CN115837058A

CN115837058A - Traditional Chinese medicine composition, preparation thereof and application of traditional Chinese medicine composition in medicine for treating diabetic peripheral neuropathy

Info

Publication number: CN115837058A
Application number: CN202211330898.XA
Authority: CN
Inventors: 余江毅; 周希乔; 王丽娟; 吴磊; 周静波; 周晓雯; 徐巍龙; 俞凡
Original assignee: Jiangsu Provincial Hospital of Chinese Medicine
Current assignee: Jiangsu Provincial Hospital of Chinese Medicine
Priority date: 2022-10-27
Filing date: 2022-10-27
Publication date: 2023-03-24
Anticipated expiration: 2042-10-27
Also published as: CN115837058B

Abstract

The invention discloses a traditional Chinese medicine composition, a preparation thereof and application of the traditional Chinese medicine composition in a medicine for treating diabetic peripheral neuropathy, wherein the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 10-50 parts of dried dendrobium, 10-40 parts of achyranthes bidentata, 15-45 parts of caulis spatholobi, 15-45 parts of Chinese starjasmine stem, 15-45 parts of uncaria, 10-40 parts of ligusticum wallichii, 10-40 parts of angelica sinensis, 10-30 parts of earthworm and 10-30 parts of safflower. The traditional Chinese medicine composition disclosed by the invention is used for treating the diabetic peripheral neuropathy from the perspective of traditional Chinese medicine, has the effects of dispelling wind and relieving pain by taking a large method of promoting blood circulation and removing meridian obstruction, and has a remarkable effect of treating the diabetic peripheral neuropathy through clinical verification.

Description

Traditional Chinese medicine composition, preparation thereof and application of traditional Chinese medicine composition in medicine for treating diabetic peripheral neuropathy

Technical Field

The invention relates to a traditional Chinese medicine composition, a preparation and application thereof, in particular to a traditional Chinese medicine composition, a preparation thereof and application thereof in a medicine for treating diabetic peripheral neuropathy.

Background

Diabetic Peripheral Neuropathy (DPN) is the manifestation of symptoms and/or signs associated with peripheral nerve dysfunction in Diabetic patients, excluding other causes. Diabetic peripheral neuropathy is the most common clinical form of diabetic neuropathy and is one of the most common chronic complications in diabetic patients.

The pathogenesis of diabetic peripheral neuropathy is not well understood, and the academia has many controversies, including the theory of oxidative stress, the theory of polyol pathway, the theory of glycosylation end products, the theory of protein kinase C pathway, the theory of hexosamine pathway, the theory of trophic factors, the theory of ion channel injury, and so on. It is far from single factor can explain, and should be the result of multifactorial effects. Recently, there are two major views on the pathogenesis of diabetic peripheral neuropathy: metabolic factors and vascular factors, and in fact, many studies prove that the metabolic factors and the vascular factors are involved in the pathogenesis of diabetic peripheral neuropathy, and because the symptoms of the diabetic peripheral neuropathy are various and the disease is repeated, the treatment period is difficult to unify. It is generally accepted that when pain begins to affect daily activities is the time at which treatment begins, the goal of treatment is to relieve symptoms rather than achieving a specific drug dose. The following principles may be referenced: firstly, in view of the fact that therapeutic measures often fail to completely relieve symptoms, reasonable therapeutic targets should be formulated to give patients moderate expectations for efficacy; second, the drug dose must be individualized, with the minimum effective dose being used; thirdly, the risk of side effects is balanced when the dosage is adjusted; finally, although studies have supported combinations to alleviate diabetic peripheral neuropathy pain, it is generally believed that multiple drug combinations should be avoided.

The western medicine method for treating diabetic neuropathy firstly focuses on controlling diabetes, and large-scale research proves that the strict control of blood sugar can prevent and delay the occurrence of diabetic neuropathy and prevent the diabetic neuropathy from further progressing and deteriorating, attention should be paid to the achievement of blood fat, blood pressure and the like while controlling the blood sugar, and smoking and the like should be controlled. Secondly, the antioxidant medicine: alpha-lipoic acid is a cofactor of a pyruvate dehydrogenase system and is also an antioxidant which is commonly used in clinic at present. Also, mecobalamin, a neurotrophic agent, is a coenzyme for methionine synthase, promotes intraaxonal transport and axonal regeneration, and restores delayed transmission of nerve bonds. Other drugs that improve neural microcirculation: mainly vasodilators, such as angiotensin converting enzyme inhibitor, pentoxifylline; finally, aldose reductase inhibitors, which can improve diabetic neuropathy by inhibiting aldose reductase activity, restoring Na + -K + -ATPase activity, and reducing sorbitol and fructose deposition in peripheral nerve tissue.

