CN115837058B - Traditional Chinese medicine composition, preparation thereof and application of traditional Chinese medicine composition in preparation of medicines for treating diabetic peripheral neuropathy - Google Patents
Traditional Chinese medicine composition, preparation thereof and application of traditional Chinese medicine composition in preparation of medicines for treating diabetic peripheral neuropathy Download PDFInfo
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Abstract
The application discloses a traditional Chinese medicine composition, a preparation thereof and application thereof in medicines 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, 15-45 parts of spatholobus stem, 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 wine earthworm and 10-30 parts of safflower. The traditional Chinese medicine composition disclosed by the application is used for treating diabetic peripheral neuropathy from the aspect of traditional Chinese medicine, has the effects of dispelling wind and relieving pain by taking the effects of activating blood and dredging collaterals as a major method, and has obvious effect of treating diabetic peripheral neuropathy through clinical verification.
Description
Technical Field
The application 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 medicines for treating diabetic peripheral neuropathy.
Background
Diabetic peripheral neuropathy (Diabetic Peripherial Neuropathy, DPN) is the occurrence of symptoms and/or signs associated with peripheral nerve dysfunction in diabetics, exclusive of other causes. Diabetic peripheral neuropathy is the most common clinical type of diabetic neuropathy, and is also one of the most common chronic complications for diabetics.
The pathogenesis of diabetic peripheral neuropathy is not currently well understood, and there is much controversy in the academy of matters 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 hexosaminium pathway, the theory of trophic factors, the theory of ion channel damage, and the like. It is far from being explained by a single factor, and should be the result of a multifactorial effect. Recently, there are two main views about the pathogenesis of diabetic peripheral neuropathy: metabolic and vascular factors, and indeed many studies confirm that metabolic and vascular factors are involved in the onset of diabetic peripheral neuropathy, and that the treatment cycle is difficult to unify because diabetic peripheral neuropathy symptoms are diverse and the conditions are often repeated. It is generally recognized that when pain begins to affect daily activities, it is the timing of the onset of treatment that is aimed at alleviating symptoms rather than achieving a specific drug dose. The following principles are to be referred to: firstly, since the symptoms cannot be completely relieved by the treatment measures, reasonable treatment targets should be formulated so that patients have moderate expectations on the curative effects; second, the drug dose must be individualized, with the minimum effective dose being used in most cases; again, dose adjustment requires balancing the risk of side effects; finally, while studies have supported combination use to alleviate diabetic peripheral neuropathy pain, it is generally recognized that multi-drug combination use should be avoided.
The method for treating diabetic neuropathy by western medicine firstly focuses on controlling diabetes, and large-scale researches prove that the method can prevent and delay the occurrence of diabetic neuropathy by strictly controlling blood sugar, prevent further progression and worsen, and pay attention to the standard of blood fat, blood pressure and the like and also control smoking and the like while controlling the blood sugar. The antioxidant medicine is as follows: alpha-lipoic acid is a cofactor of a pyruvate dehydrogenase system and is an antioxidant which is more clinically used at present. Also, the mecobalamin serving as a neurotrophic drug is used as methionine synthetase coenzyme, so that the intraaxonal delivery and the regeneration of axons are promoted, and the transmission delay of nerve bonds is recovered. Other drugs that improve neurological microcirculation: mainly vasodilators, such as angiotensin converting enzyme inhibitors, pentoxifylline; finally, aldose reductase inhibitors, which can improve diabetic neuropathy by inhibiting aldose reductase activity, restoring Na+ -K+ -ATPase activity, and reducing deposition of sorbitol and fructose on peripheral nerve tissue.
Disclosure of Invention
The application aims to: the application 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 application also aims at providing a preparation of the traditional Chinese medicine composition.
The technical scheme is as follows: the traditional Chinese medicine composition provided by the application comprises the following raw materials in parts by weight:
10-50 parts of dried dendrobium, 10-40 parts of achyranthes, 15-45 parts of spatholobus stem, 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 wine earthworm and 10-30 parts of safflower.
