CN115054649B - A Chinese medicinal composition for treating diabetic peripheral neuropathy, and its preparation method - Google Patents

Abstract

The invention belongs to the technical field of diabetes medicines, and in particular relates to a traditional Chinese medicine composition for treating diabetic peripheral neuropathy and a preparation method thereof, wherein the composition comprises the following main components in parts by weight: 20-30 parts of Chinese yam, 20-30 parts of astragalus membranaceus, 12-18 parts of ligusticum wallichii, 9-15 parts of angelica sinensis, 12-18 parts of radix paeoniae rubra, 9-15 parts of cassia twig, 25-35 parts of caulis spatholobi, 20-40 parts of ramulus mori, 20-40 parts of radix cyathulae, 9-20 parts of earthworm, 3-9 parts of leech, 9-20 parts of ground beetle, 15-25 parts of winged euonymus twig, 12-18 parts of cortex moutan, 20-30 parts of semen vaccariae, and 20-30 parts of qi-tonifying medicaments matched with blood-activating medicaments, wherein the qi-invigorating and blood-activating medicaments are effective in invigorating the circulation of blood without hurting the vital energy, and have remarkable curative effects on improving the symptoms, signs, life quality and the like of patients of diabetic peripheral neuropathy.

Description

A Chinese medicinal composition for treating diabetic peripheral neuropathy, and its preparation method

Technical Field

The invention belongs to the technical field of diabetes medicines, and in particular relates to a traditional Chinese medicine composition for treating diabetic peripheral neuropathy and a preparation method thereof.

Background

Diabetic Peripheral Neuropathy (DPN) refers to the occurrence of symptoms and/or signs associated with peripheral nerve dysfunction in diabetics, exclusive of other causes. Common symptoms are numbness of the limbs, pain, burning or other abnormal sensations. Asymptomatic diabetic neuropathy can be diagnosed by physical screening, such as muscle weakness and atrophy, regional superficial sensory decline of the limb, reduced or absent lumbar reflex, or the like, or by neurophysiologic examination. DPN is related to factors such as diabetes mellitus course, blood sugar control and the like, 50% of patients have obvious peripheral neuropathy in the course of more than 10 years, ulcers or gangrene can be formed in serious patients, amputation is finally selected, the life quality of the patients is seriously reduced, and heavy burden is brought to families, society and economy of the patients. Therefore, prevention and control of DPN has become one of the important topics of research and attack worldwide.

Because of the complex pathogenesis of peripheral neuropathy of diabetes, no specific therapy exists at home and abroad at present, western medicine treatment mainly adopts symptomatic treatment such as blood sugar control, nerve repair, antioxidation stress, microcirculation improvement, metabolic disturbance and the like, and has a plurality of unsatisfactory clinical effects.

Today, where traditional Chinese medicines are increasingly prosperous, a great deal of research has demonstrated that traditional Chinese medicines exert an unparalleled advantage in the treatment of diabetic peripheral neuropathy. Therefore, the exploration of an effective traditional Chinese medicine composition for preventing and treating diabetic peripheral neuropathy becomes a difficult problem for Chinese medical workers and is also the direction of research.

Disclosure of Invention

Aiming at the current situation that a unified and effective treatment scheme for preventing and treating diabetic peripheral neuropathy is not available in traditional Chinese medicine, the invention provides a traditional Chinese medicine composition for treating diabetic peripheral neuropathy and a preparation method thereof.

The diabetic peripheral neuropathy belongs to the category of 'arthromyodynia' complicated with chronic diabetes in traditional Chinese medicine according to the symptoms, and is called 'diabetes arthromyodynia', and the basic pathogenesis is based on deficiency, phlegm turbidity and blood stasis. From clinical manifestations, diabetic peripheral neuropathy usually manifests as limb weakness, numbness, ant circulation, limb swelling and pain, stabbing pain, lower limb, severe night pain, limb drowsiness, shortness of breath, lazy speaking, diarrhea or constipation, etc., which suggest that the present inventors have phlegm stasis blocking collaterals, and qi-blood unsmooth is actually the main mechanism of diabetic peripheral neuropathy. Diabetes is mainly caused by congenital or acquired factors, such as excessive yin deficiency, dryness-heat generation caused by yin deficiency, yin impairment and qi consumption, qi and yin deficiency, qi and body fluid movement, body fluid and blood generation, qi and yin deficiency failing to promote blood circulation or body fluid movement, and heat evil burning into phlegm and stasis, which causes internal obstruction of phlegm, body fluid stagnation and qi stagnation, blood stasis and other obstruction tendons and vessels, "pain in general" and limb pain and swelling, skin and skin mania-error: the body fluid can carry gas and nourish qi, and the longer the yin deficiency is, the qi deficiency is affected, the cloudy qi is not enough, the tingling is usually referred to as ant moving feeling and electric shock feeling, and the qi and blood homology, the qi deficiency and the qi deficiency are used for generating blood, the blood is not good for wood, the wood is referred to as skin is not good, such as thick wood feeling, and the hundred-bone limbs are lost in the nourishment of qi, blood and body fluid, and numbness, such as ant moving and hypoesthesia are caused; cold is generated due to yin impairment and yang deficiency, and the tendons and vessels are lost to the warming or congealing cold to blood vessels to form stasis, so that the limbs can be cooled; qi can promote blood circulation and take blood, qi deficiency can promote weakness, blood circulation is unsmooth, dryness-heat is generated internally, heat is forced to circulate blood and overflow vessels, blood stasis is caused, collaterals are blocked to form blood arthralgia, and serious consequences such as limb flaccidity, disuse and the like even occur.

The inventor combines the traditional medical theory of the traditional Chinese medicine, from the physiological functions of qi and blood to the basic pathogenesis of the peripheral neuropathy of diabetes, and combines the clinical practice process to find that the prescription medicine taking the principles of tonifying qi and nourishing yin, resolving phlegm and removing stasis and dredging collaterals is used for treating the patients meeting the characteristics of the pathogenesis of the qi and yin deficiency and phlegm stasis of traditional Chinese medicine in the peripheral neuropathy of diabetes, especially for improving symptoms such as limb weakness, numbness, swelling and pain and the like obviously and improving the physiological functions of the electric nerves obviously. The invention provides a traditional Chinese medicine composition for treating diabetic peripheral neuropathy, which is prepared by adding Chinese yam, cassia twig, suberect spatholobus stem, mulberry twig, medicinal cyathula root, leech, eupolyphaga, winged euonymus twig, moutan bark, cowherb seed and other medicines into the decoction of Buyang Huangwu, and matching the qi-tonifying medicines with blood-activating medicines, wherein the qi-invigorating medicines and the blood-activating medicines are matched, so that the qi-invigorating and blood-activating functions are achieved without hurting the vital energy, and the Chinese medicine composition has remarkable curative effects on improving diabetic peripheral neuropathy symptoms and physical signs, improving the life quality of patients and the like.

