CN113350446A

CN113350446A - Traditional Chinese medicine composition and application thereof

Info

Publication number: CN113350446A
Application number: CN202110855923.5A
Authority: CN
Inventors: 赵立娜
Original assignee: DONGFANG HOSPITAL BEIJING UNIVERSITY OF CHINESE MEDICINE
Current assignee: DONGFANG HOSPITAL BEIJING UNIVERSITY OF CHINESE MEDICINE
Priority date: 2021-07-28
Filing date: 2021-07-28
Publication date: 2021-09-07

Abstract

The invention provides a traditional Chinese medicine composition and application thereof, wherein the traditional Chinese medicine composition comprises the following raw material medicines: rhubarb, dahurian angelica root, bletilla tuber and gromwell root. The traditional Chinese medicine composition has the characteristics of small irritation, obvious astringency and pain relieving effects, high slough removing speed, good granulation promoting performance, less exudation, no adhesion to wounds during dressing change, small healed scar, safety, easiness in operation and the like. The invention discloses a preparation method of the traditional Chinese medicine composition. The invention also discloses application of the traditional Chinese medicine composition in preparing a medicine for treating wound surfaces.

Description

Traditional Chinese medicine composition and application thereof

Technical Field

The invention relates to the technical field of pharmacy, in particular to a traditional Chinese medicine composition and application thereof.

Background

The healing of skin soft tissue wound is the process of human immune barrier repair, and once the process is interfered by internal or external factors, the wound can be delayed and difficult to heal, and a chronic wound is formed. Common chronic wounds include ulcers and sinuses. The ulcer and sinus tract are caused by a plurality of reasons, and the common reasons include trauma, burn, skin infection, non-healing of postoperative incision, great saphenous vein varicosity, vasculitis, bedsore, abscess ulceration, incision drainage, drainage tube placement and the like, and if the treatment is not timely and proper, the condition is easy to prolong.

Ulcer refers to the broken surface of any surgical disease. The ulcer is generally called as ulcer after ulceration in traditional Chinese medicine, and an external treatment method is one of the main means for treating skin ulcer. The external treatment method is a treatment method which directly acts on a certain part of the body surface or a pathological change position of a patient by using medicines, operations, physical methods or matching with certain apparatuses and the like to achieve the purpose of treatment. The sinus tract refers to the pathological cul-de-sac where the deep tissue leads to the body surface, with dripping pus, usually having only an external orifice without an internal orifice, and not communicating with the internal organs. The treatment of sinus tract is similar to the treatment of other diseases, and can be divided into internal treatment and external treatment, but the treatment is mainly external treatment. The key points of the treatment are to remove putrefactive necrotic tissues in the sinus cavity, remove foreign matters in the sinus cavity and remove fibrous scar-shaped sinus walls. The western medicine mostly adopts operation treatment, and completely cuts off the sinus wall. However, the operation treatment has large wound, sinuous tract tortuosity and multi-root patients have the possibility of relapse if the excision is not thorough, many patients are difficult to accept, the traditional Chinese medicine treatment is selected, and most of the existing cases are to apply the erysipelas corrosive external medicine. The red lead is a holy drug for external clinical application in the surgical department of traditional Chinese medicine, but the toxicity of the red lead is not negligible. Modern medicine considers that mercurial is a toxic substance, and long-term use may cause adverse effects on liver and the like, which has caused extensive debate in medical field, so that the clinical use of mercurial can shorten the use time as much as possible.

The treatment of ulcers and sinus tracts is known to be mostly refractory and refractory diseases by consulting the literature at home and abroad for nearly 20 years. The western medicine proposes the theory of growth factors, but the application of growth factors in recent years has certain limitations, especially for chronic and refractory wounds. The reports on the treatment of body surface chronic ulcer, sinus and the like by external treatment of the traditional Chinese medicine are more, the curative effect is obvious, and the advantages of the external treatment of the traditional Chinese medicine are shown. At present, the traditional Chinese medicine for external treatment of ulcer is generally pill, powder, ointment and the like, and the compatibility and the use method of each family are different, so that certain standardization is lacked. The reported disadvantages include the following: (1) the preparation formulation has larger random selection and a plurality of varieties, and even if the same preparation formulation is used, the preparation processes are inconsistent; (2) the prescription, the treatment method and the curative effect judgment standard are different, the difference of treatment results is large, and the prior literature report lacks comprehensive, systematic and deep analysis and summary; (3) at present, the external medicine for both ulcer and sinus is not reported in detail; (4) at present, no detailed report on clinical research and curative effect evaluation of ulcer or sinus treatment by external application of oil is available; (6) the mechanism of removing putrefaction, promoting granulation and treating ulcer or sinus is not deeply explored from the theory of traditional Chinese medicine. Therefore, there is a need to develop a new low-cost external preparation of traditional Chinese medicine for treating ulcer, sinus tract and other wounds, which can be widely applied.

Disclosure of Invention

The technical problem to be solved by the invention is to provide a traditional Chinese medicine composition for treating wound surfaces.

