CN110215485B - Traditional Chinese medicine composition for treating diabetic skin ulcer and preparation method thereof - Google Patents
Traditional Chinese medicine composition for treating diabetic skin ulcer and preparation method thereof Download PDFInfo
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- CN110215485B CN110215485B CN201910636056.9A CN201910636056A CN110215485B CN 110215485 B CN110215485 B CN 110215485B CN 201910636056 A CN201910636056 A CN 201910636056A CN 110215485 B CN110215485 B CN 110215485B
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- Medicines Containing Plant Substances (AREA)
Abstract
The invention provides a traditional Chinese medicine composition for treating diabetic skin ulcer and a preparation method thereof, and relates to the technical field of traditional Chinese medicine compositions. The traditional Chinese medicine composition mainly takes raw astragalus membranaceus, fried bighead atractylodes rhizome, rhizoma atractylodis, poria cocos, cinnamon, monkshood, cornu cervi degelatinatum, pawpaw, semen brassicae, radix rehmanniae preparata, angelica sinensis, radix glehniae and the like as raw materials, and the specific dosage of the raw materials is limited, so that the compatibility of the raw materials is scientific and reasonable, the active ingredients of the raw materials supplement each other and complement each other, the obtained traditional Chinese medicine composition can improve the blood circulation of the diabetic skin ulcer part, is beneficial to tissue growth and repair, promotes the skin regeneration of the affected part, accelerates the wound healing, and has a good treatment effect on the diabetic skin ulcer. The invention also provides a preparation method of the traditional Chinese medicine composition for treating the diabetic skin ulcer, and the preparation method is simple and feasible and is suitable for industrial large-scale production.
Description
Technical Field
The invention relates to the technical field of traditional Chinese medicine compositions, and particularly relates to a traditional Chinese medicine composition for treating diabetic skin ulcer and a preparation method thereof.
Background
Diabetes is a group of metabolic diseases characterized by hyperglycemia. Hyperglycemia occurring in diabetes over a long period of time can lead to chronic damage to, and dysfunction of, various tissues, particularly the eyes, kidneys, heart, blood vessels, nerves.
The diabetic skin ulcer is a complication of diabetes, is frequently generated on feet of a patient, is also called as diabetic foot, and mainly refers to the condition that the diabetic patient is infected by lower limbs and ulcerated to form deep tissue damage due to combined nerve and vascular diseases, and once the condition is serious, the diabetic treatment effect of the patient can be directly influenced, even amputation and death are caused. At present, a plurality of medicines for treating the diabetic skin ulcer are available, but the treatment effect is not ideal.
In view of the above, the present invention is particularly proposed to solve at least one of the above technical problems.
Disclosure of Invention
The first purpose of the invention is to provide a traditional Chinese medicine composition for treating diabetic skin ulcer, and the obtained traditional Chinese medicine composition has good treatment effect on diabetic skin ulcer.
The second purpose of the invention is to provide a preparation method of the traditional Chinese medicine composition for treating diabetic skin ulcer, which is simple and feasible and is suitable for industrial large-scale production.
In order to achieve the above purpose of the present invention, the following technical solutions are adopted:
the invention provides a traditional Chinese medicine composition for treating diabetic skin ulcer, which comprises the following raw materials in parts by weight: 20-40 parts of raw astragalus membranaceus, 5-20 parts of fried bighead atractylodes rhizome, 5-15 parts of rhizoma atractylodis, 10-30 parts of poria cocos, 5-15 parts of cinnamon, 5-10 parts of monkshood, 5-15 parts of cornu cervi degelatinatum, 5-15 parts of pawpaw, 5-15 parts of semen brassicae, 5-15 parts of prepared rehmannia root, 5-15 parts of angelica sinensis and 10-20 parts of radix glehniae.
Further, the traditional Chinese medicine composition for treating diabetic skin ulcer comprises the following raw materials in parts by weight: 22-38 parts of raw astragalus membranaceus, 6-18 parts of fried bighead atractylodes rhizome, 6-14 parts of rhizoma atractylodis, 12-28 parts of poria cocos, 6-12 parts of cinnamon, 6-9 parts of monkshood, 6-12 parts of cornu cervi degelatinatum, 6-12 parts of pawpaw, 6-12 parts of semen brassicae, 6-12 parts of radix rehmanniae preparata, 6-12 parts of angelica sinensis and 12-18 parts of radix glehniae.
Further, the traditional Chinese medicine composition for treating diabetic skin ulcer comprises the following raw materials in parts by weight: 25-35 parts of raw astragalus membranaceus, 8-15 parts of fried bighead atractylodes rhizome, 8-12 parts of rhizoma atractylodis, 15-25 parts of poria cocos, 8-12 parts of cinnamon, 7-8 parts of monkshood, 8-12 parts of cornu cervi degelatinatum, 8-12 parts of pawpaw, 8-12 parts of semen brassicae, 8-12 parts of prepared rehmannia root, 8-12 parts of angelica sinensis and 14-16 parts of radix glehniae.
Furthermore, the traditional Chinese medicine composition for treating diabetic skin ulcer also comprises 5-10 parts by weight of winged euonymus twig.
Furthermore, the traditional Chinese medicine composition for treating diabetic skin ulcer also comprises 10-15 parts by weight of caulis polygoni multiflori.
The invention also provides a preparation method of the traditional Chinese medicine composition for treating diabetic skin ulcer, which comprises the following steps:
(a) decocting and separating radix astragali, parched Atractylodis rhizoma, rhizoma Atractylodis, cortex Cinnamomi, radix Aconiti lateralis, cornu Cervi Degelatinatum, fructus Chaenomelis, semen Sinapis Albae, radix rehmanniae Preparata, radix Angelicae sinensis, radix Glehniae and optionally ramulus Euonymi and optionally caulis Polygoni Multiflori with water for several times, mixing the water decoctions obtained by several times of separation, and concentrating to obtain concentrated solution;
(b) and (3) carrying out alcohol precipitation on the concentrated solution, separating, concentrating and drying the separated alcohol precipitation supernatant to obtain the traditional Chinese medicine composition for treating the diabetic skin ulcer.
