CN110115743A - A kind of Chinese medicine composition for treating diabetic foot and preparation method thereof and purposes - Google Patents

A kind of Chinese medicine composition for treating diabetic foot and preparation method thereof and purposes Download PDF

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CN110115743A
CN110115743A CN201910561091.9A CN201910561091A CN110115743A CN 110115743 A CN110115743 A CN 110115743A CN 201910561091 A CN201910561091 A CN 201910561091A CN 110115743 A CN110115743 A CN 110115743A
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parts
chinese medicine
medicine composition
radix
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刘洪涛
陈嫚
郑军平
杨化冰
邹小娟
姚小卫
夏慧
殷明珠
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Hubei College of Chinese Medicine
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Abstract

The present invention relates to technical field of Chinese medicine, disclose a kind of Chinese medicine composition for treating diabetic foot and preparation method thereof and purposes, the Chinese medicine composition is prepared by a kind of Chinese medicine material formula, life Radix Astragali of the Chinese medicine material formula containing 20-60 parts by weight, the radix scrophulariae of 15-45 parts by weight, the sun-dried ginseng of 10-30 parts by weight, the Radix Ophiopogonis of 15-45 parts by weight, the leech of 5-15 parts by weight, the tendril-leaved fritillary bulb of 10-30 parts by weight, the Chinese yam of 20-60 parts by weight and 15-45 parts by weight Radix Salviae Miltiorrhizae.Chinese medicine composition is prepared according to the method described in the present invention, and 8 taste Chinese medicines are used cooperatively, it can be with supplementing qi and nourishing yin, promoting blood circulation, eleminating phlegm and freeing channels;The phlegm-blood stasis of internal organs can also be dispelled, removing those leads to the substance of body glucose -lipid metabolism disorder with the gas yin of help lung spleen kidney.In addition, Chinese medicine composition of the present invention can promote body microcirculation, promote the secretion of vascular endothelial growth factor, there is good therapeutic effect to diabetic foot, and toxicity is small, takes safety, the value of great popularization and application.

Description

A kind of Chinese medicine composition for treating diabetic foot and preparation method thereof and purposes
Technical field
The present invention relates to technical field of Chinese medicine, and in particular to a kind of Chinese medicine composition for treating diabetic foot and its system Preparation Method and purposes.
Background technique
With the development of national economy and the raising of living standards of the people, urbanization process is accelerated, and dietary structure is increasingly western Change, material conditions constantly improve, and the amount of exercise of people is fewer and fewer, and increasing metabolic disease is following.Glycosuria Clinical syndrome caused by disease is exactly a kind of glucose -lipid metabolism disorder because of body.The data counted according to International Diabetes Federation: There are 4.25 hundred million diabetics in the whole world at present, and every about just having 1 diabetic in 11 adults, in addition there are 3.5 hundred million More High-risk Group of Diabetes.It expects 2045, it will have nearly 700,000,000 diabetic.China is that diabetes number of patients is most Country, number of patients is up to 1.14 hundred million.And during diabetes de-velopment, there are about 15%~20% patients may be in its disease Ulcer of foot or gangrene occur in journey.Population base of China is big, is influenced by aging of population, the morbidity of the diabetic foot in China Increased trend is increasingly obvious year by year for rate, and medicine and social concern brought by diabetic foot are urgently to be resolved.
Diabetic foot refers to that diabetic foot makes the decline of lower limb defencive function, big blood due to nerve and vascular lesion Pipe and microangiopathies make arterial perfusion deficiency cause microcirculation disorder and ulcer and gangrenous morbid state occurs.Diabetic foot A kind of serious complication of diabetes, control it is improper disable it is lethal.The existing general treatment for diabetic foot includes: Metabolism control, expansion blood vessel, hyperbaric oxygentherapy, local treatment etc..Though above-mentioned therapeutic modality can alleviate diabetes to a certain extent The symptom of disease, but it is palliative, it cannot fundamentally solve the caused vascular lesion of metabolic disorder.
