CN112587582A

CN112587582A - Traditional Chinese medicine composition and application and preparation method thereof

Info

Publication number: CN112587582A
Application number: CN202011146141.6A
Authority: CN
Inventors: 李晓萍; 王娟; 费炳红
Original assignee: First Affiliated Hospital of Zhengzhou University
Current assignee: First Affiliated Hospital of Zhengzhou University
Priority date: 2020-10-23
Filing date: 2020-10-23
Publication date: 2021-04-02

Abstract

The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition with the effects of promoting tissue regeneration, relieving pain, expelling sepsis, sterilizing and removing necrotic tissue. The traditional Chinese medicine composition is mainly prepared from the following raw materials: 1-55 parts of astragalus membranaceus, 1-50 parts of scutellaria baicalensis, 1-25 parts of coptis chinensis, 1-35 parts of phellodendron amurense, 1-20 parts of rheum officinale, 1-25 parts of polygonum cuspidatum, 1-15 parts of borneol, 1-15 parts of dried alum and 50-350 parts of sesame oil. The traditional Chinese medicine composition can effectively treat the phenomenon of long-term wound nonunion caused by various reasons, has the effects of disinfection and sterilization, and can replace the disinfectants such as alcohol, iodine, iodophor, benzalkonium bromide and the like used in clinical treatment of wound.

Description

Traditional Chinese medicine composition and application and preparation method thereof

Technical Field

The invention relates to a traditional Chinese medicine composition, in particular to a traditional Chinese medicine composition with the effects of promoting tissue regeneration, relieving pain and expelling pus toxin, belonging to the technical field of traditional Chinese medicines.

Background

The wound surface is the damage of normal skin (tissue) caused by external injury factors (such as surgical operation, external force, heat, current, chemical substances and low temperature) and internal factors of the body (such as local blood supply disorder). The wound surface is a disease, has the characteristics of a single disease, has etiology, epidemiology and disease symptoms, and needs disease diagnosis and treatment plans. The wound has many etiological factors, including systemic chronic diseases such as diabetes, hypertension, gout, rheumatism, lupus erythematosus and the like, vascular diseases such as great saphenous varicosity, arterial occlusion and the like, skin diseases (such as eczema, sebaceous cyst and nerve diseases), physical and mechanical injuries (such as skin and soft tissue crush injury and avulsion injury), burns and scalds, frostbite, electric shock, animal bite, chemical injuries, tumors and iatrogenic diseases (such as operations, radiotherapy, medicaments and the like).

The clinical manifestations of the wound surface mainly include skin ulceration, and the skin is characterized by skin soft tissue defect, ulceration and bleeding or tissue fluid; subcutaneous tissue lesions, such as subcutaneous neurovascular lesions, necrosis of muscle connective tissue, osteoporosis and necrosis of cortical bone; infection, local abscess, red swelling and hot pain; ischemic manifestations, tissue crust covering or tissue desiccation or limb necrosis; dysfunction, such as joint deformity and movement disorder, defecation disorder caused by perianal wound surface, mouth opening disorder caused by perioral wound surface, etc.

The differentiation and diagnosis of the wound surface diseases mainly comprise etiological differentiation, pathological differentiation, ischemic wound surfaces (such as limb artery occlusion and diabetic foot), inflammatory wound surfaces (cutaneous phlebitis, lymphangitis, dog and snake bite, vibrio maritima, skin carbuncle, skin soft tissue cellulitis, necrotizing fasciitis, benign ulcer, malignant ulcer, penetrating fistula, cecum fistula and the like.

The wound surface has various types, wide professional area, complex mechanism and great treatment difficulty, and how to effectively treat the wound surface patients is an urgent problem in the medical field.

Disclosure of Invention

The traditional Chinese medicine has the effects of diminishing inflammation, reducing swelling and the like on wounds, particularly complicated wounds, and has the effects of promoting granulation blood vessel growth, promoting wound healing and the like by local application.

One of the purposes of the invention is to provide a traditional Chinese medicine composition with the effects of promoting granulation, relieving swelling and pain, expelling sepsis, disinfecting and sterilizing and removing putrefaction, and the traditional Chinese medicine composition is mainly prepared from the following raw materials: 1-55 parts of astragalus membranaceus, 1-50 parts of scutellaria baicalensis, 1-25 parts of coptis chinensis, 1-35 parts of phellodendron amurense, 1-20 parts of rheum officinale, 1-25 parts of polygonum cuspidatum, 1-15 parts of borneol, 1-15 parts of dried alum and 50-450 parts of sesame oil.