In conclusion, the inventor finally discovers that the treatment of the peripheral neuropathy of diabetes is a main link and a main contradiction, and considers that qi-tonifying, yin-nourishing, phlegm-resolving, stasis-removing and vein relaxing are key. In clinic, more patients with deficiency of both qi and yin and blood stasis syndrome should pay attention to tonifying qi and activating blood based on treatment based on differentiation of symptoms, and qi hyperactivity promotes blood circulation without hurting healthy energy, which is a treatment mechanism proposed by the inventor and applied to a specific treatment process:

based on the treatment mechanism, the specific technical scheme provided by the invention is as follows in combination with the action mechanism of related medicines:

a traditional Chinese medicine composition for treating diabetic peripheral neuropathy comprises the following main components in parts by weight:

20-30 parts of Chinese yam, 20-30 parts of astragalus membranaceus, 12-18 parts of ligusticum wallichii, 9-15 parts of angelica sinensis, 12-18 parts of radix paeoniae rubra, 9-15 parts of cassia twig, 25-35 parts of caulis spatholobi, 20-40 parts of ramulus mori, 20-40 parts of radix cyathulae, 9-20 parts of earthworm, 3-9 parts of leech, 9-20 parts of ground beetle, 15-25 parts of winged euonymus twig, 12-18 parts of cortex moutan and 20-30 parts of semen vaccariae;

the best therapeutic effect can be obtained within the dosage range, and excessive or insufficient dosage of the medicine can lead to the primary and secondary changes of the pathogenesis surrounded by the prescription.

Preferably, the traditional Chinese medicine composition comprises the following main components in parts by weight:

21-29 parts of Chinese yam, 21-29 parts of astragalus membranaceus, 13-19 parts of ligusticum wallichii, 10-14 parts of angelica sinensis, 13-17 parts of radix paeoniae rubra, 10-14 parts of cassia twig, 26-34 parts of caulis spatholobi, 21-39 parts of ramulus mori, 21-39 parts of radix cyathulae, 10-19 parts of earthworm, 4-8 parts of leech, 10-19 parts of ground beetle, 16-24 parts of winged euonymus twig, 13-17 parts of cortex moutan and 21-29 parts of semen vaccariae.

The prescription of the invention takes astragalus and yam as the monarch, astragalus and is sweet and slightly warm, has the effects of tonifying spleen and lung qi, tonifying qi and consolidating exterior, enriching blood and activating blood, and also has the effects of raising yang and lifting sinking, tonifying primordial qi of spleen and stomach, invigorating qi and strengthening blood circulation, removing blood stasis and dredging collaterals; rhizoma Dioscoreae, sweet, has effects of invigorating spleen, tonifying deficiency, replenishing kidney essence, and invigorating stomach yin; the two medicines are matched together to be monarch medicines, and can tonify qi and nourish yin, and aim at the basic pathogenesis of deficiency of qi and yin of diabetic peripheral neuropathy.

The Chinese medicinal composition takes Ligusticum wallichii, chinese angelica, radix paeoniae rubrathe, spatholobus stem, mulberry twig, earthworm, leech, eupolyphaga, winged euonymus twig, moutan bark and cowherb seed as ministerial drugs, has warm nature and pungent taste, has the functions of promoting blood circulation, promoting qi circulation, dispelling wind and relieving pain; dang Gui, gan, pungent, wen Zhiping, replenishing and harmonizing blood, regulating menstruation and relieving pain; radix paeoniae rubra, bitter and slightly cold, has the effects of clearing heat and cooling blood, activating blood and dissolving stasis and relieving pain; caulis Spatholobi is sweet, bitter and warm, and has effects of promoting blood circulation and relaxing tendons; ramulus Mori, bitter, and flat, has effects in dispelling pathogenic wind and dampness, benefiting joint, and promoting flow of water vapor; lumbricus, salty, slightly cold, clears heat and calms wind, is good at dredging collaterals; leech, bitter and salty, has slight toxicity, and has the functions of breaking blood, removing stasis and dredging water channels; the ground beetles are salty, cold and toxic, and have the functions of breaking blood, removing stasis, removing food retention and dredging channels; ramulus Euonymi, bitter, cold, has effects of dispelling blood stasis, dredging channels, dispelling pathogenic wind, and killing parasites; cortex moutan, bitter and pungent, slightly cold, has the functions of clearing heat and cooling blood, and activating blood circulation to dissipate blood stasis; semen Vaccariae has effects of promoting blood circulation and dredging channels.

Ramulus Cinnamomi is used as adjuvant, pungent, sweet, warm, and has effects of warming and dredging channels and collaterals, dispelling cold and relieving pain. Radix Cyathulae is used as the guiding drug for promoting the downward movement, and is sweet and bitter, and is used for relieving flatly, removing blood stasis and dredging channels. The medicines are compatible, and have the effects of tonifying qi and yin, resolving phlegm and removing blood stasis and dredging collaterals.

The more specific mechanism of the Chinese and western prescription for each medicine is as follows:

radix astragali: sweet and slightly warm, enter spleen and lung meridians. The first place in Shen nong Ben Cao Jing (Shen nong's herbal), li Shi Zhen (Li Shi Zhen) is called "Huang, a long term for tonic herbs" in Ben Cao gang mu. It has the actions of tonifying spleen and lung qi, invigorating qi, consolidating superficial resistance, replenishing blood and activating blood, and also has the actions of raising yang and trapping. In the book of this meridian dredging syndrome, "Huang Qi dredges the root of three jiaos, li Ying defensive qi", so ying and wei are blocked and unblocked. Astragalus root, radix astragali has the effect of invigorating spleen and lung qi, and promoting qi to be vigorous to promote blood circulation, remove blood stasis and dredge collaterals, and Ying Wei Diaohe, wen Xuru nourishes tendons, muscles, skin and striae. Modern pharmacology shows that astragalus has the functions of regulating body immunity, resisting inflammation, resisting oxidation, inhibiting platelet aggregation and the like and delays the DPN development. Astragalus contains a plurality of active ingredients, wherein astragalus polysaccharide has function regulating effect on vascular endothelial cells, and can improve immunity and regulate blood sugar. In recent pharmacological research, the astragalus membranaceus traditional Chinese medicine particles can effectively regulate the insulin-like growth factor level of DM patients and change carotid intima thickness, so that the astragalus membranaceus has an antioxidant stress response and participates in inhibiting arteriosclerosis.

Chinese yam: the Chinese medicinal composition is characterized by being superior to Tang Dynasty Hou Ning in medicinal spectrum, sweet, flat, entering lung and spleen channels, strengthening spleen and stomach, tonifying lung and kidney and tonifying deficiency. Modern pharmacology: the yam can improve the function of damaged islet beta cells and restore the function of insulin secretion so as to realize blood sugar control.

Ligusticum wallichii: pungent and warm, enter liver, gallbladder and pericardium meridians. It is a qi-flowing herb in blood, and has the actions of activating blood and promoting qi circulation, removing arthralgia due to astringency of blood, and dispelling wind and relieving pain. "Rihua Zi Ben Cao" cloud: chuan Xiong is indicated for all kinds of wind, all kinds of qi, all kinds of strain and all kinds of blood. Tonify five consumptions, strengthen tendons and bones, regulate pulse, break and treat stagnation and sink blood, nourish heart blood, and grow meat. Chuan Xiong can promote blood circulation and promote blood circulation, so that qi can promote blood circulation, and the blood circulation reaches the extremities to stop numbness, coldness and pain. The decoction of rhizoma Ligustici Chuanxiong has effects of inhibiting central nervous system, and can be used for relieving pain. Modern pharmacological researches have found that chuanxiong rhizome contains ligustrazine, alkaloid, phenols and lactone, and has the functions of dilating capillary vessel, resisting platelet aggregation, improving microcirculation, relieving inflammation and pain, protecting nerve, etc.