The traditional Chinese medicine preparation is prepared from decoction obtained by decocting and filtering the traditional Chinese medicine composition with water, and auxiliary materials are added or not added.
The preparation is in the form of decoction, oral liquid, paste, granule or capsule.
The application of the traditional Chinese medicine composition in preparing medicines for treating diabetic peripheral neuropathy.
The application of the traditional Chinese medicine preparation in preparing the medicine for treating diabetic peripheral neuropathy.
The details of the materials in the application are as follows:
the dry dendrobium is a cultivation product of dendrobium nobile, dendrobium chrysotoxum or dendrobium fimbriatum belonging to Orchidaceae and stems of similar species of the same plants, and enters stomach and kidney channels. 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 indicated for fever, fluid consumption, dry mouth, polydipsia, anorexia, retching, excessive heat due to deficiency after illness, hyperactivity of fire due to yin deficiency, flaccidity of tendons and bones.
Achyranthes root is the dry root of achyranthes bidentata belonging to amaranthaceae, and enters liver and kidney meridians. The achyranthes root can remove blood stasis and cure carbuncle and swelling, and is mainly used for treating gonorrhea, hematuria, amenorrhea, abdominal mass, dystocia, indigestion, postpartum abdominal pain due to blood stasis, pharyngitis, carbuncle and swelling and traumatic injury. It is used to tonify liver and kidney, strengthen tendons and bones.
Caulis Spatholobi is stem of Spatholobi, such as Spatholobus stem, sparassis crispa, or Sparassis crispa of Leguminosae, and enters liver and kidney channels. Caulis Spatholobi has effects of replenishing blood, promoting blood circulation, and dredging collaterals, and can be used for treating menoxenia, blood deficiency sallow complexion, numbness paralysis, rheumatalgia.
Caulis Trachelospermi is dry caulis Trachelospermi of Apocynaceae, and is returned to heart, liver and kidney channels. The caulis trachelospermi has effects of dispelling pathogenic wind, dredging collaterals, cooling blood, and relieving swelling, and can be used for treating rheumatic fever arthralgia, spasm of tendons and vessels, soreness of waist and knees, pharyngitis, carbuncle, swelling, and traumatic injury.
Ramulus Uncariae cum Uncis is branch with hook of ramulus Uncariae cum Uncis or ramulus Uncariae cum Uncis of Rubiaceae and its same genus plants, and is used for liver and pericardium meridian. Ramulus Uncariae cum Uncis has effects of clearing heat and suppressing hyperactive liver, and calming endogenous wind and arresting convulsion, and can be used for treating headache and giddiness, common cold and convulsion, gestational eclampsia, hypertension, etc.
Ligusticum wallichii is the dried rhizome of Ligusticum wallichii of Umbelliferae, and is classified into liver, gall bladder and pericardium. Rhizoma Ligustici Chuanxiong has effects of promoting blood circulation, activating qi-flowing, dispelling pathogenic wind, and relieving pain, and can be used for treating menoxenia, amenorrhea dysmenorrhea, abdominal pain, chest and hypochondrium pain, traumatic injury, headache, and rheumatalgia.
Radix Angelicae sinensis is root of Angelica sinensis (L.) Diels of Umbelliferae, and is mainly produced in Gansu province. Sweet and pungent in flavor, warm in nature, prone to sedimentation, and enters liver, heart and spleen meridians. It is indicated for blood deficiency with cold syndrome with the effects of replenishing blood, activating blood, regulating menstruation, relieving pain, and relaxing bowel. It is often used for dizziness, palpitation, menoxenia, amenorrhea, dysmenorrhea, abdominal pain due to deficiency-cold, rheumatalgia, traumatic injury, carbuncle, ulcer, constipation due to dryness of the intestines.
