CN110403988B

CN110403988B - A Chinese medicinal ointment with effects of promoting blood circulation and removing blood stasis, and its preparation method

Info

Publication number: CN110403988B
Application number: CN201910837871.1A
Authority: CN
Inventors: 过建春; 梁泽华; 金策; 潘颖洁; 程君凤; 王雅琳
Original assignee: Hangzhou Xixi Hospital
Current assignee: Hangzhou Xixi Hospital
Priority date: 2019-09-05
Filing date: 2019-09-05
Publication date: 2021-11-30
Anticipated expiration: 2039-09-05
Also published as: CN110403988A

Abstract

The invention relates to the field of traditional Chinese medicine ointment, and particularly discloses a traditional Chinese medicine ointment with an external blood circulation promoting and blood stasis removing effect, which is composed of the following raw medicinal materials in parts by weight: 11-14 parts of dandelion, 1-3 parts of coptis root, 5-8 parts of liquorice, 1-2 parts of borneol and 1-2 parts of menthol. The invention also discloses a method for preparing the traditional Chinese medicine ointment by mixing the raw material medicines and the auxiliary materials. The traditional Chinese medicine ointment has the effects of promoting blood circulation, removing blood stasis, relieving swelling and pain, is easy to obtain the preparation raw materials, simple in components, safer and more effective, greatly reduces the allergenicity and the production cost, is very suitable for people with skin allergy, and is convenient to popularize and apply clinically.

Description

A Chinese medicinal ointment with effects of promoting blood circulation and removing blood stasis, and its preparation method

Technical Field

The invention relates to the field of traditional Chinese medicine ointment, in particular to a traditional Chinese medicine ointment with the functions of promoting blood circulation and removing blood stasis for external use and a preparation method thereof.

Background

Traumatic injury generally refers to soft tissue injury of people caused by falling, hitting, bumping, knocking and the like, is mainly manifested by swelling and pain, and is frequently generated in life, the existing external medicament for traumatic injury is mainly prepared from plaster and safflower oil, the plaster layer is thinner, the duration of the medicament effect is shorter, and the rubber product on the outer layer can aggravate the burden of skin and possibly cause allergy; the smell of safflower oil also causes allergies and discomfort to some people.

In order to solve the above problems, researchers and researchers developed a series of external traditional Chinese medicine ointments for traumatic injuries, for example, chinese patent application publication nos. CN104940803A, CN104888113A, and CN104840892A all disclose a cool massage ointment for activating blood circulation to dissipate blood stasis and activating collaterals to relieve pain, which all contain twelve specific traditional Chinese medicine components, and although the ointment has the curative effects of activating blood circulation to dissipate blood stasis and activating collaterals to relieve pain, the raw materials of the ointment are various, the preparation method is complex, and not only more side effects and anaphylactic reactions are likely to be brought, but also the production cost is greatly increased.

Therefore, the externally applied traditional Chinese medicine ointment for traumatic injury, which has the advantages of few types of traditional Chinese medicine components, simple preparation method and obvious curative effect, has extremely strong practical significance, has simple components, is safer and more effective, greatly reduces the production cost, and is very suitable for people with skin allergy.

Disclosure of Invention

The invention aims to provide the traditional Chinese medicine ointment with the functions of promoting blood circulation and removing blood stasis for external use, which not only simplifies the traditional Chinese medicine components, improves the safety and reduces the production cost, but also can keep good effects of promoting blood circulation and removing blood stasis, and relieving swelling and pain.

The invention also aims to provide a preparation method of the traditional Chinese medicine ointment with the functions of externally activating blood and dissolving stasis, which simplifies the production flow and provides a new dosage form for treating bruises.

The technical scheme adopted by the invention is as follows:

a traditional Chinese medicine ointment with the functions of promoting blood circulation and removing blood stasis for external use is composed of the following raw medicinal materials in parts by weight: 11-14 parts of dandelion, 1-3 parts of coptis root, 5-8 parts of liquorice, 1-2 parts of borneol and 1-2 parts of menthol.