Chinese angelica root: sweet and pungent in nature Wen Zhiping, it enters heart, liver and spleen meridians. It is good at activating blood, removing blood stasis without damaging blood, good at replenishing blood, and tonifying but not greasy, and has analgesic effect. In Ben Cao gang mu, dang Gui (radix Angelicae sinensis) Xin Wenneng, which is a good herb for blood arthralgia, has the actions of dispelling internal cold and bitter warm and assisting heart to dispel cold. Modern pharmacological researches have found that angelica sinensis can inhibit cell calcium overload, improve endothelial cell injury and protect ischemia injury cells. The angelica is rich in effective components such as saccharides, vitamins, amino acids, neutral oil and the like, and modern pharmacological researches prove that the angelica is good at activating blood to influence hematopoiesis, and has various effects of resisting thrombosis, resisting inflammation, easing pain, protecting nerves, resisting platelet aggregation and the like. The ferulic acid in the effective component of radix Angelicae sinensis can reduce the content of peroxide, scavenge free radical, reduce injury of oxidative stress reaction, protect nerve cells, reduce nerve tissue injury, and improve clinical symptoms.

Radix paeoniae rubra: bitter, slightly cold, enter liver meridian. Has the main effects of clearing heat and cooling blood, and has the effects of activating blood, removing stasis and relieving pain. The following are "compendium of materia: radix Paeoniae Rubra can dispel pathogenic factors to promote blood circulation. Enters the liver meridian, clears the liver to cool blood, removes stasis to promote blood circulation, and the liver governs tendons and vessels to nourish, thus relieving the symptoms of incapacity. The effect of red peony root on activating blood and resolving stasis to relieve pain is especially suitable for the pathogenesis of pain caused by the obstruction of the disease. Pharmacological studies prove that the red paeony root contains various glycoside components and has various neuroprotection effects of protecting liver, inhibiting tumor, dilating capillary, scavenging oxygen free radicals, resisting oxidative stress reaction and the like.

Ramulus Cinnamomi: pungent and sweet, warm, enter heart, lung and bladder meridians. The medicine is pungent and sweet in flavor and can warm up, induce sweat to relieve exterior syndrome, warm and dredge meridians, dispel cold to alleviate pain. In Changsha Yao Jie (Changsha Yao Jie) the liver is entered to promote blood circulation and the channels and collaterals are followed to achieve the effects of treating spasm of tendons and collaterals due to ying-qi stagnation … …, relieving obstruction of joints, dredging channels and collaterals to relieve arthralgia and remove damp-cold very much. Of the effective components of ramulus Cinnamomi, cinnamaldehyde has antiinflammatory, analgesic, and blood sugar lowering effects;

cinnamic acid has obvious analgesic effect; cinnamyl alcohol can improve nerve conduction velocity and protect nerve.

Caulis Spatholobi: sweet and bitter, warm, and good in effect of activating blood and relaxing tendons, and enters heart and spleen meridians. The "Dabuqi blood" can generate blood, harmonize blood, enrich blood and break blood; but also can unblock seven orifices. Five zang organs, tendons and collaterals are cleared away, and decoction pieces of new ginseng are called "cloud: removing blood stasis, promoting tissue regeneration and dredging channels.

Ramulus Mori: bitter in flavor, calm, enter liver meridian, dispel wind-damp, promote the circulation of water and vapor, and induce drug delivery to upper limbs. The mulberry twig mainly comprises flavonoid compounds, polysaccharide compounds, alkaloids, tannins, amino acids, succinic acid and other chemical components, and the total alkaloids of the mulberry twig have good effects of regulating lipid metabolism, reducing blood sugar, resisting inflammation, resisting oxidation and the like.

Radix Cyathulae: sweet, bitter, and flat, it enters liver and kidney meridians, and it has the actions of expelling stasis and inducing menstruation in Shennong Ben Cao Jing. The "Zhong Shen xi Lu" in medical science is characterized in that it is good for guiding qi and blood downward, and it is always used as guiding qi for the people who want to descend with herbs. Modern pharmacological researches show that chemical components such as achyranthes polysaccharide in achyranthes root can protect and repair islet beta cells, thereby playing a role in reducing blood sugar.

Earthworm: salty, slightly cold, enter liver, spleen and bladder meridians. It has the main actions of clearing heat and calming endogenous wind, and is good at dredging collaterals, inducing diuresis and relieving dyspnea. The description of Ben Cao gang mu is: lumbricus has cold nature and downward action, and can relieve various heat diseases and promote urination, so that it can be used for treating foot diseases, and has effects of dredging channels and collaterals, promoting blood circulation and removing blood stasis. Modern pharmacological researches have found that earthworm enzyme extracted from earthworm has the functions of anticoagulation, platelet aggregation resistance, capillary expansion, microcirculation improvement, free radical removal, and lipid oxidation resistance.

Leech: bitter and salty, with slight toxicity, it enters liver meridian. Has the main effects of breaking blood and removing stasis, and promoting diuresis, is commonly used for treating hematopathy, and is often used for treating symptoms of long-term blood stasis and accumulation. The Shennong Ben Cao Jing (Shennong's herbal medicine book) is: leech is mainly used for expelling malignant blood, blood stasis and blood breaking force, and does not damage healthy qi. Pharmacological researches show that the leech saliva contains various active ingredients such as hirudin, heparin and the like, has pharmacological effects of anticoagulation, microcirculation improvement, platelet aggregation resistance and the like, can improve the blood viscosity state of DPN patients, increases the blood supply and oxygen supply of nerve cells, and improves the recovery of nerve functions.

Ground beetle: salty, cold, toxic and enter liver meridian. It is salty and cold in nature and enters blood, so it is good at moving and moving, and can break blood and dispel stasis, remove food retention and promote menstruation. In modern pharmacological research, the Eupolyphaga Seu Steleophaga extract and water extract and alcohol precipitation respectively have antithrombotic and thrombolytic effects; the extract can inhibit platelet aggregation and adhesion, and reduce aggregation number.

Ramulus Euonymi: bitter, cold and entering liver and spleen meridians. Bitter and cold has the effects of clearing away heat and toxic materials, entering liver meridian, promoting blood circulation, and expelling pathogenic wind and insect. According to modern researches, euonymus alatus mainly contains euonymus alatus, tripterygium wilfordii, euonymus alatus, bergamot essence, euonymus alatus and other components. Has effects of reducing blood sugar, increasing myocardial nutritional blood flow, and increasing oxygen and nutrient supply.