Further, in the step (a), the decoction time is 1-2 h each time;
preferably, the water decoctions obtained by multiple times of separation are combined and concentrated until each milliliter of the liquid medicine contains 0.8-1.2 g of the crude drug, so as to obtain a concentrated solution.
Further, in the step (b), ethanol with the volume fraction of 90-95% being 1.5-4 times of that of the ethanol is adopted for alcohol precipitation;
preferably, the alcohol precipitation temperature is 2-6 ℃, further preferably 3-5 ℃, and more preferably 4 ℃;
preferably, the alcohol precipitation time is 12-24 h, more preferably 15-20 h, and even more preferably 16 h.
Further, in the step (b), the concentration is reduced pressure concentration;
preferably, in the step (b), the drying is freeze drying, the temperature of the freeze drying is-25 to-15 ℃, and the time of the freeze drying is 1.5 to 3 hours.
Further, the preparation method of the traditional Chinese medicine composition for treating the diabetic skin ulcer comprises the following steps:
(a) adding water into raw astragalus, fried bighead atractylodes rhizome, rhizoma atractylodis, cinnamon, monkshood, cornu cervi degelatinatum, pawpaw, semen brassicae, radix rehmanniae preparata, angelica, radix glehniae and optional winged euonymus twig and optional caulis polygoni multiflori according to the formula amount for decocting and separating for multiple times, combining water decoctions obtained by multiple separation, and concentrating until each milliliter of liquid medicine contains 0.8-1.2 g of crude drug to obtain concentrated solution;
(b) carrying out alcohol precipitation on the concentrated solution by using 1.5-4 times of 90-95% ethanol in volume fraction, separating, carrying out reduced pressure concentration on the separated alcohol precipitation supernatant until the relative density is 1.18-1.22, and freeze-drying the obtained fluid extract at the temperature of-25-15 ℃ for 1.5-3 h to obtain the traditional Chinese medicine composition for treating the diabetic skin ulcer;
preferably, the preparation method comprises the following steps:
(a) decocting and separating radix astragali, parched Atractylodis rhizoma, rhizoma Atractylodis, cortex Cinnamomi, radix Aconiti lateralis Preparata, cornu Cervi Degelatinatum, fructus Chaenomelis, semen Sinapis Albae, radix rehmanniae Preparata, radix Angelicae sinensis, radix Glehniae and optionally ramulus Euonymi and optionally caulis Polygoni Multiflori with water twice, mixing the water decoctions, and concentrating to obtain concentrated solution containing crude drug 1.0g per ml;
(b) and (2) carrying out alcohol precipitation on the concentrated solution by adopting 95% ethanol in 2 times volume fraction, separating, carrying out reduced pressure concentration on the separated alcohol precipitation supernatant until the relative density is 1.18-1.22, and freeze-drying the obtained fluid extract at the temperature of-20 ℃ for 2 hours to obtain the traditional Chinese medicine composition for treating the diabetic skin ulcer.
Compared with the prior art, the traditional Chinese medicine composition for treating diabetic skin ulcer and the preparation method thereof provided by the invention have the following beneficial effects:
(1) the invention provides a traditional Chinese medicine composition for treating diabetic skin ulcer, which mainly takes raw astragalus root, fried bighead atractylodes rhizome, rhizoma atractylodis, tuckahoe, cinnamon, monkshood, cornu cervi degelatinatum, pawpaw, white mustard seed, prepared rehmannia root, angelica, radix glehniae and the like as raw materials, and the specific dosage of the raw materials is limited, so that the compatibility of the raw materials is scientific and reasonable, the functional components of the raw materials supplement each other and complement each other, the obtained traditional Chinese medicine composition can improve the blood circulation of the diabetic skin ulcer part, is beneficial to tissue growth and repair, promotes the skin regeneration of an affected part, accelerates the healing of a wound surface, and has a good treatment effect on the diabetic skin ulcer.
(2) The traditional Chinese medicine composition for treating the diabetic skin ulcer provided by the invention is an oral medicine, is mild, does not stimulate, has no side effect on intestines and stomach, and is suitable for people suffering from the diabetic skin ulcer.
(3) The invention provides a preparation method of a traditional Chinese medicine composition for treating diabetic skin ulcer, which can furthest reserve active ingredients in each traditional Chinese medicine raw material and improve the utilization rate of the active ingredients.
Detailed Description
Embodiments of the present invention will be described in detail below with reference to examples, but it will be understood by those skilled in the art that the following examples are only illustrative of the present invention and should not be construed as limiting the scope of the present invention. The examples, in which specific conditions are not specified, were conducted under conventional conditions or conditions recommended by the manufacturer. The reagents or instruments used are not indicated by the manufacturer, and are all conventional products available commercially.
According to one aspect of the invention, the traditional Chinese medicine composition for treating diabetic skin ulcer comprises the following raw materials in parts by weight: 20-40 parts of raw astragalus membranaceus, 5-20 parts of fried bighead atractylodes rhizome, 5-15 parts of rhizoma atractylodis, 10-30 parts of poria cocos, 5-15 parts of cinnamon, 5-10 parts of monkshood, 5-15 parts of cornu cervi degelatinatum, 5-15 parts of pawpaw, 5-15 parts of semen brassicae, 5-15 parts of prepared rehmannia root, 5-15 parts of angelica sinensis and 10-20 parts of radix glehniae.
The traditional Chinese medicine composition for treating the diabetic skin ulcer provided by the invention mainly takes raw astragalus membranaceus, fried bighead atractylodes rhizome, rhizoma atractylodis, poria cocos, cinnamon, monkshood, cornu cervi degelatinatum, pawpaw, semen brassicae, prepared rehmannia root, angelica sinensis, radix glehniae and the like as raw materials, and the specific dosage of the raw materials is limited, so that the compatibility of the raw materials is scientific and reasonable, the functional components of the raw materials complement each other and complement each other, and the obtained traditional Chinese medicine composition can improve the blood circulation of the diabetic skin ulcer part, is beneficial to tissue growth and repair, promotes skin regeneration of an affected part, accelerates wound healing, and has a good treatment effect on the diabetic skin ulcer.