Lumbricus is the whole body of limnodrilus of giant lumbricidae, such as limnodrilus and limnodrilus wilsonii, limnodrilus pubescens Gu Huanmao, and limnodrilus pectinate, and enters liver, spleen and bladder channels. Lumbricus has effects of clearing heat, arresting convulsion, dredging collaterals, relieving asthma, promoting urination, and can be used for treating hyperpyrexia, unconsciousness, convulsion, arthralgia, limb numbness, hemiplegia, lung heat asthma cough, oliguria edema, and hypertension.
Safflower is the dried flower of Compositae plant safflower, and enters heart and liver meridian. The safflower has the effects of promoting blood circulation, dredging channels, removing blood stasis and relieving pain, and is mainly used for treating amenorrhea, dysmenorrhea, lochia, mass, chest pain, abdominal pain, thorny chest pain, traumatic injury and sore pain.
Wherein caulis Spatholobi is used for activating blood and dredging collaterals; ligusticum wallichii, chinese starjasmine stem and Chinese angelica are ministerial drugs. Chuan Xiong is a medicine for activating blood, dispelling wind and qi in blood, and assisting monarch medicine to activate blood; collaterals Dan Tengliang blood dredging collaterals; chinese angelica can nourish blood and activate blood; the three herbs together assist the actions of promoting blood circulation and relieving pain. The dried dendrobium candidum has the effects of nourishing yin and promoting the production of body fluid, the achyranthes root has the effects of tonifying kidney and dredging channels, the safflower has the effects of activating blood and dredging channels, the uncaria has the effects of clearing heat and calming liver, and the four medicines are used as adjuvant medicines, and are used as auxiliary medicines for dredging collaterals and relieving pain, nourishing yin and promoting the production of body fluid without dispersing. Lumbricus is used for dredging collaterals and relieving pain, and can be used for treating disease. The nine herbs together have the actions of activating blood and removing obstruction in collaterals, dispelling wind and removing arthralgia.
The beneficial effects are that: compared with the prior art, the traditional Chinese medicine composition treats the diabetic peripheral neuropathy from the perspective of traditional Chinese medicine, has the effects of dispelling wind and relieving pain by taking the effects of activating blood and removing obstruction in collaterals as a major method, and has obvious effect of treating the diabetic peripheral neuropathy through clinical verification.
Detailed Description
The technical scheme of the application is further described in detail through specific examples.
Example 1
Technological research of sugar arthralgia and vein relaxing formula (namely the traditional Chinese medicine composition)
The experimental method comprises the following steps: (1) By adopting an orthogonal test method, the influence of the decoction time, the decoction times and the water addition amount on the extraction effect is examined by taking the transfer rate of the trachelospermi glycoside and the extract yield as indexes. The investigation result shows that the water decoction quadrature of the sugar arthralgia dredging composition prefers the levels of all factors, the decoction time, the decoction times and the water adding amount have no obvious influence on the extraction effect, the production cost and the production efficiency are considered, and the optimal process is as follows in combination with the clinical conventional decoction method: adding 10 times of water, decocting for 2 times, and each time for 30 minutes. The verification test result shows that the preferable water decoction process is good.
(2) The method uses the transfer rate of the trachelospermine glycoside as an index, and carries out investigation tests of different concentration processes on the water decoction, thereby comparing the influence of the normal pressure and reduced pressure concentration processes on the investigation index. The investigation result shows that there is no obvious difference between the two processes, and the decompression 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, 30g of suberect spatholobus stem, 30g of Chinese starjasmine stem, 30g of uncaria, 15g of szechuan lovage rhizome, 15g of Chinese angelica, 20g of earthworm with wine and 10g of safflower.
The preparation method comprises the following steps: weighing the raw materials in parts by weight, decocting with 10 times of water for 30 minutes, cooling, filtering to collect liquid medicine, decocting residues with 10 times of water for 30 minutes, filtering, combining the liquid medicine obtained by the two steps, and packaging into bags.