Cortex moutan radicis): bitter and pungent, slightly cold, enter heart, liver and kidney meridians. Clear heat and cool blood, activate blood and remove stasis. Can be used for treating toxic heat, speckle, hematemesis, epistaxis, night fever, early cooling, sweating, bone steaming, amenorrhea, dysmenorrhea, carbuncle, skin sore, and traumatic injury. Modern pharmacological researches have found that paeonol and other glycoside components contained in moutan bark have anti-inflammatory effect; the methanol extract of cortex moutan has platelet inhibiting effect; the paeonol has effects of tranquilizing, cooling, relieving fever, relieving pain, relieving spasm, inhibiting central nervous system, resisting atherosclerosis, promoting urination, and resisting ulcer.

Semen Vaccariae: bitter and flat, enter stomach and liver meridians. Promoting blood circulation, dredging channels, promoting lactation and relieving swelling. Can be used for treating breast milk disorder, amenorrhea, dysmenorrhea, and acute mastitis. The semen Vaccariae extract has effects of remarkably inhibiting proliferation, migration and adhesion of endothelial cells, inhibiting angiogenesis, resisting coagulation, relieving inflammation, resisting oxidation and relieving pain.

Furthermore, the inventor reasonably optimizes the above-mentioned medicine components, and finally obtains the following technical scheme: the medicine comprises the following main components in parts by weight:

20 parts of Chinese yam, 20 parts of astragalus, 15 parts of szechuan lovage rhizome, 12 parts of Chinese angelica, 15 parts of red paeony root, 12 parts of cassia twig, 30 parts of suberect spatholobus stem, 30 parts of mulberry twig, 30 parts of medicinal cyathula root, 15 parts of earthworm, 6 parts of leech, 15 parts of ground beetle, 20 parts of winged euonymus twig, 15 parts of tree peony bark and 20 parts of cowherb seed.

Based on the above pharmaceutical composition, the inventors further provide the preparation and administration methods thereof as follows:

firstly, weighing the traditional Chinese medicines according to the proportion of the raw materials, adding water until the traditional Chinese medicines are 3-5 cm above the medicine surface, soaking for 1.5 hours, boiling with strong fire, decocting with slow fire for 40-50 minutes, filtering the medicine juice for standby, adding water into the medicine residues again until the medicine residues are 1-2 cm above the medicine residue surface, boiling with strong fire, decocting with slow fire for 20-30 minutes, filtering the medicine juice, and combining the medicine juice with the medicine juice of the last time to obtain the traditional Chinese medicine decoction.

The administration method comprises the following steps: 1 dose daily, divided into two times a day and a night, and taken warm 1-2 hours after meal.

The medicine obtained by the prescription and the preparation method of the invention is applied to clinic, has very obvious curative effect, and the inventor has proved that compared with the traditional medicine mecobalamin for treating diabetic peripheral neuropathy, which is commonly used in clinic, the medicine composition of the invention has obvious curative effect, not only obviously increases nerve conduction speed, but also has obvious advantages in reducing blood sugar, improving clinical symptoms and improving the life quality of patients. Therefore, the technical scheme of the invention has obvious advantages from theory to clinical effect. In the actual condition, the composition of the invention can be selected to be matched with western medicines (such as mecobalamin tablets) for use together.

In conclusion, the Chinese medicinal composition specially used for treating the diabetic peripheral neuropathy is obtained based on the yang-tonifying five-returning decoction and combined with the traditional Chinese medicine theory according to the disease-pattern combined theory, and has the obvious curative effects of tonifying qi, nourishing yin, resolving phlegm, removing stasis, dredging collaterals, improving the life quality of patients and the like by matching qi-tonifying medicaments with blood-activating medicaments, enabling qi to flow in an excessive manner, activating blood without damaging the body, and jointly playing the roles of tonifying qi, activating blood, dredging collaterals.

Detailed Description

The present invention is not limited by the following examples, which are described in the following examples and descriptions merely illustrate the principles of the invention, and various changes and modifications can be made therein without departing from the spirit and scope of the invention as claimed.

Example 1

A traditional Chinese medicine composition for treating diabetic peripheral neuropathy is prepared from the following medicines:

20g of Chinese yam, 20g of astragalus root, 15g of szechuan lovage rhizome, 12g of Chinese angelica, 15g of red paeony root, 12g of cassia twig, 30g of suberect spatholobus stem, 30g of mulberry twig, 30g of medicinal cyathula root, 15g of earthworm, 6g of leech, 15g of ground beetle, 20g of winged euonymus twig, 15g of tree peony bark and 20g of cowherb seed.

The preparation method comprises the following steps:

(1) Firstly, weighing the traditional Chinese medicines according to the proportion of the raw materials, uniformly mixing, adding 1200ml of cold water, and soaking for 1.5 hours;

(2) Boiling the mixed raw materials with strong fire, decocting with slow fire for 45 min, and filtering with gauze to obtain filtrate and residue;

(3) Mixing the residues obtained in the step (2) with 550ml of hot water, namely pure water at 80 ℃, boiling with strong fire, decocting with slow fire for 25 minutes, and filtering with gauze again to obtain filtrate and residues;

(4) Mixing the filtrate obtained in the step (2) and the filtrate obtained in the step (3) to obtain the traditional Chinese medicine decoction for treating diabetic peripheral neuropathy.

Example 2

A traditional Chinese medicine composition for treating diabetic peripheral neuropathy is prepared from the following medicines:

20g of Chinese yam, 20g of astragalus root, 12g of szechuan lovage rhizome, 9g of Chinese angelica, 12g of red paeony root, 9g of cassia twig, 25g of suberect spatholobus stem, 20g of mulberry twig, 20g of medicinal cyathula root, 9g of earthworm, 3g of leech, 9g of ground beetle, 15g of winged euonymus twig, 12g of tree peony bark and 20g of cowherb seed. The preparation method comprises the following steps:

(1) Firstly, weighing the traditional Chinese medicines according to the proportion of the raw materials, uniformly mixing, adding 900ml of cold water, and soaking for 1.5 hours;

(2) Boiling the mixed raw materials with strong fire, decocting with slow fire for 40 min, and filtering with gauze to obtain filtrate and residue;

(3) Mixing the residues obtained in the step (2) with 400ml of hot water, namely pure water at 80 ℃, boiling with strong fire, decocting with slow fire for 20 minutes, and filtering with gauze again to obtain filtrate and residues;

(4) Mixing the filtrate obtained in the step (2) and the filtrate obtained in the step (3) to obtain the traditional Chinese medicine decoction for treating diabetic peripheral neuropathy.

Example 3

A traditional Chinese medicine composition for treating diabetic peripheral neuropathy is prepared from the following medicines:

30g of Chinese yam, 30g of astragalus root, 18g of szechuan lovage rhizome, 15g of Chinese angelica, 18g of red paeony root, 15g of cassia twig, 35g of suberect spatholobus stem, 40g of mulberry twig, 40g of medicinal cyathula root, 20g of earthworm, 9g of leech, 20g of ground beetle, 25g of winged euonymus twig, 18g of tree peony bark and 30g of cowherb seed. The preparation method comprises the following steps:

(1) Firstly, weighing the traditional Chinese medicines according to the proportion of the raw materials, uniformly mixing, adding 1500ml of cold water, and soaking for 1.5 hours;

(2) Boiling the mixed raw materials with strong fire, decocting with slow fire for 50 min, and filtering with gauze to obtain filtrate and residue;

(3) Mixing the residues obtained in the step (2) with 600ml of hot water, namely pure water with the temperature of 80 ℃, boiling with strong fire, decocting with slow fire for 30 minutes, and filtering with gauze again to obtain filtrate and residues;

(4) Mixing the filtrate obtained in the step (2) and the filtrate obtained in the step (3) to obtain the traditional Chinese medicine decoction for treating diabetic peripheral neuropathy.