Specifically, raw radix astragali is root of Astragalus mongholicus (Fisch.) bge or Astragalus membranaceus (Fisch.) bge of Leguminosae, is sweet in taste and slightly warm in nature, enters spleen and lung channels, and is mainly used for consolidating exterior, supporting sore, inducing diuresis and the like. Typical but non-limiting parts by weight of raw astragalus are 10 parts, 15 parts, 20 parts, 22 parts, 25 parts, 30 parts, 35 parts, 38 parts or 40 parts.
The parched Atractylodis rhizoma is prepared by parching rhizoma Atractylodis Macrocephalae with sand or testa Tritici. The parched Atractylodis rhizoma has effects of relieving dryness, invigorating spleen, invigorating qi, eliminating dampness, promoting diuresis, arresting sweating, and preventing miscarriage. Typical but non-limiting parts by weight of roasted rhizoma atractylodis macrocephalae are 5 parts, 6 parts, 10 parts, 12 parts, 15 parts, 18 parts or 20 parts.
Rhizoma Atractylodis is dried rhizome of Atractylodes lancea or Atractylodes chinensis of Compositae, is pungent, bitter, and warm in nature, and has effects of eliminating dampness, invigorating spleen, dispelling pathogenic wind, dispelling cold, and improving eyesight. Typical but non-limiting parts by weight of atractylodes lancea are 5 parts, 6 parts, 8 parts, 10 parts, 12 parts, 14 parts or 15 parts.
Poria is commonly known as poria, pine pollen and poria cocos wolf, is a fungus plant parasitic on pine roots, has sweet and mild nature and taste, enters heart, lung and spleen channels, and has the effects of excreting dampness and promoting diuresis, strengthening spleen and stomach, calming heart and soothing nerves. Typical but non-limiting parts by weight of poria cocos are 10, 12, 15, 18, 20, 22, 24, 25, 28 or 30 parts.
The cortex Cinnamomi is dry bark of Cinnamomum Cassia Presl of Lauraceae, has pungent and sweet nature, and large heat nature, and has effects of tonifying fire, supporting yang, inducing fire, restoring primordial qi, dispelling cold, relieving pain, and warming and dredging channels and collaterals. Typical but non-limiting parts by weight of cinnamon are 5 parts, 6 parts, 8 parts, 10 parts, 12 parts, 14 parts or 15 parts.
The aconite or aconite accessory slice, pungent and sweet in nature and flavor, warm in nature, entering heart, spleen and kidney meridians, has the effects of tonifying fire and supporting yang and expelling wind-cold-dampness. Typical but non-limiting parts by weight of monkshood are 5 parts, 6 parts, 7 parts, 8 parts, 9 parts or 10 parts.
Cornu Cervi Degelatinatum is the bone residue obtained by decocting cornu Cervi Pantotrichum with Cervus nippon Temminck or Cervus elaphus Linnaeus of Cervidae. Salty and astringent in nature and taste, warm in nature, entering liver and kidney meridians, and has the effects of warming kidney, tonifying yang, astringing and stopping bleeding. Typical but non-limiting parts by weight of cornu cervi degelatinatum are 5 parts, 6 parts, 8 parts, 10 parts, 12 parts, 14 parts or 15 parts.
The pawpaw is sour in nature and warm in nature, enters liver and spleen channels, and has the effects of calming the liver, relaxing muscles and tendons, harmonizing stomach, eliminating dampness, dispelling wind, removing dampness, warming channels and relieving pain. Typical but non-limiting parts by weight of papaya are 5 parts, 6 parts, 8 parts, 10 parts, 12 parts, 14 parts or 15 parts.
Semen Sinapis Albae is pungent in property and warm in nature, enters lung channel, and has effects of regulating qi-flowing for eliminating phlegm, dredging collaterals for relieving pain, warming spleen and stomach for dispelling cold, and relieving cough and asthma. Typical but non-limiting parts by weight of white mustard are 5 parts, 6 parts, 8 parts, 10 parts, 12 parts, 14 parts or 15 parts.
Prepared rehmannia root, radix rehmanniae Praeparata is sweet in taste and slightly warm in nature, enters liver and kidney meridians, and has the effects of enriching blood and nourishing yin, and replenishing essence and marrow. Typical but not limiting parts by weight of prepared rehmannia root are 5 parts, 6 parts, 8 parts, 10 parts, 12 parts, 14 parts or 15 parts.
The angelica has sweet, pungent and bitter taste and warm nature, enters liver, heart and spleen channels, and has the effects of nourishing blood, regulating menstruation, promoting blood circulation, relieving pain, loosening the bowel to relieve constipation. Typical but non-limiting parts by weight of angelica are 5 parts, 6 parts, 8 parts, 10 parts, 12 parts, 14 parts or 15 parts.
Bei Sha Shen is sweet and slightly bitter in flavor and slightly cold in nature, enters lung and spleen channels, and has the effects of nourishing yin, clearing away lung-heat, eliminating phlegm and relieving cough. Typical but non-limiting parts by weight of radix glehniae are 10 parts, 12 parts, 14 parts, 15 parts, 16 parts, 18 parts or 20 parts.
In the raw materials, the raw astragalus, the fried bighead atractylodes rhizome, the rhizoma atractylodis and the poria cocos are used as monarch drugs and have the effects of tonifying spleen and supplementing qi, the cinnamon, the monkshood and the cornu cervi degelatinatum are used as ministerial drugs and have the effects of tonifying kidney and restoring yang, the angelica, the radix glehniae and the prepared rhizome of rehmannia are used as adjuvant drugs and have the effects of nourishing blood and promoting blood circulation, and the pawpaw and the semen brassicae are used as conductant drugs and. According to the drug properties and the dosage of the raw materials, the formed specific monarch, minister, assistant and guide compatibility relationship is scientific and reasonable, the active ingredients of the raw materials supplement each other and complement each other, and the obtained traditional Chinese medicine composition has good treatment effect on the diabetic skin ulcer.
