Plaster for treating bone rheumatism and preparation method thereof

文档序号:1437891 发布日期:2020-03-24 浏览:6次 中文

阅读说明:本技术 治疗骨痹症的贴膏剂及其制备方法 (Plaster for treating bone rheumatism and preparation method thereof ) 是由 张立明 赵雨 褚海清 王结鑫 肖冬 王倩 陈洁 白子君 于 2019-12-20 设计创作,主要内容包括:一种治疗骨痹症的贴膏剂及其制备方法,涉及中药技术领域,该治疗骨痹症的贴膏剂,由没药、红花、白胡椒、川乌、伸筋草、桑枝制成,其中,没药10~14质量份、红花6~10质量份、白胡椒6~10质量份、川乌6~10质量份、伸筋草22~26质量份、桑枝14~18质量份,上述六味药均为中药原料,通过改善骨痹症的气血痹阻不通、加强筋脉关节濡养的方式,能够有效地治疗各种骨痹症。将上述中药原料制备成贴膏剂,通过直接外敷在患者酸胀肿痛处的方式来改善骨痹症状。(The emplastrum for treating the bone rheumatism is prepared from 10-14 parts by mass of myrrh, 6-10 parts by mass of safflower, 6-10 parts by mass of white pepper, 6-10 parts by mass of monkshood, 22-26 parts by mass of lycopodium clavatum and 14-18 parts by mass of mulberry twigs, and the six medicines are all traditional Chinese medicine raw materials, so that various bone rheumatism can be effectively treated by improving the obstruction of qi and blood stagnation of the bone rheumatism and strengthening the nourishing of tendon and vessel joints. The Chinese medicinal raw materials are prepared into emplastrum, and the emplastrum is directly applied to the sore swelling and pain part of a patient to improve the symptoms of bone impediment.)

1. A preparation method of a emplastrum for treating bone rheumatism is characterized by comprising the following steps: the method comprises the following steps:

(1) taking 10-14 parts by mass of myrrh, 6-10 parts by mass of safflower, 6-10 parts by mass of white pepper, 6-10 parts by mass of radix aconiti, 22-26 parts by mass of lycopodium clavatum and 14-18 parts by mass of ramulus mori, drying, uniformly mixing and crushing into particles of 10-14 meshes to obtain mixed raw materials;

(2) adding distilled water in a predetermined proportion into the mixed raw materials to obtain a prepared mixture, placing the prepared mixture in an extractor, heating to slightly boil, extracting volatile oil, and taking the residual liquid-residue mixture;

(3) filtering the liquid residue mixture to obtain residue, adding ethanol into the residue, reflux-extracting, and filtering to obtain filtrate;

(4) putting the filtrate into a round-bottom flask, installing the round-bottom flask on a rotary evaporator, starting the rotary evaporator to evaporate the filtrate in the round-bottom flask, evaporating the filtrate to form a thick extract, volatilizing ethanol in the extract, putting the extract into an oven, drying, and pulverizing into fine powder to obtain medicinal powder;

(5) mixing the powder with matrix at a predetermined ratio to obtain patch.

2. The method for preparing the emplastrum for treating rheumatism involving bone according to claim 1, wherein the emplastrum comprises the following steps: in the step (1), the mass ratio of myrrh, safflower, white pepper, monkshood, lycopodium clavatum and ramulus mori is 3:2:2:2:6: 4.

3. The method for preparing the emplastrum for treating rheumatism involving bone according to claim 2, wherein the emplastrum comprises the following steps: the step (2) is specifically as follows: adding distilled water with the volume 10 times of the mixed raw materials into the mixed raw materials, soaking for 1 hour to obtain a prepared mixture, placing the prepared mixture into an extractor, heating to slightly boil, extracting volatile oil for 10 hours, and taking the residual liquid-residue mixture.

4. The method for preparing the emplastrum for treating rheumatism involving bone according to claim 3, wherein the emplastrum comprises the following steps: the step (3) is specifically as follows: filtering the medicinal liquid to obtain residue, adding 85% ethanol (6 times of the residue), extracting under reflux for 3 hr, and filtering to obtain filtrate.