In order to solve the technical problems, the invention adopts the following technical scheme:

in a first aspect, the present invention provides a Chinese medicinal composition comprising dried root and rhizome of rhubarb (Rheum palmatum L., Rheum tanguticum Maxim. ex Balf. or Rheum officinale R. f. officinalis Baill. of Polygonaceae), Angelica dahurica (Fisch. ex Hoffm) Benth. et Hook. f. of Umbelliferae), dried root of Angelica dahurica (Fisch. ex Hoffm) Benth. or Angelica dahurica (Fisch. ex Hoffm) Benth. et Hook.f. var. fortiana (Boiss.) Shann Yuan), dried rhizome of Bletilla striata (Boiss.) Reichb. f. of Orchidaceae), dried tuber of Bletilla striata (root of Araceae), dried root tuber of Reichb. f. of Arachis corporation, Arnica (Roche) of Boraginaceae), dried root of Lithospermum officinale, or Lithospermum officinale, having effects of cooling blood, and the like. The profile of the four drugs of efficacy is as follows:

rhubarb: is bitter in taste and cold in nature, enters spleen, stomach, large intestine and liver channels, and has the effects of removing food retention, removing food stagnation, purging pathogenic fire, cooling blood, removing blood stasis and dredging channels.

Radix angelicae: warm in nature, fragrant in smell, pungent and slightly bitter in taste, and has effects of dispelling pathogenic wind, removing dampness, dredging orifice, relieving pain, relieving swelling, and expelling pus.

And (3) common bletilla pseudobulb: is slightly cold in nature and bitter and astringent in taste, enters lung, liver and stomach channels, and has the effects of astringing to stop bleeding, relieving swelling and promoting granulation.

Lithospermum: bitter and cold in property, sweet and salty in taste, enter heart and liver meridians, and have the effects of clearing heat, detoxifying, cooling blood, activating blood and the like.

The rhubarb in the invention comprises raw rhubarb, wine rhubarb, cooked rhubarb and rhubarb charcoal.

In a specific embodiment of the invention, the rhubarb is raw rhubarb.

Further, the traditional Chinese medicine composition comprises the following raw material medicines in parts by weight: 45-55 parts of rhubarb, 45-55 parts of angelica dahurica, 45-55 parts of bletilla striata and 27-33 parts of lithospermum.

Further, the traditional Chinese medicine composition comprises the following raw material medicines in parts by weight: 50 parts of rhubarb, 50 parts of angelica dahurica, 50 parts of bletilla and 30 parts of lithospermum.

In the present invention, parts by weight means any unit of weight, such as grams (g), kilograms (kg), and the like.

The weight of the raw material medicines of the composition is calculated by crude medicines, and the raw material medicines are used as the proportion by weight, so that the raw material medicines can be increased or reduced in proportion during production, but the proportion of the raw material medicines in the weight proportion among the components is unchanged.

Furthermore, the dosage forms of the traditional Chinese medicine composition comprise paste, powder, decoction, tincture, membrane and oil.

Furthermore, the dosage form of the traditional Chinese medicine composition is oil.

In a second aspect, the present invention provides a method for preparing the Chinese medicinal composition of the first aspect, the method comprising:

(1) soaking radix et rhizoma Rhei, radix Angelicae Dahuricae, and rhizoma Bletillae in oleum Sesami, heating, and frying until the decoction pieces are brown;

(2) stirring radix Arnebiae in oil to make radix Arnebiae scorched. Soaking the decoction pieces in the oil, cooling at room temperature, removing residues, filtering, packaging, and sterilizing.

Further, the soaking time in the step (1) is more than 6 hours.

Further, the time of the normal-temperature cooling in the step (2) is more than 12 hours.

Further, the volume ratio of the sesame oil in the step (1) to the weight of the traditional Chinese medicine composition is 21-35mL:3-5 g.

The volume ratio of the sesame oil to the weight of the traditional Chinese medicine composition is 21-35mL:3-5g, and the range covered by the sesame oil can be that the minimum ratio is 21mL:5g, and the maximum ratio is 35mL:3 g; the units "mL", "g" used in this ratio are used only for the distinction of volume and weight units and are not to be taken as specific limitations of the volume, weight units described herein. The unit of the volume of the sesame oil provided by the invention includes, but is not limited to, mu L, mL and L, and the unit of the weight of the traditional Chinese medicine composition includes, but is not limited to, mu g, mg, g and kg. Further, the ratio of the volume of the sesame oil to the weight of the traditional Chinese medicine composition is 77mL:9g

Further, the heating in step (1) is heating to a temperature of about 150 ℃ to 200 ℃.

The third aspect of the invention provides an application of the traditional Chinese medicine composition of the first aspect of the invention in preparing a medicine for treating wound surfaces.

The medicine also comprises pharmaceutically acceptable auxiliary materials, wherein the pharmaceutically acceptable auxiliary materials comprise but are not limited to solvents, propellants, solubilizers, cosolvents, emulsifiers, colorants, adhesives, disintegrants, fillers, lubricants, wetting agents, osmotic pressure regulators, stabilizers, glidants, flavoring agents, preservatives, suspending agents, coating materials, fragrances, anti-adhesives, integration agents, permeation promoters, pH value regulators, buffering agents, plasticizers, surfactants, foaming agents, antifoaming agents, thickening agents, coating agents, humectants, absorbents, diluents, flocculants and deflocculants, filter aids, release retardants and the like.