As a preferred embodiment of the invention, the traditional Chinese medicine composition for treating diabetic skin ulcer comprises the following raw materials in parts by weight: 22-38 parts of raw astragalus membranaceus, 6-18 parts of fried bighead atractylodes rhizome, 6-14 parts of rhizoma atractylodis, 12-28 parts of poria cocos, 6-12 parts of cinnamon, 6-9 parts of monkshood, 6-12 parts of cornu cervi degelatinatum, 6-12 parts of pawpaw, 6-12 parts of semen brassicae, 6-12 parts of radix rehmanniae preparata, 6-12 parts of angelica sinensis and 12-18 parts of radix glehniae.
Preferably, the traditional Chinese medicine composition for treating diabetic skin ulcer comprises the following raw materials in parts by weight: 25-35 parts of raw astragalus membranaceus, 8-15 parts of fried bighead atractylodes rhizome, 8-12 parts of rhizoma atractylodis, 15-25 parts of poria cocos, 8-12 parts of cinnamon, 7-8 parts of monkshood, 8-12 parts of cornu cervi degelatinatum, 8-12 parts of pawpaw, 8-12 parts of semen brassicae, 8-12 parts of prepared rehmannia root, 8-12 parts of angelica sinensis and 14-16 parts of radix glehniae.
By further limiting the dosage of each raw material in the traditional Chinese medicine composition for treating the diabetic skin ulcer, the synergistic effect among the raw materials is more obvious, the blood circulation and the nutrition condition of the skin can be improved, and the traditional Chinese medicine composition is effective for patients with chronic ulcer who are not healed for a long time.
The term "comprising" as used herein means that it may include other components in addition to the components described, which impart different properties to the Chinese medicinal composition. In addition, the term "comprising" as used herein may be replaced by "being" or "consisting of … …" as closed.
As a preferred embodiment of the invention, the raw materials of the traditional Chinese medicine composition for treating diabetic skin ulcer further comprise 5-10 parts by weight of winged euonymus twig.
Ramulus Euonymi is bitter, pungent and cold in flavor, enters liver meridian, and has effects of dredging collaterals, relieving pain, removing blood stasis and dredging channels. Typical but not limiting parts by weight of winged euonymus twig are 5 parts, 6 parts, 7 parts, 8 parts, 9 parts or 10 parts.
As a preferred embodiment of the invention, the raw materials of the traditional Chinese medicine composition for treating diabetic skin ulcer further comprise 10-15 parts by weight of caulis polygoni multiflori.
The caulis polygoni multiflori is sweet, slightly bitter and neutral in nature, enters liver channel and enters heart, and has the effects of nourishing blood, dredging collaterals and guiding yang to yin. Typical but non-limiting parts by weight of the vine of multiflower knotweed are 10 parts, 11 parts, 12 parts, 13 parts, 14 parts or 15 parts.
The traditional Chinese medicine composition for treating diabetic skin ulcer can be prepared into different dosage forms, such as tablets, pills, granules, powder, capsules and the like, and is not particularly limited herein.
According to another aspect of the present invention, there is also provided a method for preparing a Chinese medicinal composition for treating diabetic skin ulcer, comprising the steps of:
(a) decocting and separating radix astragali, parched Atractylodis rhizoma, rhizoma Atractylodis, cortex Cinnamomi, radix Aconiti lateralis, cornu Cervi Degelatinatum, fructus Chaenomelis, semen Sinapis Albae, radix rehmanniae Preparata, radix Angelicae sinensis, radix Glehniae and optionally ramulus Euonymi and optionally caulis Polygoni Multiflori with water for several times, mixing the water decoctions obtained by several times of separation, and concentrating to obtain concentrated solution;
(b) and (3) carrying out alcohol precipitation on the concentrated solution, separating, concentrating and drying the separated alcohol precipitation supernatant to obtain the traditional Chinese medicine composition for treating the diabetic skin ulcer.
The preparation method of the traditional Chinese medicine composition for treating the diabetic skin ulcer provided by the invention can furthest reserve the active ingredients in the traditional Chinese medicine raw materials and improve the utilization rate of the active ingredients, and meanwhile, the preparation method is simple and feasible, and the adopted production equipment is conventional, does not need additional equipment, and is suitable for industrial large-scale production.
Specifically, each raw material medicine is decocted and separated for a plurality of times by water, so that water-soluble effective components such as alkaloid, organic acid salt, amino acid and the like in each raw material can be fully extracted, and a plurality of water-soluble impurities are extracted. The ethanol precipitation is adopted after the water decoction, the characteristics that the effective components can be dissolved in the alcohol and the impurities can not be dissolved in the alcohol are utilized, and after the alcohol is added, the effective components are dissolved in the alcohol and the impurities are precipitated. The purpose of alcohol precipitation is to remove impurities, retain effective components of the medicine, and improve the purity and clarity of the extraction of the traditional Chinese medicine, thereby improving the quality of the product.
As a preferable embodiment of the invention, in the step (a), the decoction time is 1-2 h per time;
preferably, the water decoctions obtained by multiple times of separation are combined and concentrated until each milliliter of the liquid medicine contains 0.8-1.2 g of the crude drug, so as to obtain a concentrated solution.
Decocting the raw materials for several times, wherein each decocting time is typically but not limited to 1h, 1.5h or 2 h.
Mixing the water decoctions, concentrating, and typically but not restrictively containing crude drug 0.8g, 1.0g or 1.2g per ml of the decoction.
In a preferred embodiment of the present invention, in the step (b), ethanol with a volume fraction of 90-95% in an amount of 1.5-4 times that of the ethanol is used for ethanol precipitation;
preferably, the alcohol precipitation temperature is 2-6 ℃, further preferably 3-5 ℃, and more preferably 4 ℃;
preferably, the alcohol precipitation time is 12-24 h, more preferably 15-20 h, and even more preferably 16 h.
In the alcohol precipitation, the volume of the ethanol used is typically but not limited to 1.5 times, 2 times, 2.5 times, 3.5 times or 4 times that of the concentrated liquid, and the concentration (volume fraction) of the ethanol is typically but not limited to 90%, 92% or 95%.