The present invention is based on Chinese medicines to the basic understandings of diabetes basic pathogenesis " dirty void network numbness ", proposes that " mending dirty dredging collateral " is basic The rules for the treatment of prepare a kind of Chinese medicine composition.For the composition to give birth to Radix Astragali and radix scrophulariae as monarch, the gas of help lung spleen kidney is negative;Sun-dried ginseng, wheat Winter, leech, tendril-leaved fritillary bulb are minister, the raw Radix Astragali help visceral-qi of sun-dried ginseng principal drug assistance, the dirty yin of Radix Ophiopogonis principal drug assistance radix scrophulariae help;Leech promoting blood circulation by The stasis of blood, tendril-leaved fritillary bulb resolving sputum disappear it is turbid, to dredge network numbness;Chinese yam, Radix Salviae Miltiorrhizae are that assistant makes, and Chinese yam helps the monarch and his subjects' help lung spleen kidney qi negative, and Radix Salviae Miltiorrhizae is assisted Leech eliminating blood stasis and smoothing collaterals.Full Fang Hetong plays supplementing qi and nourishing yin altogether and mends dirty, dissolving stasis eleminating phlegm and freeing channels function, is named as " mending dirty dredging collateral side ".This The Chinese medicine composition of invention effectively can prevent and delay the generation of diabetic foot, have protective effect to diabetic vascular, promote Into the angiogenesis of ischemic tissue, increase blood flow, reduction inflammatory reaction.
Summary of the invention
Although the purpose of the invention is to overcome the therapeutic modality of diabetic foot of the existing technology can be one Determine the symptom for alleviating diabetic foot in degree, but it is palliative, it cannot fundamentally solve the caused of metabolic disorder Vascular lesion the problem of, a kind of Chinese medicine composition and preparation method thereof for treating diabetic foot, the Chinese medicine composition are provided The generation that effectively can prevent and delay diabetic foot, has protective effect to diabetic vascular, promotes the blood vessel of ischemic tissue Newborn, increase blood flow, reduction inflammatory reaction.
To achieve the goals above, one aspect of the present invention provides a kind of Chinese medicine composition for treating diabetic foot, institute It states Chinese medicine composition to be prepared by a kind of Chinese medicine material formula, the Chinese medicine material formula contains the raw yellow of 20-60 parts by weight Stilbene, the radix scrophulariae of 15-45 parts by weight, the sun-dried ginseng of 10-30 parts by weight, the Radix Ophiopogonis of 15-45 parts by weight, 5-15 parts by weight leech, The tendril-leaved fritillary bulb of 10-30 parts by weight, the Chinese yam of 20-60 parts by weight and 15-45 parts by weight Radix Salviae Miltiorrhizae.
Preferably, life Radix Astragali of the Chinese medicine material formula containing 30-50 parts by weight, 25-35 parts by weight radix scrophulariae, 15- The sun-dried ginseng of 25 parts by weight, the Radix Ophiopogonis of 25-35 parts by weight, the leech of 7-12 parts by weight, the tendril-leaved fritillary bulb of 15-25 parts by weight, 30-50 weight Measure the Chinese yam of part and the Radix Salviae Miltiorrhizae of 25-35 parts by weight.
Preferably, the dosage form of the Chinese medicine composition is granule, capsule, tablet, pill, paste or aqua.
Second aspect of the present invention provides a kind of side of Chinese medicine composition for preparing previously described treatment diabetic foot Method, method includes the following steps:
(1) raw Radix Astragali, radix scrophulariae, sun-dried ginseng, Radix Ophiopogonis, leech, tendril-leaved fritillary bulb, Chinese yam and Radix Salviae Miltiorrhizae are mixed according to formula with water, is decocted It is filtered after boiling, collects the first filtrate;
(2) dregs of a decoction obtained by step (1) are mixed with water, is filtered after decoction, collect the second filtrate;
(3) it after mixing the first filtrate with the second filtrate, is concentrated under reduced pressure into decocting liquid.
Preferably, in step (1), the raw Radix Astragali, radix scrophulariae, sun-dried ginseng, Radix Ophiopogonis, leech, tendril-leaved fritillary bulb, Chinese yam and Radix Salviae Miltiorrhizae Gross mass and the mass ratio of water are 1:(10-15).
Preferably, the decoction temperature is 90-100 DEG C;The decocting time is 1-2 hours.
Preferably, in step (2), the mass ratio of the dregs of a decoction and water is 1:(5-10).
Preferably, in step (2), the decoction temperature is 90-100 DEG C;The decocting time is 1-2 hours.
