaction occurred.

[0057] The pharmacological effects of various Chinese medicinal raw materials involved in the Chinese medicinal composition of the embodiment of the present invention are as follows:

[0058] Potentilla fruticosa L., a deciduous shrub belonging to the genus Potentilla in the family Rosaceae, is also known as golden old plum, golden winter plum, and Yaowang tea. It is a commonly used medicinal material in Tibetan medicine, and its Tibetan name is Banna. Modern research has found that Potentilla fruticosa mainly contains chemical components such as flavonoids, triterpenes, polysaccharides, tannins, and quinones. Pharmacological studies have shown that Potentilla fruticosa improves insulin sensitivity by inhibiting α-glucosidase and activating the AMPK pathway; it scavenges free radicals and reduces oxidative stress damage caused by hyperglycemia. It can effectively reduce blood sugar in patients.

[0059] Lanbuzheng, a Chinese medicine name. It is the dried whole herb of Geum aleppicum Jacq. or Geumjaponicum Thunb.var.chinense Bolle, a plant of the Rosaceae family. Common aliases include Chasing Wind Seven, Five Qi Chaoyang Grass, Red Heart Grass, Water Bayberry, Dizziness Medicine, and Roadside Yellow. It has the effects of invigorating qi and strengthening the spleen, nourishing blood and yin, moistening the lungs and resolving phlegm. It is often used for insufficient qi and blood, consumptive cough, and leukorrhea due to spleen deficiency. The main active ingredients are tannic acids, organic acids, and polysaccharides, which reduce blood viscosity and increase capillary blood flow velocity; by regulating GLUT4 transport, it enhances the hypoglycemic effect of Golden Pot. It can improve the patient's vascular circulation and enhance qi and blood.

[0060] Panax notoginseng, a Chinese medicine name. It is the dried root of Panax notoginseng (Burk.) FHChen of the Araliaceae family. It has the effects of removing blood stasis and stopping bleeding, promoting blood circulation and relieving pain. It is mainly used to treat bleeding, traumatic injuries, and blood stasis and swelling. The main active ingredients are saponins, flavonoids and polysaccharides, which can inhibit TNF-α and IL-6 inflammatory factors, reduce neuroinflammation; promote the secretion of nerve growth factor (NGF) and repair damaged nerves. It can have an analgesic effect on patients.

[0061] In the Chinese medicine composition of the present invention, Herba Citri Reticulatae is used as the main drug, and its active ingredients (such as flavonoids) can directly play a hypoglycemic effect by inhibiting the activity of α-glucosidase and promoting insulin secretion; Herba Citri Reticulatae is used as the auxiliary drug, which synergistically enhances the hypoglycemic effect of Herba Citri Reticulatae by improving microcirculation and reducing blood viscosity, and relieves the common symptoms of poor blood circulation in diabetic patients; Panax Notoginseng is used as an adjuvant, and it effectively improves numbness of hands and feet caused by peripheral neuropathy by virtue of the anti-inflammatory and analgesic effects of saponin components. After the three drugs are combined, a synergistic system of "reducing blood sugar, activating blood circulation, and unblocking collaterals" is formed. Research data show that the symptom relief is significantly improved compared with the use of each single drug alone, and no obvious adverse reactions are observed, which reflects the comprehensiveness of functional complementarity and treatment target coverage.

[0062] The safety of each Chinese medicine raw material involved in the Chinese medicine composition of the present invention:

[0063] Lanbuzheng: Lanbuzheng as the main active ingredient of drugs have been launched, such as Lanzhi Annao Capsules (approval number: National Medicine Standard Z20043647), and the drug is an over-the-counter drug, and its safety has been proven in many years of clinical application. At the same time, Lanbuzheng has in-hospital preparations launched in Yunnan Province and Hunan Province, and no adverse events have been reported.

[0064] Potentilla fruticosa: Hospitals in Qinghai, Tibet and other places may use it as an in-hospital formula for gastroenteritis and trauma hemostasis, and its good safety has been proven in many years of clinical application.