Preferably, the traditional Chinese medicine composition is mainly prepared from the following raw materials: 1-30 parts of astragalus membranaceus, 1-15 parts of scutellaria baicalensis, 1-30 parts of coptis chinensis, 1-20 parts of phellodendron amurense, 1-25 parts of rheum officinale, 1-20 parts of polygonum cuspidatum, 1-15 parts of borneol, 1-10 parts of dried alum and 50-200 parts of sesame oil.

Further preferably, the traditional Chinese medicine composition is mainly prepared from the following raw materials: 4-5 parts of astragalus membranaceus, 4-6 parts of scutellaria baicalensis, 3-5 parts of coptis chinensis, 4-6 parts of phellodendron amurense, 2-3 parts of rheum officinale, 2-4 parts of polygonum cuspidatum, 1-2 parts of borneol, 2-4 parts of dried alum and 90-190 parts of sesame oil.

The second purpose of the invention is to provide a preparation method of the traditional Chinese medicine composition, which mainly comprises the following steps:

step A: pulverizing Borneolum Syntheticum and dried Alumen, sieving with 120 mesh sieve, and collecting fine powder;

and B: preparing crude drugs of radix scutellariae, phellodendron, rhubarb and giant knotweed into coarse particles, and adding sesame oil for soaking, and mixing the coarse particles and the sesame oil for later use;

and C: b, preparing the astragalus and coptis into coarse particles, adding sesame oil, soaking for 24 hours, heating with strong fire, adding the mixture obtained in the step B, heating, filtering, and cooling to obtain liquid medicine for later use;

step D: and D, adding the fine powder obtained in the step A into the liquid medicine obtained in the step C to obtain the medicine.

Preferably, the preparation method mainly comprises the following steps:

and C: taking astragalus and coptis medicinal materials, preparing coarse particles, adding sesame oil, soaking for 24 hours, heating with strong fire until the astragalus and the coptis are brown, adding the mixture obtained in the step B, heating until all the medicinal materials are brown, filtering, cooling, and keeping liquid medicine for later use;

step D: and D, slowly adding the fine powder obtained in the step A into the liquid medicine obtained in the step C, stirring and dissolving to obtain the medicine.

The third purpose of the invention is to provide the application of the traditional Chinese medicine composition, namely the application in preparing medicines for disinfection, sterilization, putrefaction removal and pus discharge and the application in preparing medicines for promoting wound healing.

The fourth purpose of the invention is to provide a Chinese medicinal preparation containing the Chinese medicinal composition; preferably, the Chinese medicinal preparation is a clinically acceptable preparation; further preferably, the clinically acceptable dosage form is an external ointment; more preferably, the external ointment is one or more of ointment, cataplasm, plastics and liniments.

Compared with the prior art, the invention has the following remarkable technical effects:

1) the traditional Chinese medicine composition can effectively treat long-term wound nonunion caused by various reasons, and particularly solves the problems that the treated wound base tissue is fresh, the granulation is rich, the bleeding is obvious, and the peripheral skin does not spread to the center.

2) The traditional Chinese medicine composition can also dissolve secretion around and in the sores, so that the sores are easy to clean, and the healing time of normal wounds is shortened.

3) The Chinese medicinal composition has definite curative effect and no irritation, and can replace disinfectant and disinfectants such as alcohol, iodine, iodophor, benzalkonium bromide and the like used in clinical treatment of wound.

Drawings

FIG. 1 anal skin appearance of typical case 1 of the invention (2013, 07 Yue 04)

FIG. 2 perianal skin appearance of typical case 1 of the invention (2013, month 07, day 12)

FIG. 3 perianal skin appearance of typical case 1 of the invention (2013, month 07, 16)

FIG. 4 typical case 2 of the present invention acute myelogenous leukemia-M2 perianal infection (2013, month 07, 18)

FIG. 5 acute myelogenous leukemia-M2 perianal infection of typical case 2 of the present invention (2013, month 07 and 22 days)

DETAILED DESCRIPTION OF EMBODIMENT (S) OF INVENTION

The inventors note that the following examples are only some representative formulations and methods of preparation of the present invention, but it should be understood by those skilled in the art that the examples are not intended to limit the present invention in any way. Further, those skilled in the art can make many possible variations and modifications to the disclosed embodiments, or modify equivalent embodiments, using the teachings disclosed herein, without departing from the scope of the present invention. Therefore, any simple modification, equivalent change and modification made to the following embodiments according to the technical spirit of the present invention should fall within the protection scope of the technical scheme of the present invention, unless the technical spirit of the present invention departs from the content of the technical scheme of the present invention.