Furthermore, the wound surface comprises an acute wound surface and a chronic wound surface.

Further, the wound surface is a chronic wound surface.

Furthermore, the chronic wound comprises sinus, ulcer, fistula, bedsore, scald and eczema.

Furthermore, the sinus passages include sinus passages formed by mastitis and sinus passages formed by mammary abscess.

Further, the mastitis may include non-lactation mastitis.

Further, the non-lactation mastitis may include periductal mastitis, plasma cell mastitis, and granulomatous mastitis.

Further, the non-lactation mastitis is plasma cell mastitis and/or granulomatous mastitis.

Further, the fistula may comprise a drainage fistula.

Further, the ulcer comprises diabetic ulcer and postoperative ulcer.

The invention has the advantages and beneficial effects that:

the invention provides a traditional Chinese medicine composition for treating wound surfaces, which comprises the following raw material medicines: rhubarb, dahurian angelica root, bletilla tuber and gromwell root. The Chinese medicinal composition has the characteristics of small irritation, convergence, obvious pain relieving effect, high putrefaction removing speed, good tissue regeneration promoting performance, less exudation, no adhesion to wound during dressing change, small scar after healing, safety, easiness and the like.

Drawings

FIG. 1 is a visual simulation chart of pain;

FIG. 2 is a graph showing the results of an experiment for examining pus chamber tissues by HE staining, in which graph A shows a 3-day group of convalescent liquid, graph B shows a 3-day group of ulcer red oil, graph C shows a 7-day group of convalescent liquid, graph D shows a 7-day group of ulcer red oil, graph E shows a 14-day group of convalescent liquid, and graph F shows a 14-day group of ulcer red oil;

FIG. 3 is a graph showing the results of experiments for immunohistochemical detection of VEGF, wherein panel A is a 3-day group of neofluid for rehabilitation, panel B is a 3-day group of ulcer red oil, panel C is a 7-day group of neofluid for rehabilitation, panel D is a 7-day group of ulcer red oil, panel E is a 14-day group of neofluid for rehabilitation, and panel F is a 14-day group of ulcer red oil;

FIG. 4 is an experimental diagram of expression change of VEGF detected by Western-blot;

FIG. 5 is a statistical graph of expression change of VEGF detected by Western-blot;

FIG. 6 is a diagram of the postoperative wound surface of a patient with (before) a drug-induced head abscess;

FIG. 7 is a diagram of the postoperative wound surface of a patient with (after drug administration) head abscess.

Detailed Description

The technical solutions of the present invention are further illustrated by the following specific examples, which do not represent limitations to the scope of the present invention. Insubstantial modifications and adaptations of the present invention by others of the concepts fall within the scope of the invention.

EXAMPLE 1 preparation of ulcer Red oil

The first step is that the medicine composition: 50g of raw rhubarb, 50g of angelica dahurica, 50g of bletilla striata and 30g of lithospermum; the medicine is prepared by soaking in oleum Sesami and decocting.

Secondly, the preparation method comprises the following steps: soaking radix et rhizoma Rhei, radix Angelicae Dahuricae, and rhizoma Bletillae in 1540mL of oleum Sesami for more than 6 hr, heating to 150-. Soaking the decoction pieces in the oil, cooling at room temperature for more than 12 hr, removing residues, filtering, packaging, and sterilizing.

EXAMPLE 2 clinical efficacy of ulcer Red oil in the treatment of non-lactating mastitis sinus formation

First, case data

1. Source of case

The observed cases are from the inpatients of the mammary gland department in the oriental hospital of Beijing university of traditional Chinese medicine, and the inpatient time is 1 month to 8 months in 2007 to 2010.

45 patients with hospitalized non-lactation mastitis (plasma cell mastitis, granulomatous mastitis) with sinus formation were selected. In 45 cases of this group, all were women. Age 13-53 years, mean (32.31 ± 8.71) years; 34 married cases, 11 unmarried cases, 16 lactation cases and 29 lactation cases; the disease course is 4 days to 30 years, and the average (613.53 +/-1702.31) days; there are 25 cases of 1 sinus, 2-3 12 cases, and more than 3 cases and 8 cases. The number of sinus tracts is 1-12, and the number of sinus tracts is 2.22 +/-2.25 on average; the total time of the dressing change treatment is 7-96 days, and the average (39.00 +/-24.77) days.

2. General data

3. Diagnostic criteria

According to the patient's history, symptoms, signs and color Doppler ultrasound, and the pathological examination of the patients does not show cancer cells and tuberculosis, and the patients are non-breast-feeding mastitis patients with local sinus formation. Refer to the "New century national higher Chinese medicine college planning teaching material" of Chinese medicine science and technology "2002 edition of Chinese medicine Press.