Preferably, in step (3), the temperature of the reduced pressure is 40~60 DEG C.
Preferably, in step (3), the concentration of the decocting liquid is 1-2g/mL.
Third aspect present invention provides a kind of previously described Chinese medicine composition or according to previously described method system Application of the standby Chinese medicine composition in treatment diabetic foot.
Preferably, the dosage of the Chinese medicine composition is 0.2-1g crude drug/kg weight.
Chinese medicine composition is prepared according to the method described in the present invention, and 8 taste Chinese medicines are used cooperatively, it can be living with supplementing qi and nourishing yin Blood and dissolving stasis, eleminating phlegm and freeing channels;The phlegm-blood stasis of internal organs can also be dispelled, removing those leads to body glycolipid generation with the gas yin of help lung spleen kidney Thank to the substance of disorder.In addition, Chinese medicine composition of the present invention can promote body microcirculation, promote vascular endothelial growth factor Secretion, there is good therapeutic effect to diabetic foot, and toxicity is small, takes safety, the valence of great popularization and application Value.
Specific embodiment
Detailed description of the preferred embodiments below.It should be understood that described herein specific Embodiment is merely to illustrate and explain the present invention, and is not intended to restrict the invention.
The endpoint of disclosed range and any value are not limited to the accurate range or value herein, these ranges or Value should be understood as comprising the value close to these ranges or value.For numberical range, between the endpoint value of each range, respectively It can be combined with each other between the endpoint value of a range and individual point value, and individually between point value and obtain one or more New numberical range, these numberical ranges should be considered as specific open herein.
To achieve the goals above, the present invention provides a kind of Chinese medicine composition for treating diabetic foot, the Chinese medicines Composition is prepared by a kind of Chinese medicine material formula, life Radix Astragali, 15- of the Chinese medicine material formula containing 20-60 parts by weight The radix scrophulariae of 45 parts by weight, the sun-dried ginseng of 10-30 parts by weight, the Radix Ophiopogonis of 15-45 parts by weight, the leech of 5-15 parts by weight, 10-30 weight Measure the tendril-leaved fritillary bulb, the Chinese yam of 20-60 parts by weight and the Radix Salviae Miltiorrhizae of 15-45 parts by weight of part.
Diabetic foot of the present invention, clinical symptoms are ischemic, anoxic caused by pedal blood arterial perfusion is insufficient The disease of the dangerous consequences such as ulcer, gangrene can occur when serious for state.
In Chinese medicine composition of the present invention, it is preferable that the life of the Chinese medicine material formula containing 30-50 parts by weight Radix Astragali, the radix scrophulariae of 25-35 parts by weight, the sun-dried ginseng of 15-25 parts by weight, the Radix Ophiopogonis of 25-35 parts by weight, 7-12 parts by weight water Leech, the tendril-leaved fritillary bulb of 15-25 parts by weight, the Chinese yam of 30-50 parts by weight and 25-35 parts by weight Radix Salviae Miltiorrhizae.In a specific embodiment, raw Radix Astragali can be 30 parts by weight, 35 parts by weight, 40 parts by weight, 45 parts by weight or 50 parts by weight;Radix scrophulariae can be 25 parts by weight, 30 Parts by weight or 35 parts by weight;Sun-dried ginseng can be 15 parts by weight, 20 parts by weight or 25 parts by weight;Radix Ophiopogonis can for 25 parts by weight, 30 parts by weight or 35 parts by weight;Leech can be 7 parts by weight, 8 parts by weight, 9 parts by weight, 10 parts by weight, 11 parts by weight or 12 weights Measure part;Tendril-leaved fritillary bulb can be 15 parts by weight, 20 parts by weight or 25 parts by weight;Chinese yam can be 30 parts by weight, 35 parts by weight, 40 weight Part, 45 parts by weight or 50 parts by weight;Radix Salviae Miltiorrhizae can be 25 parts by weight, 30 parts by weight or 35 parts by weight.
In most preferred embodiments, life Radix Astragali of the Chinese medicine material formula containing 40 parts by weight, 30 parts by weight Radix scrophulariae, the sun-dried ginseng of 20 parts by weight, the Radix Ophiopogonis of 30 parts by weight, the leech of 10 parts by weight, the tendril-leaved fritillary bulb of 20 parts by weight, 40 parts by weight The Radix Salviae Miltiorrhizae of Chinese yam and 30 parts by weight.