Disclosure of Invention

The purpose of the invention is as follows: the invention aims to provide a traditional Chinese medicine composition for treating diabetic peripheral neuropathy and application thereof in preparing medicines for treating diabetic peripheral neuropathy. The invention also aims to provide a preparation of the traditional Chinese medicine composition.

The technical scheme is as follows: the traditional Chinese medicine composition comprises the following raw materials in parts by weight:

10-50 parts of dried dendrobium, 10-40 parts of achyranthes bidentata, 15-45 parts of caulis spatholobi, 15-45 parts of Chinese starjasmine stem, 15-45 parts of uncaria, 10-40 parts of ligusticum wallichii, 10-40 parts of angelica sinensis, 10-30 parts of earthworm and 10-30 parts of safflower.

The traditional Chinese medicine preparation is prepared by adding or not adding auxiliary materials into a decoction obtained by decocting and filtering the traditional Chinese medicine composition with water.

The Chinese medicinal preparation can be prepared into decoction, oral liquid, paste, granules and capsules.

The traditional Chinese medicine composition is applied to preparing a medicine for treating diabetic peripheral neuropathy.

The application of the traditional Chinese medicine preparation in preparing the medicine for treating diabetic peripheral neuropathy is provided.

The details of the materials in the present invention are as follows:

the herba Dendrobii is cultivated product of Dendrobium nobile Lindl, dendrobium chrysotoxum Lindl or Dendrobium fimbriatum Lindl of Orchidaceae and stem of similar species of plants of the same genus, and enters stomach and kidney meridians. The dry dendrobium is slightly cold in nature and sweet in taste, and has the effects of tonifying stomach, promoting fluid production, nourishing yin and clearing heat. Clinically, it is commonly indicated for body fluid deficiency due to febrile disease, dry mouth with polydipsia, poor appetite and retching, persistent asthenic fever after disease, hyperactivity of fire due to yin deficiency, flaccidity of tendons and bones.

Achyranthis radix is the dry root of achyranthes bidentata belonging to Amaranthaceae, and enters liver and kidney meridians. Achyranthes root has the functions of dissipating blood stasis and eliminating carbuncle and swelling, and is mainly used for treating gonorrhea, hematuria, amenorrhea, abdominal mass, dystocia, retained afterbirth, postpartum abdominal pain due to blood stasis, pharyngitis, carbuncle and swelling and traumatic injury. It is used for tonifying liver and kidney, strengthening tendons and bones after being cooked.

Caulis Spatholobi is rattan of Leguminosae plant Calycanthus praecox, mucuna birdwoodiana or Mucuna lianae, and enters liver and kidney channels. Spatholobus stem has the functions of enriching blood, promoting blood circulation and removing obstruction in channels, is mainly used for treating the irregular menstruation, blood deficiency, sallow complexion, numbness, paralysis, and arthralgia due to wind-dampness.

Trachelospermi caulis is dried caulis et folium Gaultheriae Yunnanensis of Trachelospermi of Apocynaceae, and enters heart, liver and kidney channels. Trachelospermi caulis has effects of dispelling pathogenic wind, dredging collaterals, cooling blood, and relieving swelling, and can be used for treating rheumatism, arthralgia, spasm of tendons and vessels, soreness of waist and knees, pharyngitis, carbuncle, swelling, and traumatic injury.

Ramulus Uncariae cum uncis is ramulus Uncariae cum uncis of Rubiaceae, ramulus Uncariae cum uncis of the same genus, and enters liver and pericardium channels. Ramulus Uncariae cum uncis has effects of clearing heat and calming liver, calming endogenous wind and arresting convulsion, and can be used for treating headache, giddiness, common cold with convulsion, convulsive epilepsy, convulsion, gestational eclampsia, hypertension, etc.