4. Case inclusion criteria

(1) The wound is not healed after non-lactation mastitis incision drainage, puncture or self-ulceration, so that the patient with the breast sinus is formed.

(2) Signing the informed consent.

5. Exclusion criteria

(1) Serious cardiovascular and cerebrovascular diseases and blood system diseases are combined;

(2) serious damage to liver and kidney functions;

(3) patients with diabetes.

6. Rejection standard:

(1) those who fail to adhere to the treatment as required;

(2) other external medicines are applied to treat patients in the treatment process.

7. Standard of discontinuation study

The purpose of the study discontinuation is mainly to protect the patient's rights and interests, ensure the quality of the subject study and avoid unnecessary economic losses. Discontinuation of the study may be considered from the following points:

(1) in the treatment process, patients with serious adverse reactions appear;

(2) in the research process, a determined clinical research scheme has major errors, and the effect of the clinical research scheme is difficult to evaluate; or, the designed solution has significant variation in implementation, and it is difficult to evaluate the effect.

8. The therapeutic effect judgment standard is as follows:

the traditional Chinese medicine is formulated according to the traditional Chinese medicine industry standard 'standard for diagnosing the curative effect of the traditional Chinese medicine symptoms' published by the State administration of traditional Chinese medicine in 1995: the sinus tract is completely healed; the sinus area is reduced by more than 70 percent to show effect; the sinus surface is reduced by more than 30 percent, and the improvement is realized when the sinus surface is reduced by less than 70 percent; after treatment, the sinus tract is reduced by less than 30%, or not reduced at all, or tends to enlarge to be ineffective.

Second, research method

In view of the complex and intractable nature of the disease, all 45 patients were treated and compared before and after themselves.

1. Method of treatment

The ulcer red oil is applied to the affected part.

The method comprises the following specific steps: sterilizing the affected skin, cleaning and washing sinus, and filling the sinus with gauze filled with ulcer red oil for 1-2 days 1 time.

2. Observation indexes are as follows:

the sinus tract local indexes are observed for sinus tract length, width, area, mass area and pain index of the patient, recorded and scored according to grading scoring standards, and recorded before and after treatment. Before and after treatment, the digital camera is used for photographing and recording the sinus condition. Adverse reactions were recorded at any time.

(1) Measurement items:

a. sinus length, depth, wound area: the area of the sinus tract in two dimensions is calculated as the longest (depth) and largest diameter of the sinus tract as measured with a ruler.

b. The mass area: the area of the tumor is calculated by the longest and widest diameters of the tumor as measured with a ruler.

(2) Patient pain self-assessment:

according to a pain visual simulation table, grading and scoring standard is 0-10 points: the grade 0 is no pain, the grade 10 is the most pain, and the pain is obviously increased from slight pain to the pain in 1-9 steps. The patient was asked to draw o on the corresponding pain scale on the visual simulation chart (as shown in fig. 1).

(3) And (4) keeping the photo: before treatment and at the end of treatment (if special changes are met, photos can be taken during the treatment).

3. The observation method comprises the following steps:

before, during and after treatment, local condition changes are respectively observed, pictures are taken, and various indexes are recorded.

4. The statistical method comprises the following steps:

statistical analysis was performed using SPSS 17.0 software. Measurement data for comparative analysis before and after treatment in groupAnd (3) adopting t test when the distribution belongs to normal distribution, and adopting nonparametric test when the distribution belongs to non-normal distribution. X for count data of comparative analysis before and after treatment in group²And (4) testing and Fisher accurate probability method.

Statistical analysis, data by mean ± standard deviation

It shows that SPSS 17.0 statistical software is used for statistical analysis, Wilcoxon rank sum test is adopted for the measured data, and the difference is significant when P is less than 0.05.

Third, clinical results

After external treatment, local conditions of 45 patients are improved, and finally, radical operation treatment is performed.

As shown in tables 1-3, the difference of the index P < 0.05 after treatment is significant according to statistical analysis, and the experimental result shows that the red oil external application of the ulcer has significant effect on the treatment of non-lactation mastitis sinus.

TABLE 1 comparison of sinus tract measurements before and after treatment

Compared with before treatment, indicates that P is less than 0.01

TABLE 2 comparison of tumor and pain indices before and after treatment

Compared with before treatment, indicates that P is less than 0.01

TABLE 3 statistics of post-treatment efficacy

Example 3 clinical efficacy of ulcer Red oil on dressing change after granulomatous mastitis debridement

First, case data

52 granulomatous mastitis patients were selected during the period 2020.01.01-2021.04.01 who were treated at the outpatient clinic of the breast department and were admitted to the hospital for acute abscess cleaning.

In 52 group-entering cases, the cases are randomly divided into two groups, and the treatment group and the control group are 26 cases respectively, wherein 1 case of the control group indicates that the breast tissue is chronic inflammation due to postoperative pathology, malignant tumor infiltration can be seen in a local focus, and people who are wrongly included because the disease does not meet the diagnosis standard are removed.