5. The method for preparing the emplastrum for treating rheumatism involving bone according to claim 4, wherein the emplastrum comprises the following steps: the step (4) is specifically as follows: putting the filtrate into a round-bottom flask, installing the round-bottom flask on a rotary evaporator, starting the rotary evaporator to evaporate the filtrate in the round-bottom flask, evaporating the filtrate to form a thick extract, volatilizing ethanol in the prepared extract, putting the volatilized ethanol prepared extract into a 65 ℃ oven, drying for 48-72 hours, taking out, and crushing into fine powder to obtain the medicinal powder.

6. The method for preparing the emplastrum for treating arthromyodynia according to any one of claims 1 to 5, wherein the emplastrum comprises the following steps: the step (5) is specifically as follows: taking glycerol, sodium polyacrylate, carbomer and sodium carboxymethylcellulose in predetermined amounts, heating and melting the glycerol and the sodium polyacrylate in water at 70-80 ℃ in a water bath, slowly adding the sodium carboxymethylcellulose, stirring and grinding uniformly to obtain a matrix; mixing carbomer with distilled water to fully swell carbomer to obtain adjuvants; adding distilled water into the medicinal powder, and heating to obtain soft extract; slowly pouring the prepared ointment and auxiliary materials into the matrix to be mixed to obtain a mixture, putting the mixture into water with the temperature of 70-80 ℃ to carry out water bath heating and melting, stopping heating after fully and uniformly stirring, and stirring the mixture into an ointment state again to obtain the emplastrum.

7. The method for preparing the emplastrum for treating rheumatism involving bone according to claim 6, wherein the emplastrum comprises the following steps: the weight of the glycerin is 2-4 g, the weight of the sodium polyacrylate is 0.4-0.6 g, the weight of the carbomer is 0.1-0.2 g, the weight of the sodium carboxymethyl cellulose is 4g, the weight of the predetermined amount of distilled water is 4g, and the weight of the medicinal powder is 1 g.

8. The method for preparing the emplastrum for treating rheumatism involving bone according to claim 7, wherein the emplastrum comprises the following steps: in the step (5), "stirring the mixture again to an ointment state to obtain the emplastrum" specifically includes: and (3) stirring the mixture into an ointment state again, taking the volatile oil extracted in the step (4), adding all the volatile oil into the ointment at one time, stirring again to fully and uniformly mix the ointment and the volatile oil to obtain a plaster, and spreading the plaster on a non-woven fabric to obtain the plaster.

9. A patch which is prepared by the preparation method of any one of claims 1 to 5 and 7 to 8.

Technical Field

The invention relates to the technical field of traditional Chinese medicines, in particular to a plaster for treating bone rheumatism and a preparation method thereof.

Background

Bone bi-arthralgia is one of five-body bi-arthralgia, which is a limb bi-arthralgia disease mainly manifested by heaviness, numbness and weakness of limbs, pain and swelling of bone and joints, stiff and deformed joints and limited movement of bones and joints due to the fact that wind-cold-dampness pathogen keeps the muscles and joints of human body for a long time, and the qi and blood of meridians are blocked, or old people are aged and physically weak, and bones are lost to nourish and bone are weak. Is equivalent to the bone injury arthralgia such as rheumatoid arthritis, lumbar intervertebral disc protrusion, ankylosing spondylitis, scapulohumeral periarthritis and the like in modern medicine. Its pathogenesis is caused by obstruction of qi and blood and failure of nourishing tendons, vessels and joints.

The traditional western medicine treatment means comprise oral non-steroidal anti-inflammatory analgesic drugs, oral glucosamine and intra-articular injection of sodium hyaluronate, the patients with serious symptoms need joint cleaning or joint replacement, but the western medicine treatment cost is high, the cause of the disease is still not very clear in western medicine, and compared with the symptomatic treatment in western medicine, the traditional Chinese medicine considers that qi-blood obstruction is not smooth and the tendon and vessel joints are not nourished by soft tissue as the main pathogenesis.

Disclosure of Invention

In view of the above, there is a need for a method for preparing a patch for treating arthromyodynia using a pharmaceutical composition.

Also provides a plaster for treating the bone rheumatism by using the pharmaceutical composition.

