Composition for preventing and treating diabetic skin ulcer as well as preparation method and application thereof

Abstract

The invention relates to the technical field of traditional Chinese medicines, and particularly discloses a composition for preventing and treating diabetic skin ulcers and a preparation method and application thereof, the composition comprises bunge cherry seeds, rhizoma atractylodis, rice-grain sprouts, mangnolia officinalis, cortex lycii radicis, whole radix ophiopogonis, Chinese yam, dandelion, raw astragalus membranaceus, salvia miltiorrhiza, caulis spatholobi, radix paeoniae rubra and liquorice; through the steps of graded extraction, freeze drying, microencapsulation and the like, full extraction and stable preservation of effective components are ensured, the extraction efficiency and the product stability are greatly improved, and the effective components in the composition can be better absorbed and utilized by skin.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicine, and specifically relates to a composition for preventing and treating diabetic skin ulcers, and a preparation method and application thereof. Background Art

[0002] As a global chronic metabolic disease, the number of diabetes patients continues to grow worldwide and has become a serious public health problem. Due to long-term hyperglycemia, diabetic patients are prone to a variety of complications, among which skin ulcers are a more common one. Diabetic skin ulcers not only affect the patient's appearance and quality of life, but may also cause serious consequences such as infection and gangrene, and even threaten the patient's life.

[0003] At present, the treatment of diabetic skin ulcers mainly adopts comprehensive treatment methods such as controlling blood sugar, anti-infection, local debridement and dressing change in clinical practice. In the field of traditional Chinese medicine, although there are formulas for treating skin ulcers, traditional Chinese medicine preparations often have shortcomings such as low content of effective ingredients and poor stability, which affects their efficacy and clinical application. Summary of the invention

[0004] The purpose of the present invention is to provide a composition for preventing and treating diabetic skin ulcers, and a preparation method and application thereof, so as to solve the problems raised in the above background technology.

[0005] To achieve the above object, the present invention provides the following technical solutions:

[0006] A composition for preventing and treating diabetic skin ulcers, comprising the following raw materials in parts by weight:

[0007] 12-18 parts of Prunus mume seeds, 9-11 parts of Atractylodes lancea, 7-9 parts of rice sprouts, 10-14 parts of Magnolia officinalis, 8-12 parts of Lycium bark, 7-11 parts of Radix Ophiopogonis, 9-13 parts of Dioscorea opposita, 8-12 parts of Taraxacum herb, 8-12 parts of Astragalus membranaceus, 10-14 parts of Salvia miltiorrhiza, 7-11 parts of Millettia reticulata, 6-9 parts of Red Peony Root, and 6-10 parts of Licorice.

[0008] A method for preparing a composition for preventing and treating diabetic skin ulcers comprises the following steps:

[0009] S1. Rinse the raw materials with clean water, dry them until there is no moisture on the surface, and then dry them at a low temperature of 40-50℃ to constant weight;

[0010] S2, crushing the pretreated raw material into powder with a particle size of less than 80 microns, and then sieving it to separate the powder into three levels: <40 microns, 40-60 microns and 60-80 microns, and collecting them separately;

[0011] S3. Extract each level of powder separately:

[0012] Place the powder <40 microns in a dynamic extractor, add 8 times the amount of water, heat to 90°C, extract for 1 hour, and collect the extract;

[0013] Place the 40-60 micron powder in another dynamic extractor, add 6 times the amount of 50% ethanol, heat to 85°C, extract for 1.5 hours, and collect the extract;

[0014] The 60-80 micron powder was placed in a third dynamic extractor, 4 times the amount of 70% ethanol was added, heated to 80°C, extracted for 2 hours, and the extract was collected;

[0015] S4, combining the three extracts, removing macromolecular impurities through a 0.45 micron microfiltration membrane, and then separating small molecule active ingredients through an ultrafiltration membrane with a molecular weight cutoff of 1000 Daltons, and concentrating the small molecule solution under reduced pressure until the volume is reduced to 1 / 10 of the original solution, to obtain a high-concentration active ingredient extract;

[0016] S5, placing the concentrated extract in a freeze dryer at -20°C for pre-freezing for 2 hours, and then drying at -50°C and vacuum degree <10Pa for 24 hours to obtain a dry extract powder, and using spray drying microencapsulation technology to mix the dried extract powder with the wall material and form microcapsules through a spray dryer;

[0017] S6. Mix the microencapsulated extract with natural plant oil and moisturizer, and form a composition for preventing and treating diabetic skin ulcers by high-speed stirring and homogenization at 40°C.

[0018] Preferably, in S5, the wall material is one of maltodextrin and gum arabic.

[0019] Preferably, in S6, the natural vegetable oil is one of olive oil and sweet almond oil.