Second, research method

A prospective, random, parallel and positive drug control research method is adopted, a SPASS 20.0 random number table is adopted to generate two groups, 26 cases are generated in each group, and the group A: ulcer red oil changing medicine group, group B: compound phellodendron bark liquid medicine. The operation sore cavity is respectively filled with corresponding medicine changing yarn strips after the operations of the group A and the group B. The two groups of cases adopt the same basic treatment and different external medicine slivers for treatment, statistical analysis is carried out after 6 weeks of dressing change, the treatment time is counted for patients with closed sore surfaces due to less than 6 weeks of dressing change, and the observation is finished.

The detailed conditions of wound surface healing are observed in the two groups respectively at the first dressing change, dressing change week 2, week 4 and week 6 after operation, the curative effect is counted, and the menstrual period is avoided when the amount of secretion in the menstrual period is more than usual.

Third, experimental results

1. Comparison of patient Condition before drug administration

Compared with the control group, the patients in the treatment group and the control group have no obvious difference in the onset age, the course of disease, the size of the lump when the patients are admitted, and the first dressing change sore surface area after sore clearing operation (P is more than 0.05), and have comparability. As shown in table 4.

TABLE 4 comparison of the onset of disease in two groups of patients

The age, the course of disease, the size of the lump when the patient is admitted and the first dressing change sore surface area after sore clearing operation of two groups of patients are tested by independent samples t, have no significant difference (p is more than 0.05) and are comparable.

2. Comparison of wound healing Effect

The area reduction rate of the sore surface can reflect the healing effect of the sore surface more objectively, so the area reduction of the sore surface is adopted in the research to calculate the healing rate of the sore surface, and the clinical total curative effect analysis is carried out. The ulcer red oil changed group is cured for 9 cases, accounting for 34.6 percent, when the observation is finished in the 6 th week of the change of the medicine; the effective rate is 13 cases, accounting for 50 percent; 3 effective cases account for 11.5 percent; ineffective 1 case, accounting for 3.8%; the total effective rate is 96.2%; the compound phellodendron bark liquid medicine changing group is cured for 2 cases, accounting for 8 percent; 17 cases of obvious effect account for 68 percent; 4 cases of effectiveness account for 16 percent; ineffective 2 cases, account for 8%; the total effective rate is 92%. As shown in table 5.

TABLE 5 comparison of the healing efficacy of the wound surfaces of two groups of patients

Note: through the rank-sum test, Z is-1.968, P is 0.049(P is less than 0.05), the difference is significant, the statistical significance is achieved, and the healing rate of the sore surface of the ulcer red oil drug changing group is proved to be superior to that of the compound phellodendron bark liquid drug changing group.

3. Comparison of the efficacy of the traditional Chinese medicine syndrome scores

Based on the analysis of the curative effect of the traditional Chinese medicine syndrome score, 8 ulcer red oil drug change medicines are cured at the end of observation of the 6 th week of the drug change, accounting for 30.8 percent; 16 cases of remarkable effect account for 61.5 percent; 2 cases of effectiveness account for 7.7 percent; the compound phellodendron bark liquid medicine changing group heals 4 cases, accounting for 16 percent; 18 cases of obvious effect account for 72 percent; the effective rate is 3 cases, accounting for 12 percent. As shown in table 6.

TABLE 6 comparison of the efficacy of the Chinese medical syndrome scores of two groups of patients

Note: through rank-sum test, Z is-1.225, P is 0.221(P is more than 0.05), the difference has no statistical significance, and the two groups have curative effect on relieving the symptom of the Chinese traditional syndrome and have equivalent curative effect.

4. Other data

The healing rate of the sore surface, the longest diameter of the sore surface, the depth of the sore cavity, the VAS pain score of the sore opening, the secretion of the sore surface, the growth condition of granulation, the redness and swelling around the sore and the like of the nodes at different time points of dressing change after the operation of the two groups of patients are compared statistically. As shown in tables 7-13.

TABLE 7 comparison of the healing rate (%) of the wound surface at two different time nodes

Note: the statistical result shows that independent sample t test is adopted for comparison between the two groups, the healing rates of the sore surfaces at the 2 nd week, the 4 th week and the 6 th week after dressing change are compared, P is less than 0.05, the difference has statistical significance, the healing rates of the two groups of sore surfaces in the dressing change process are remarkably different, and the ulcer red oil dressing change set is faster than the healing rate of the sore surfaces of the compound phellodendron bark liquid dressing change set.

TABLE 8 comparison of the longest diameter of the sore surface

Note: the statistical result shows that independent sample t test is adopted for comparison between two groups, and the initial longest diameter of the two groups is compared, wherein P is more than 0.05, and the two groups have comparability; the longest diameter changes of the sore surfaces of the two groups after the 2 nd week and the 4 th week of dressing change are compared, P is more than 0.05, the difference is not statistically significant, and the two groups have no obvious difference in the reduction of the longest diameter of the sore surfaces. The changes of the longest diameter of the two groups of sore surfaces at the 6 th week are compared, P is less than 0.05, the difference has statistical significance, and the result shows that the reduction degree of the longest diameter of the sore surfaces at the 6 th week is obviously different, and the ulcer red oil drug changing group is more obviously reduced than the compound phellodendron bark liquid drug changing group.