Example 3
Preparation of oral liquid
The medicine comprises the following components: 20g of dried dendrobium, 20g of achyranthes, 15g of suberect spatholobus stem, 15g of Chinese starjasmine stem, 15g of uncaria, 15g of szechuan lovage rhizome, 15g of Chinese angelica, 15g of earthworm with wine and 10g of safflower.
The preparation method comprises the following steps: weighing the raw materials in parts by weight, decocting with 10 times of water, cooling, filtering, discarding residues, and adding sucrose, sodium carboxymethyl cellulose and potassium sorbate.
Example 4
Preparation of paste for treating arthralgia and removing obstruction in collaterals
The medicine comprises the following components: 40g of dried dendrobium, 30g of achyranthes, 20g of suberect spatholobus stem, 20g of Chinese starjasmine stem, 20g of uncaria, 20g of szechuan lovage rhizome, 20g of Chinese angelica, 20g of earthworm with 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 with 10 times of water for 30 minutes, cooling, filtering to collect liquid medicine, adding 10 times of water into residues, decocting for 30 minutes, filtering, combining the liquid medicine obtained by the two times, decompressing and evaporating the liquid medicine to paste, adding 50mL of honey, and uniformly stirring.
Example 5
Preparation of granule for treating arthralgia and dredging collaterals
The medicine comprises the following components: 30g of dried dendrobium, 30g of achyranthes, 20g of suberect spatholobus stem, 20g of Chinese starjasmine stem, 20g of uncaria, 20g of szechuan lovage rhizome, 20g of Chinese angelica, 20g of earthworm, 15g of safflower
The preparation method comprises the following steps: the nine materials 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 ℃). And (3) placing a proper amount of dextrin into a fluidized bed, setting the air inlet temperature to be 100 ℃, and starting liquid feeding when the material temperature is raised to 70 ℃, wherein the liquid feeding speed is controlled to be 80-150 r/min, and the atomization pressure is 0.2MPa outside and 0.15MPa inside. And (5) continuing to dry at 70 ℃ for 1 hour after spraying, finishing granules, and mixing.
Example 6
Preparation of capsules
The medicine comprises the following components: 30g of dried dendrobium, 30g of achyranthes, 20g of suberect spatholobus stem, 20g of Chinese starjasmine stem, 20g of uncaria, 20g of szechuan lovage rhizome, 20g of Chinese angelica, 20g of earthworm with wine and 15g of safflower.
The preparation method comprises the following steps: encapsulating the granule obtained in example 5 to obtain capsule.
Example 7
The preparation method of the example 5 is used for producing the granule for treating the arthralgia and dredging collaterals.
277.7g of dried dendrobium, 277.7g of achyranthes root, 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 wine and 138.8g of safflower
Dextrin addition amount (g) =1000-total amount of fluid extract before granulation solid content yield
Yield (%) =actual yield of the batch/theoretical yield of the batch x 100%.
The total amount of the prescription of the nine decoction pieces is 1944g, and the nine decoction pieces are prepared into 1000g granules, and each bag is 12g. Each 1g is equivalent to 1.94g of decoction pieces. The product is taken 2-3 times per day with boiled water, 2 bags each time.
Example 8
A total of 58 patients meeting the diabetic peripheral neuropathy (qi and yin deficiency with blood stasis) were collected, and the treatment scheme is to take the paste for treating the arthralgia and the obstruction in collaterals of example 4 twice a day. Basic information of a patient is collected, the clinical scores (TCSS) of Toronto before and after treatment are detected, and the sensory branch sensory nerve conduction speeds of the median nerve, the ulnar nerve and the tibial nerve are detected by using electromyography to evaluate the clinical curative effect. Toronto clinical score (TCSS) see Bril V, perkins BA.validation of the Toronto Clinical Scoring System for diabetic polyneuropathy.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 liver and kidney functions.