Chinese medicine composition of the present invention can conventionally add when in use customary adjuvant (containing filler and Corrigent) clinically acceptable regular dosage form is made.Specifically, the dosage form of the Chinese medicine composition for example can be particle Agent, capsule, tablet, pill, paste or aqua;Preferably, the dosage form of the Chinese medicine composition is oral aqua.
Second aspect of the present invention provides a kind of side of Chinese medicine composition for preparing previously described treatment diabetic foot Method, method includes the following steps:
(1) raw Radix Astragali, radix scrophulariae, sun-dried ginseng, Radix Ophiopogonis, leech, tendril-leaved fritillary bulb, Chinese yam and Radix Salviae Miltiorrhizae are mixed according to formula with water, is decocted It is filtered after boiling, collects the first filtrate;
(2) dregs of a decoction obtained by step (1) are mixed with water, is filtered after decoction, collect the second filtrate;
(3) it after mixing the first filtrate with the second filtrate, is concentrated under reduced pressure into decocting liquid.
Can have according to Chinese medicine composition prepared by Chinese medicine material formula of the present invention and method of the present invention Effect prevention and delay the generation of diabetic foot, have protective effect to diabetic vascular, promote ischemic tissue angiogenesis, Increase blood flow, reduce inflammatory reaction.
In method of the present invention, in step (1), the raw Radix Astragali, radix scrophulariae, sun-dried ginseng, Radix Ophiopogonis, leech, river The mass ratio of shellfish, the gross mass of Chinese yam and Radix Salviae Miltiorrhizae and water is preferably 1:(10-15).
In a specific embodiment, the raw Radix Astragali, radix scrophulariae, sun-dried ginseng, Radix Ophiopogonis, leech, 8 taste of tendril-leaved fritillary bulb, Chinese yam and Radix Salviae Miltiorrhizae The gross mass of Chinese medicine and the mass ratio of water can be 1:10,1:11,1:12,1:13,1:14 or 1:15.
In most preferred embodiments, the raw Radix Astragali, radix scrophulariae, sun-dried ginseng, Radix Ophiopogonis, leech, tendril-leaved fritillary bulb, Chinese yam and Radix Salviae Miltiorrhizae The gross mass of 8 taste Chinese medicines and the mass ratio of water are 1:12.
In method of the present invention, in step (1), the decoction temperature can be 90-100 DEG C;The decoction Time can be 1-2 hours.In a specific embodiment, in step (1), the decoction temperature can be 90 DEG C, 92 DEG C, 94 DEG C, 96 DEG C, 98 DEG C or 100 DEG C;The decocting time can for 1 hour, 1.2 hours, 1.4 hours, 1.6 hours, 1.8 hours or 2 hours.
In most preferred embodiments, in step (1), the decoction temperature is 95 DEG C;The decocting time is 1.5 Hour.
In method of the present invention, in step (2), the mass ratio of the dregs of a decoction and water can be 1:(5- 10).In a specific embodiment, in step (2), the mass ratio of the dregs of a decoction and water can for 1:5,1:6,1:7,1:8, 1:9 or 1:10.
In most preferred embodiments, in step (2), the mass ratio of the dregs of a decoction and water is 1:8.
In method of the present invention, in step (2), the decoction temperature can be 90-100 DEG C;The decoction Time can be 1-2 hours.In a specific embodiment, in step (2), the decoction temperature can be 90 DEG C, 92 DEG C, 94 DEG C, 96 DEG C, 98 DEG C or 100 DEG C;The decocting time can for 1 hour, 1.2 hours, 1.4 hours, 1.6 hours, 1.8 hours or 2 hours.
In most preferred embodiments, in step (2), the decoction temperature is 95 DEG C;The decocting time is 1.5 Hour.
In method of the present invention, in step (3), the temperature of the reduced pressure can be 40~60 DEG C.? In specific embodiment, in step (3), the temperature of the reduced pressure can be 40 DEG C, 45 DEG C, 50 DEG C, 55 DEG C or 60 DEG C.
In most preferred embodiments, in step (3), the temperature of the reduced pressure is 50 DEG C.
