CN115414446B - Traditional Chinese medicine composition for stopping bleeding of trauma and preparation method thereof - Google Patents

Abstract

The invention discloses a traditional Chinese medicine composition for stopping bleeding of trauma and a preparation method thereof, and relates to the technical field of traditional Chinese medicines, wherein the traditional Chinese medicine composition is prepared by taking a traditional Chinese medicine formula for treating bleeding of trauma as a raw material, mixing the raw material with a pharmaceutic adjuvant after heating reflux extraction, and preparing an external preparation, wherein the traditional Chinese medicine formula comprises the following components: herba Clinopodii, herba Sedi Aizoon, herba Portulacae, chitosan and wheat bran. Compared with the prior art, the invention can realize rapid hemostasis, can prevent bacterial infection and inflammation, has better effect on repairing wound skin, and in addition, the invention creatively prepares the external preparation and applies the external preparation to industrialized production, thereby not only compensating for the gap of the external preparation of the clinopodium polycephalum in the market, but also improving the compliance of patients, thereby better playing the role of medicine and improving the curative effect.

Description

Traditional Chinese medicine composition for stopping bleeding of trauma and preparation method thereof

Technical Field

The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for stopping bleeding of trauma and a preparation method thereof.

Background

Traumatic bleeding, if not controlled in time, can increase blood loss and even endanger the life of the patient. At present, the local hemostatic materials with more clinical application mainly comprise collagen hemostatic agents (such as gelatin sponge), oxidized celluloses (such as SUXIANGYAN, SURGICel) and the like, wherein the gelatin collagen materials are from cowhide, are easy to cause allergic reaction due to species difference, increase the infection rate of wounds, especially to polluted wounds, have poor adhesiveness and are easy to fall off. The oxidized cellulose fibers are loose, the possibility of re-bleeding is caused, the bleeding stopping time is long, the effect on bleeding fast people is poor, and the oxidized cellulose fibers are not suitable for being independently used as wound hemostatic materials, so that the application is limited;

in addition, bacterial infection and inflammation often occur during traumatic hemorrhage. Therefore, it is expected that therapeutic drugs have antibacterial effects while stopping bleeding, and in recent years, there is increasing interest in such drugs, but the variety of such drugs is still small, and the formulations developed from natural drugs are lacking.

Therefore, we propose a traditional Chinese medicine composition for traumatic hemostasis and a preparation method thereof.

Disclosure of Invention

The invention aims to solve the problems and provide a traditional Chinese medicine composition for stopping bleeding of trauma and a preparation method thereof, so as to provide a novel external preparation which can realize rapid stopping bleeding, prevent bacterial infection and inflammation and promote the repair of the trauma skin.

The invention realizes the above purpose through the following technical scheme:

the invention provides a traditional Chinese medicine composition for stopping bleeding of trauma, which is prepared by taking a traditional Chinese medicine formula for treating bleeding of trauma as a raw material, heating, refluxing and extracting the raw material, and mixing the raw material with a pharmaceutic adjuvant, wherein the traditional Chinese medicine formula comprises the following components: herba Clinopodii, herba Sedi Aizoon, herba Portulacae, chitosan and wheat bran.

As a further optimization scheme of the invention, the traditional Chinese medicine composition comprises, by weight, 20-25 parts of clinopodium polycephalum, 2-5 parts of chitosan, 15-20 parts of aizoon stonecrop, 12-18 parts of purslane and 20-25 parts of wheat bran.

As a further optimized scheme of the invention, the external preparation is one of gel, ointment, cream, film, patch and emplastrum.

As a further optimization scheme of the invention, when the external preparation is a gel, the pharmaceutical excipients are aqueous gel matrix, humectant, bacteriostat and pH regulator, but are not limited thereto, and the types and the dosage of the pharmaceutical excipients can be configured according to the requirements of the gel preparation, for example, carbomer can be used as aqueous gel matrix, glycerin can be used as humectant, ethylparaben can be used as bacteriostat, triethanolamine can be used as pH regulator, and the like.