Experimental example

1. Clinical data

1.1 study source and sample size:

study selection object: and a patient who is in an endocrinology clinic and is in a hospital at a second affiliated hospital of Shandong traditional Chinese medicine university in 2018, 9 months to 2020, 12 months. Sample size estimation: according to the formula n=2 [ (α+β) ×σ/δ ]2, the minimum sample size required was estimated to be 60 cases, and 60 patients were included in this experimental example.

1.2 diagnostic criteria:

1.2.1 Western diagnostic criteria:

(1) Diabetes diagnostic criteria:

reference is made to diabetes diagnostic criteria (1999) by the WHO diabetes expert committee: typical diabetes symptoms (polydipsia, diuresis, polyphagia, weight loss due to unknown reasons) plus random blood glucose not less than 11.1mmol/L; or the fasting blood glucose is more than or equal to 7.0mmol/L; or 75g of glucose tolerance test is added, and the blood sugar is more than or equal to 11.1mmol/L after 2 hours; patients without typical diabetes symptoms need to be rechecked and confirmed by changing the date.

(2) Diagnostic criteria for diabetic peripheral neuropathy:

reference is made to "diabetic peripheral neuropathy traditional Chinese medicine diagnosis and treatment Specification manuscript (2010):

(1) has a clear history of diabetes; (2) neuropathy occurring at or after diagnosis of diabetes: (3) clinical symptoms and signs are consistent with the manifestation of DPN; (4) patients with clinical manifestations of pain, numbness, paresthesia, etc., 5 examinations: ankle reflex, acupuncture pain sensation, vibration sensation, pressure sensation, and temperature sensation, wherein any 1 item is abnormal; in the absence of clinical manifestations, any 2 of them are abnormal, clinically diagnosed with DPN; (5) excluding peripheral neuropathy patients caused by other causes, such as cervical and lumbar vertebra lesions.

1.2.2 traditional Chinese medicine diagnosis criteria the diagnosis criteria for determining the qi-yin deficiency and blood stasis syndrome are as follows, according to the guidelines for clinical diagnosis and treatment of diabetes peripheral neuropathy in traditional Chinese medicine (2016 edition) and the guidelines for clinical research of new traditional Chinese medicine (2002 edition):

main symptoms are as follows: numbness of the limbs, such as termite, stabbing pain in the lower extremities, is severe at night.

Secondary symptoms: dry mouth and preference for drinking, frequent eating, hunger, lassitude and debilitation, spontaneous perspiration and aversion to wind, dysphoria with smothery sensation in the chest, soreness of the waist and knees, palpitation

Insomnia, dizziness, tinnitus, dry throat, dry mouth, constipation due to dark urine, and skin with wrong nails.

Tongue pulse: dark tongue or ecchymosis, little coating and body fluid, and thready and wiry or deep and astringent pulse.

The diagnosis of the syndrome of deficiency of both qi and yin with blood stasis can be made by the main symptoms and any 3 times of symptoms and tongue pulse.

1.3 case selection criteria

1.3.1 inclusion criteria:

(1) Meets the diagnosis standard of Chinese and Western medicine of DPN;

(2) Age is less than or equal to 20 years old and less than or equal to 75 years old, and the sex is unlimited;

(3) Has normal language communication ability and thinking ability;

(4) The entire content of the clinical trial can be understood and voluntarily attended, while signing patient informed consent.

1.3.2 exclusion criteria

(1) Not meeting the above diagnostic and inclusion criteria;

(2) Has serious complications of heart, brain and kidney or other serious primary diseases;

(3) An unintelligible and non-recipient of the treatment regimen;

(4) Those with a history of allergy to some of the drugs in the study;

(5) Allergic constitution;

(6) Pregnant women or lactating women or pregnancy-preparing persons;

(7) Mental disorders or not explicitly stated. :

1.3.3 drop criteria

Subjects enrolled in the study were judged to be abscission cases at any time for which the prescribed course of treatment was withdrawn from the study.

1.3.4 rejection (termination) criteria

(1) Serious adverse reactions such as allergy and the like occur during observation, and it is difficult to continue the maintenance treatment;

(2) Those who were taking other drugs that affected the efficacy without permission during the trial;

(3) Patients fail to review on time with diagnosis, and compliance is poor, so that curative effect judgment cannot be carried out due to incomplete data.

2. Research method

2.1 study design:

60 patients with qi-yin deficiency and blood stasis syndrome among diabetic peripheral neuropathy patients meeting western medicine diagnosis standards are selected, and are randomized into a test group and a control group by adopting a random digital table method, wherein 30 patients are respectively treated in the two groups. Clinical efficacy observation was carried out by comparing the treatment of the pharmaceutical composition of example 1 (200 ml of the Chinese medicinal decoction obtained by applying the process and dosage of the decoction of example 1, which is taken warm twice a day, 100ml each time) with mecobalamin. The treatment course is 8 weeks, and the quantitative scoring change and experimental value index change of the traditional Chinese medicine symptoms of the diagnosis scale of the peripheral neuropathy (qi-yin deficiency and blood stasis syndrome) of diabetes of two groups of patients before and after treatment are observed. All data were statistically analyzed using the statistical software SPSS 25.0 after the end of the treatment period, and differences between the treatment and both groups were compared between the test group and the control group.

2.2 treatment methods base treatment: both groups firstly give diabetes personalized treatment, and education such as diet, exercise and the like is carried out, so that the blood sugar is kept stable, and the blood sugar reaches within the target limit: fasting blood sugar is less than or equal to 7.0mmol/L, postprandial blood sugar is less than or equal to 11.1mmol/L, glycosylated hemoglobin is less than or equal to 8%, and the treatment is started after 2 weeks of control and stabilization respectively. For patients with high blood lipid and blood pressure, the measures of reducing blood lipid and blood pressure are taken.

Grouping treatment:

(1) Test group:

the pharmaceutical composition of example 1 was taken for treatment (200 ml of the medicinal liquid was obtained by applying the process and the dose of example 1 and decocting, and taken twice a day in the morning and at night, 100ml each time).

(2) Control group:

0.5mg (1 tablet) of mecobalamin tablet is applied, 3 times a day, 1 time 1 tablet (trade name: maikebao, manufactured by the pharmaceutical industry Co., ltd., chinese medicine standard H20143107).

The observation time of the test group and the control group is 8 weeks, and the patients can be informed about subjective symptom improvement before and after treatment and about laboratory examination improvement and record adverse reactions.

2.3 observations index

(1) Efficacy index

(1) Clinical symptom score: reference is made to the first draft of diagnosis and treatment specifications of peripheral neuropathy of diabetes in 2010 and the guidelines of clinical research on new traditional Chinese medicines in 2002: the method adopts 16 items of limb numbness, limb pain, limb coolness, dry mouth, eating and hunger, etc. to carry out grading quantification, and the main symptoms are respectively set to 0, 2, 4 and 6 according to the 4 grades of scores of no, mild, moderate and severe: the secondary symptoms are scored according to the grade 4 of none, mild, moderate and severe, the corresponding scores are respectively 0, 1, 2 and 3, and the total score is 0 to 60, see annex 1.