The traditional Chinese medicine ointment is prepared from pure natural raw material traditional Chinese medicines, all the medicines are organically matched, mutually supported and reasonably compatible, dandelion can remove heat toxin and reduce swelling, coptis can treat carbuncle and furuncle, liquorice can alleviate the bitter cold property of dandelion and coptis, and can also strengthen bones and muscles, grow muscle, borneol penetrates through the medicine and reaches the inside, so that the traditional Chinese medicine ointment with simple components has good curative effects of promoting blood circulation to remove blood stasis, reducing swelling and relieving pain.

Preferably, the traditional Chinese medicine ointment consists of the following raw medicinal materials in parts by weight: 12 parts of dandelion, 2 parts of coptis root, 6 parts of liquorice, 1 part of borneol and 1 part of menthol.

The ointment prepared by the raw material medicines can achieve good dredging curative effect under the condition of the specific proportion, and meanwhile, the medicines can be uniformly mixed and are convenient to use.

The traditional Chinese medicine ointment further comprises pharmaceutical excipients, wherein the pharmaceutical excipients comprise, by weight, 10-13 parts of liquid paraffin, 4-6 parts of white vaseline, 4-7 parts of stearic acid, 2-4 parts of glyceryl monostearate, span-605-7 parts, 3-5 parts of glycerol and 11-15 parts of water.

Preferably, the pharmaceutical adjuvant further comprises a preservative, and the preservative is sorbic acid. The Chinese medicinal ointment added with antiseptic can be stored for a long time, and has prolonged shelf life.

More preferably, the pharmaceutical excipients are 12 parts of liquid paraffin, 5 parts of white vaseline, 6 parts of stearic acid, 2 parts of glyceryl monostearate, span-605 parts, 4 parts of glycerol, 13.4 parts of water and 0.1 part of sorbic acid in parts by weight.

The ointment prepared by the dosage of the medicinal auxiliary materials in the specific proportion has moderate consistency, fineness, luster, good ductility and moisture retention, is cool and comfortable after being smeared, has good stability and fresh and elegant smell.

The invention also discloses a preparation method of the external traditional Chinese medicine ointment for promoting blood circulation and removing blood stasis, which comprises the following steps:

(1) extracting herba Taraxaci, Coptidis rhizoma and Glycyrrhrizae radix with ethanol under reflux twice, mixing filtrates, removing tannin, recovering ethanol, concentrating under reduced pressure to obtain extract, heating, drying, grinding, sieving to obtain fine powder, dissolving in ethanol, and making into extract with relative density of 1.35-1.40;

(2) preparing liquid paraffin, white vaseline, stearic acid, glyceryl monostearate and span-60 into uniform oil phase, preparing extract, glycerol and water into uniform water phase, adding the water phase into the oil phase, heating and stirring to obtain matrix; grinding Borneolum Syntheticum and Mentholum to liquefy, adding matrix, and grinding to obtain ointment.

In the step (1), preferably, the extraction method is: adding 14-16 times of 70-80% ethanol for reflux extraction, and fully extracting effective components from the raw materials by using an ethanol extraction process.

Preferably, alkali is added into the filtrate to adjust the pH value to 7.5-8.5, and then tannin is removed.

In the step (2), the temperature for heating and stirring the water phase and the oil phase is preferably 70-90 ℃, because the stirring and mixing are more uniform at the heating temperature, and the efficacy of the active ingredients in the raw material medicines is not affected.

Preferably, the pH value of the base is adjusted to be 5.5-6.5 by adding alkali, and the traditional Chinese medicine ointment prepared in the pH value range has no stimulation and milder medicine effect, and is more suitable for people with skin allergy.

The raw medicinal materials for the traditional Chinese medicine ointment are as follows:

the dandelion has the effects of clearing away heat and toxic materials, reducing swelling and resolving masses, inducing diuresis and treating stranguria, is mainly clinically used for treating acute mastitis, furuncle and other symptoms, and modern researches show that the dandelion has various chemical components and has pharmacological activities in the aspects of antibiosis, endotoxin resistance, stomach injury resistance, anti-tumor effect, immunoregulation and the like.