Typical but not limiting alcohol precipitation temperature is 2 ℃, 3 ℃, 4 ℃, 5 ℃ or 6 ℃, and typical but not limiting alcohol precipitation time is 12h, 14h, 15h, 16h, 18h, 20h, 22h or 24 h.
The extraction purity and clarity of the traditional Chinese medicine are further improved by limiting the dosage of ethanol, the concentration of the ethanol, the precipitation temperature and the precipitation time during the precipitation of the ethanol, so that the product quality is improved.
As a preferred embodiment of the present invention, in the step (b), the concentration is a concentration under reduced pressure;
preferably, in the step (b), the drying is freeze drying, the temperature of the freeze drying is-25 to-15 ℃, and the time of the freeze drying is 1.5 to 3 hours.
Typical but non-limiting freeze drying temperatures are-25 deg.C, -20 deg.C or-15 deg.C, and typical but non-limiting freeze drying times are 1.5h, 2.0h, 2.5h or 3 h.
As a preferred embodiment of the present invention, the preparation method of the traditional Chinese medicine composition for treating diabetic skin ulcer comprises the following steps:
(a) adding water into raw astragalus, fried bighead atractylodes rhizome, rhizoma atractylodis, cinnamon, monkshood, cornu cervi degelatinatum, pawpaw, semen brassicae, radix rehmanniae preparata, angelica, radix glehniae and optional winged euonymus twig and optional caulis polygoni multiflori according to the formula amount for decocting and separating for multiple times, combining water decoctions obtained by multiple separation, and concentrating until each milliliter of liquid medicine contains 0.8-1.2 g of crude drug to obtain concentrated solution;
(b) carrying out alcohol precipitation on the concentrated solution by using 1.5-4 times of 90-95% ethanol in volume fraction, separating, carrying out reduced pressure concentration on the separated alcohol precipitation supernatant until the relative density is 1.18-1.22, and freeze-drying the obtained fluid extract at the temperature of-25-15 ℃ for 1.5-3 h to obtain the traditional Chinese medicine composition for treating the diabetic skin ulcer;
preferably, the preparation method of the traditional Chinese medicine composition for treating diabetic skin ulcer comprises the following steps:
(a) decocting and separating radix astragali, parched Atractylodis rhizoma, rhizoma Atractylodis, cortex Cinnamomi, radix Aconiti lateralis Preparata, cornu Cervi Degelatinatum, fructus Chaenomelis, semen Sinapis Albae, radix rehmanniae Preparata, radix Angelicae sinensis, radix Glehniae and optionally ramulus Euonymi and optionally caulis Polygoni Multiflori with water twice, mixing the water decoctions, and concentrating to obtain concentrated solution containing crude drug 1.0g per ml;
(b) and (2) carrying out alcohol precipitation on the concentrated solution by adopting 95% ethanol in 2 times volume fraction, separating, carrying out reduced pressure concentration on the separated alcohol precipitation supernatant until the relative density is 1.18-1.22, and freeze-drying the obtained fluid extract at the temperature of-20 ℃ for 2h to obtain the traditional Chinese medicine composition which exists in the form of freeze-dried extract and is used for treating the diabetic skin ulcer.
The preparation method of the traditional Chinese medicine composition is limited in steps and technological parameters, so that the effective components in the raw materials are reserved as much as possible, and the treatment effect of the traditional Chinese medicine composition is more obvious.
The traditional Chinese medicine composition for treating diabetic skin ulcer can be prepared into different dosage forms, such as tablets, pills, granules, powder, capsules and the like, according to different specific post-treatment processes.
The present invention will be further described with reference to specific examples and comparative examples.
Example 1
The embodiment provides a traditional Chinese medicine composition for treating diabetic skin ulcer, which is prepared from the following raw materials in parts by weight: 20 parts of raw astragalus membranaceus, 20 parts of fried bighead atractylodes rhizome, 5 parts of rhizoma atractylodis, 30 parts of poria cocos, 6 parts of cinnamon, 5 parts of monkshood, 5 parts of cornu cervi degelatinatum, 5 parts of pawpaw, 8 parts of semen brassicae, 12 parts of radix rehmanniae preparata, 15 parts of angelica sinensis and 10 parts of radix glehniae.
The preparation method of the traditional Chinese medicine composition for treating diabetic skin ulcer provided by the embodiment comprises the following steps:
(a) soaking the raw materials in water for 30min, decocting with strong fire until boiling, maintaining with slow fire for 30min, filtering to obtain primary water decoction, decocting the residue twice (the same decocting step in the secondary decocting step), mixing the water decoctions obtained by two times of separation, and concentrating to obtain concentrated solution containing crude drug 0.8g per ml;
(b) carrying out alcohol precipitation on the concentrated solution by adopting 1.5 times of 90% ethanol in volume fraction at the alcohol precipitation temperature of 2 ℃ for 20h, separating, carrying out reduced pressure concentration on the separated alcohol precipitation supernatant until no alcohol smell exists and the relative density is 1.18, cooling at room temperature, and freeze-drying the obtained fluid extract at the temperature of-15 ℃ for 1.5h to obtain the traditional Chinese medicine composition for treating the diabetic skin ulcer.
Example 2
The embodiment provides a traditional Chinese medicine composition for treating diabetic skin ulcer, which is prepared from the following raw materials in parts by weight: 30 parts of raw astragalus membranaceus, 10 parts of fried bighead atractylodes rhizome, 10 parts of rhizoma atractylodis, 20 parts of poria cocos, 10 parts of cinnamon, 10 parts of monkshood, 10 parts of cornu cervi degelatinatum, 10 parts of pawpaw, 10 parts of semen brassicae, 10 parts of radix rehmanniae preparata, 10 parts of angelica sinensis and 15 parts of radix glehniae.