A preparation method of a emplastrum for treating bone rheumatism is characterized by comprising the following steps: the method comprises the following steps:

(1) taking 10-14 parts by mass of myrrh, 6-10 parts by mass of safflower, 6-10 parts by mass of white pepper, 6-10 parts by mass of radix aconiti, 22-26 parts by mass of lycopodium clavatum and 14-18 parts by mass of ramulus mori, drying, uniformly mixing and crushing into particles of 10-14 meshes to obtain mixed raw materials;

(2) adding distilled water in a predetermined proportion into the mixed raw materials to obtain a prepared mixture, placing the prepared mixture in an extractor, heating to slightly boil, extracting volatile oil, and taking the residual liquid-residue mixture;

(3) filtering the liquid residue mixture to obtain residue, adding ethanol into the residue, reflux-extracting, and filtering to obtain filtrate;

(4) putting the filtrate into a round-bottom flask, installing the round-bottom flask on a rotary evaporator, starting the rotary evaporator to evaporate the filtrate in the round-bottom flask, evaporating the filtrate to form a thick extract, drying the ethanol in the extract, putting the dried extract into an oven, drying, and pulverizing into fine powder to obtain medicinal powder;

(5) mixing the powder with matrix at a predetermined ratio to obtain patch.

Preferably, the mass ratio of the myrrh, the safflower, the white pepper, the monkshood, the lycopodium clavatum and the mulberry twig in the step (1) is 3:2:2:2:6: 4.

Preferably, the step (2) is specifically: adding distilled water with the volume 10 times of the mixed raw materials into the mixed raw materials, soaking for 1 hour to obtain a prepared mixture, placing the prepared mixture into an extractor, heating to slightly boil, extracting volatile oil for 10 hours, and taking the residual liquid-residue mixture.

Preferably, the step (3) is specifically: filtering the medicinal liquid to obtain residue, adding 85% ethanol (6 times of the residue), extracting under reflux for 3 hr, and filtering to obtain filtrate.

Preferably, the step (4) is specifically: putting the filtrate into a round-bottom flask, installing the round-bottom flask on a rotary evaporator, starting the rotary evaporator to evaporate the filtrate in the round-bottom flask, evaporating the filtrate to form a thick extract, volatilizing ethanol in the prepared extract, putting the volatilized ethanol prepared extract into a 65 ℃ oven, drying for 48-72 hours, taking out, and crushing into fine powder to obtain the medicinal powder.

Preferably, the step (5) is specifically: taking glycerol, sodium polyacrylate, carbomer and sodium carboxymethylcellulose in predetermined amounts, heating and melting the glycerol and the sodium polyacrylate in water at 70-80 ℃ in a water bath, slowly adding the sodium carboxymethylcellulose, stirring and grinding uniformly to obtain a matrix; mixing carbomer with distilled water to fully swell carbomer to obtain adjuvants; adding distilled water into the medicinal powder, and heating to obtain soft extract; slowly pouring the prepared ointment and auxiliary materials into the matrix to be mixed to obtain a mixture, putting the mixture into water with the temperature of 70-80 ℃ to carry out water bath heating and melting, stopping heating after the mixture is fully and uniformly stirred, and stirring the mixture into an ointment state again to obtain the emplastrum.

Preferably, the weight of the glycerin is 2-4 g, the weight of the sodium polyacrylate is 0.4-0.6 g, the weight of the carbomer is 0.1-0.2 g, the weight of the sodium carboxymethyl cellulose is 4g, the weight of the predetermined amount of distilled water is 4g, and the weight of the medicinal powder is 1 g.

Preferably, in the step (5), "stirring the mixture again to form an ointment to obtain the emplastrum" specifically comprises: and (3) stirring the mixture into an ointment state again, taking the volatile oil extracted in the step (4), adding all the volatile oil into the ointment at one time, stirring again to fully and uniformly mix the ointment and the volatile oil to obtain a plaster, and spreading the plaster on a non-woven fabric to obtain the plaster.

The invention also provides a emplastrum which is prepared by the preparation method.

By adopting the technical scheme, the invention has the beneficial effects that: myrrh, safflower, white pepper, monkshood, lycopodium clavatum and mulberry twig are all traditional Chinese medicine raw materials, can effectively improve various bone rheumatism symptoms by improving the qi-blood obstruction of the bone rheumatism and strengthening the soft-nourishing of tendons, vessels and joints, and the traditional Chinese medicine raw materials are prepared into emplastrum which is directly applied to the sore swelling and pain part of a patient to improve the symptoms of the bone rheumatism.