Rhizoma Ligustici Chuanxiong is dry rhizome of Umbelliferae plant rhizoma Ligustici Chuanxiong, and belongs to liver, gallbladder and pericardium. Chuan Xiong can activate blood and move qi, dispel wind and alleviate pain, and is mainly used for irregular menstruation, amenorrhea and dysmenorrhea, abdominal pain, stabbing pain in chest and hypochondrium, traumatic injury and swelling pain, headache and wind-damp arthralgia.

Dang Gui is the root of Angelica acutiloba Kitagawa, which is produced in Gansu. Sweet and pungent in flavor, warm in nature and tending to sink and enter liver, heart and spleen meridians. Has the functions of enriching blood, promoting blood circulation, regulating menstruation, relieving pain and relaxing bowel, and is suitable for the symptoms of blood deficiency and blood stasis with cold. It is commonly used for vertigo, palpitation, menoxenia, amenorrhea, dysmenorrhea, asthenia cold, abdominal pain, rheumatalgia, traumatic injury, superficial infection, pyocutaneous disease, and constipation due to intestinal dryness.

The Lumbricus is the whole body of Membristylis lanceolata and Membristylis williamsii, dryopteris Gu Huan, and Pheretima aspergillus (L.) Membristipula of Membristidae, and belongs to liver, spleen, and bladder channels. Lumbricus has effects in clearing away heat, arresting convulsion, dredging collaterals, relieving asthma, and promoting urination, and can be used for treating hyperpyrexia, unconsciousness, convulsive epilepsy, convulsion, arthralgia, numbness of limbs, hemiplegia, lung heat cough and asthma, oliguria, edema, and hypertension.

Carthami flos is dried flower of Carthamus tinctorius L of Compositae, and enters heart and liver channels. Safflower has the functions of promoting blood circulation and stimulating the menstrual flow, and removing blood stasis and relieving pain, and is mainly used for amenorrhea, dysmenorrhea, lochiorrhea, abdominal mass, thoracic obstruction, cardialgia, abdominal pain due to stasis, stabbing pain in chest and hypochondrium, traumatic injury, sore and ulcer with swelling and pain.

Wherein the caulis Spatholobi is used for promoting blood circulation and dredging collaterals; rhizoma ligustici wallichii, chinese starjasmine stem and angelica are used as ministers. The hemlock parsley has the effects of promoting blood circulation and dispelling wind, and the blood-qi-promoting medicine helps the monarch medicine to promote blood circulation; caulis Trachelospermi has effects of cooling blood and dredging collaterals; chinese angelica root, radix Angelicae sinensis has the effects of nourishing blood and promoting blood circulation; the three herbs have the action of promoting blood circulation to alleviate pain. The dried dendrobium nobile nourishes yin and generates body fluid, the achyranthes bidentata tonifies kidney and stimulates menstrual flow, the safflower activates blood and stimulates menstrual flow, the uncaria rhynchophylla clears heat and pacifies liver, the four medicines are adjuvant medicines and assist monarch and minister medicines in dredging collaterals and relieving pain, and the dried dendrobium nobile nourishes yin and generates body fluid without dredging powder corn poppy. Earthworm is used to activate collaterals to alleviate pain and to make herbs reach the disease. The nine medicines have the effects of promoting blood circulation, dredging collaterals, dispelling wind and removing arthralgia.

Has the advantages that: compared with the prior art, the traditional Chinese medicine composition has the effects of dispelling wind and relieving pain by taking blood circulation promoting and vein relaxing as a big method for treating the diabetic peripheral neuropathy from the traditional Chinese medicine perspective, and the traditional Chinese medicine composition has an obvious effect of treating the diabetic peripheral neuropathy through clinical verification.

Detailed Description

The technical solution of the present invention is further described in detail by the following specific examples.

Example 1

Process research of Tangbi Tongluo prescription (namely traditional Chinese medicine composition) described in the application

The experimental method comprises the following steps: (1) An orthogonal test method is adopted, the transfer rate of the trachelospermin and the yield of the extract are taken as indexes, and the influence of the decoction time, the decoction times and the water addition amount on the extraction effect is examined. The investigation result shows that the decoction of the Tangbi Tongluo group Fang Shui is optimized in an orthogonal manner, the decoction time, the decoction times and the water addition amount have no significant influence on the extraction effect, the production cost and the production efficiency are considered, and meanwhile, the optimized process is that by combining a clinical conventional decoction method: adding 10 times of water, decocting for 2 times, each time for 30 minutes. The verification test result shows that the preferable water decocting process is good.