TABLE 9 comparison of depth changes of two sets of sore cavities

Note: the statistical result shows that independent sample t test is adopted for comparison between two groups, and the depth of two groups of initial sore cavities is compared, wherein P is more than 0.05, and the two groups of initial sore cavities are comparable; p is more than 0.05 at 2 weeks, 4 weeks and 6 weeks, the difference has no statistical significance, and the two groups have no obvious difference in depth reduction of the sore cavity, which indicates that the two groups have equivalent effect on the degree of reduction of the sore cavity in the dressing change process.

TABLE 10 comparison of VAS pain scores for two groups of sores

Note: the statistical result shows that independent sample t test is adopted for comparison between two groups, and pain comparison before treatment between two groups is carried out, wherein P is more than 0.05 and is comparable; p is less than 0.05 in week 2, week 4 and week 6, the difference has statistical significance, which shows that the pain degree of the two groups in the dressing change process is obviously different, and the ulcer red oil dressing change can obviously reduce the pain degree of dressing change compared with the dressing change of the compound phellodendron bark liquid.

TABLE 11 comparison of granulation freshness scores of two groups of sore surfaces

Note: the statistical result shows that independent sample t test is adopted for comparison between the two groups, and the granulation freshness degree scores of the first dressing change sore surface after the operation of the two groups are compared, wherein P is more than 0.05 and is comparable; the freshness degree of granulation on the sore surface at 2 weeks after dressing change of two groups of patients is compared, wherein P is more than 0.05, which shows that the freshness degree of granulation on the sore surface of the two groups of patients has no obvious difference; the freshness degree of the granulation on the sore surface at the 4 th week and the 6 th week after dressing change of the two groups of patients is compared, P is less than 0.05, the difference has statistical significance, and the ulcer red oil dressing change group is obviously superior to the compound phellodendron bark liquid dressing change group in the aspect of the freshness degree of the granulation on the sore surface after dressing change at the 4 th week.

TABLE 12 comparison of scores of two groups of new granulation tissues on sore surface

Note: the statistical result shows that the comparison between the two groups adopts independent sample t test, and the comparison between the two groups of postoperative first dressing change sore surface new granulation tissues shows that P is more than 0.05 and is comparable; the comparison of the 2 nd week sore surface granulation tissues of the two groups of patients after dressing change shows that P is more than 0.05, which indicates that the two groups of sore surface granulation tissues have no obvious difference; compared with the new granulation tissues on the sore surface at the 4 th week and the 6 th week after dressing change, P is less than 0.05, and the difference has statistical significance, which shows that the ulcer red oil dressing change set is obviously superior to the compound phellodendron bark liquid dressing change set in the aspect of improving the new granulation tissues on the sore surface after dressing change at the 4 th week.

TABLE 13 comparison of the scores of the two groups of sores

Note: the statistical result shows that independent sample t test is adopted for comparison between two groups, the first postoperative dressing change sore periredness score of the two groups is compared, P is more than 0.05, and the two groups are comparable; the comparison of the scores of the redness and swelling around the sores at 2 weeks, 4 weeks and 6 weeks after the change of the medicines of the two groups of patients shows that the P is less than 0.05, the difference has statistical significance, the comparison of the redness and swelling around the sores in the change of the medicines of the two groups of patients shows that the redness and swelling around the sores are obviously different, and the ulcer redness oil change group is obviously superior to the compound phellodendron bark liquid change medicine group in the aspect of improving the redness and swelling around the sores.

In conclusion, the application of the ulcer red oil to dressing change after the granulomatous mastitis sore-clearing operation can promote the growth of the granulation and accelerate the healing of the sore surface. Compared with the compound phellodendron bark liquid, the ulcer red oil can shorten the healing time of the sore surface, effectively relieve the pain caused by dressing change and promote the red swelling in the sore period to subside. Along with the changing of the dressing, the red oil dressing of the ulcer changes the color of the sore surface to be fresh and alive and ruddy, and the new granulation tissue is continuously increased, so that the longest diameter of the sore surface is effectively reduced, and the dressing has clinical safety.

Example 4 Observation of the therapeutic Effect of ulcer Red oil on mammary abscess and VEGF expression

First, experiment method

A rat abscess model simulation mammary abscess model is established by adopting staphylococcus aureus thigh external injection, and 3 days after the staphylococcus aureus is injected subcutaneously, an abscess cavity is formed and pus is exuded, so that success of molding is prompted. After the model is formed, debridement treatment is carried out, ulcer red oil and rehabilitation new liquid treatment are respectively carried out, 36 patients are treated in each group, 12 patients are sacrificed on 3 days, 7 days and 14 days in each group, 6 patients are used for histological and immunohistochemical examination, and 6 patients are used for Western-blot examination.