Drawings

FIG. 1 is a schematic diagram showing the effect of different extraction sites of herbs on the analgesic activity of mice in a hot plate experiment.

Detailed Description

The embodiment of the invention provides a preparation method of a emplastrum for treating bone rheumatism, which is characterized by comprising the following steps: the method comprises the following steps:

step S01, taking 12g of myrrh, 8g of safflower, 8g of white pepper, 8g of monkshood, 24g of lycopodium clavatum and 16g of mulberry twigs, drying, uniformly mixing and crushing into 12-mesh particles to obtain mixed raw materials;

step S02, adding distilled water with the volume 10 times of that of the mixed raw materials into the mixed raw materials, soaking for 1 hour to obtain a prepared mixture, placing the prepared mixture into an extractor, heating to slightly boil, extracting volatile oil for 10 hours, and taking the residual liquid-residue mixture;

step S03, filtering the liquid medicine to obtain medicine dregs, adding 85% ethanol into the medicine dregs, wherein the volume of the ethanol is 6 times of that of the medicine dregs, continuously refluxing and extracting for 3 hours, and filtering to obtain filtrate;

step S04, putting the filtrate into a round-bottom flask, installing the round-bottom flask on a rotary evaporator, starting the rotary evaporator to rotatably evaporate the filtrate in the round-bottom flask, rotatably evaporating the filtrate to form a thick extract to obtain a prepared extract, volatilizing ethanol in the prepared extract, putting the volatilized ethanol prepared extract into a 65 ℃ oven, drying for 48-72 hours, taking out, and crushing into fine powder to obtain medicinal powder;

step S05, taking 4g of glycerin, 0.6g of sodium polyacrylate and 4g of sodium carboxymethyl cellulose, heating and melting the glycerin and the sodium polyacrylate in water bath at 70-80 ℃, slowly adding the sodium carboxymethyl cellulose, stirring and grinding uniformly to obtain a matrix;

step S06, taking 0.15g of carbomer, and mixing the carbomer with distilled water to fully swell the carbomer to obtain auxiliary materials;

step S07, adding 4g of distilled water into 1g of the medicinal powder and heating the medicinal powder into thick paste to obtain a preparation ointment;

step S08, slowly pouring the prepared ointment and the auxiliary materials into the matrix to be mixed to obtain a mixture, putting the mixture into water of 70-80 ℃ to be heated and melted in a water bath, stirring the mixture fully and uniformly, stopping heating, stirring the mixture into an ointment state again, adding all the volatile oil into the ointment at one time, stirring again to fully and uniformly mix the ointment and the volatile oil to obtain a emplastrum, and spreading the emplastrum on a non-woven fabric to obtain the plaster.

In another preferred embodiment, step S08 is: slowly pouring the prepared ointment and auxiliary materials into the matrix to be mixed to obtain a mixture, putting the mixture into water with the temperature of 70-80 ℃ to carry out water bath heating and melting, stopping heating after the mixture is fully and uniformly stirred, and stirring the mixture into an ointment state again; putting the volatile oil into a vacuum container, adding a predetermined amount of cyclodextrin into the volatile oil, mixing the volatile oil and the cyclodextrin to prepare a volatile oil-cyclodextrin molecular compound by using a Chinese medicinal volatile oil cyclodextrin inclusion technology, adding all the volatile oil-cyclodextrin molecular compounds into the ointment at one time, stirring again to fully and uniformly mix the ointment and the volatile oil-cyclodextrin molecular compounds to obtain a patch, and spreading the patch on a non-woven fabric to obtain the patch.

The volatile oil is a secondary metabolite in a plant body, and clinical and modern pharmacological studies show that the volatile oil has small molecular weight, strong fat solubility, high bioavailability and rapid absorption and effect taking, can easily penetrate through a biological membrane in the body, and has the anti-inflammatory and analgesic effects. In addition, the volatile oil has the property of easy oxidation and volatilization, so that the method for preparing the volatile oil-cyclodextrin molecular compound is added in the preparation process of the step S08 in another preferred embodiment, so that the oxidation and volatilization of the volatile oil can be inhibited, and the utilization rate of the volatile oil is further improved.