The invention also provides a preparation method of the traditional Chinese medicine composition for stopping bleeding of trauma, which comprises the following steps:

(1) Weighing herba Clinopodii, herba Sedi Aizoon, herba Portulacae and wheat bran according to the amount of the prescription, drying, removing impurities, and pulverizing to 20 mesh to obtain crude powder;

(2) Adding ethanol solution with volume concentration of 75% 12 times into coarse powder, reflux extracting for 2 times under heating for 2 hr each time, mixing filtrates, filtering under reduced pressure, concentrating the extractive solution, rotary evaporating, and drying to obtain Chinese medicinal extract;

(3) Dissolving chitosan in a proper amount of ultrapure water according to the prescription amount, and fully stirring to dissolve to obtain chitosan sol;

(4) Mixing the medicinal adjuvants with the Chinese medicinal extract under stirring to obtain the Chinese medicinal composition.

The principle of the invention is as follows:

the clinopodium polycephalum has the effects of astringing and stopping bleeding, is suitable for metrorrhagia, hematuria, epistaxis, gingival bleeding and traumatic hemorrhage, contains a large amount of total saponins, and can inhibit the growth of staphylococcus aureus, escherichia coli, bacillus dysenteriae and the like.

The aizoon stonecrop herb is the whole herb and root of aizoon stonecrop herb and root of fiveleaf sedge herb, and has the functions of dispersing blood stasis, stopping bleeding, calming heart, tranquilizing mind and detoxifying. Is externally applied to traumatic injury, traumatic hemorrhage, burn, scald, sore, furuncle, carbuncle, swelling, etc.

The medicine parts of the purslane are dry overground parts of purslane, have the functions of clearing heat and detoxicating, cooling blood and stopping bleeding, and stopping dysentery, and are used for treating heat toxin bloody dysentery, carbuncle and furuncle, eczema, erysipelas, snake and insect bites, hematochezia, hemorrhoids and bleeding, metrorrhagia and metrostaxis;

the wheat bran is the outermost epidermis of barley, contains abundant B vitamins, and has effects of stimulating appetite, invigorating spleen, clearing intestine, moistening lung, moistening skin, and caring skin.

The invention has the beneficial effects that:

the traditional Chinese medicine clinopodium polycephalum, aizoon stonecrop herb, purslane, chitosan and wheat bran are matched to prepare the external preparation for traumatic hemorrhage, the external preparation has a synergistic effect, can realize rapid bleeding stopping, can prevent bacterial infection and inflammation, and has a good effect on repairing wound skin.

Detailed Description

The following detailed description of the invention is provided to illustrate the invention and should not be construed as limiting the scope of the invention since it is intended that the following detailed description is given for the purpose of illustration only, and that certain non-essential modifications and adaptations of the invention may occur to those skilled in the art in light of the foregoing disclosure.

Example 1

The traditional Chinese medicine composition for traumatic hemostasis is prepared by taking a traditional Chinese medicine formula for treating traumatic hemorrhage as a raw material, heating, refluxing and extracting the raw material, and mixing the raw material with a pharmaceutic adjuvant to prepare an external gel, wherein the traditional Chinese medicine formula comprises the following components in parts by weight: 30 parts of clinopodium polycephalum, 8 parts of chitosan, 14 parts of aizoon stonecrop herb, 16 parts of purslane and 20 parts of wheat bran; in this embodiment, the chitosan is carboxymethyl chitosan with a mass fraction of 2%, and the pharmaceutical excipients include an aqueous gel matrix, a humectant, a bacteriostatic agent and a pH regulator, and in this embodiment, the pharmaceutical excipients include: 35 parts of carbomer with the mass fraction of 0.1%, 25 parts of glycerin with the mass fraction of 20%, 15 parts of ethylparaben with the mass fraction of 0.1%, a proper amount of triethanolamine, a proper amount of ultrapure water, and a proper amount of aromatic agent can be added according to requirements.