The preparation method of the traditional Chinese medicine composition for treating diabetic skin ulcer provided by the embodiment comprises the following steps:
(a) soaking the raw materials in water for 30min, decocting with strong fire until boiling, maintaining with slow fire for 30min, filtering to obtain primary water decoction, decocting the residue twice (the same decocting step in the secondary decocting step), mixing the water decoctions obtained by two times of separation, and concentrating to obtain concentrated solution containing crude drug 1.0g per ml;
(b) carrying out alcohol precipitation on the concentrated solution by adopting 2 times of 95% ethanol with the volume fraction of 4 ℃, carrying out alcohol precipitation for 16h, separating, carrying out reduced pressure concentration on the separated alcohol precipitation supernatant until no alcohol smell exists and the relative density is 1.20, cooling at room temperature, and carrying out freeze drying on the obtained fluid extract at the temperature of-20 ℃ for 2h to obtain the traditional Chinese medicine composition for treating the diabetic skin ulcer.
Example 3
This example provides a traditional Chinese medicine composition for treating diabetic skin ulcer, which is prepared from the same raw materials and using amounts as in example 2, except that 25 parts by weight of raw astragalus membranaceus, 15 parts by weight of fried bighead atractylodes rhizome and 10 parts by weight of poria cocos.
The preparation method of the traditional Chinese medicine composition for treating diabetic skin ulcer provided by the embodiment is the same as that of the embodiment 3.
Example 4
The embodiment provides a traditional Chinese medicine composition for treating diabetic skin ulcer, which is prepared from the raw materials of 5 parts by weight of winged euonymus twig, and the rest raw materials and the using amount are the same as those in the embodiment 2.
The preparation method of the traditional Chinese medicine composition provided in this example is the same as that of example 2.
Example 5
The embodiment provides a traditional Chinese medicine composition for treating diabetic skin ulcer, which is prepared from the following raw materials in parts by weight, 10 parts of caulis polygoni multiflori and the same amount as the embodiment 2.
The preparation method of the traditional Chinese medicine composition provided in this example is the same as that of example 2.
Example 6
The embodiment provides a traditional Chinese medicine composition for treating diabetic skin ulcer, which is prepared from the following raw materials in parts by weight: 40 parts of raw astragalus membranaceus, 5 parts of fried bighead atractylodes rhizome, 15 parts of rhizoma atractylodis, 10 parts of poria cocos, 15 parts of cinnamon, 8 parts of monkshood, 15 parts of cornu cervi degelatinatum, 15 parts of pawpaw, 15 parts of semen brassicae, 6 parts of radix rehmanniae preparata, 5 parts of angelica sinensis, 20 parts of radix glehniae, 10 parts of winged euonymus twig and 15 parts of caulis polygoni multiflori.
The preparation method of the traditional Chinese medicine composition for treating diabetic skin ulcer provided by the embodiment comprises the following steps:
(a) soaking the raw materials in water for 30min, decocting with strong fire until boiling, maintaining with slow fire for 30min, filtering to obtain primary water decoction, decocting the residue twice (the same decocting step in the secondary decocting step), mixing the water decoctions obtained by two times of separation, and concentrating to obtain concentrated solution containing crude drug 1.2g per ml;
(b) carrying out alcohol precipitation on the concentrated solution by adopting 4 times of 92% ethanol by volume fraction, wherein the alcohol precipitation temperature is 3 ℃, the alcohol precipitation time is 14h, separating, carrying out reduced pressure concentration on the separated alcohol precipitation supernatant until no alcohol smell exists and the relative density is 1.22, cooling at room temperature, and carrying out freeze drying on the obtained fluid extract at the temperature of-20 ℃ for 2h to obtain the traditional Chinese medicine composition for treating the diabetic skin ulcer.
Comparative example 1
The comparative example provides a traditional Chinese medicine composition for treating diabetic skin ulcer, which is prepared from the following raw materials in parts by weight: 10 parts of fried bighead atractylodes rhizome, 10 parts of rhizoma atractylodis, 20 parts of poria cocos, 10 parts of cinnamon, 10 parts of monkshood, 10 parts of cornu cervi degelatinatum, 10 parts of pawpaw, 10 parts of semen brassicae, 10 parts of radix rehmanniae preparata, 10 parts of angelica sinensis and 15 parts of radix glehniae.
The preparation method of the traditional Chinese medicine composition for treating diabetic skin ulcer provided by the comparative example is the same as that of the example 2.
Comparative example 2
The comparative example provides a traditional Chinese medicine composition for treating diabetic skin ulcer, which is prepared from the following raw materials in parts by weight: 10 parts of raw astragalus membranaceus, 3 parts of fried bighead atractylodes rhizome, 10 parts of rhizoma atractylodis, 8 parts of poria cocos, 10 parts of cinnamon, 10 parts of monkshood, 10 parts of cornu cervi degelatinatum, 10 parts of pawpaw, 10 parts of semen brassicae, 10 parts of radix rehmanniae preparata, 10 parts of angelica sinensis and 15 parts of radix glehniae.
The preparation method of the traditional Chinese medicine composition for treating diabetic skin ulcer provided by the comparative example is the same as that of the example 2.
Comparative example 3
The comparative example provides a traditional Chinese medicine composition for treating diabetic skin ulcer, which is prepared from the following raw materials in parts by weight: 30 parts of raw astragalus membranaceus, 10 parts of fried bighead atractylodes rhizome, 10 parts of rhizoma atractylodis, 20 parts of poria cocos, 4 parts of cinnamon, 3 parts of monkshood, 2 parts of cornu cervi degelatinatum, 10 parts of pawpaw, 10 parts of semen brassicae, 10 parts of radix rehmanniae preparata, 10 parts of angelica sinensis and 15 parts of radix glehniae.
The preparation method of the traditional Chinese medicine composition for treating diabetic skin ulcer provided by the comparative example is the same as that of the example 2.
Comparative example 4
The comparative example provides a traditional Chinese medicine composition for treating diabetic skin ulcer, which is prepared from the following raw materials in parts by weight: 40 parts of raw astragalus membranaceus, 5 parts of fried bighead atractylodes rhizome, 15 parts of rhizoma atractylodis, 10 parts of poria cocos, 15 parts of cinnamon, 8 parts of monkshood, 15 parts of cornu cervi degelatinatum, 3 parts of pawpaw, 2 parts of semen brassicae, 6 parts of radix rehmanniae preparata, 10 parts of winged euonymus twig and 15 parts of caulis polygoni multiflori.