The embodiment of the invention also provides a emplastrum which is prepared by the steps S01-S08.

All the above-mentioned "slight boiling" is the same as the description concept of the general rule for measuring volatile oil in the pharmacopoeia, i.e. the state of liquid just before boiling, i.e. the stage of just starting to generate bubbles and being open and not open.

The characteristics of the traditional Chinese medicine raw materials are described as follows:

myrrh: pungent, bitter and neutral in nature. It enters heart, liver and spleen meridians. Dispel stasis, relieve pain, resolve swelling and promote tissue regeneration. Can be used for treating thoracic obstruction, cardialgia, gastralgia, dysmenorrhea, amenorrhea, rheumatalgia, traumatic injury, carbuncle, swelling, and pyocutaneous disease.

Safflower: blood-activating herbs and pain-relieving herbs. Pungent flavor and warm property, entering meridians: heart meridian entered; the liver meridian. The main functions are activating blood and stimulating the menstrual flow, removing stasis and relieving pain.

White pepper: it has the effects of warming middle-jiao, descending qi, eliminating phlegm, and removing toxic substance.

Radix aconiti: pungent, bitter and hot in property and flavor, with strong toxicity. It enters heart, liver, kidney and spleen meridians. Dispel wind and dampness, warm meridians and alleviate pain. Can be used for treating arthralgia due to wind-cold-dampness, arthralgia, and hernia of cold. Can be used for treating arthralgia due to wind-cold-dampness and arthralgia.

B, common clubmoss herb: pungent and slightly bitter in nature, dispel wind and remove dampness, relax tendons and activate collaterals. Can be used for treating joint pain and difficulty in flexion and extension.

Mulberry twig: mild in nature and taste, slightly bitter, dispelling wind-damp and benefiting joints. Can be used for treating rheumatism, shoulder pain, arm pain, and arthralgia.

First, the best material taking quality test 1 and test group for glycerin, sodium polyacrylate and carbomer in the step S05 are determined

Test group 1: the weight of glycerin is 2g, the weight of sodium polyacrylate is 0.4g, the weight of carbomer is 0.1g, the weight of sodium carboxymethylcellulose is 4g, the weight of distilled water is 4g, and the weight of medicinal powder is 1 g;

test group 2: the weight of glycerin is 3g, the weight of sodium polyacrylate is 0.5g, the weight of carbomer is 0.2g, the weight of sodium carboxymethylcellulose is 4g, the weight of distilled water is 4g, and the weight of medicinal powder is 1 g;

test group 3: the weight of glycerin is 4g, the weight of sodium polyacrylate is 0.6g, the weight of carbomer is 0.15g, the weight of sodium carboxymethylcellulose is 4g, the weight of distilled water is 4g, and the weight of medicinal powder is 1 g.

2. Test materials

A weight (Qingdao Tongxi weight Co., Ltd.), a steel ball (Kangda steel ball Co., Ltd., Shandong province), an inclined plate and a glass plate.

3. Test method

Three test groups are respectively subjected to steps S01-S08 to support three groups of emplastrums, the three groups of emplastrums are compared through the evaluation standards of adhesion, lasting adhesion, skin adhesion and sensory indexes, and the optimal material taking amount of glycerin, sodium polyacrylate and carbomer is selected.

4. Test results

Glycerol: sodium polyacrylate: the preferable proportion of carbomer is 4.0: 0.6: when 0.15 hour, the prepared emplastrum has good skin-sticking property, easy uncovering and pasting, ideal physical properties, flat and smooth paste surface, uniform and consistent color, moderate paste hardness, slight elasticity, comfortable skin surface application, capability of resisting certain external force and good shape retention.

Second, pharmacodynamic test

Mouse hot plate analgesic test (test for determining whether the volatile oil is added into ointment to prepare plaster in step S08, that is, whether the mixing of volatile oil and medicinal powder can achieve optimal analgesic effect)

1. Test materials

(1) Medicine

① group of test drugs

A volatile oil moiety group: the volatile oil obtained in step S02;

alcohol-soluble moiety group: the powder obtained in step S04;

volatile oil + alcohol soluble moiety group: mixing the above volatile oil and medicinal powder to obtain volatile oil 3ml/kg and medicinal powder 3 g/kg;

② Positive control drug group

Positive control drug group 1: diclofenac sodium sustained-release tablets (Nouhua pharmaceutical production, batch number: H10980297)

Positive control drug group 2: compound paracetamol tablets (batch number: H20013003, manufactured by southwest pharmaceutical Co., Ltd.)