In method of the present invention, in step (3), the concentration of the decocting liquid can be 1-2g/mL.Specific Embodiment, in step (3), the concentration of the decocting liquid can for 1g/mL, 1.2g/mL, 1.4g/mL, 1.6g/mL, 1.8g/mL or 2g/mL.
In most preferred embodiments, in step (3), the concentration of the decocting liquid is 1.5g/mL.
Third aspect present invention provides a kind of previously described Chinese medicine composition or according to previously described method system Application of the standby Chinese medicine composition in treatment diabetic foot.
In method of the present invention, the dosage of the Chinese medicine composition can be 0.2-1g crude drug/kg weight.? In specific embodiment, the dosage of the Chinese medicine composition can for 0.2g crude drug/kg weight, 0.4g crude drug/kg weight, 0.6g crude drug/kg weight, 0.8g crude drug/kg weight, 1.0g crude drug/kg weight.In most preferred embodiments, the Chinese medicine The dosage of composition is 0.4g crude drug/kg weight.
Be prepared into Chinese medicine composition according to the method described in the present invention, 8 taste Chinese medicines be used cooperatively, can with supplementing qi and nourishing yin, Promoting blood circulation, eleminating phlegm and freeing channels;The phlegm-blood stasis of internal organs can also be dispelled, removing those leads to body glycolipid with the gas yin of help lung spleen kidney The substance of metabolic disorder.In addition, Chinese medicine composition of the present invention can promote body microcirculation, promote vascular endothelial growth factor Secretion, there is good therapeutic effect to diabetic foot, and toxicity is small, takes safety, the valence of great popularization and application Value.
The present invention will be described in detail by way of examples below, but protection scope of the present invention is not limited to that.
Embodiment 1
(1) according to formula (the life Radix Astragali of 20 parts by weight, the radix scrophulariae of 45 parts by weight, the sun-dried ginseng of 20 parts by weight, 15 parts by weight Radix Ophiopogonis, the leech of 10 parts by weight, the tendril-leaved fritillary bulb of 30 parts by weight, the Chinese yam of 20 parts by weight and the Radix Salviae Miltiorrhizae of 30 parts by weight) will raw Radix Astragali, Radix scrophulariae, sun-dried ginseng, Radix Ophiopogonis, leech, tendril-leaved fritillary bulb, Chinese yam and Radix Salviae Miltiorrhizae are mixed with water, the raw Radix Astragali, radix scrophulariae, sun-dried ginseng, Radix Ophiopogonis, water Leech, tendril-leaved fritillary bulb, the gross mass of Chinese yam and Radix Salviae Miltiorrhizae and water mass ratio be 1:15, filtered after being decocted 1 hour at 95 DEG C, collection the One filtrate;
(2) dregs of a decoction obtained by step (1) are mixed with water, the mass ratio of the dregs of a decoction and water is 1:5, is decocted at 90 DEG C It is filtered after 2 hours, collects the second filtrate;
(3) after mixing the first filtrate with the second filtrate, the decocting liquid A1 at 1.0g/mL is concentrated under reduced pressure at 40 DEG C.
Embodiment 2
(1) according to formula (the life Radix Astragali of 40 parts by weight, the radix scrophulariae of 30 parts by weight, the sun-dried ginseng of 10 parts by weight, 30 parts by weight Radix Ophiopogonis, the leech of 5 parts by weight, the tendril-leaved fritillary bulb of 20 parts by weight, the Chinese yam of 60 parts by weight and the Radix Salviae Miltiorrhizae of 45 parts by weight) will raw Radix Astragali, Radix scrophulariae, sun-dried ginseng, Radix Ophiopogonis, leech, tendril-leaved fritillary bulb, Chinese yam and Radix Salviae Miltiorrhizae are mixed with water, the raw Radix Astragali, radix scrophulariae, sun-dried ginseng, Radix Ophiopogonis, water Leech, tendril-leaved fritillary bulb, the gross mass of Chinese yam and Radix Salviae Miltiorrhizae and water mass ratio be 1:12, filtered after being decocted 1.5 hours at 100 DEG C, receipts Collect the first filtrate;
(2) dregs of a decoction obtained by step (1) are mixed with water, the mass ratio of the dregs of a decoction and water is 1:10, is decocted at 100 DEG C It is filtered after boiling 1.5 hours, collects the second filtrate;
(3) after mixing the first filtrate with the second filtrate, the decocting liquid A2 at 2g/mL is concentrated under reduced pressure at 50 DEG C.