(2) Nerve Conduction Velocity (NCV) is a diagnostic gold standard for DPN, and the nerve conduction velocity (MNCV) of the right limb tibial nerve and the total fibular nerve, and the Sensory Nerve Conduction Velocity (SNCV) of the superficial fibular nerve and the sural nerve are measured before and after treatment.

(3) The Michigan Diabetic Neuropathy Score (MDNS) content contains: tendon reflex scoring, limb distal muscle strength, big toe sensation, are bilateral scores. Disease degree determination criteria for DPN: grade I, grade 7-12, grade II, grade 13-29, grade III, grade 30-45, are mild, respectively, and see appendix 2.

(4) Toronto Clinical Scoring System (TCSS), a comprehensive scoring system formulated based on DPN characteristics.

Including neurological symptoms, neurological reflexes, sensory function examination scores. The total division is 0 to 19, the diagnosis cut-off point is more than or equal to 6, and no: 0 to 5 minutes, light: 6-8 minutes, moderate: 9-11 minutes, severe: 12-19 minutes, see appendix 3. (2) safety index: vital signs, liver function, blood routine, electrolytes, stool routine, electrocardiographic examination, etc.; adverse drug reactions were noted during the treatment.

The symptoms and indexes are checked and recorded once before and after treatment.

Appendix 1:

clinical symptom score table

Name: gender: age: hospitalization number/clinic number:

clinical diagnosis: date: day of year, month and day

1. Main symptoms

1. Numbness of limbs

0 point: without any means for

2, the method comprises the following steps: occasional numbness, less than 2 times daily, each time within 10min

4, the following steps: frequent numbness, less than 4 times daily, each time within 30min

And 6, dividing: numbness can not be relieved continuously, more than 4 times a day, and even more than 30 minutes each time

2. Pain in limbs

0 point: without any means for

2, the method comprises the following steps: occasional pain, less than 2 times daily, each time within 10min

4, the following steps: frequent pain, each time of less than 4 times and each time of less than 30 minutes

And 6, dividing: pain is not relieved continuously for more than 4 times each time and even more than 30 minutes each time

3. Cool limbs

0 point: without any means for

2, the method comprises the following steps: occasionally cool and can be relieved when the clothes are closed

4, the following steps: can cool frequently and relieve the short quilt for 30-60min

And 6, dividing: can not be relieved after being cooled for more than 60 minutes

4. Hypoesthesia

0 point: without any means for

2, the method comprises the following steps: limb dysesthesia, 10g nylon yarn test negative

4, the following steps: limb dysesthesia, 10g nylon yarn test positive

And 6, dividing: the limbs feel dullness and only feel in the needling test

2. Secondary symptoms

1. Thirst happiness drink

0 point: without any means for

1, the method comprises the following steps: slightly increasing the water intake

2, the method comprises the following steps: the water intake is increased by more than half of that of the prior art

3, the method comprises the following steps: the water intake is increased by more than 1 time than the prior art

2. Food with multiple functions and easy hunger

0 point: without any means for

1, the method comprises the following steps: obvious hunger sensation

2, the method comprises the following steps: hunger sensation before meal is difficult to endure

3, the method comprises the following steps: hunger is difficult to endure and is easy to be accompanied with hypoglycemia reaction

3. Dry throat and mouth

0 point: without any means for

1, the method comprises the following steps: even feeling of dry throat and mouth, and a small amount of drinking water can be relieved

2, the method comprises the following steps: dry mouth and throat, and proper drinking water can alleviate the symptoms

3, the method comprises the following steps: a lot of drinking water is needed for treating dry throat and mouth

4. Lassitude and debilitation

0 point: without any means for

1, the method comprises the following steps: force of intolerance

2, the method comprises the following steps: can insist on light physical labor

3, the method comprises the following steps: barely support daily activities

5. Spontaneous perspiration and aversion to wind

0 point: without any means for

1, the method comprises the following steps: slight sweating after activity, and even aversion to wind

2, the method comprises the following steps: sweating after a little movement, and persistent aversion to wind

3, the method comprises the following steps: plain sweat is the deficiency of body and even more marked by movement

6. Dysphoria with feverish sensation in the chest and abdomen

0 point: without any means for

1, the method comprises the following steps: slight fever of the palms and soles and dysphoria with feverish sensation in the chest and heart are sometimes observed between them

2, the method comprises the following steps: feverish palms, soles and chest, feverish sensation in the chest and sometimes

3, the method comprises the following steps: feverish palms and soles, comfortable sensation in the chest and heart, restlessness and fever due to the desire for near cold

7. Soreness and weakness of waist and knees

0 point: without any means for

1, the method comprises the following steps: sometimes the waist and knee are soreness and weakness, and can be relieved after rest

2, the method comprises the following steps: general movement is just sensitive to soreness and weakness of waist and knees

3, the method comprises the following steps: soreness and weakness of waist and knees due to inactivity, preference for lying

8. Palpitation and insomnia

0 point: without any means for

1, the method comprises the following steps: less sleep and easy awakening

2, the method comprises the following steps: is difficult to fall asleep and easy to wake

3, the method comprises the following steps: difficult sleep at night

9. Dizziness and tinnitus

0 point: without any means for

1, the method comprises the following steps: occasionally occur

2, the method comprises the following steps: frequently occurs

3, the method comprises the following steps: continuously occurring, cannot be relieved

10. Frequent urination

0 point: without any means for

1, the method comprises the following steps: urine volume of 2-2.5L/day

2, the method comprises the following steps: urine volume of 2.5-3L/day

3, the method comprises the following steps: urine volume of 3L/day or more

11. Constipation

0 point: without any means for

1, the method comprises the following steps: hard and laborious defecation

2, the method comprises the following steps: dry stool for 2-3 days

3, the method comprises the following steps: dry stool for more than 3 days

12. Skin nail error

0 point: without any means for

1, the method comprises the following steps: is occasionally found in body parts

2, the method comprises the following steps: the body can be seen at various places

3, the method comprises the following steps: appearance of the whole body

Total score:

(note: tongue pulse is recorded only, not scored)

Appendix 2: michigan Diabetic Neuropathy Score (MDNS)

Appendix 3: toronto Clinical Scoring System (TCSS)

Note that: symptoms are as follows: a score of 1 appears, and no score is 0; reflection score: each side had 2 minutes of reflection disappeared, 1 minute of decline, 0 minutes normal, 4 minutes maximum: sensory testing was divided into: counting 1 minute when an abnormality occurs, and counting 0 minute when no abnormality occurs; the higher the score, the more severe the nerve function impairment, with a total score of 19 points.

2.4 clinical efficacy decision criteria

The traditional Chinese medicine syndrome curative effect judging standard refers to the "new traditional Chinese medicine clinical research guidelines" in 2002

The therapeutic index formula (nimodipine method) is [ (pre-treatment integral-post-treatment integral)/(pre-treatment integral) ] X100%.