[0020] Preferably, in S6, the moisturizing agent is one of glycerin and sodium hyaluronate.

[0021] The invention discloses an application of a composition for preventing and treating diabetic skin ulcers, characterized in that the composition is used to prepare a pharmaceutical preparation for treating diabetic skin ulcers, and the pharmaceutical preparation comprises an external ointment, a spray and an injection.

[0022] Compared with the prior art, the present invention has the following beneficial effects:

[0023] (1) Through the combination of various Chinese herbal raw materials, effective prevention and treatment are achieved for the pathological characteristics of diabetic skin ulcers. It has multiple effects such as anti-inflammatory, antibacterial, and promoting wound healing, and can work synergistically to accelerate the healing process of ulcers.

[0024] (2) Through the steps of graded extraction, freeze drying and microencapsulation, the effective ingredients are fully extracted and stably preserved, which greatly improves the extraction efficiency and product stability, so that the effective ingredients in the composition can be better absorbed and utilized by the skin. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Figure 1 It is a process flow chart of the present invention. DETAILED DESCRIPTION

[0026] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0027] Embodiment 1:

[0028] See also Figure 1 As shown, a composition for preventing and treating diabetic skin ulcers comprises the following raw materials in parts by weight:

[0029] 12 parts of Semen Pruni, 9 parts of Atractylodes, 7 parts of Rice Buds, 10 parts of Magnolia Bark, 8 parts of Cortex Lycii, 7 parts of Radix Ophiopogonis, 9 parts of Dioscorea Oppositae, 8 parts of Herba Taraxaci, 8 parts of Astragalus, 10 parts of Salvia miltiorrhizae, 7 parts of Millettia Spatholobi, 6 parts of Paeonia lactiflora, and 6 parts of Radix Glycyrrhizae.

[0030] A method for preparing a composition for preventing and treating diabetic skin ulcers comprises the following steps:

[0031] S1. Rinse the raw materials with clean water, dry them until there is no moisture on the surface, and then dry them at a low temperature of 40-50℃ to constant weight;

[0032] S2, crushing the pretreated raw material into powder with a particle size of less than 80 microns, and then sieving it to separate the powder into three levels: <40 microns, 40-60 microns and 60-80 microns, and collecting them separately;

[0033] S3. Extract each level of powder separately:

[0034] Place the powder <40 microns in a dynamic extractor, add 8 times the amount of water, heat to 90°C, extract for 1 hour, and collect the extract;

[0035] Place the 40-60 micron powder in another dynamic extractor, add 6 times the amount of 50% ethanol, heat to 85°C, extract for 1.5 hours, and collect the extract;

[0036] The 60-80 micron powder was placed in a third dynamic extractor, 4 times the amount of 70% ethanol was added, heated to 80°C, extracted for 2 hours, and the extract was collected;

[0037] S4, combining the three extracts, removing macromolecular impurities through a 0.45 micron microfiltration membrane, and then separating small molecule active ingredients through an ultrafiltration membrane with a molecular weight cutoff of 1000 Daltons, and concentrating the small molecule solution under reduced pressure until the volume is reduced to 1 / 10 of the original solution, to obtain a high-concentration active ingredient extract;

[0038] S5, placing the concentrated extract in a freeze dryer at -20°C for pre-freezing for 2 hours, and then drying at -50°C and vacuum degree <10Pa for 24 hours to obtain a dry extract powder, and using spray drying microencapsulation technology to mix the dried extract powder with the wall material and form microcapsules through a spray dryer;

[0039] S6. Mix the microencapsulated extract with natural plant oil and moisturizer, and form a composition for preventing and treating diabetic skin ulcers by high-speed stirring and homogenization at 40°C.

[0040] In one embodiment of the present invention, in S5, the wall material is one of maltodextrin and gum arabic;

[0041] In one embodiment of the present invention, in S6, the natural vegetable oil is one of olive oil and sweet almond oil;

[0042] In one embodiment of the present invention, in S6, the moisturizing agent is one of glycerin and sodium hyaluronate.

[0043] The invention discloses an application of a composition for preventing and treating diabetic skin ulcers, characterized in that the composition is used to prepare a pharmaceutical preparation for treating diabetic skin ulcers, and the pharmaceutical preparation includes an external ointment, a spray and an injection.

[0044] Embodiment 2:

[0045] The difference from Example 1 is that a composition for preventing and treating diabetic skin ulcers comprises the following raw materials in parts by weight:

[0046] 15 parts of Semen Pruni, 10 parts of Atractylodes, 8 parts of Rice Buds, 12 parts of Magnolia Officinalis, 10 parts of Cortex Lycii, 9 parts of Radix Ophiopogonis, 11 parts of Dioscorea Oppositae, 10 parts of Herba Taraxaci, 10 parts of Astragalus, 12 parts of Salvia Miltiorrhizae, 9 parts of Millettia Spatholobi, 7.5 parts of Paeonia lactiflora, and 8 parts of Licorice;

[0047] The preparation method and application are the same as those in Example 1 and will not be described in detail here.