[0065] Panax notoginseng: There are many drugs on the market with Panax notoginseng as the main active ingredient, including Panax notoginseng tablets (national medicine standard number Z22024469, etc.), Panax notoginseng hemostatic capsules (national medicine standard number Z20050521), Panax notoginseng capsules (national medicine standard number Z20054644), etc. They are widely used in clinical practice and have good safety.

[0066] Based on the implementation mode of the present invention, the present invention proposes "three-target synergistic intervention" for the first time: Herba Citri Reticulatae (main drug) targets "sugar toxicity" and directly lowers blood sugar by inhibiting α-glucosidase and AMPK activation; Herba Citri Reticulatae (minister drug) targets "blood stasis", improves microcirculation, enhances the hypoglycemic effect of Herba Citri Reticulatae and prevents vascular complications; Panax Notoginseng (adjuvant drug) targets "collateral damage", reduces neuroinflammation by inhibiting TNF-α and IL-6, and directly relieves numbness. The therapeutic effect is significant.

[0067] Although the embodiments of the present invention have been disclosed, it is not limited to the applications listed in the specification and embodiments. It can be fully applied to various fields suitable for the present invention. For those familiar with the field, under the general concept defined by the equivalent scope, the present invention is not limited to implementing additional modifications. Therefore, without departing from the claims and specific details.

Claims

1. A traditional Chinese medicine preparation for treating numbness in hands and feet caused by diabetes, characterized in that, The traditional Chinese medicine preparation comprises the following raw medicinal materials in parts by weight: 15 - 21 parts of Potentilla discolor, 27 - 33 parts of Potentilla fruticosa, and 2 - 12 parts of Panax notoginseng.

2. The traditional Chinese medicine preparation for treating numbness of hands and feet caused by diabetes according to claim 1, wherein Comprises the following raw medicinal materials in parts by weight: 18 parts of Potentilla discolor, 30 parts of Potentilla fruticosa, and 10 parts of Panax notoginseng.

3. The preparation method of the traditional Chinese medicine preparation for treating numbness of hands and feet caused by diabetes according to claim 1, characterized in that, Comprises the following steps: (1) Mix the following raw medicinal materials in parts by weight: 15 - 21 parts of Potentilla discolor, 27 - 33 parts of Potentilla fruticosa, and 2 - 12 parts of Panax notoginseng evenly, then crush and pass through a 50 - mesh sieve to obtain a powder. (2) Add the powder obtained in step (1) to an ethanol aqueous solution with a concentration of 48 - 52 v / v% for impregnation extraction, with a material - liquid ratio of 1:8 - 1:12, an extraction temperature of 40 - 60 °C, and an extraction time of 2 - 4 h to obtain an extract. (3) Take the extract described in step (2), filter it, and remove ethanol and water from the filtrate to obtain a crude extract. (4) Take the crude extract described in step (3), add petroleum ether for extraction, remove the petroleum ether, and the lower layer is the refined product. (5) Take the refined product described in step (4), and obtain the finished medicine powder by spray - drying.

4. The preparation method of the traditional Chinese medicine preparation for treating numbness of hands and feet caused by diabetes according to claim 3, characterized in that, In step (1), the parts by weight of the raw medicinal materials are: 18 parts of Potentilla discolor, 30 parts of Potentilla fruticosa, and 10 parts of Panax notoginseng.

5. The preparation method of the traditional Chinese medicine preparation for treating numbness of hands and feet caused by diabetes according to claim 3, characterized in that, In step (2), the concentration of the ethanol aqueous solution is 50 v / v%, the material - liquid ratio is 1:10, the extraction temperature is 50 °C, and the extraction time is 3 h.

6. Use of the traditional Chinese medicine preparation according to claim 1 or 2, characterized in that, The traditional Chinese medicine preparation is used for preparing a dosage form for treating numbness of hands and feet caused by diabetes, including but not limited to any one of oral liquid, decoction, granule, pill, enema, capsule, suppository, and freeze - dried powder.

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