EXAMPLE 1 ointment preparation

Prescription: 1g of astragalus, 1g of scutellaria, 1g of coptis, 1g of phellodendron, 20g of rheum officinale, 25g of polygonum cuspidatum, 1g of borneol, 1g of dried alum and 50g of sesame oil;

the preparation method comprises the following steps:

step A: mixing Borneolum Syntheticum and dried Alumen, pulverizing, sieving with 120 mesh sieve, and making into fine powder;

and B: mixing Scutellariae radix, cortex Phellodendri, radix et rhizoma Rhei, and rhizoma Polygoni Cuspidati, pulverizing, making into coarse granule, adding appropriate amount of oleum Sesami, soaking for 24 hr, and mixing;

and C: mixing radix astragali and Coptidis rhizoma, pulverizing, making into coarse granule, soaking in appropriate amount of oleum Sesami for 24 hr, heating with strong fire until radix astragali and Coptidis rhizoma turn brown, adding the mixture obtained in step B, heating until all the medicines turn brown, immediately filtering, cooling to room temperature, and keeping the medicinal liquid;

step D: and D, slowly adding the fine powder obtained in the step A into the liquid medicine obtained in the step C, and stirring to dissolve the fine powder to obtain the traditional Chinese medicine composition.

The traditional Chinese medicine composition is prepared into ointment according to a conventional process.

EXAMPLE 2 preparation of film coating Agents

Prescription: 55g of astragalus, 50g of scutellaria, 25g of coptis, 35g of phellodendron, 1g of rhubarb, 1g of giant knotweed, 15g of borneol, 15g of dried alum and 250g of sesame oil

The preparation method of the traditional Chinese medicine composition is the same as that of example 1, and the traditional Chinese medicine composition is prepared into the film coating agent according to the conventional process.

EXAMPLE 3 preparation of the Liniment

Prescription:

10g of astragalus, 10g of scutellaria, 10g of coptis, 10g of phellodendron, 5g of rheum officinale, 5g of polygonum cuspidatum, 5g of borneol, 5g of dried alum and 200g of sesame oil;

the preparation method of the traditional Chinese medicine composition is the same as that of example 1, and the traditional Chinese medicine composition is prepared into liniment according to the conventional process.

EXAMPLE 4 preparation of the paste

Prescription:

4g of astragalus, 6g of scutellaria, 3g of coptis, 6g of phellodendron, 2g of rheum officinale, 4g of polygonum cuspidatum, 1g of borneol, 4g of dried alum and 90g of sesame oil.

The preparation method of the traditional Chinese medicine composition is the same as that of example 1, and the traditional Chinese medicine composition is prepared into paste according to the conventional process.

EXAMPLE 5 preparation of paste

Prescription:

5g of astragalus, 4g of scutellaria, 5g of coptis, 4g of phellodendron, 3g of rheum officinale, 2g of polygonum cuspidatum, 2g of borneol, 2g of dried alum and 190g of sesame oil.

1. Effect of the traditional Chinese medicine composition of the present invention on wound healing after hemorrhoid surgery in rats

In order to verify the effects of the Chinese medicinal composition in promoting granulation, relieving pain, excreting sepsis, sterilizing, removing necrotic tissue, promoting wound healing and the like, the inventor develops pharmacodynamic test research and medicament clinical research. In the following, only a part of pharmacodynamic experiments are described by taking the most representative formula of the present invention as an example; the other formulations and effects included in the present invention, which the inventor has conducted pharmacodynamic experiments as well, all have the same or similar effects, but are not exhaustive due to space limitations.

The inventor explains that the following experimental studies are carried out on the basis of the safety of the drug proved by acute toxicity tests and long-term toxicity tests, and the administration dose in the experimental studies is within a safe dose range.