[0048] Embodiment three:

[0049] The difference from Example 1 is that a composition for preventing and treating diabetic skin ulcers comprises the following raw materials in parts by weight:

[0050] 18 parts of Semen Pruni, 11 parts of Atractylodes, 9 parts of Rice Buds, 14 parts of Magnolia Officinalis, 12 parts of Cortex Lycii, 11 parts of Radix Ophiopogonis, 13 parts of Dioscorea Oppositae, 12 parts of Herba Taraxaci, 12 parts of Astragalus, 14 parts of Salvia Miltiorrhizae, 11 parts of Millettia Spatholobi, 9 parts of Paeonia lactiflora, and 10 parts of Licorice;

[0051] The preparation method and application are the same as those in Example 1 and will not be described in detail here.

[0052] Application test examples:

[0053] The effects of the compositions of Example 1, Example 2 and Example 3 of the present invention and the existing diabetic skin ulcer treatment drugs on the market in promoting the healing of diabetic skin ulcers were compared. 60 volunteers with diabetes and skin ulcers were selected and randomly divided into four groups, with 15 people in each group. The four groups were treated with the compositions of Example 1, Example 2 and Example 3 and a control drug of the diabetic skin ulcer treatment drug on the market, respectively.

[0054] Each group applied the drug twice a day for 4 consecutive weeks. During the treatment period, all volunteers maintained their original diabetes treatment regimen and avoided using other drugs that might affect the healing of skin ulcers.

[0055] Measure the ulcer area once a week, record and calculate the reduction ratio of the ulcer area, as shown in the following table:

[0056]

[0057] As can be seen from the above, after 4 weeks of treatment, the ulcer area reduction ratios of the combination treatment groups of Example 1, Example 2, and Example 3 were all higher than those of the control drug group, and the differences were statistically significant (P<0.05);

[0058] Record the time it takes for the ulcer to completely heal, as shown in the following table:

[0059] Group Average healing time (days) Embodiment 1 21.5 Embodiment 2 19.0 Embodiment 3 22.0 Control drug group 25.5

[0060] The ulcer healing time of the combination treatment groups of Example 1, Example 2, and Example 3 was shorter than that of the control drug group, and the difference was statistically significant (P<0.05). Among them, the healing time of the combination treatment group of Example 2 was the shortest.

[0061] Observe and record adverse reactions during treatment, as shown in the following table:

[0062] Group Minor skin irritation (number of people) Other adverse reactions (number of people) Embodiment 1 2 0 Embodiment 2 1 0 Embodiment 3 3 0 Control drug group 2 1(mild allergy)

[0063] No serious adverse reactions were observed in any group. Only a few volunteers experienced mild skin irritation symptoms, but all of them were able to tolerate the treatment and continued the treatment.

[0064] Among them, Prunus mume has the effects of moistening the intestines, promoting bowel movements, promoting diuresis and reducing swelling, helping to improve the intestinal function of diabetic patients, promoting the discharge of metabolic waste in the body, and is beneficial to skin health;

[0065] Atractylodes lancea can dry out dampness and strengthen the spleen, dispel wind and dissipate cold. It can relieve the symptoms of spleen deficiency and dampness in diabetic patients, help improve the internal environment, and promote ulcer healing.

[0066] Rice sprouts can help digestion and invigorate the stomach, strengthen the spleen and stimulate appetite, enhance spleen and stomach function, promote the absorption of nutrients, and provide necessary nutrients for skin repair;

[0067] Magnolia officinalis, which dries up dampness and eliminates phlegm, relieves qi and relieves fullness, helps to improve the condition of excessive moisture in the body and reduce skin problems caused by moisture;

[0068] Rehmannia root bark cools the blood and removes steam, clears the lungs and reduces fire, relieves the symptoms of yin deficiency and hyperactivity of fire in diabetic patients, and helps to reduce the inflammatory response of skin ulcers;

[0069] The whole herb of Ophiopogon japonicus nourishes yin and produces body fluid, moistens the lungs and clears the heart. It can replenish the missing yin fluid in diabetic patients and improve symptoms such as dry skin and itching.

[0070] Chinese yam nourishes the spleen and stomach, promotes the production of body fluids and benefits the lungs, nourishes the kidneys and astringes the essence. It has a conditioning effect on the spleen and kidney deficiency of diabetic patients, helps to enhance the body's resistance and promotes ulcer healing.