The preparation method of the traditional Chinese medicine composition comprises the following steps:

(1) Respectively weighing herba Clinopodii, chitosan, herba Sedi Aizoon, herba Portulacae, wheat bran according to the prescription, drying, removing impurities, and pulverizing to 20 mesh to obtain coarse powder;

(2) Adding ethanol solution with volume concentration of 75% 12 times into coarse powder, reflux extracting for 2 times under heating for 2 hr each time, mixing filtrates, filtering under reduced pressure, concentrating the extractive solution, rotary evaporating, and drying to obtain Chinese medicinal extract;

(3) Dissolving 2% of carboxymethyl chitosan in a proper amount of ultrapure water, and fully stirring to dissolve the carboxymethyl chitosan to obtain carboxymethyl chitosan sol;

(4) Dispersing carbomer with mass fraction of 0.1% in a proper amount of ultrapure water to naturally swell the carbomer to obtain carbomer sol;

(5) Weighing 20% glycerol, adding into carbomer sol, stirring, slowly adding carboxymethyl chitosan sol, stirring, mixing, adding the prepared Chinese medicinal extract, adding ethylparaben, adjusting pH to 7-7.5 with triethanolamine, and adding ultrapure water to 100g to obtain herba Clinopodii chitosan gel.

Example 2

The traditional Chinese medicine composition for traumatic hemostasis is prepared by taking a traditional Chinese medicine formula for treating traumatic hemorrhage as a raw material, heating, refluxing and extracting the raw material, and mixing the raw material with a pharmaceutic adjuvant to prepare an external gel, wherein the traditional Chinese medicine formula comprises the following components in parts by weight: 35 parts of clinopodium polycephalum, 5 parts of chitosan, 18 parts of aizoon stonecrop herb, 12 parts of purslane and 25 parts of wheat bran; the pharmaceutical excipients comprise an aqueous gel matrix, a humectant, a bacteriostat and a pH regulator, and in the embodiment, the pharmaceutical excipients comprise: 35 parts of carbomer with the mass fraction of 0.1%, 25 parts of glycerin with the mass fraction of 20%, 15 parts of ethylparaben with the mass fraction of 0.1%, a proper amount of triethanolamine, a proper amount of ultrapure water, and a proper amount of aromatic agent can be added according to requirements.

The preparation method of the traditional Chinese medicine composition is the same as that of the example 1.

Example 3

The traditional Chinese medicine composition for traumatic hemostasis is prepared by taking a traditional Chinese medicine formula for treating traumatic hemorrhage as a raw material, heating, refluxing and extracting the raw material, and mixing the raw material with a pharmaceutic adjuvant to prepare an external gel, wherein the traditional Chinese medicine formula comprises the following components in parts by weight: 32 parts of clinopodium polycephalum, 6 parts of chitosan, 16 parts of aizoon stonecrop herb, 14 parts of purslane and 22 parts of wheat bran; the pharmaceutical excipients comprise an aqueous gel matrix, a humectant, a bacteriostat and a pH regulator, and in the embodiment, the pharmaceutical excipients comprise: 35 parts of carbomer with the mass fraction of 0.1%, 25 parts of glycerin with the mass fraction of 20%, 15 parts of ethylparaben with the mass fraction of 0.1%, a proper amount of triethanolamine, a proper amount of ultrapure water, and a proper amount of aromatic agent can be added according to requirements.

The preparation method of the traditional Chinese medicine composition is the same as that of the example 1.

Comparative example 1

The comparative example provides a traditional Chinese medicine composition for trauma hemostasis, which comprises the following components in parts by weight: 6 parts of chitosan, 16 parts of aizoon stonecrop herb, 14 parts of purslane, 22 parts of wheat bran and other components and preparation methods thereof are the same as in example 3.