(1) Has obvious effect that clinical symptoms are obviously improved, and integral is reduced by more than 70 percent;

(2) Effective that all clinical symptoms are improved and the integral is reduced by more than 30 percent;

(3) None of the clinical symptoms is obviously improved or even worsened, and the integral reduction is less than 30 percent.

2.5 safety evaluation criteria reference the clinical study guidelines for the treatment of diabetes with New Chinese medicine in 2002

(1) Stage 1: no adverse reaction and no abnormality in safety index inspection.

(2) 2 stages: slight adverse reaction occurs, no special intervention is performed, the original treatment is continued, and the inspection safety index shows no abnormality.

(3) 3 stages: moderate adverse reactions or slight abnormalities in safety indicators occur, and the original treatment can be continued after intervention.

(4) 4 stages: the test is stopped due to severe adverse reactions or obvious abnormalities are screened by the safety index.

2.6, establishing an Excel database by statistical analysis, carrying out data analysis by applying SPSS 25.0 statistical software, enabling data to obey normal distribution, describing metering data by means of mean value standard deviation (X+/-S), using t-test for compliance with variance alignment, and using approximate t-test for noncompliance with variance alignment; count data is described in terms of rate (%), checked by chi-square (x 2); the rank data and data are not in accordance with normal distribution and are described by median and quartile interval, and non-parameter rank sum test is used. All statistical methods were double-sided, and differences were statistically significant at P < 0.05.

3. Results and analysis

3.1 general data

All patients were from endocrinology portal and inpatients of the second affiliated hospital of Shandong traditional Chinese medicine university, 9 months 2018 to 12 months 2020, 60 cases were included, 30 cases were included in each of the test group and the control group, and no cases were dropped during both treatment groups. Of these, 17 men and 13 women in the test group, the average age (58.40 ±8.66) was old; control group of 14 men, 16 women, average age (57.20.+ -. 7.98) years old; the pre-treatment sex (p=0.438), age (p= 0.579), disease course (p=0.188) were not statistically different (P > 0.05) for both groups of patients, with comparability. (see tables 1, 2, 3)

Table 1 comparison of the gender of two groups of patients

Table 2 age comparison of two groups of patients (X soil S)

Table 3 comparison of the course of two groups of patients

3.2 curative effect

3.2.1 clinical symptom efficacy comparison: (see table 4) after 8 weeks of treatment, the total effective rate of the test group was 93.33%, the total effective rate of the control group was 70%, and the test group was compared with the control group, the unidirectional sequential profile data were tested by non-parametric test, z= -2.376, p=0.018 <0.05, and the difference was statistically significant.

TABLE 4 clinical symptomatic curative effect

3.2.2 clinical symptom score comparison: (see Table 5) the clinical symptom scores of the two groups of patients before treatment were compared, P >0.05, and the difference was not statistically significant. The scores of the two groups are compared before and after treatment, P is less than 0.01, and the difference has significance, which indicates that the scores can be reduced by both treatment schemes; score comparison between the two groups after treatment, P <0.01, and difference has significance, which shows that the syndrome score of the test group is reduced better than that of the control group.

Table 5 two sets of pre-and post-treatment symptom scoring conditions

3.2.3 comparison of nerve conduction velocity: (see table 6) no statistical difference (P > 0.05) between the test and control groups for each nerve conduction velocity comparison prior to treatment; after treatment, the total sural nerve, the sural shallow nerve and the sural nerve conduction velocity of the control group are obviously increased (P < 0.01), the conduction velocity of each nerve of the test group is obviously increased (P < 0.01), and compared with the control group, the test group has statistical difference (P < 0.01) in the sural nerve, the total sural nerve and the sural nerve conduction velocity, and the test group has better curative effect.

Table 6 comparison of nerve conduction velocity of two groups (X soil S)

Note that: compared with the control group before treatment, +.P >0.05; compared with the prior treatment of the group, P is less than 0.01; compared to control post-treatment, #p <0.01.

3.2.4MDNS score comparison: (see table 7) MDNS scores of test and control groups were compared using t-test, t=1.369 before treatment, p=0.176 >0.05, the differences were statistically significant, and were comparable, t=2.502 after treatment, p=0.00 <0.05, the differences were statistically significant; in-group comparison, treatment group t=3.548, p=0.001 <0.05, the differences were statistically significant, control group t=6.694, p=0.00 <0.05, the differences were statistically significant.

Table 7 two sets of pre-and post-treatment Michigan diabetic neuropathy scoring conditions (X soil S)

3.2.5 TCSS score comparison: (see table 8) comparing the test group with the control group, adopting t test before treatment to obtain t=1.053, p=0.297 >0.05, the difference has no statistical significance, the comparison is made, adopting non-parameter test after treatment to obtain z= -3.470, p=0.001 <0.05, the difference has statistical significance; the comparison in the group adopts non-parametric test, the test group Z= -6.037, P=0.00 <0.05, the difference has statistical significance, the comparison group Z= -4.901, P=0.00 <0.05, the difference has statistical significance.

Table 8 two sets of pre-and post-treatment toronto clinical scoring conditions

3.3 evaluation of safety

Both groups of patients have no discomfort symptoms related to the drug and no adverse reaction event in the treatment process, so both patients have better integrity and the safety evaluation is grade 1.

Specific cases

Case 1 (see case 1 for details)

Liang Mou, female, 74 years old, 12 months 15 years 2019 were treated by the endocrinology department clinic of the second affiliated hospital of Shandong traditional Chinese medicine university for ' feet numbness ' more than 6 months ', and before 15 years, the patients were not induced to find blood sugar rise, the period was treated by the mountain big two-hospital for a plurality of times, feet numbness appears after acupuncture and moxibustion before half years, the feet are heavy, the feet are light, the feeling of stepping on cotton is realized, and the craniocerebral CT is not abnormal. The symptoms are as follows: numbness of feet, such as ant, stabbing pain of lower limbs, especially at night, dry mouth, preference for drinking, listlessness, debilitation, dizziness and tinnitus, dysphoria with smothery sensation, palpitation and insomnia, anorexia, urination and defecation, 1 st 2-3 days, difficulty in resolving, dark tongue, little body fluid, and thready and wiry pulse. The fasting blood glucose was examined at 10.2mmol/L, and the sensory nerve conduction velocity was 36m/s. The prescription is as follows: 20g of Chinese yam, 20g of astragalus, 15g of szechuan lovage rhizome, 12g of Chinese angelica, 12g of red paeony root, 12g of cassia twig, 30g of suberect spatholobus stem, 30g of mulberry twig, 30g of medicinal cyathula root, 15g of earthworm, 6g of leech, 15g of ground beetle, 20g of winged euonymus twig, 15g of tree peony bark, 20g of cowherb seed, 200ml of Chinese medicinal decoction obtained according to the preparation method of the embodiment 1, twice a day, 100ml of warm taking every morning and 28 pairs of Chinese medicaments;

2020.1.12 review, present symptoms: numbness of feet is relieved, stabbing pain of lower limbs, dry mouth, debilitation, dizziness and tinnitus, dysphoria with smothery sensation before, sleep improvement, anorexia, urination adjustment, easy digestion before defecation, deep tongue, red tongue coating, little body fluid, thin and wiry pulse, fasting blood glucose of 7.0mmol/L and sensory nerve conduction speed of 38m/s; the upper part is taken continuously, and 28 pairs of the medicines are taken continuously;

2020.2.9 review, present symptoms: the symptoms are relieved or eliminated, the sleep is easy, the urination and defecation are regulated, the tongue is red, the tongue fur is thin, the pulse is thin, the fasting blood sugar is 6.5mmol/L, and the sensory nerve conduction speed is 40m/s; the upper part is followed by 7 pairs of clothes;

the score of traditional Chinese medicine symptoms before treatment is 42 points, the score of Toronto is 12 points, the score of traditional Chinese medicine symptoms after 8 weeks of treatment is 18 points, and the score of Toronto is 7 points.