The preparation method of the traditional Chinese medicine composition for treating diabetic skin ulcer provided by the comparative example is the same as that of example 6.
In order to further verify the effects of the above examples and comparative examples, the following experimental examples were specified.
Experimental example 1
Pharmacodynamic experiments are carried out on the traditional Chinese medicine composition for treating diabetic skin ulcer, which is prepared in each embodiment and comparative example of the invention, and the adopted experimental animals and experimental methods are as follows:
experimental animals: db/m mice and db/db mice (diabetic mice), 130 in total, are male, and are 8-12 weeks old, wherein the number of db/m mice is 10, and the number of db/db mice is 120;
the experimental method and the steps are as follows: db/m mice were used as a blank group (10), and the db/db mice were divided into a model group (10), a positive control (bFGF) group (10), and an internal prescription group (examples 1-6 and comparative examples 1-4, 100 in total). After anaesthetizing, mice were prepared with full-thickness skin excision wounds of 6mm in diameter and raised in a single cage. After the model is made, the oral prescription is used for intragastric administration, 1 ml of the traditional Chinese medicine is taken once a day. Gelatin sponges containing normal saline are externally applied to the blank group, the model group and the oral prescription group, gelatin sponges containing bFGF are externally applied to the positive control group, the gelatin sponges are bound by disposable sterile dressing, and the medicines are changed 1 time every other day and pictures are taken.
The results of the pharmacodynamic experiments are shown in tables 1 and 2.
TABLE 1 Effect of the Chinese medicinal compositions provided in the examples and comparative examples on wound healing rates in db/db mice (n 10)
And (delta): compared with the blank group, P is less than 0.05, and the difference has statistical significance. *: compared with the model group, P is less than 0.05, and the difference has statistical significance.
TABLE 2 Effect of the Chinese medicinal compositions provided in the examples and comparative examples on mRNA expression of transforming growth factor beta (TGF-. beta.) from the wound surface of db/db mice (day 14)
| Group of | TGF-β |
| Blank group | 1.20±0.31 |
| Model set | 0.32±0.08△ |
| Positive control group | 1.49±0.88* |
| Square group for internal medicine (example 1) | 1.07±0.44* |
| Internal square group (example 2) | 1.27±0.54* |
| Internal square group (example 3) | 1.25±0.40* |
| Internal square group (example 4) | 1.45±0.34* |
| Internal square group (example 5) | 1.40±0.28* |
| Square group for internal medicine (example 6) | 1.90±0.40* |
| Square group for internal medicine (comparison example 1) | 0.37±0.15 |
| Square group for internal medicine (comparison example 2) | 0.59±0.18 |
| Internal square group (comparison example 3) | 0.58±0.08 |
| Internal square group (comparative example 4) | 0.60±0.07 |
And (delta): compared with the blank group, P is less than 0.05, and the difference has statistical significance. *: compared with the model group, P is less than 0.05, and the difference has statistical significance.
As can be seen from the data in Table 1, the wound healing rate of the model group db/db mice was decreased compared to the blank group, and the difference was statistically significant, indicating that the diabetic mice suffered from delayed wound healing. Compared with the model group, the healing rate of the wound surface of db/db mouse of the oral prescription group (examples 1-6) is higher than that of the model group, which shows that the traditional Chinese medicine composition provided by the invention can obviously improve the healing rate of the wound surface of db/db mouse on days 3, 7 and 13, and the difference has statistical significance. Therefore, the traditional Chinese medicine composition can promote the healing of the wound of the diabetic mouse.
As can be seen from the data in Table 2, compared with the blank group, the TGF-beta gene expression of the wound tissue of the model group db/db mouse is reduced, and the difference has statistical significance, so that the reduction of the wound healing rate of the model group db/db mouse is related to the reduction of the TGF-beta content in the wound tissue. Compared with the model group, the TGF-beta gene expression of the wound tissue of db/db mice in the oral administration formula group (examples 1-6) is higher than that in the model group, the difference has statistical significance, and the possible reason for promoting the wound healing of db/db mice by the traditional Chinese medicine oral administration formula is to improve the TGF-beta gene expression of the wound tissue, promote the wound tissue to grow and further accelerate the wound healing.
Specifically, compared with example 2, the raw astragalus root is not added in the raw materials of the traditional Chinese medicine composition in the comparative example 1, the dosage of the raw astragalus root and the stir-fried bighead atractylodes rhizome in the raw materials of the traditional Chinese medicine composition in the comparative example 2 is beyond the numerical range defined by the invention, and the dosage of the cinnamon, the monkshood and the cornu cervi degelatinatum in the raw materials of the traditional Chinese medicine composition in the comparative example 3 is beyond the numerical range defined by the invention. The pharmacodynamic experimental data of comparative examples 1-3 are overall inferior to example 2 compared to the pharmacodynamic experimental data of example 2 provided in tables 1 and 2.
Compared with example 6, the Chinese medicinal composition of comparative example 4 has no radix Angelicae sinensis or radix Glehniae added. The pharmacodynamic experimental data of comparative example 4 is also inferior to example 6 as a whole, compared to the pharmacodynamic experimental data of example 6 provided in tables 1 and 2.
Meanwhile, as can be seen from table 2, comparative examples 1 to 4 did not promote growth factor expression.
Therefore, the traditional Chinese medicine composition can achieve good drug effect only if the composition and the dosage of the raw materials are within the range defined by the invention.
Finally, it should be noted that: the above embodiments are only used to illustrate the technical solution of the present invention, and not to limit the same; while the invention has been described in detail and with reference to the foregoing embodiments, it will be understood by those skilled in the art that: the technical solutions described in the foregoing embodiments may still be modified, or some or all of the technical features may be equivalently replaced; and the modifications or the substitutions do not make the essence of the corresponding technical solutions depart from the scope of the technical solutions of the embodiments of the present invention.