Comparative example 2

The comparative example provides a traditional Chinese medicine composition for trauma hemostasis, which comprises the following components in parts by weight: 32 parts of clinopodium polycephalum, 16 parts of aizoon stonecrop herb, 14 parts of purslane, 22 parts of wheat bran and other components and preparation methods thereof are the same as in example 3.

Comparative example 3

The comparative example provides a traditional Chinese medicine composition for trauma hemostasis, which comprises the following components in parts by weight: 32 parts of clinopodium polycephalum, 6 parts of chitosan, 14 parts of purslane, 22 parts of wheat bran and other components and preparation methods thereof are the same as in example 3.

Comparative example 4

The comparative example provides a traditional Chinese medicine composition for trauma hemostasis, which comprises the following components in parts by weight: 32 parts of clinopodium polycephalum, 6 parts of chitosan, 16 parts of aizoon stonecrop, 22 parts of wheat bran and other components and preparation methods thereof are the same as in example 3.

Comparative example 5

The comparative example provides a traditional Chinese medicine composition for trauma hemostasis, which comprises the following components in parts by weight: 32 parts of clinopodium polycephalum, 6 parts of chitosan, 16 parts of aizoon stonecrop herb, 14 parts of purslane and other components and preparation methods thereof are the same as in example 3.

In order to verify the product performance of the invention, the following test and detection of corresponding product treatment effect are carried out, and the specific steps are as follows:

1. trauma hemostasis test

24 healthy, clean grade New Zealand rabbits were divided into 8 groups and dehaired around the border veins and anesthetized with 35mg/kg border intravenous injection of 2% pentobarbital sodium. After the sterilization with 75% medical alcohol, each rabbit was isolated from the vein at 7cm from the tip of the ear, and the external gel preparation obtained in example 3 and control groups 1 to 5 was dusted after 5s free bleeding, and the bleeding amount was calculated by pressing the wound with the blood shield hemostatic powder and the rapid yarn as a control agent, and using a weight of 50g as an external force, observing the bleeding condition of the wound every 5s, adsorbing the bleeding liquid with absorbent cotton, and recording the weight of absorbent cotton before and after adsorption. The time to bleeding from the time of cutting off the ear vein to no longer bleeding was recorded, and each group was repeated 4 times, and the results are shown in table 1.

TABLE 1 traumatic hemostasis test results

The results show that in the hemostasis test of rabbit ear vein injury, the hemostasis effect of the comparative example 1 group without the clinopodium polycephalum is reduced to a certain extent compared with that of the examples 1-3, and the hemostasis effect of the traditional Chinese medicine formula of the comparative examples 2-5 after the clinopodium polycephalum is added is improved to a certain extent, but the hemostasis effect is inferior to that of the examples 1-3, because the comparative examples 2-5 remove chitosan, the aizoon stonecrop herb, the purslane and the wheat bran correspondingly, and the compatibility of the clinopodium polycephalum and the chitosan, the aizoon stonecrop herb, the purslane and the wheat bran proves that the synergistic effect is achieved, and the rapid hemostasis effect can be realized.

2. Antibacterial test

Activating strains: taking escherichia coli as gram-negative bacteria, staphylococcus aureus and bacillus subtilis as gram-positive bacteria, taking a freeze-dried strain tube, adding nutrition broth with proper concentration on the strain, inoculating the strain into a 10mL liquid nutrition broth culture medium test tube after the strain is melted and dispersed, and placing the test tube in a shaking table with the temperature of 37 ℃ and the rotating speed of 180rpm for shake culture for 24 hours to enable the strain solution to reach a certain concentration;

preparation of bacterial suspension: picking the bacterial suspension of the first generation culture by an inoculating needle, streaking and inoculating the bacterial suspension on an agar culture medium plate, and culturing the bacterial suspension in a culture box at 37 ℃ for 24 hours to obtain the second generation culture. And (3) picking a typical colony in the second-generation culture, streaking and inoculating the colony in an agar slant culture medium test tube, and placing the culture in a 37 ℃ incubator for culturing for 24 hours, namely a third-generation culture. Taking a third-generation culture of a strain, sucking 3-5 mL of sterile water by a suction pipe, adding into a slant culture medium test tube, repeatedly purging, washing out bacterial colonies, transferring the washing liquid into another sterile test tube by the suction pipe, oscillating on a palm until bacterial colonies are free from agglomerations and uniformly dispersed, obtaining bacterial suspension, and diluting the bacterial suspension to 10 ⁶ CFU/mL-10 ⁷ CFU/mL was used as a test bacterial suspension, which was stored in a refrigerator at 4℃for further use.