Embodiment 3
(1) according to formula (the life Radix Astragali of 60 parts by weight, the radix scrophulariae of 15 parts by weight, the sun-dried ginseng of 30 parts by weight, 45 parts by weight Radix Ophiopogonis, the leech of 15 parts by weight, the tendril-leaved fritillary bulb of 10 parts by weight, the Chinese yam of 40 parts by weight and the Radix Salviae Miltiorrhizae of 15 parts by weight) will raw Radix Astragali, Radix scrophulariae, sun-dried ginseng, Radix Ophiopogonis, leech, tendril-leaved fritillary bulb, Chinese yam and Radix Salviae Miltiorrhizae are mixed with water, the raw Radix Astragali, radix scrophulariae, sun-dried ginseng, Radix Ophiopogonis, water Leech, tendril-leaved fritillary bulb, the gross mass of Chinese yam and Radix Salviae Miltiorrhizae and water mass ratio be 1:10, filtered after being decocted 2 hours at 90 DEG C, collection the One filtrate;
(2) dregs of a decoction obtained by step (1) are mixed with water, the mass ratio of the dregs of a decoction and water is 1:7, is decocted at 95 DEG C It is filtered after 1.0 hours, collects the second filtrate;
(3) after mixing the first filtrate with the second filtrate, the decocting liquid A3 at 1.5g/mL is concentrated under reduced pressure at 60 DEG C.
Embodiment 4
Chinese medicine composition decocting liquid A4 is prepared according to the method for embodiment 3, unlike, it is described raw yellow in step (1) Stilbene, radix scrophulariae, sun-dried ginseng, Radix Ophiopogonis, leech, tendril-leaved fritillary bulb, Chinese yam and the gross mass of Radix Salviae Miltiorrhizae and the mass ratio of water are 1:14.
Comparative example 1
Chinese medicine composition decocting liquid D1 is prepared according to the method for embodiment 3, unlike, in step (1), the formula In without containing raw Radix Astragali.
Comparative example 2
Chinese medicine composition decocting liquid D2 is prepared according to the method for embodiment 3, unlike, in step (1), the formula In do not contain radix scrophulariae.
Comparative example 3
Chinese medicine composition decocting liquid D3 is prepared according to the method for embodiment 3, unlike, in step (1), the formula In do not contain sun-dried ginseng.
Comparative example 4
Chinese medicine composition decocting liquid D4 is prepared according to the method for embodiment 3, unlike, in step (1), the formula In do not contain Radix Ophiopogonis.
Comparative example 5
Chinese medicine composition decocting liquid D5 is prepared according to the method for embodiment 3, unlike, in step (1), the formula In do not contain leech.
Comparative example 6
Chinese medicine composition decocting liquid D6 is prepared according to the method for embodiment 3, unlike, in step (1), the formula In do not contain tendril-leaved fritillary bulb.
Comparative example 7
Chinese medicine composition decocting liquid D7 is prepared according to the method for embodiment 3, unlike, in step (1), the formula In do not contain Chinese yam.
Comparative example 8
Chinese medicine composition decocting liquid D8 is prepared according to the method for embodiment 3, unlike, in step (1), the formula In do not contain Radix Salviae Miltiorrhizae.
Test case
The Chinese medicine composition decocting liquid A1-A4 and D1-D8 that prepare in embodiment and comparative example are used to improve II type glycosuria Foot disease disease small sample clinical observation,
(1) clinical observation
233 type-2 diabetes mellitus pedopathy patients (clinical symptoms show as foot infection, ulcer or deep tissues and destroy), choosing From traditional Chinese medical science hall clinic, Hubei University of Chinese Medicine patient, it is randomly divided into 12 groups, first group 18, male 12, female 6, the age 42-69 years old, course of disease 1-20;Second group 20, male 13, female 7, the age 41-70 years old, course of disease 1-20;Third group 21, Male 14, female 7, the age 40-68 years old, course of disease 1-20;4th group 19, male 12, female 7, the age 40-71 years old, the course of disease 1-20;5th group 20, male 13, female 7, the age 45-70 years old, course of disease 1-20;6th group 21, male 14, female 7 Example, the age 42-70 years old, course of disease 1-20;7th group 19, male 13, female 6, the age 40-70 years old, course of disease 1-20;8th Group 20, male 12, female 8, the age 43-71 years old, course of disease 1-20;9th group 18, male 12, female 6, age 42-70 Year, course of disease 1-20;Tenth group 19, male 13, female 6, the age 40-69 years old, course of disease 1-20;11st group 20, male 13, female 7, the age 41-68 years old, course of disease 1-20;12nd group 18, male 12, female 6, the age 40-70 years old, the course of disease 1-20.12 groups of patients there are no significant in terms of sex, age, course of disease, etc. difference, is comparable.