(2) The investigation tests of different concentration processes are carried out on the water-decocted liquid by taking the transfer rate of the trachelospermin as an index, and the influence of the normal-pressure and reduced-pressure concentration processes on the investigation index is compared. The results of the examination suggest that there is no significant difference between the two processes, and reduced pressure concentration is adopted in the pilot scale-up process.

Example 2

Preparation of decoction

The medicine comprises the following components: 20g of dried dendrobium, 20g of achyranthes bidentata, 30g of caulis spatholobi, 30g of Chinese starjasmine stem, 30g of uncaria, 15g of ligusticum wallichii, 15g of angelica, 20g of earthworm prepared with wine and 10g of safflower.

The preparation method comprises the following steps: weighing the raw materials in parts by weight, decocting the raw materials with 10 times of water for 30 minutes, cooling, filtering and collecting liquid medicine, adding 10 times of water into the decoction dregs, decocting for 30 minutes, filtering, combining the liquid medicine obtained in two times, and subpackaging the liquid medicine into a plurality of bags.

Example 3

Preparation of oral liquid

The medicine comprises the following components: 20g of dried dendrobium, 20g of achyranthes bidentata, 15g of caulis spatholobi, 15g of Chinese starjasmine stem, 15g of uncaria, 15g of ligusticum wallichii, 15g of angelica, 15g of earthworm in wine and 10g of safflower.

The preparation method comprises the following steps: weighing the raw materials in parts by weight, decocting the raw materials in 10 times of water, cooling, filtering, removing residues, and adding sucrose, sodium carboxymethylcellulose and potassium sorbate.

Example 4

Preparation of Tangbi Tongluo paste

The medicine comprises the following components: 40g of dried dendrobium, 30g of achyranthes, 20g of caulis spatholobi, 20g of Chinese starjasmine stem, 20g of uncaria, 20g of ligusticum wallichii, 20g of angelica, 20g of earthworm in wine and 20g of safflower.

The preparation method comprises the following steps: the preparation method comprises the following steps: weighing the raw materials in parts by weight, decocting the raw materials with 10 times of water for 30 minutes, cooling, filtering and collecting liquid medicine, adding 10 times of water into the decoction dregs, decocting for 30 minutes, filtering and combining the liquid medicine of the two times, decompressing and evaporating the liquid medicine to be pasty, adding 50mL of honey, and uniformly stirring.

Example 5

Preparation of Tangbi Tongluo granules

The medicine comprises the following components: 30g of dried dendrobium, 30g of achyranthes, 20g of caulis spatholobi, 20g of Chinese starjasmine stem, 20g of uncaria, 20g of ligusticum wallichii, 20g of angelica, 20g of earthworm in wine and 15g of safflower

The preparation method comprises the following steps: the nine medicines are decocted with water twice. Adding 10 times of water each time, decocting for 30 minutes, and filtering. The two filtrates were combined and concentrated under reduced pressure to a relative density of about 1.15 (60 ℃). Putting a proper amount of dextrin into a fluidized bed, setting the air inlet temperature to be 100 ℃, starting to feed liquid when the temperature of the materials rises to 70 ℃, and controlling the liquid feeding speed to be 80-150 r/min and the atomization pressure to be 0.2MPa outside and 0.15MPa inside. After spraying, the mixture was dried at 70 ℃ for 1 hour, and the granules were granulated and mixed.

Example 6

Preparation of capsules

The medicine comprises the following components: 30g of dried dendrobium, 30g of achyranthes, 20g of caulis spatholobi, 20g of Chinese starjasmine stem, 20g of uncaria, 20g of ligusticum wallichii, 20g of angelica, 20g of earthworm in wine and 15g of safflower.

The preparation method comprises the following steps: the granules obtained in example 5 were encapsulated to prepare capsules.

Example 7

The tangbi Tongluo granules are produced in an enlarged way according to the preparation method of the example 5.

