CN108392572B

CN108392572B - Plaster for removing stasis, promoting tissue regeneration, healing sore and relieving pain and preparation method and application thereof

Info

Publication number: CN108392572B
Application number: CN201810351783.6A
Authority: CN
Inventors: 吴汶轩
Original assignee: Nanjing University Of Chinese Medicine Hanlin College
Current assignee: Nanjing University Of Chinese Medicine Hanlin College
Priority date: 2018-04-19
Filing date: 2018-04-19
Publication date: 2021-03-23
Anticipated expiration: 2038-04-19
Also published as: CN108392572A

Abstract

The invention discloses a plaster for removing blood stasis, promoting tissue regeneration, healing sore and relieving pain, which comprises 20-40 parts of Chinese herbal raw materials including radix rehmanniae, 20-40 parts of rhizoma bletillae, 40-80 parts of calcined gypsum, 30-60 parts of calcined keel, 30-60 parts of pearl, 10-20 parts of dragon's blood and 10-20 parts of cinnabar. According to the traditional Chinese medicine theory, the plaster is prepared by screening traditional Chinese medicines through a large number of experiments, wherein 20g of white astringing, 20g of bletilla striata, 40g of calcined gypsum, 30g of calcined dragon bone and 30g of pearl are used as traditional Chinese medicine components as first components, and 10g of dragon blood and cinnabar ultrafine powder are respectively used as second components. The preparation method of the plaster provided by the invention has the advantages of stable and reliable process, low production cost and strong operability, and is suitable for industrial mass production.

Description

Plaster for removing stasis, promoting tissue regeneration, healing sore and relieving pain and preparation method and application thereof

Technical Field

The invention relates to a medicament, in particular to a plaster for removing blood stasis, promoting tissue regeneration, healing sore and relieving pain, a preparation method and application thereof.

Background

With the aging population, the metabolism of the old people in the new city is slow, the wound healing capability is poor, particularly for people with diabetes, the wound is difficult to heal, great pain is brought to patients, and chemical medicaments generally adopt analgesic medicaments and anti-inflammatory medicaments, so that the effect is poor, and the adverse reaction is large. At present, a safe traditional Chinese medicine plaster which has the functions of removing blood stasis, promoting tissue regeneration, astringing dampness, healing sore and relieving pain is lacked in the market.

Therefore, it is necessary to develop a safe Chinese medicinal plaster with reasonable compatibility of medicines, and effects of removing blood stasis, promoting granulation, eliminating dampness, healing sore and relieving pain based on the prior art.

Disclosure of Invention

The purpose of the invention is as follows: the invention aims to solve the defects of the prior art, and develops a safe traditional Chinese medicine plaster which is reasonable in compatibility, and has the effects of removing stasis, promoting granulation, astringing dampness, healing sore and relieving pain on the basis of the prior art. The invention also aims to provide a preparation method and application of the traditional Chinese medicine plaster.

The technical scheme is as follows: in order to achieve the above purpose, the invention adopts the technical scheme that:

a plaster for removing blood stasis, promoting tissue regeneration, healing sore and relieving pain comprises the following raw materials in parts by weight:

20-40 parts of raw white atractylodes rhizome, 20-40 parts of raw bletilla striata, 40-80 parts of calcined gypsum, 30-60 parts of calcined keel, 30-60 parts of pearl, 10-20 parts of dragon's blood and 10-20 parts of cinnabar.

As a preferred scheme, the plaster for removing blood stasis, promoting tissue regeneration, healing sore and relieving pain is prepared from the following raw materials in parts by weight:

20 parts of raw white atractylodes rhizome, 20 parts of raw bletilla striata, 40 parts of calcined gypsum, 30 parts of calcined keel, 30 parts of pearl, 10 parts of dragon's blood and 10 parts of cinnabar.

Preferably, the preparation method of the plaster for removing blood stasis, promoting tissue regeneration, healing sore and relieving pain comprises the following steps:

(1) adjusting the temperature of the constant-temperature water tank to 50-80 ℃, adding water, and placing the beaker into the constant-temperature water tank;

(2) melting vaseline in a beaker;

(3) mixing and grinding the white calx, the bletilla striata, the calcined gypsum, the calcined keel and the pearl into superfine powder, pouring the superfine powder into a beaker filled with vaseline, and stirring uniformly;

(4) cooling to 35 deg.C, adding sanguis Draxonis and Cinnabaris micropowder, and stirring.