1 Material

1.1 animals:

SD rat, 180-220 g, license number of experimental animal: SYXK (lu) 20180008, acclimatized for one week prior to the experiment.

1.2 test substances

1.2.1 medicaments

The Chinese medicinal composition prepared according to the prescription and the preparation method of the embodiment 5 (concentrated to 1mL of liquid medicine containing 0.5g, 1g and 1.5g of raw medicinal materials respectively as low, medium and high doses of the invention).

1.2.2 methods of use

It is applied externally. The ointment is applied to the wound surface (the thickness is thinner than 1mm), and a new medicine is replaced every 4-6 hours. Before dressing change, the medicine and liquefied substance remained on the wound surface are wiped off to expose the wound surface for application.

2. Modeling, grouping and administration

2.1 Molding

The intra-anal local injection of glacial acetic acid was used to establish a wound infection model after hemorrhoid surgery, which is established by adopting an perianal local injection glacial acetic acid method, and the specific operation is as follows: the iodophor cotton ball is used for disinfecting the skin around the anus of a rat, 75% glacial acetic acid is injected under the skin at the periphery of the anus of the rat in a sector mode, and the anus is locally massaged after injection, so that the liquid medicine is fully dispersed. Topical ulcer, red swelling, inflammatory exudation of anus are observed 24h after injection.

The successful molding standard is as follows: the swelling and swelling of the local anus is more than or equal to 1mm, the inflammation is exuded more than the ulcer surface, and the ulcer surface is more than or equal to 0.3cm²。

2.2 grouping and administration

On the 2 nd day of successful model building, 40 rats with successful model building are taken and randomly divided into a model group and a (high, medium and low) dose group of the invention, and each group comprises 10 rats.

Another 10 normal rats were selected as a blank group.

The three dosage groups of the invention are respectively smeared with corresponding medicines in the wound area according to the '1.2.2 using method', and the blank group and the model group are smeared with 0.9% physiological saline.

The administration was continued for 7 days.

3. Examination item

3.1 rat perianal edema degree and wound area detection

After the last administration, the size of ulcer area and the degree of edema of the perianal wound surface were measured and subjected to standard scoring. No edema was 0 points, barely 1 point, 2 points with margin above the skin, and 3 points with marked swelling.

3.2 statistical methods

Data processing was performed using SPSS22.0 software. Data obtained are averaged. + -. standard deviation

The data of each group are subjected to a normal distribution test and a homogeneity test of variance, and the comparison among the groups is performed by using one-factor variance analysis. The difference is statistically significant when P is less than 0.05.

4 results and conclusions

The degree score of perianal edema of the rats in the model group is obviously higher than that of the wound area of the blank group (P is less than 0.01), the degree score of perianal edema of the high and medium dose groups of the invention is not different from that of the blank group (P is more than 0.05), and the wound area is higher than that of the blank group (P is less than 0.01).

TABLE 1 evaluation of perianal edema degree and wound area comparison of rats (

n＝10)

Note: in contrast to the blank group,^@P＜0.05，^#P＜0.01；

in contrast to the model set,^&P＜0.01；

second, clinical typical cases

The clinical indications are: is suitable for various unhealed wounds for a long time due to unknown reasons. Solves the problems of unhealed wound for a long time caused by various reasons, in particular to the problems of fresh tissue at the base part of the treated wound, abundant granulation, obvious bleeding by touch and no spread of peripheral skin to the center. The invention can also dissolve secretion around and in the pyocutaneous disease, so that the pyocutaneous disease surface is easy to clean, and the healing time of normal wound surface is shortened.

The application method and the dosage are as follows: the wound surface can not be healed for a long time (the thickness is thinner than 1mm) due to various unknown reasons, and the new medicine is replaced every 4-6 hours. Before changing the dressing, the residual medicine and liquefied substance on the wound surface should be wiped off to expose the wound surface for application.

The inventor aims to show that the wound diseases are wide in related aspects and many in types, and since 2012, 40 patients who have collected various types of unknown wound surfaces (surgical surfaces, burn and scald surfaces and non-healing caused by genetic diseases) for a long time are reported in the first subsidiary hospital of zhengzhou university, and only some typical cases in the clinical treatment process are listed below for illustration.