Claims (19)
1. A traditional Chinese medicine composition for treating diabetic skin ulcer is characterized by being prepared from the following raw materials in parts by weight: 20-40 parts of raw astragalus membranaceus, 5-20 parts of fried bighead atractylodes rhizome, 5-15 parts of rhizoma atractylodis, 10-30 parts of poria cocos, 5-15 parts of cinnamon, 5-10 parts of monkshood, 5-15 parts of cornu cervi degelatinatum, 5-15 parts of pawpaw, 5-15 parts of semen brassicae, 5-15 parts of prepared rehmannia root, 5-15 parts of angelica sinensis and 10-20 parts of radix glehniae.
2. The traditional Chinese medicine composition according to claim 1, which is prepared from the following raw materials in parts by weight: 22-38 parts of raw astragalus membranaceus, 6-18 parts of fried bighead atractylodes rhizome, 6-14 parts of rhizoma atractylodis, 12-28 parts of poria cocos, 6-12 parts of cinnamon, 6-9 parts of monkshood, 6-12 parts of cornu cervi degelatinatum, 6-12 parts of pawpaw, 6-12 parts of semen brassicae, 6-12 parts of radix rehmanniae preparata, 6-12 parts of angelica sinensis and 12-18 parts of radix glehniae.
3. The traditional Chinese medicine composition according to claim 1, which is prepared from the following raw materials in parts by weight: 25-35 parts of raw astragalus membranaceus, 8-15 parts of fried bighead atractylodes rhizome, 8-12 parts of rhizoma atractylodis, 15-25 parts of poria cocos, 8-12 parts of cinnamon, 7-8 parts of monkshood, 8-12 parts of cornu cervi degelatinatum, 8-12 parts of pawpaw, 8-12 parts of semen brassicae, 8-12 parts of prepared rehmannia root, 8-12 parts of angelica sinensis and 14-16 parts of radix glehniae.
4. A traditional Chinese medicine composition for treating diabetic skin ulcer is characterized in that 5-10 parts by weight of winged euonymus twig are further added on the basis of the raw materials of the traditional Chinese medicine composition of any one of claims 1-3.
5. A traditional Chinese medicine composition for treating diabetic skin ulcer is characterized in that 10-15 parts by weight of caulis polygoni multiflori is further added on the basis of the raw materials of the traditional Chinese medicine composition of any one of claims 1-3.
6. The method for preparing the traditional Chinese medicine composition for treating the diabetic skin ulcer as claimed in any one of claims 1 to 5, which is characterized by comprising the following steps:
(a) adding water into the raw materials according to the formula amount, decocting and separating for multiple times, combining water decoctions obtained by multiple separation, and concentrating to obtain a concentrated solution;
(b) and (3) carrying out alcohol precipitation on the concentrated solution, separating, concentrating and drying the separated alcohol precipitation supernatant to obtain the traditional Chinese medicine composition for treating the diabetic skin ulcer.
7. The preparation method according to claim 6, wherein in the step (a), the decoction time is 1-2 h.
8. The preparation method according to claim 7, wherein the water decoctions obtained by multiple separation are combined and concentrated to a concentration of 0.8-1.2 g crude drug per ml liquid medicine to obtain a concentrated solution.
9. The preparation method according to claim 6, wherein in the step (b), 1.5-4 times of ethanol with volume fraction of 90-95% is used for alcohol precipitation.
10. The method according to claim 9, wherein the alcohol precipitation temperature in step (b) is 2-6 ℃.
11. The method according to claim 9, wherein the alcohol precipitation temperature in step (b) is 3-5 ℃.
12. The method according to claim 9, wherein the alcohol precipitation temperature in the step (b) is 4 ℃.
13. The preparation method according to claim 9, wherein in the step (b), the alcohol precipitation time is 12-24 hours.
14. The preparation method according to claim 9, wherein in the step (b), the alcohol precipitation time is 15-20 h.
15. The method according to claim 9, wherein the alcohol precipitation time in step (b) is 16 h.
16. The method according to claim 6, wherein the concentration in the step (b) is a concentration under reduced pressure.
17. The preparation method according to claim 6, wherein in the step (b), the drying is freeze-drying, the temperature of the freeze-drying is-25 to-15 ℃, and the time of the freeze-drying is 1.5 to 3 hours.
18. The method of any one of claims 6 to 17, comprising the steps of:
(a) adding water into the raw materials according to the formula amount, decocting and separating for multiple times, combining water decoctions obtained by multiple separation, and concentrating until each milliliter of liquid medicine contains 0.8-1.2 g of crude drug to obtain a concentrated solution;
(b) and (2) carrying out alcohol precipitation on the concentrated solution by using 1.5-4 times of 90-95% ethanol in volume fraction, separating, carrying out reduced pressure concentration on the separated alcohol precipitation supernatant until the relative density is 1.18-1.22, and freeze-drying the obtained fluid extract at the temperature of-25-15 ℃ for 1.5-3 h to obtain the traditional Chinese medicine composition for treating the diabetic skin ulcer.
19. The method of claim 18, comprising the steps of:
(a) adding water into the raw materials according to the formula ratio, decocting and separating for two times, combining the water decoctions obtained by the two-time separation, and concentrating until each milliliter of liquid medicine contains 1.0g of the crude drug to obtain a concentrated solution;
(b) and (2) carrying out alcohol precipitation on the concentrated solution by adopting 95% ethanol in 2 times volume fraction, separating, carrying out reduced pressure concentration on the separated alcohol precipitation supernatant until the relative density is 1.18-1.22, and freeze-drying the obtained fluid extract at the temperature of-20 ℃ for 2 hours to obtain the traditional Chinese medicine composition for treating the diabetic skin ulcer.
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| CN1765416A (en) * | 2005-09-03 | 2006-05-03 | 骆根兴 | Health caring plaster |
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| CN1765416A (en) * | 2005-09-03 | 2006-05-03 | 骆根兴 | Health caring plaster |
| CN103550616A (en) * | 2013-11-07 | 2014-02-05 | 王纯治 | Traditional Chinese medicinal prescription for treating diabetic gangrene |
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| Title |
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| 真武汤临床运用探讨;唐祖宣;《新中医》;19801231(第5期);第32-34页 * |
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