As a more preferable scheme, the preparation method of the plaster for removing blood stasis, promoting tissue regeneration, healing sore and relieving pain comprises the following steps:

(1) adjusting the temperature of a constant-temperature water tank to 50 ℃, adding 1000mL of water, and placing the beaker into the constant-temperature water tank;

(2) taking 500 g of Vaseline, and putting the Vaseline into a beaker for melting;

(3) mixing 20g of radix Ampelopsis, 20g of bletilla striata, 40g of calcined gypsum, 30g of calcined keel and 30g of pearl, grinding into superfine powder, pouring into a beaker filled with vaseline, and stirring uniformly;

(4) cooling to 35 deg.C, adding sanguis Draxonis and Cinnabaris micropowder 10g each, and stirring.

The plaster for removing blood stasis, promoting tissue regeneration, healing sore and relieving pain disclosed by the invention is applied to preparation of the plaster for removing blood stasis, promoting tissue regeneration, astringing dampness, healing sore and relieving pain.

The plaster provided by the invention has the effects of removing necrotic tissue, promoting granulation, astringing dampness, healing sore and relieving pain. Can be used for treating cold accumulation, blood stasis, and vein blockage of gangrene and bedsore. Is equivalent to the 3-grade or above diabetic foot and the pressure sore and other wounds difficult to heal in clinical medicine.

In the plaster of the invention, dragon's blood: the essential herbs for dissipating blood stasis and generating new blood are mainly used to break accumulated blood and alleviate pain and generate flesh. Experiments show that the water-decocted alcohol-precipitated liquid can obviously inhibit platelet aggregation and prevent thrombosis. The water extract has different degrees of inhibition effects on staphylococcus aureus, staphylococcus albus and various pathogenic fungi, so the water extract has a promotion effect on the surface healing of diabetic foot ulcer and prevents foot blood vessel blockage and tissue necrosis; and the antibacterial effect of the traditional Chinese medicine composition is beneficial to ulcer recovery.

Ampelopsis japonica: abscess, swelling, deep-rooted carbuncle and sore, nodulation and pain relieving are the main drugs for treating furuncle, deep-rooted carbuncle and deep-rooted carbuncle. The ampelopsis japonica has strong bacteriostatic action and strong antifungal effect. Can effectively inhibit fungal infection at diabetic foot ulcer.

Pearl: clearing away heat and toxic material, removing necrotic tissue and promoting granulation. The pearl can promote granulation hyperplasia of wound surface by external application. The pearl can eliminate inflammation caused by diabetic foot, remove slough and promote new skin growth.

Bletilla striata: astringe to stop bleeding, resolve swelling and promote granulation. The topical preparation has good topical hemostatic effect, and can promote platelet aggregation of wound surface of hemorrhage, increase phagocyte number, and inhibit hemorrhage such as blood vessel; has inhibitory effect on Bacillus subtilis, Candida albicans, and Staphylococcus aureus. The medicine is used for dredging qi and blood caused by stasis, so that the organism is promoted to generate new skin, and the medicine plays an important role in treating diabetic foot.

Frankincense: promoting blood circulation, relieving pain, eliminating swelling, and promoting granulation. Olibanum can improve metabolism, thereby resisting infection. Is beneficial to relieving the pain of the diabetic foot patients and promoting the healing of the ulcer wound.

Myrrh: the traditional Chinese medicine considers that the traditional Chinese medicine has the effects of diminishing swelling, promoting tissue regeneration, dissipating blood stasis and relieving pain, and can stimulate leucocytes and activate an immune system; it can directly resist microorganisms, quickly recover the sick body, accelerate the metabolism of diabetic foot ulcer, and promote the healing of wound surface.

Pharmacological research shows that: the traditional Chinese medicine components in the plaster prepared by the invention have inhibition effects on staphylococcus aureus, most gram-positive bacteria, some gram-negative bacteria, common pathogenic fungi bacillus anthracis and the like, and are not easy to generate drug resistance. In addition, the plaster also has the functions of adsorbing secretion and stopping bleeding, can absorb dampness and relieve pain, and is beneficial to protecting the wound surface so as to quickly repair and heal the wound surface. The plaster is used for external application on the basis of controlling blood sugar and resisting infection, has remarkable effects of removing necrosis and promoting granulation, astringing dampness and healing sore and relieving pain, can reduce the risk of amputation of surgery and improve the life quality of patients with diabetic foot.

Has the advantages that: compared with the prior art, the plaster for removing blood stasis, promoting tissue regeneration, healing sore and relieving pain provided by the invention has the following advantages:

1. according to the traditional Chinese medicine theory, the plaster is prepared by screening traditional Chinese medicines through a large number of experiments, wherein 20g of white astringing, 20g of bletilla striata, 40g of calcined gypsum, 30g of calcined dragon bone and 30g of pearl are used as traditional Chinese medicine components as first components, and 10g of dragon blood and cinnabar ultrafine powder are respectively used as second components. The invention has good safety when being used as an external preparation.

2. The preparation method of the plaster provided by the invention has the advantages of stable and reliable process, easy implementation, low production cost and strong operability, and is suitable for industrial mass production.