277.7g of dried dendrobium, 277.7g of achyranthes, 208.3g of suberect spatholobus stem, 208.3g of Chinese starjasmine stem, 208.3g of uncaria, 208.3g of szechuan lovage rhizome, 208.3g of Chinese angelica, 208.3g of earthworm in wine, and 138.8g of safflower

Dextrin addition (g) = 1000-clear paste total amount before pelletization solid content yield

Yield (%) of the finished product is = actual finished product amount of the batch/theoretical finished product amount of the batch x 100%.

The total amount of the nine decoction pieces is 1944g, and the decoction pieces are made into 1000g of granules, and each bag is 12g. Each 1g of the decoction pieces is equal to 1.94g of the decoction pieces. The product is taken 2-3 times with boiled water every day, 2 bags each time.

Example 8

58 patients who are in line with diabetic peripheral neuropathy (qi-yin deficiency with blood stasis) are collected, and the treatment scheme is that the diabetic obstruction-removing and collateral-dredging ointment of the example 4 is taken twice a day. Collecting basic information of a patient, detecting Toronto clinical scores (TCSS) before and after treatment, and evaluating clinical curative effect by detecting sensory branch sensory nerve conduction velocity of median nerve, ulnar nerve and tibial nerve by electromyogram. Toronto Clinical score (TCSS) see Bril V, perkins BA. Differentiation of the Toronto Clinical Scoring System for metabolic polynucleotides, diabetes Care.2002;25 (11): 2048-2052.

In the aspect of safety observation, no obvious adverse reaction is observed, and no obvious abnormality occurs in the functions of the liver and the kidney.

TCSS score content includes sensations (pressure, temperature, pain, vibration and position), neuroreflexes (knee reflexes, ankle reflexes) and symptoms (foot pain, numbness, prickling, weakness, ataxia, upper limb symptoms). Wherein, the total score of symptom score is 6, the score of existence is 1, and the score of no symptom is 0. The total score of the reflex is 8, the normal score is 0, the attenuation score is 1, and the disappearance score is 2. The total sensory score was 5 points, the normal score was 0 points, and the abnormal score was 1 point. The total score of TCSS is 19 points, and 6 to 8 points are defined as light DPN; scores 9-11 were defined as medium DPN; scores 12-19 define the severity DPN.

Table 1 comparison of overall TCSS score efficacy (x ± s, min, n = 58)

P < 0.05 compared to pre-treatment;

and (4) conclusion: the TCSS score was reduced after treatment compared to before treatment (P < 0.05).

TABLE 2 TCSS score comparison of treatment efficacy for patients with mild DPN and moderate DPN (x + -s, points)

P < 0.05 compared to pre-treatment;

the number of mild and moderate DPN patients before treatment was 22 and 36 respectively, and the total number was 58. After treatment, 13 people in the original mild DPN score is less than 6 points, and 9 people still have mild DPN; the score of 3 of the original moderate DPN was less than 6, 26 were converted to mild DPN, and the remaining 4 were still moderate DPN.

And (4) conclusion: TCSS score decreased after treatment for patients with mild DPN compared to before treatment (P < 0.05); the TCSS score decreased after treatment in moderate DPN patients compared to pre-treatment (P < 0.05).

TABLE 3 EMG efficacy comparison (x + -s, m/s, n = 58)

Note: p < 0.05 compared to before treatment

As a result: the conduction speed of sensory branches of median nerve, ulnar nerve and tibial nerve is improved (P is less than 0.05) after taking the sugar arthralgia dredging collaterals plaster.

Claims

1. The traditional Chinese medicine composition is characterized by comprising the following raw materials in parts by weight:

2. A Chinese medicinal preparation, which is characterized in that the Chinese medicinal composition of claim 1 is prepared by adding or not adding auxiliary materials into a decoction obtained by decocting and filtering the decoction.

3. The traditional Chinese medicine preparation according to claim 2, wherein the preparation is in the form of decoction, oral liquid, paste, granules or capsules.

4. The use of the Chinese medicinal composition of claim 1 in the preparation of a medicament for treating diabetic peripheral neuropathy.

5. The use of the Chinese medicinal preparation of claim 2 in the preparation of a medicament for the treatment of diabetic peripheral neuropathy.