Coptis root, rhizoma Coptidis clears heat and dampness, purges fire and detoxifies. The traditional Chinese medicine composition is commonly used for symptoms such as damp-heat fullness and distension, vomiting, dysentery, jaundice, blood heat hematemesis and epistaxis, conjunctival congestion and acid regurgitation, diabetes, carbuncle, furuncle, ear purulence and the like, and modern researches find that the coptis chinensis has practical value for cardiovascular systems, tumor diseases, diabetes, digestive systems and the like.

The liquorice has the efficacies of tonifying spleen qi, moistening lung to arrest cough and moderating drug property, has the advantages of mild drug property, passing through twelve meridians, and has various functions of harmonizing various drugs, detoxifying, tonifying deficiency, arresting cough and moistening lung and the like.

The borneol is considered by the traditional Chinese medicine to have the effects of inducing resuscitation, refreshing mind, clearing heat, relieving pain and promoting tissue regeneration, and the modern medical research shows that the borneol has the effects of resisting inflammation, relieving pain, resisting bacteria and viruses, protecting heart and brain, regulating nervous system in two directions, improving the biological utilization of other medicines and the like.

The Mentholum has effects of clearing heat and detoxicating, relieving sore throat, and eliminating swelling, and is suitable for treating swelling and pain of throat, dryness, pharynx itch, cough, etc.

Compared with the prior art, the invention has the following beneficial effects:

the invention is based on natural medicines, utilizes the mutual cooperation of the medicines and adopts an emulsification method to prepare the traditional Chinese medicine ointment for promoting blood circulation and removing blood stasis with better effects of promoting blood circulation and removing blood stasis and relieving swelling and pain. The prepared traditional Chinese medicine ointment has the advantages of easily obtained raw materials, simple components, safety and effectiveness, greatly reduced allergenicity and production cost, suitability for people with skin allergy, and convenience for clinical popularization and application.

Drawings

FIG. 1 is a photograph of the finished ointment of the Chinese herbs prepared in example 1;

FIG. 2 is a photograph of a single application test in the skin sensitization test of the ointment of the Chinese medicinal materials prepared in example 1;

FIG. 3 is a photograph of a plurality of application tests in the skin sensitization test of the ointment of the Chinese medicinal materials prepared in example 1;

FIG. 4 is a photograph of bruising in a blank set of efficacy tests;

FIG. 5 is a photograph showing the bruising of the pharmacodynamic test of the matrix composition of comparative example 1;

FIG. 6 is a photograph showing the bruising state in the efficacy test of the herbal ointment set prepared in example 1.

Detailed Description

The present invention will be further described with reference to the following examples.

Example 1

The formula of the traditional Chinese medicine ointment with the functions of promoting blood circulation and removing blood stasis for external use comprises the following components:

the preparation method of the traditional Chinese medicine ointment with the functions of promoting blood circulation and removing blood stasis for external use comprises the following steps:

(1) preparing raw material medicines: extracting herba Taraxaci 12g, Glycyrrhrizae radix 6g, and Coptidis rhizoma 2g with 15 times of 75% ethanol under reflux for 2 times, each for 2 hr, hot filtering, mixing filtrates, adjusting pH to 8 with NaOH, removing tannin, recovering ethanol, concentrating to obtain extract, heating, drying, grinding, and sieving with No. 6 sieve to obtain fine powder.

(2) Preparing an ointment: adding 5g of fine powder prepared in the step (1) into ethanol to dissolve to obtain a crude drug extract with a relative density of 1.38(80 ℃); and putting the oil phase and the water phase in a beaker and a conical flask with a plug according to the table 1 respectively, heating and stirring the mixture in a water bath kettle at the temperature of 80 ℃, adding a preservative into the oil phase for mixing, stirring the mixture in the same direction until the mixture is uniform, then adding the extract of the raw material medicine into the water phase for stirring the mixture uniformly, slowly adding the water phase into the oil phase for stirring simultaneously, keeping stirring the mixture in the same direction all the time in the process, adding a proper amount of NaOH to adjust the pH value to 6, continuously stirring the mixture for 5min, taking out the mixture and cooling the mixture to room temperature to obtain the matrix. Grinding 1g of borneol and 1g of menthol in a mortar to be liquefied, adding a matrix, continuously grinding in the same direction until the ointment is uniform and dense, collecting, sealing and storing for later use.