3. The invention is an external ointment, which has the following advantages:

the tea is fine and uniform and has no rough feeling; secondly, the viscosity is proper, and the coating is easy; the texture is relatively stable; fourthly, the water absorption is better,

the release and penetration capacity of the contained medicine is stronger; no bad irritation and allergy, and little adverse reaction.

Detailed Description

The present invention is further illustrated by the following examples, which are intended to be purely exemplary and are not intended to limit the scope of the invention, as various equivalent modifications of the invention will occur to those skilled in the art upon reading the present disclosure and fall within the scope of the appended claims.

Example 1

1. A plaster for removing blood stasis, promoting tissue regeneration, healing sore and relieving pain is composed of the following raw materials in parts by weight:

20 parts of radix ampelopsis, 20 parts of bletilla striata, 40 parts of calcined gypsum, 30 parts of calcined keel, 30 parts of pearl, 10 parts of dragon's blood and 10 parts of cinnabar.

2. The preparation method of the plaster for removing blood stasis, promoting tissue regeneration, healing sore and relieving pain provided by the invention comprises the following steps:

Example 2

40 parts of radix ampelopsis, 40 parts of bletilla striata, 80 parts of calcined gypsum, 60 parts of calcined keel, 60 parts of pearl, 20 parts of dragon's blood and 20 parts of cinnabar.

(1) adjusting the temperature of a constant-temperature water tank to 50 ℃, adding 2000mL of water, and placing the beaker into the constant-temperature water tank;

(2) putting 1000 g of Vaseline into a beaker for melting;

(3) mixing 40 parts of radix Ampelopsis, 40 parts of rhizoma Bletillae, 80 parts of Gypsum Fibrosum Preparatum, 60 parts of Os Draconis Preparata and 60 parts of Margarita, grinding into superfine powder, pouring into a beaker containing vaseline, and stirring;

(4) cooling to 35 deg.C, adding sanguis Draxonis and Cinnabaris micropowder 20g each, and stirring.

EXAMPLE 3 clinical efficacy Studies

1 materials and methods

1.1 study object

Selecting 60 diabetic foot patients from Yixing Chinese medical hospitals, wherein the patients meet the WHO diabetes diagnosis standard, wherein 30 men and 30 women are type 2 diabetes, the patients are 51-75 years old, the average age is 61 years old, the course of disease is 5-12 years old, the average age is 7 years old, the patients are treated by oral hypoglycemic drugs before admission, the abdominal blood sugar is 11.32 +/-1.56 mmol/L during admission, the patients are unilateral lower limb ulcers, and the ulcer area is 146.3 +/-3.14 cm^2，It is not cured for a long time.

1.2 methods of investigation

The treatment groups of 60 patients were randomly divided into a treatment group and a control group, wherein 40 patients (the plaster prepared in the invention example 1) in the treatment group were 20 male patients and 20 female patients; the clinical basic data of each group of 20 control groups, 10 men and 10 women, are comparable.

Both groups of patients were fed a diabetic diet and insulin controlled blood glucose in the ideal range. The treatment group patients are externally treated by the plaster prepared in the embodiment 1 of the invention, and 4 weeks are 1 course of treatment; patients in the control group were treated with Befuji (externally applied recombinant bovine basic fibroblast growth factor) for 2 weeks as 1 course of treatment.

1.3 therapeutic efficacy criteria

The effect is shown: the wound is healed by more than 80 percent, and the granulation or epithelial tissue grows well; the method has the following advantages: the wound is healed by more than 40 percent, the wound surface is ruddy, no blood seeps, and granulation tissues grow; and (4) invalidation: there was no improvement before and after treatment.

1.4 statistical methods

Descriptive statistics: the counting data is represented by composition ratio or rate, and the metering data is represented by

Represents; and (3) statistical inference: statistical methods have parametric tests and nonThe parameter test includes chi-square test, paired t-test, grouped sample t-test, etc. and the statistical software adopts SPSS 13.0.

2 results

The test results in Table 1 show that the total effective rates of the traditional Chinese medicine plaster and the Beifuji are 85% and 45% respectively, the results show that the traditional Chinese medicine plaster provided by the invention has better curative effect than the Beifuji, obvious difference and statistical significance (p is less than 0.01)

TABLE 1 comparison of the clinical efficacy of the two groups

Diabetic foot is a serious chronic complication that causes disability and death in diabetics, leading to infections and amputations. It has symptoms and signs of surgical disease of local infection, ulcer, gangrene or necrosis, so that the treatment of local wounds is indispensable in the treatment. The plaster provided by the invention has good healing promoting effect for treating diabetic ulcer, and has no obvious adverse reaction.