Determination of the zone of inhibition: the sterilized beef extract peptone culture medium 10mL-15mL is poured into the culture dish, and the solution is cooled and solidified. 0.1mL of the prepared 10 ⁶ -10 ⁷ The CFU/mL bacterial suspension is uniformly smeared on beef extract peptone culture medium, after the surface of the culture medium is dried, a 5mm sterile puncher is used for punching, and 30 mu L of the bacterial suspension-containing culture dish is added respectively. And (3) placing the inoculated culture medium in a constant temperature incubator at 37 ℃ for culturing for 24 hours, and measuring the size of the inhibition zone.

The test was performed three times, and the average value thereof was taken as a test result.

The external gel preparations prepared in examples 1 to 3 and comparative examples 1 to 5 were respectively selected for antibacterial test, and the results are shown in Table 2:

TABLE 2 antibacterial test

The results show that the external gel preparation prepared by the invention has good antibacterial performance against escherichia coli, staphylococcus aureus and bacillus subtilis.

3. Trauma repair Effect test

Taking 12 healthy clean New Zealand rabbits, each half of male and female, taking 220+/-20 g of body weight, dividing into 4 groups, carrying out intravenous injection on the treated animals by using 35mg/kg of 2% pentobarbital sodium and 75% medical alcohol for anesthesia, then carrying out scratch treatment on each group, enabling the depth and the length of wounds to be consistent, enabling the free bleeding of the wounds to be 5 seconds, carrying out sterilization on the wounds by using 75% medical alcohol, then smearing the trauma gel preparation prepared in the example 3 and the comparative example 5 with the same amount on the scratched parts, taking the blood shield hemostatic powder and the quick-acting yarn as a reference drug, respectively carrying out treatment for 1 time in the morning, the middle and the evening every day, respectively observing the repair effect of the wounds of each group after the treatment for 4 weeks, and obtaining the following results,

(1) The external gel preparation prepared in the example 3 is adopted to treat wounds, the hemostasis of the wounds is rapid, the redness and swelling of the wounds are weakened, with the continuous administration, the proliferation and differentiation of new skin cells are carried out to fill and cover the wounds to form scars, the skin at the scars is smooth after the treatment of 4 weeks of administration, the scars are lighter in color, and the problem of wound proliferation does not occur;

(2) The external gel preparation prepared in the comparative example 5 is used for treating wounds, the hemostasis of the wounds is rapid, the swelling of the wounds is weakened, with the continuous administration, the proliferation and differentiation of new skin cells are carried out to fill and cover the wounds to form scars, after the treatment of 4 weeks of administration, the scars are obvious, the smoothness of the skin at the scars is poorer than that of the example 3, the color of the scars is darker than that of the example 3, and the overall wound skin repairing effect is inferior to that of the example 3;

(3) The blood shield hemostatic powder and the quick-acting yarn are used as the control medicines for treating wounds, the hemostatic speed of the wounds is lower than that of the example 1 and the comparative example 5, the duration of red swelling of the wounds is longer than that of the example 1 and the comparative example 5, the elimination speed of the red swelling is lower, along with the continuous medication, the proliferation and differentiation of the newborn skin cells are used for filling and covering the wounds to form scars, the scars of the wounds using the blood shield hemostatic powder are obvious compared with that of the example 3 after 4 weeks of administration treatment, the skin smoothness of the scars is poor, the color of the scars is deep, the proliferation problem of the wounds using the quick-acting yarn occurs, the color of the wound proliferation is deep, and the scars are obvious.