TCSS scoring content includes sensation (sense of touch, sense of temperature, sense of pain, sense of vibration and sense of position), neuroreflex (knee reflex, ankle reflex) and symptoms (foot pain, numbness, sense of acupuncture, weakness, ataxia, upper limb symptoms). Wherein, the total score of symptoms is 6 points, the total score of symptoms is 1 point, and the total score of no symptoms is 0 point. The total score of the nerve reflex is 8 points, normally 0 points, and the total score is weakened by 1 point and disappears by 2 points. Sensory totals were 5 points, normally 0 points and abnormalities were 1 point. TCSS score 19, defined as mild DPN from 6 to 8; 9-11 minutes is defined as moderate DPN;12-19 points are defined as severe DPN.
Table 1 overall TCSS score efficacy comparison (x±s, score, n=58)
P < 0.05 compared to pre-treatment;
conclusion: the TCSS score was reduced after treatment compared to that before treatment (P < 0.05).
Table 2 efficacy of light DPN versus moderate DPN patient TCSS score (x+ -s, score)
P < 0.05 compared to pre-treatment;
the number of the light and moderate DPNs before treatment is 22 and 36 respectively, and the total number is 58. 13 persons in original mild DPN after treatment have scores less than 6 points, and 9 persons still are mild DPN; 3 persons in the original moderate DPN have scores less than 6 points, 26 persons are converted into mild DPN, and the rest 4 persons are still moderate DPN.
Conclusion: TCSS scores decreased after treatment compared to pre-treatment (P < 0.05) for mild DPN patients; TCSS scores were reduced after treatment compared to pre-treatment (P < 0.05) for moderate DPN patients.
Table 3 electromyographic effect contrast (x±s, m/s, n=58)
Note that: p < 0.05 compared to pre-treatment
Results: after the paste is taken, the sensory branch transmission speed of median nerve, ulnar nerve and tibial nerve is improved (P is less than 0.05) compared with that before treatment.
Claims (5)
1. The traditional Chinese medicine composition for treating diabetic peripheral neuropathy is characterized by comprising the following raw materials in parts by weight:
10-50 parts of dried dendrobium, 10-40 parts of achyranthes, 15-45 parts of spatholobus stem, 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 wine earthworm and 10-30 parts of safflower.
2. A Chinese medicinal preparation for treating diabetic peripheral neuropathy is characterized in that the Chinese medicinal preparation is prepared by decocting the Chinese medicinal composition in water and filtering to obtain decoction, and adding or not adding auxiliary materials.
3. The Chinese medicinal preparation for treating diabetic peripheral neuropathy according to claim 2, wherein the preparation is in the form of decoction, oral liquid, paste, granule, capsule.
4. The use of the Chinese medicinal composition according to claim 1 for preparing a medicament for treating diabetic peripheral neuropathy.
5. The use of the Chinese medicinal preparation according to claim 2 for preparing a medicament for treating diabetic peripheral neuropathy.
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| CN108524832A (en) * | 2018-05-28 | 2018-09-14 | 河北中唐医药有限公司 | A kind of Chinese medicine composition and preparation method thereof for treating diabete peripheral herve pathology |
| CN112022929A (en) * | 2019-06-03 | 2020-12-04 | 鲁南制药集团股份有限公司 | Traditional Chinese medicine composition for treating diabetic peripheral neuropathy and preparation method thereof |
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| CN108524832A (en) * | 2018-05-28 | 2018-09-14 | 河北中唐医药有限公司 | A kind of Chinese medicine composition and preparation method thereof for treating diabete peripheral herve pathology |
| CN112022929A (en) * | 2019-06-03 | 2020-12-04 | 鲁南制药集团股份有限公司 | Traditional Chinese medicine composition for treating diabetic peripheral neuropathy and preparation method thereof |
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| 补阳还五汤加减治疗糖尿病周围神经病变50例分析;梁兴先等;赣南医学院学报;-;第30卷(第04期);639 * |
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