In addition, the plaster prepared by the method of the embodiment 1 is used for treating infection, ulcer, gangrene or necrosis of type 2 diabetes, and has a poor healing promoting effect on type 2 diabetes, wherein the healing promoting effect is lower than 50%.

Example 4 animal efficacy Studies

1. Experimental animals: 100 clean-grade Kunming mice are male, and 35-40 g of the clean-grade Kunming mice are used.

2. Molding: mice were normally fed for one week, fasted for 12 hours, and injected intraperitoneally with Streptozotocin (STZ)80 mg/kg. Blood is taken after 72 hours to detect the blood sugar, the blood sugar level is more than 16.7mmol/L, and the modeling standard can be reached. After anesthetizing a mouse meeting the modeling standard, the hind limb of the mouse is shaved and disinfected, and a full-thickness skin ulceration model of about 1.5cm x 0.5cm is prepared by a surgical method.

3. Grouping experiments: the 60 mice with diabetic foot skin ulceration are divided into 30 ointment groups and blank ointment control groups in the example 1 according to a random numerical table; wound healing was recorded before each administration. The experimental animals are fed in cages, one cage is used for each cage, and the phenomenon that the accuracy of experimental results is influenced by mutual licking of wound surfaces in collective feeding is prevented; the wound surface is protected by a small, light and thin plastic film, so that the mouse can be prevented from licking, and the experimental result is prevented from being influenced.

4. The administration method comprises the following steps:

experimental groups: 2g of the ointment set of the example 1 is uniformly applied to the ulcer surface after daily local disinfection.

Control group: after local disinfection every day, 2g of blank ointment is given to the wound surface and is evenly smeared on the ulcer surface.

5. Observation indexes are as follows: rate of wound healing

After modeling and at the end of observation (by days), the shape and size of the wound surface were drawn with a transparent square tissue, the image was photographed with the pattern drawn with a camera, the area of the wound surface was calculated by introducing the photograph into a computer using ImageJ software, and the healing rate was calculated, where the shrinkage rate is (original area-area covered by wound)/original area of wound surface × 100%).

6. Results of the experiment

TABLE 2 comparison of the clinical effects of the two groups

Example 5 stimulation experiments

1. Experimental animals: healthy no-skin disease new zealand white rabbits 3, common grade, provided in jingling rabbit farm, certificate number: SCXK (Su) 2012-0003, weight 2.6-2.7 kg. The experimental animals are raised in cages, and each cage is provided with one animal.

2. Experimental methods

3cm multiplied by 3cm is cut and skin preserved on two sides of the spine 24h before the rabbit experiment, 75% alcohol is used for cleaning and exposing the skin on the dehaired skin of 2.5cm multiplied by 2.5cm before the rabbit is coated with the ointment group of the embodiment 1 on the next day, and a sterilized triangular needle is used for scratching a well-shaped damaged area in the skin preserved area, so that the skin is only damaged to the epidermis.

5g of the plaster of example 1 (maximum dose) was applied to the damaged area, covered with two layers of gauze and one layer of oiled paper, and fixed with a non-irritating adhesive tape, and the other side was coated with a control of 5g of a blank plaster, and after 4h application, the residual jade cream was washed away with sterile physiological saline, and after 1/24/48h observation, skin reactions were recorded.

3. Results of the experiment

After the plaster prepared by the invention is coated on the surface of skin, no irritation reactions such as erythra, allergy and the like occur, which indicates mild condition and no obvious irritation.

The foregoing is only a preferred embodiment of the present invention, and it should be noted that, for those skilled in the art, various modifications and decorations can be made without departing from the principle of the present invention, and these modifications and decorations should also be regarded as the protection scope of the present invention.

Claims

1. A plaster for removing blood stasis, promoting tissue regeneration, healing sore and relieving pain is characterized by being prepared from the following raw materials in parts by weight:

2. The process for preparing a plaster for removing blood stasis, promoting tissue regeneration, healing sore and relieving pain as claimed in claim 1, which comprises the steps of:

(1) adjusting the temperature of the constant-temperature water tank to 50-80 ℃, adding water, and placing the beaker into the constant-temperature water tank; (2) putting vaseline into a beaker for melting;

3. The preparation method of the plaster for removing blood stasis, promoting tissue regeneration, healing sores and relieving pain as claimed in claim 2, is characterized by comprising the following steps:

(1) adjusting the temperature of a constant-temperature water tank to 50 ℃, adding 1000mL of water, and placing the beaker into the constant-temperature water tank; (2) putting 500 g of Vaseline into a beaker for melting;

4. The use of the plaster for removing blood stasis, promoting tissue regeneration, healing sore and relieving pain of claim 1 in the preparation of the plaster for removing blood stasis, promoting tissue regeneration, eliminating dampness, healing sore and relieving pain.