Example 2

The preparation method is the same as that of the embodiment 1, and the formula ratio is as follows:

the raw material drugs are prepared from 11g of dandelion, 7g of liquorice, 1g of coptis root, 1g of borneol and 1g of menthol to prepare the traditional Chinese medicine ointment.

Example 3

the raw material drugs are prepared from 14g of dandelion, 8g of liquorice, 3g of coptis, 1g of borneol and 1g of menthol to prepare the traditional Chinese medicine ointment.

Comparative example 1

The same conditions as example 1 were used except that the matrix contained no extract of the drug substance.

Comparative example 2

Under the same conditions as in example 1, except that the crude drug coptis chinensis in step (1) is replaced by scutellaria baicalensis, it was found that the time for the ointment to dissipate blood stasis is prolonged and the efficacy is deteriorated.

Comparative example 3

The conditions of the example 1 are the same, except that liquorice is not added into the raw material medicine in the step (1), and the discomfort phenomenon of rats is found through animal experiments.

Test example 1: physical and chemical indexes

The physical and chemical indexes of the examples 1 to 3 are as follows:

1.1 Properties

The ointment finished product prepared by the invention is shown in figure 1, is tan, has moderate consistency, is fine and glossy, has good ductility and moisture retention, is cool and comfortable after being smeared, has good stability, and has fresh and elegant smell.

1.2 centrifugal stability test

Taking a proper amount of ointment about 1ml to a graduated centrifuge tube, filling the ointment to be flush with the graduation, centrifuging the ointment for 15min at 3000r/min, and observing no phenomena of obvious layering, demulsification and foaming, and no foam layer.

1.3 Cold and Heat resistance stability test

Placing appropriate amount of ointment in 45 deg.C incubator for 24 hr and-15 deg.C incubator for 24 hr, standing, and observing, the ointment has no obvious change in consistency, color and appearance, and no mildew or oil-water separation phenomenon.

1.4, pH determination

Adding 10 times of purified water into 0.1g ointment, heating to 40 deg.C in water bath, stirring, cooling to room temperature, measuring pH with pH meter, and making ointment average pH 6.18.

Test example 2: animal testing

2.1 skin sensitization test

Examples 1 to 3 were tested for allergenicity as follows:

24 healthy SD rats (female and male, the experiment is divided into 1 time of administration skin irritation test and 12 times of administration skin irritation test) are selected, the experiment adopts a same-body self-contrast method, a blank matrix group (a control group) is arranged in a right depilatory area, and a ointment group (an experimental group) is arranged in a left depilatory area. Shearing the soft hair on two sides of the spinal column of the rat by using scissors 24 hours before administration, shaving off part of the hair by using a shaver, then uniformly coating the depilatory cream, cleaning the depilatory cream and the fallen hair together by using cotton warm water after about 10 minutes, and checking whether the skin of the hair-removed part is damaged or not after 24 hours of hair removal, wherein the depilatory cream is preferably free of erythema, redness and swelling and damage.

2.1.1 Single application test:

taking 12 rats, dividing into blank control group and blood circulation promoting and blood stasis removing ointment experimental group, unhairing two sides 24h before administration, taking appropriate amount of prescription medicine-containing cream, coating on the left unhairing area of the rats, rubbing and massaging until basic absorption, coating appropriate amount of prescription blank cream substrate on the right unhairing area, repeatedly massaging until basic absorption is taken as control, and fixing with gauze.

As can be seen from FIG. 2, after 24h of administration, the residual cream and the blank cream matrix were washed off by soaking cotton in warm water, and no significant difference was observed between the left and right sides of the head and body of the rat, and no local erythema and redness reaction were observed.

2.2.2 multiple drug application tests:

taking 12 rats, coating proper amount of the medicinal cream on the left unhairing region of the rat, kneading and massaging until basic absorption, coating proper amount of the blank cream matrix on the right unhairing region, repeatedly massaging until absorption is used as control, and fixing with gauze.

Continuously applying the medicine for 7d, observing and recording every day, soaking cotton in warm water 6h after the last administration to wash off residual cream and blank cream matrix, and observing whether skin edema and erythema exist after 1h, 24h, 48h and 72h, wherein the left side and the right side of the rat head are not obviously different as shown in figure 3.