(2) it is included in standard
The subject of voluntary participation clinical test;Meet 0-5 grades of diagnostic criteria persons of doctor trained in Western medicine clinical diabetes pedopathy;In meeting Cure the dialectical standard of " quenching one's thirst, the gangrene of finger or toe " scope;Age is between -75 years old 40 years old;Regular receiving treatment can be compared and can Cooperate the subject accordingly detected.
(3) exclusion criteria
Mechanical injuries person;Amputee;With serious heart, hypertension, blood disease patient;Dysnoesia, essence Refreshing obstacle person;It is indefinite to live, and easily causes person lost to follow-up;Allergic constitution person;Original dermatosis patient.
(4) treatment method
12 groups of patients maintain diabetic diet control and kinesiatrics.It is made that 12 groups of patients take orally the present invention respectively Standby Chinese medicine composition decocting liquid A1-A4 and D1-D8, the course for the treatment of is 4 weeks.
(5) efficacy assessment standard
It is formulated referring to " Chinese medicine new drug clinic grinds the guideline that makes internal disorder or usurp " gangrene of finger or toe curative effect determinate standard.
Effective: tcm clinical practice symptom: sign is obviously improved, and syndrome integral reduces >=70%;Ulcer surface healing, purulent secretion Object significantly reduces, and surface of a wound area reduces 50% or more, and skin function restores.
Effective: tcm clinical practice symptom: sign take a favorable turn, and disease integration reduces >=30%;Ulcer surface heals substantially, purulence Secretion is reduced, and surface of a wound area reduces 50% or less.
Invalid: tcm clinical practice symptom: sign is without improvement, even aggravating, syndrome total mark is reduced less than 30%;Ulcer surface Nothing is substantially change, before treatment.The surface of a wound and its surrounding have no and substantially change.
(6) efficacy result
Total effective rate=(significant number+efficiently individual quantity)/total number of persons, treatment results are as shown in table 1.
Table 1
Group Decocting liquid number Number of cases It is effective Effectively In vain Total effective rate (%)
First group A1 18 7 9 2 88.89%
Second group A2 20 6 11 3 85.00%
Third group A3 21 10 8 3 85.71%
4th group A4 19 5 11 3 84.21%
5th group D1 20 1 7 12 40.00%
6th group D2 21 3 5 13 38.10%
7th group D3 19 2 4 13 31.58%
8th group D4 20 2 6 12 40.00%
9th group D5 18 3 4 11 38.89%
Tenth group D6 19 1 6 12 36.84%
11st group D7 20 3 5 12 40.00%
12nd group D8 18 2 5 11 38.89%
It can be seen that the clinical verification of the Chinese medicine composition using method of the present invention preparation by the result of table 1 Efficacy result makes us very satisfied.This small sample clinical observation shows using Chinese medicine composition decocting liquid of the present invention It is oral, the symptom of type-2 diabetes mellitus pedopathy patients feet's ulcer is effectively improved, not only purulent secretion is reduced, but also in skin It also has a significant effect on functional restoration.Illustrate that Chinese medicine composition of the present invention can not only be obviously improved II type glycosuria The clinical symptoms of foot disease disease, moreover it is possible to which promoting blood circulation promotes human microvascular to generate, and increases blood circulation, and antibacterial anti-inflammatory improves sugar Lipid metaboli balance;And it is without side-effects, patient finds no because caused by using the traditional chinese medicine composition of the invention after use Anomalous variation is worth clinical promotion and application.
The preferred embodiment of the present invention has been described above in detail, and still, the present invention is not limited thereto.In skill of the invention In art conception range, can with various simple variants of the technical solution of the present invention are made, including each technical characteristic with it is any its Its suitable method is combined, and it should also be regarded as the disclosure of the present invention for these simple variants and combination, is belonged to Protection scope of the present invention.