Case 2 (see case 2 for details)

Shao Mou A, 59 years old, 2021, 9 months 4 are treated by the endocrinology department clinic of the second affiliated hospital of Shandong traditional Chinese medicine university because of 'finding that the blood sugar is increased for 1 year', and the traditional Chinese medicine is always taken orally by a patient after the blood sugar is increased because of the physical examination of the patient 1 year ago; the symptoms are as follows: numbness of limbs, burning pain, severe night, spontaneous perspiration, aversion to wind, lassitude, soreness of the waist and knees, anorexia, insomnia, dreaminess, 1 line of stool, dark tongue, deep and astringent pulse, and 11.0mmol/L of fasting blood glucose, and sensory nerve conduction velocity of 38m/s;

the traditional Chinese medicine decoction obtained by the formula and the preparation method of the example 1 is taken at 200ml each day twice a day, 100ml each time and 28 pairs of medicines are taken at twice a day;

2019.10.2 the treatment is repeated, the symptoms are relieved before, limb numbness, pain, weakness, soreness of waist and knees, anorexia, sleep improvement before, urination and defecation regulation, deep red tongue, deep pulse, 6.5mmol/L of fasting blood glucose, sensory nerve conduction speed of 40m/s and 28 pairs of patients taking the medicine from above;

2019.10.30 the treatment is repeated, the numbness of limbs, pain and sporadic pain are caused, the weakness is relieved, the sleep is easy, the urination and defecation are convenient, the tongue is red, the coating is thin and white, the pulse is deep, the fasting blood glucose is checked for 5.5mmol/L, the sensory nerve conduction speed is 41m/s, and 7 pairs of patients are taken above;

the score of traditional Chinese medicine symptoms before treatment is 36 points, the score of Toronto is 11 points, the score of traditional Chinese medicine symptoms after 8 weeks of treatment is 17 points, and the score of Toronto is 9 points.

Case 3 (see case 3 for details)

Zhou Mou, female, 58 years old, 12 months 7 in 2019, the patient is treated by oral administration of metformin without causing blood sugar rise before 5 years because of 'more than 3 months of lower limb numbness caused by blood sugar rise found in the second affiliated hospital clinic of the Shandong traditional Chinese medicine university'; the symptoms are as follows: numbness of the lower limbs, burning pain, severe night, hypoesthesia of the lower limbs, lassitude, debilitation, dizziness and tinnitus, dysphoria with feverish sensation in the chest, dry mouth, happy drinking, anorexia, dreaminess, constipation, deep red tongue, little body fluid, wiry and thin pulse, fasting blood glucose of 9.0mmol/L, and sensory nerve conduction velocity of 37m/s; the traditional Chinese medicine decoction obtained by the formula and the preparation method of the example 1 is taken at 200ml each day twice a day, 100ml each time and 28 pairs of medicines are taken at twice a day;

2019.12.30 review, now: numbness of lower limbs, pain with earlier relief, debilitation, tinnitus, dry mouth, dysphoria with feverish sensation in chest, anorexia, sleep dreaminess, stool, deep tongue, little body fluid, thin pulse, recheck of fasting blood glucose 8.0mmol/L, sensory nerve conduction velocity 39m/s, and taking 28 pairs above;

2020.1.22 the symptoms are relieved, the patient can receive sleep, can regulate the stool, has deep tongue, thin and white coating and deep pulse, and can review fasting blood glucose of 7.0mmol/L, sensory nerve conduction speed of 40m/s and take 7 pairs above;

the score of traditional Chinese medicine symptoms before treatment is 37 points, the score of Toronto is 12 points, the score of traditional Chinese medicine symptoms after 8 weeks of treatment is 18 points, and the score of Toronto is 8 points.

The traditional Chinese medicine composition special for treating diabetic peripheral neuropathy has the total effective rate of 93.33% and obvious curative effect. The traditional Chinese medicine composition for treating diabetic peripheral neuropathy provided by the invention has the main effects of tonifying qi and nourishing yin, resolving phlegm and removing stasis and dredging collaterals, and has obvious curative effects of tonifying qi and activating blood and dredging collaterals when being matched with qi-invigorating drugs for promoting blood circulation without hurting the healthy energy when qi is hyperactivity, and has the effects of reducing blood sugar, improving diabetic peripheral neuropathy symptoms, improving life quality of patients and the like.

Claims (3)

1. A traditional Chinese medicine composition for treating diabetic peripheral neuropathy is characterized in that: the raw material medicaments comprise the following components in part by weight: 20-30 parts of Chinese yam, 20-30 parts of astragalus membranaceus, 12-18 parts of ligusticum wallichii, 9-15 parts of angelica sinensis, 12-18 parts of radix paeoniae rubra, 9-15 parts of cassia twig, 25-35 parts of caulis spatholobi, 20-40 parts of ramulus mori, 20-40 parts of radix cyathulae, 9-20 parts of earthworm, 3-9 parts of leech, 9-20 parts of ground beetle, 15-25 parts of winged euonymus twig, 12-18 parts of cortex moutan and 20-30 parts of semen vaccariae.

2. The traditional Chinese medicine composition for treating diabetic peripheral neuropathy according to claim 1, wherein: the raw material medicaments comprise the following components in part by weight: 20 parts of Chinese yam, 20 parts of astragalus, 15 parts of szechuan lovage rhizome, 12 parts of Chinese angelica, 15 parts of red paeony root, 12 parts of cassia twig, 30 parts of suberect spatholobus stem, 30 parts of mulberry twig, 30 parts of medicinal cyathula root, 15 parts of earthworm, 6 parts of leech, 15 parts of ground beetle, 20 parts of winged euonymus twig, 15 parts of tree peony bark and 20 parts of cowherb seed.

3. The method for preparing the traditional Chinese medicine composition for treating diabetic peripheral neuropathy according to any one of claims 1-2, which is characterized in that: the method comprises the following specific steps: firstly, weighing the traditional Chinese medicines according to the proportion of the raw materials, adding water until the water is 3-5 cm above the medicine surface, soaking for 1.5 hours, boiling with strong fire, decocting with slow fire for 40-50 minutes, filtering the medicine juice for standby, adding water again into the medicine residues until the medicine residues are 1-2 cm above the medicine residues, boiling with strong fire, decocting with slow fire for 20-30 minutes, filtering the medicine juice, and combining the medicine juice with the medicine juice.