2. Test of drug efficacy

2.1 rat bruise model establishment

Fixing the rat on a beating table, beating the same part of the rat at the same height by using a blunt iron pestle for 4 times, wherein the beating area is about 1, the beating part is swollen, the bleeding part is scattered but the skin is not damaged, the fracture and dislocation are avoided by touching the hand, the right hind limb condition of the rat is observed after 24 hours, the swelling is obvious and ecchymosis exists.

2.2 administration and grouping

The recovery conditions of the SPF SD rats with 180-220 g and 30 animals with half male and female bodies are observed in the following table 1, wherein the 7 groups are randomly divided after the bruise treatment, the blank group is not treated, the ointment prepared in the examples is respectively applied to the examples, the ointment prepared in the comparative examples is respectively applied to the comparative examples, each group is applied once a day.

TABLE 1

As can be seen from Table 1, the recovery time was short and the recovery effect was better in the experimental group than in the control group and the blank group. The photograph of the bruising in the above blank group efficacy test is shown in FIG. 4, the photograph of the bruising in the matrix group efficacy test of comparative example 1 is shown in FIG. 5, and the photograph of the bruising in the efficacy test of the Chinese medicinal ointment group prepared in example 1 is shown in FIG. 6.

The comparison shows that the bruising of the blank group appears aggravated in the first three days, the bruising basically disappears after 11 days, and the bruising returns to normal in the 15 th day; the sudden aggravation of bruise does not appear in the stroma group, the bruise basically disappears after 11 days, and the normal state is recovered on day 13; the bruise of the experimental group is relieved and the swelling disappears after the application of the medicine for 2 days, the bruise basically disappears after 8 days, and the bruise basically returns to normal after 10 days.

Test example 3: typical cases

Wu Jia, female, age 22, placed at high position, injured the shoulder by heavy object, causing swelling and pain in the shoulder. The swelling disappears after 5 days and the pain disappears and returns to normal after 8 days.

Claims

1. A traditional Chinese medicine ointment with the functions of promoting blood circulation and removing blood stasis for external use is characterized by being prepared from the following raw medicinal materials in parts by weight: 11-14 parts of dandelion, 1-3 parts of coptis root, 5-8 parts of liquorice, 1-2 parts of borneol and 1-2 parts of menthol;

2. The external traditional Chinese medicine ointment with the effects of promoting blood circulation and removing blood stasis as claimed in claim 1, which is prepared from the following raw medicinal materials in parts by weight: 12 parts of dandelion, 2 parts of coptis root, 6 parts of liquorice, 1 part of borneol and 1 part of menthol.

3. The topical Chinese medicinal ointment with effects of promoting blood circulation and removing blood stasis of claim 1, wherein the pharmaceutical excipients further comprise a preservative, and the preservative is sorbic acid.

4. The traditional Chinese medicine ointment with the effect of promoting blood circulation to remove blood stasis for external use according to claim 3, which is characterized in that the pharmaceutic adjuvant comprises 12 parts by weight of liquid paraffin, 5 parts by weight of white vaseline, 6 parts by weight of stearic acid, 2 parts by weight of glyceryl monostearate, span-605 parts by weight, 4 parts by weight of glycerol, 13.4 parts by weight of water and 0.1 part by weight of sorbic acid.

5. A method for preparing the externally applied traditional Chinese medicine ointment for promoting blood circulation and removing blood stasis according to claim 1, which comprises the following steps:

6. The method for preparing external traditional Chinese medicine ointment for promoting blood circulation to remove blood stasis as claimed in claim 5, wherein in the step (1), the extraction method comprises the following steps: adding 14-16 times of 70-80% ethanol for reflux extraction.

7. The method for preparing a topical Chinese medicinal ointment for promoting blood circulation and removing blood stasis according to claim 5, wherein in step (1), alkali is added into the filtrate to adjust pH to 7.5-8.5, and tannin is removed.

8. The method for preparing a topical Chinese medicinal ointment for promoting blood circulation and removing blood stasis as claimed in claim 5, wherein in step (2), alkali is added to adjust pH of the base to 5.5-6.5.