[0071] Dandelion can clear away heat and detoxify, reduce swelling and resolve lumps. It has a direct therapeutic effect on the inflammation and infection of skin ulcers and promotes the healing of ulcer surfaces.

[0072] Raw Astragalus (raw Astragalus) can replenish Qi and raise Yang, strengthen the body's defense system, promote diuresis and reduce swelling. It can improve symptoms such as Qi deficiency, fatigue, and decreased resistance in diabetic patients, and help enhance the skin barrier function.

[0073] Danshen, which can invigorate blood circulation, remove blood stasis, relieve pain, and clear the heart and relieve restlessness, can improve the microcirculation disorder of diabetic patients, promote local blood circulation, and accelerate the healing of ulcers;

[0074] Millettia reticulata can nourish blood and invigorate blood circulation, regulate menstruation and relieve pain, relax muscles and activate collaterals, and has an auxiliary therapeutic effect on vascular lesions and neuropathy caused by diabetes, and helps improve local blood circulation of skin ulcers;

[0075] Red peony root, clears away heat and cools blood, dissipates blood stasis and relieves pain, relieves inflammation and pain of skin ulcers, and promotes the healing of ulcer surfaces;

[0076] Licorice can nourish the spleen and replenish qi, clear away heat and detoxify, relieve pain, and harmonize various medicines. As a harmonizing agent in the formula, it can enhance the efficacy of the entire prescription while reducing the side effects of other medicines.

[0077] Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions and variations may be made to the embodiments without departing from the principles and spirit of the present invention, and that the scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. A composition for preventing and treating diabetic skin ulcers, characterized in that: The composition comprises the following raw materials in parts by weight: 12-18 parts of Prunus mume seeds, 9-11 parts of Atractylodes lancea, 7-9 parts of rice sprouts, 10-14 parts of Magnolia officinalis, 8-12 parts of Lycium bark, 7-11 parts of Radix Ophiopogonis, 9-13 parts of Dioscorea opposita, 8-12 parts of Taraxacum herb, 8-12 parts of Astragalus membranaceus, 10-14 parts of Salvia miltiorrhiza, 7-11 parts of Millettia reticulata, 6-9 parts of Red Peony Root, and 6-10 parts of Licorice.

2. A method for preparing a composition for preventing and treating diabetic skin ulcers, characterized in that: The following steps are involved: S1. Rinse the raw materials with clean water, dry them until there is no moisture on the surface, and then dry them at a low temperature of 40-50℃ to constant weight; S2, crushing the pretreated raw material into powder with a particle size of less than 80 microns, and then sieving it to separate the powder into three levels: <40 microns, 40-60 microns and 60-80 microns, and collecting them separately; S3. Extract each level of powder separately: Place the powder <40 microns in a dynamic extractor, add 8 times the amount of water, heat to 90°C, extract for 1 hour, and collect the extract; Place the 40-60 micron powder in another dynamic extractor, add 6 times the amount of 50% ethanol, heat to 85°C, extract for 1.5 hours, and collect the extract; The 60-80 micron powder was placed in a third dynamic extractor, 4 times the amount of 70% ethanol was added, heated to 80°C, extracted for 2 hours, and the extract was collected; S4, combining the three extracts, removing macromolecular impurities through a 0.45 micron microfiltration membrane, and then separating small molecule active ingredients through an ultrafiltration membrane with a molecular weight cutoff of 1000 Daltons, and concentrating the small molecule solution under reduced pressure until the volume is reduced to 1 / 10 of the original solution, to obtain a high-concentration active ingredient extract; S5, placing the concentrated extract in a freeze dryer at -20°C for pre-freezing for 2 hours, and then drying at -50°C and vacuum degree <10Pa for 24 hours to obtain a dry extract powder, and using spray drying microencapsulation technology to mix the dried extract powder with the wall material and form microcapsules through a spray dryer; S6. Mix the microencapsulated extract with natural plant oil and moisturizer, and form a composition for preventing and treating diabetic skin ulcers by high-speed stirring and homogenization at 40°C.

3. The method for preparing a composition for preventing and treating diabetic skin ulcers according to claim 2, characterized in that: In the S5, the wall material is one of maltodextrin and gum arabic.

4. The method for preparing a composition for preventing and treating diabetic skin ulcers according to claim 2, characterized in that: In S6, the natural vegetable oil is one of olive oil and sweet almond oil.

5. The method for preparing a composition for preventing and treating diabetic skin ulcers according to claim 2, characterized in that: In the S6, the moisturizing agent is one of glycerin and sodium hyaluronate.

6. An application of a composition for preventing and treating diabetic skin ulcers, characterized in that: The composition is used to prepare a pharmaceutical preparation for treating diabetic skin ulcers, and the pharmaceutical preparation includes an external ointment, a spray and an injection.

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