The specific method comprises the following steps:

1. bacterial culture

After the Staphylococcus aureus strain was recovered in a nutrient broth at 37 ℃ for 6 hours, it was transferred to an agar plate, cultured at 37 ℃ for 17 hours, washed rapidly with sterile physiological saline 2 times, and then the bacteria were suspended in sterile physiological saline and adjusted to a bacterial concentration of 1X 10¹¹CFUs·100μL^-1。

2. Establishment of rat abscess model

And inoculating the counted bacteria to thick thigh tissues of rats, inoculating 100 mu L of each bacteria, and after 1-3 days of incubation, ulcerating the inoculated part, enabling pus to flow out and gradually forming sinus tracts, thereby prompting that the rat simulates a human mammary abscess model to be successfully established.

3. Experiment grouping

Rehabilitation new group: injecting 100 μ L of Staphylococcus aureus to the outer thigh, cleaning wound after molding, and filling the gauze with rehabilitation solution.

Ulcer red oil group: injecting 100 μ L of Staphylococcus aureus to thigh, cleaning wound after molding, and filling with gauze dipped with ulcer red oil.

4. Observing the molding condition (diameter of the pus cavity, amount of pus liquid, inflammation around the pus cavity at each time point, whether or not there is a self-healing phenomenon, etc.)

Recording the sinus formation time, the sinus depth, the pus secretion amount and other related data, and performing statistical analysis to ensure that no statistical difference exists between the two groups of patients before intervention treatment. The inflammatory condition around the pustule cavity and the self-healing condition around the pustule cavity (such as granulation tissue regeneration, scar tissue formation and the like) are observed at different time points, so that a basis is provided for comparing the pathological changes of subsequent treatment groups at different time points.

5. HE and immunohistochemistry

Rapidly placing the pustule tissue in 4% paraformaldehyde for fully fixing, conventionally dehydrating, embedding paraffin, HE staining to observe pathological changes of each group, and immunohistochemically detecting the expression condition of cytochrome-C, TNF-alpha of each group.

6. Western blot detection

Shearing pus cavity tissue, adding cell lysate for full lysis, centrifuging, and collecting supernatant. After the BCA is used for determining the protein concentration, adding loading-buffer and boiling to ensure that the protein is fully denatured, and subpackaging for later use; after SDS-PAGE electrophoresis, the sample is subjected to membrane transfer, sealing, first antibody overnight incubation and second antibody incubation, and then a color picture is taken.

Second, experimental results

1. The results of comparison of healing condition, pus cavity diameter and pus amount

3 days after the staphylococcus aureus injection, the staphylococcus aureus injection was randomly divided into two groups, and the healing conditions, the pus cavity diameter and the pus volume were recorded at 3, 7 and 14 days respectively (non-healing, inflammatory exudation and granulation tissue was observed as 3, wound crusting was observed as 2, basic healing was observed as 1, and complete healing was observed as 0. the pus volume and the pus cavity diameter were measured practically). The diameters of the two groups of pus cavities are not different at each time point; the pus volume is not different between day 3 and day 7, and the red oil group is obviously lower than the rehabilitation new fluid group (P is less than 0.05) on day 14; healing was not statistically different between the two groups at day 3 and day 7, with the red oil group being significantly lower than the convalescent group at day 14 (P < 0.05) (as shown in Table 14).

TABLE 14 comparison of healing, abscess diameter, pus volume in two groups at each time point

Note: comparing two groups at each time point, wherein P is less than 0.05, and P is less than 0.01

2. HE staining results of each group

After changing the medicine for three days, two groups of the medicines can form obvious pus cavities, purulent secretion and necrosis exist in the pus cavities, a large amount of inflammatory cell infiltration is accompanied around the pus cavities, interstitial fiber tissue hyperplasia, interstitial vasodilation and congestion are caused; at 7 days, the pus cavity is slightly reduced compared with the front, the interstitial fiber hyperplasia is obvious compared with the front, the infiltration degree of inflammatory cells in the interstitium is reduced, and a little new granulation tissue can be seen around the residual pus cavity; at 14 days, the pus cavity is further reduced or only residual minicell infiltration foci are seen, most or all of the pus cavity is replaced by the hyperplastic fibrous tissue, and the blood vessel tissue and the new granulation tissue with a large amount of impurities are obviously increased compared with those at 7 days, wherein at 14 days, the ulcer red oil is more obvious than the rehabilitation new liquid set. As shown in fig. 2, wherein, panel A is a 3-day group of the new healing fluid, panel B is a 3-day group of the ulcer red oil, panel C is a 7-day group of the new healing fluid, panel D is a 7-day group of the ulcer red oil, panel E is a 14-day group of the new healing fluid, and panel F is a 14-day group of the ulcer red oil.

3. Immunohistochemical staining results for each group

There was no significant difference in VEGF expression between the two groups at 3 days of treatment. At 7 days of treatment, the ulcer red oil group VEGF expression was higher than the convalescent group (P < 0.05), and at 14 days, the ulcer red oil group VEGF expression was significantly higher than the convalescent group (P < 0.01) (see FIG. 3, Table 15). Wherein, the picture A is a group of 3 days of the new healing liquid, the picture B is a group of 3 days of the ulcer red oil, the picture C is a group of 7 days of the new healing liquid, the picture D is a group of 7 days of the ulcer red oil, the picture E is a group of 14 days of the new healing liquid, and the picture F is a group of 14 days of the ulcer red oil.