1. Wei and Yi (a certain number of men) 18 years old. The patients find that the perianal has hard swelling with tenderness for more than 1 year, dry stool, hard defecation, abdominal distension, incomplete defecation, no fever, abdominal pain, nausea and vomiting, hematochezia and bloody purulent stool. The operation and thread hanging in local hospitals have poor effect, and the wound part of the sacral tail part is bled and pus is infiltrated when defecates every time for 1 year after the operation. After the wound is treated by diagnosis of sacrococcygeal hair-hiding sinus after the wound is placed in the hospital, the operation of 'sacrococcygeal hair-hiding sinus resection and expanding wound surgery' is performed, anti-inflammation and continuous negative pressure suction are given after the operation, and after the external wound of the posterior local wound is healed for No. 1 month, the wound surface grows well after the granulation of the sacrococcygeal wound is fresh, and the wound heals. The appearance phenomena are shown in figure 1 (year 2013, month 07, 04), figure 2 (year 2013, month 07, 12) and figure 3 (year 2013, month 07, 16).

2. Some Zhu, male, 16 years old. The patient is admitted to the hospital for ' 10 months after the loss of consciousness is interrupted ', is diagnosed as acute myeloid leukemia-M2 through bone puncture and other examinations, and is treated by chemotherapy by a ' DA ' scheme, a ' MEA (Mega administration), high-dose cytarabine and TA (TA) scheme. The patient has poor curative effect after the perianal debridement due to perianal infection by administration of strong antibiotics, and the post-external wound heals No. I, so that the perianal wound is gradually recovered. The appearance is shown in figure 4 (18 th 07/2013), and figure 5 (22 th 07/2013).

Claims

1. A traditional Chinese medicine composition is characterized by being mainly prepared from the following raw materials: 1-55 parts of astragalus membranaceus, 1-50 parts of scutellaria baicalensis, 1-25 parts of coptis chinensis, 1-35 parts of phellodendron amurense, 1-20 parts of rheum officinale, 1-25 parts of polygonum cuspidatum, 1-15 parts of borneol, 1-15 parts of dried alum and 50-450 parts of sesame oil.

2. The traditional Chinese medicine composition of claim 1, which is prepared from the following raw materials: 1-30 parts of astragalus membranaceus, 1-15 parts of scutellaria baicalensis, 1-30 parts of coptis chinensis, 1-20 parts of phellodendron amurense, 1-25 parts of rheum officinale, 1-20 parts of polygonum cuspidatum, 1-15 parts of borneol, 1-10 parts of dried alum and 50-200 parts of sesame oil.

3. The traditional Chinese medicine composition of claim 2, which is prepared from the following raw materials: 4-5 parts of astragalus membranaceus, 4-6 parts of scutellaria baicalensis, 3-5 parts of coptis chinensis, 4-6 parts of phellodendron amurense, 2-3 parts of rheum officinale, 2-4 parts of polygonum cuspidatum, 1-2 parts of borneol, 2-4 parts of dried alum and 90-190 parts of sesame oil.

4. The Chinese medicinal composition according to any one of claims 1 to 3, wherein the preparation method of the Chinese medicinal composition mainly comprises the following steps:

and B: preparing crude drugs of radix scutellariae, phellodendron, rhubarb and giant knotweed into coarse particles, adding sesame oil, soaking for 24 hours, and then mixing for later use;

and C: taking the astragalus and the coptis, preparing coarse particles, adding sesame oil, soaking for 24 hours, heating with strong fire until the astragalus and the coptis are brown, adding the mixture obtained in the step B, heating until all the medicinal materials are brown, filtering, and cooling to obtain liquid medicine for later use;

5. The method of claim 4, wherein the method of preparation essentially comprises the steps of:

6. Use of the Chinese medicinal composition according to any one of claims 1 to 3 for the preparation of a medicament for disinfection and sterilization, removal of necrotic tissue and promotion of granulation, detumescence and analgesia, and sepsis elimination.

7. Use of a Chinese medicinal composition according to any one of claims 1 to 3 in the preparation of a medicament for promoting wound healing.

8. A Chinese medicinal preparation comprising the Chinese medicinal composition of any one of claims 1-3.

9. The Chinese medicinal preparation according to claim 8, wherein the Chinese medicinal preparation is a clinically acceptable dosage form; preferably, the clinically acceptable dosage form is an external ointment.

10. The Chinese medicinal preparation of claim 9, wherein the topical ointment is one or more of an ointment, a paste, a film coating agent and a liniment.