Claims (10)

1. a kind of Chinese medicine composition for treating diabetic foot, which is characterized in that the Chinese medicine composition is by a kind of Chinese medicine material Formula is prepared, radix scrophulariae, the 10-30 of life Radix Astragali of the Chinese medicine material formula containing 20-60 parts by weight, 15-45 parts by weight The sun-dried ginseng of parts by weight, the Radix Ophiopogonis of 15-45 parts by weight, the leech of 5-15 parts by weight, the tendril-leaved fritillary bulb of 10-30 parts by weight, 20-60 weight The Chinese yam of part and the Radix Salviae Miltiorrhizae of 15-45 parts by weight.
2. Chinese medicine composition according to claim 1, which is characterized in that the Chinese medicine material formula contains 30-50 weight Life Radix Astragali, the radix scrophulariae of 25-35 parts by weight, the sun-dried ginseng of 15-25 parts by weight, the Radix Ophiopogonis of 25-35 parts by weight, 7-12 parts by weight of part Leech, the tendril-leaved fritillary bulb of 15-25 parts by weight, the Chinese yam of 30-50 parts by weight and 25-35 parts by weight Radix Salviae Miltiorrhizae.
3. Chinese medicine composition according to claim 1 or 2, which is characterized in that the dosage form of the Chinese medicine composition is particle Agent, capsule, tablet, pill, paste or aqua.
4. a kind of prepare the method that the Chinese medicine composition of diabetic foot is treated described in any one of claim 1-3, It is characterized in that, method includes the following steps:
(1) raw Radix Astragali, radix scrophulariae, sun-dried ginseng, Radix Ophiopogonis, leech, tendril-leaved fritillary bulb, Chinese yam and Radix Salviae Miltiorrhizae are mixed with water according to formula, after decoction The first filtrate is collected in filtering;
(2) dregs of a decoction obtained by step (1) are mixed with water, is filtered after decoction, collect the second filtrate;
(3) it after mixing the first filtrate with the second filtrate, is concentrated under reduced pressure into decocting liquid.
5. according to the method described in claim 4, it is characterized in that, in step (1), the raw Radix Astragali, radix scrophulariae, sun-dried ginseng, Radix Ophiopogonis, leech, tendril-leaved fritillary bulb, Chinese yam and the gross mass of Radix Salviae Miltiorrhizae and the mass ratio of water are 1:(10-15);
Preferably, the decoction temperature is 90-100 DEG C;The decocting time is 1-2 hours.
6. the method according to any one of claim 4 or 5, which is characterized in that in step (2), the dregs of a decoction with The mass ratio of water is 1:(5-10).
7. according to the method described in claim 6, it is characterized in that, the decoction temperature is 90-100 DEG C in step (2); The decocting time is 1-2 hours.
8. according to the method described in claim 4, it is characterized in that, in step (3), the temperature of the reduced pressure is 40~ 60℃。
9. according to the method described in claim 8, it is characterized in that, the concentration of the decocting liquid is 1-2g/ in step (3) mL。
10. Chinese medicine composition described in any one of claim 1-3 or according to any one of claim 4-9 Method preparation Chinese medicine composition treatment diabetic foot in application;
Preferably, the dosage of the Chinese medicine composition is 0.2-1g crude drug/kg weight.
CN201910561091.9A 2019-06-26 2019-06-26 A kind of Chinese medicine composition for treating diabetic foot and preparation method thereof and purposes Pending CN110115743A (en)

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102526420A (en) * 2011-12-31 2012-07-04 陕西步长制药有限公司 Traditional Chinese medicine preparation for treating diabetes and preparation method thereof
CN104740349A (en) * 2015-04-23 2015-07-01 李建鹏 Traditional Chinese medicine composition used for treating diabetic foot and preparation method

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102526420A (en) * 2011-12-31 2012-07-04 陕西步长制药有限公司 Traditional Chinese medicine preparation for treating diabetes and preparation method thereof
CN104740349A (en) * 2015-04-23 2015-07-01 李建鹏 Traditional Chinese medicine composition used for treating diabetic foot and preparation method

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* Cited by examiner, † Cited by third party
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