TABLE 15 two groups of VEGF expression at each time point

Note: comparison between two groups at different time points P < 0.05P < 0.01

4. Western-blot results for each group

At 3 days of treatment, the expression of the VEGF in the convalescent group is not statistically different from that of the VEGF in the red oil group, and at 7 days and 14 days, the expression of the VEGF protein in the red oil group is remarkably higher than that of the VEGF in the convalescent group, wherein P is less than 0.01, as shown in figure 4 and table 16.

TABLE 16 Western-blot analysis of the changes in expression of two VEGF groups at various time points

Note: at different time points, comparison between the two groups indicates P < 0.05, and P < 0.01.

In conclusion, the abscess of each group gradually heals with the time, wherein the pus volume and healing condition of the ulcer red oil group are obviously superior to those of the rehabilitation new liquid group at the 14 th day. Histological morphology observations showed: at 14 days, the angiogenesis and granulation tissues of the ulcer red oil group are superior to those of the rehabilitation new liquid group. Immunohistochemistry and Western-blot show that the VEGF expression of the ulcer red oil group is obviously higher than that of a rehabilitation new fluid group (P is less than 0.01) in 7 to 14 days of treatment. The experimental result proves that the ulcer red oil plays an active role in the dressing change of the mammary abscess, obviously reduces the pus volume, reduces the inflammatory reaction and promotes the regeneration of granulation tissues; when the red oil group is treated for 7 days and 14 days, VEGF is obviously higher than that of a new rehabilitation group, and the ulcer red oil is prompted to improve VEGF expression, promote angiogenesis and accelerate abscess healing.

Example 5 use of ulcer Red oil in the treatment of post-operative ulcers

The cases are as follows: for men, the head of the male is huge and has abscess at 31 years old, local ulcer after incision drainage becomes more and more severe after 2 months of conventional treatment, and the wound surface is not limited (as shown in figure 6).

The treatment effect is as follows: the red oil for ulcer is treated for 2 weeks, the wound surface is rapidly limited, the granulation is fresh (as shown in figure 7), and the opportunity is created for the subsequent operation.

Example 6 application of ulcer red oil in treating other wounds

The ulcer red oil is also used for diabetic ulcer, bedsore, drainage fistula, scald, eczema and the like, and has better effect.

The above description of the embodiments is only intended to illustrate the method of the invention and its core idea. It should be noted that, for those skilled in the art, without departing from the principle of the present invention, several improvements and modifications can be made to the present invention, and these improvements and modifications will also fall into the protection scope of the claims of the present invention.

Claims

1. The traditional Chinese medicine composition is characterized by comprising the following raw material medicines: rhubarb, dahurian angelica root, bletilla tuber and gromwell root, preferably, the rhubarb is raw rhubarb.

2. The traditional Chinese medicine composition according to claim 1, wherein the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 45-55 parts of rhubarb, 45-55 parts of angelica dahurica, 45-55 parts of bletilla striata and 27-33 parts of lithospermum.

3. The traditional Chinese medicine composition according to claim 1 or 2, wherein the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 50 parts of rhubarb, 50 parts of angelica dahurica, 50 parts of bletilla and 30 parts of lithospermum.

4. The traditional Chinese medicine composition according to any one of claims 1 to 3, wherein the dosage form of the traditional Chinese medicine composition comprises ointment, powder, decoction, tincture, membrane and oil, and preferably the dosage form of the traditional Chinese medicine composition is oil.

5. A method of preparing the traditional Chinese medicine composition of claim 1, comprising:

6. The method of claim 5, wherein the soaking time in step (1) is greater than 6 hours, and preferably the cooling time in step (2) is greater than 12 hours.

7. The method according to claim 5, wherein the ratio of the volume of the sesame oil to the weight of the traditional Chinese medicine composition in the step (1) is 21-35mL:3-5g, and preferably, the ratio of the volume of the sesame oil to the weight of the traditional Chinese medicine composition is 77mL:9 g.

8. The method as claimed in claim 5, wherein the heating in step (1) is performed to a temperature of about 150 ℃ to about 200 ℃.

9. Use of the Chinese medicinal composition of claim 1 in the preparation of a medicament for the treatment of wounds.

10. Use according to claim 9, wherein the wound comprises an acute wound, a chronic wound, preferably the wound is a chronic wound, preferably the chronic wound comprises a sinus tract, an ulcer, a fistula, a decubital ulcer, a scald, an eczema, preferably the sinus tract comprises a sinus tract formed by mastitis, a sinus tract formed by an abscess of mammary gland, preferably the mastitis comprises a non-lactation mastitis, preferably the non-lactation mastitis comprises peri-ductal mastitis, plasmacytic mastitis, granulomatous mastitis, preferably the non-lactation mastitis is plasmacytic mastitis and/or granulomatous mastitis, preferably the fistula comprises a drainage fistula, preferably the ulcer comprises a diabetic ulcer, a post-operative ulcer.