The results show that the external gel preparation prepared in the example 3 can realize rapid hemostasis and has strong antibacterial property, and meanwhile, the external gel preparation also has better effect on repairing wound skin after continuous treatment and use, the trauma repairing effect of the comparative example 5 is lower than that of the example 3, and compared with the example 3, the components of the external gel preparation lack of wheat bran, and the wheat bran has a certain positive effect on repairing the trauma skin.

In addition, in the process of carrying out the related verification test, researchers find that the same effects of rapid hemostasis, antibiosis and traumatic skin repair can be achieved when the external preparation is prepared into ointments, creams, films, patches and emplastrum except for gel by adjusting the types of the medical dressings.

In conclusion, the traditional Chinese medicines of clinopodium polycephalum, aizoon stonecrop herb, purslane, chitosan and wheat bran are compatible to prepare the external preparation for traumatic hemorrhage, the external preparation has a synergistic effect, can realize rapid bleeding stopping, can prevent bacterial infection and inflammation, and has a good effect on repairing wound skin.

The foregoing examples illustrate only a few embodiments of the invention and are described in detail herein without thereby limiting the scope of the invention. It should be noted that it will be apparent to those skilled in the art that several variations and modifications can be made without departing from the spirit of the invention, which are all within the scope of the invention.

Claims (5)

1. A traditional Chinese medicine composition for stopping bleeding of trauma is characterized in that the traditional Chinese medicine composition is prepared by taking a traditional Chinese medicine formula for treating bleeding of trauma as a raw material, mixing the raw material with a pharmaceutic adjuvant after heating reflux extraction, and preparing an external preparation; the preparation method comprises the steps of weighing 30-35 parts of clinopodium polycephalum, 14-18 parts of aizoon stonecrop herb, 12-16 parts of purslane and 20-25 parts of wheat bran according to parts by weight, drying, removing impurities, crushing to obtain crude drug powder, heating and reflux-extracting the crude drug powder to obtain a traditional Chinese medicine extract, weighing 5-8 parts of chitosan, dissolving in ultrapure water, fully stirring to dissolve to obtain chitosan sol, and stirring and mixing the traditional Chinese medicine extract, the chitosan sol and the pharmaceutic adjuvant to obtain the traditional Chinese medicine composition.

2. The traditional Chinese medicine composition for traumatic hemostasis according to claim 1, wherein the external preparation is one of gel, ointment, cream, film, patch and emplastrum.

3. The traditional Chinese medicine composition for traumatic hemostasis according to claim 2, wherein when the external preparation is a gel, the pharmaceutical excipients are aqueous gel matrix, humectant, bacteriostat and pH regulator.

4. The traditional Chinese medicine composition for traumatic hemostasis according to claim 3, wherein the chitosan is carboxymethyl chitosan, the aqueous gel matrix is carbomer, the humectant is glycerin, the bacteriostatic agent is ethylparaben, and the pH regulator is triethanolamine.

5. A method of preparing a traditional Chinese medicine composition for traumatic hemostasis as claimed in any one of claims 1-4, and including the steps of:

(1) Weighing herba Clinopodii, herba Sedi Aizoon, herba Portulacae and wheat bran according to the amount of the prescription, drying, removing impurities, and pulverizing to 20 mesh to obtain crude powder;

(2) Adding ethanol solution with volume concentration of 75% 12 times into coarse powder, reflux extracting for 2 times under heating for 2 hr each time, mixing filtrates, filtering under reduced pressure, concentrating the extractive solution, rotary evaporating, and drying to obtain Chinese medicinal extract;

(3) Dissolving chitosan into ultrapure water according to the prescription amount, and fully stirring to dissolve to obtain chitosan sol;

(4) Mixing medicinal adjuvants, chitosan sol and Chinese medicinal extract under stirring to obtain the final product.