③ Chinese medicinal control group

Wild papaya slice (Guangdong peace pharmaceutical industry Co., Ltd., batch No. Z44021242)

④ blank group

(2) Animal(s) production

SPF grade mice, weighing 18-22g, female, 70 (supplied by Ningxia university of medicine laboratory animal center).

2. Testing instrument

YLS-6B intelligent hot plate instrument 3 and test method

(1) Grouping and dosing

After the mice are adaptively fed for three days, the mice are randomly divided into 7 groups, each group comprises 10 mice, the tested drug group is a group for administering 3 different extracted substances, and 3ml/kg of volatile oil, 3g/kg of medicinal powder and 3ml/kg of volatile oil and 3g/kg of medicinal powder are respectively administered; 0.04g/kg of diclofenac sodium sustained-release tablets are given to the positive control drug group 1, and 0.3g/kg of compound acetaminophen tablets are given to the positive control drug group 2; 1.2g/kg of stauntonia chinensis slices are given to a traditional Chinese medicine control group; the blank group was given 1ml of physiological saline.

The above groups were administered by intragastric administration 1 time per day.

(2) Dosing and pain threshold determination

The dose (0.1ml/10g) was determined from the body weight of the mice, and each group was administered by gavage 1 time daily for 7 days continuously, and the hot plate method was used after the last administration: the temperature of an YLS-6B intelligent hot plate instrument is adjusted to 55+0.5 ℃, a mouse is placed on the YLS-6B intelligent hot plate instrument, the foot licking of the mouse is recorded as an index of pain response, 1-time pain threshold value is measured every 0min, 15min, 30min and 60min after the last administration, the foot licking of the mouse is used as the index of pain response, if the pain threshold value reaches 60 seconds, the test is stopped, the mouse is taken out, and the pain threshold value of the mouse is calculated in 60 seconds.

(3) Calculation by statistical method

All the data are used

Figure BDA0002327478190000082

Statistical analysis was performed using SPSS 20.0 and the pain threshold differences between groups were compared using the t-test between groups.

5. Test results (see Table 1)

TABLE 1 influence of different substances of herbs on pain threshold of heat-stimulated mice

Figure BDA0002327478190000081

Note: denotes P <0.05(P is probability)

As can be seen from table 1, the pain threshold ratio of the volatile oil + alcohol-soluble fraction group in the heat-stimulated mice was significantly affected (P <0.05) compared to the blank group, the volatile oil fraction group, and the alcohol-soluble fraction group, and thus the analgesic effect was exhibited in the volatile oil + alcohol-soluble fraction group, and the effect was the best, so that the best analgesic effect could be achieved in the patch prepared by adding the volatile oil to the ointment in step S08.

(II) mouse ear swelling method anti-inflammatory test (test for determining whether the volatile oil is added into ointment for preparing emplastrum in step S08, and whether the volatile oil and the medicinal powder are mixed to achieve anti-inflammatory effect)

1. Test materials

(1) Medicine

① group of test drugs

A volatile oil moiety group: the volatile oil obtained in step S02;

alcohol-soluble moiety group: the powder obtained in step S04;

volatile oil + alcohol soluble moiety group: mixing the above volatile oil and medicinal powder to obtain volatile oil 3ml/kg and medicinal powder 3 g/kg;

② Positive control drug group

Positive control drug group 1: diclofenac sodium sustained-release tablets (Nouhua pharmaceutical production, batch number: H10980297)

Positive control drug group 2: compound paracetamol tablets (batch number: H20013003, manufactured by southwest pharmaceutical Co., Ltd.)

③ Chinese medicinal control group

Wild papaya slice (Guangdong peace pharmaceutical industry Co., Ltd., batch No. Z44021242)

④ blank group

(2) Animal(s) production

SPF grade mice, weighing 18-22g, female, 70 (supplied by Ningxia university of medicine laboratory animal center).

2. Testing instrument

XB 220A electronic analytical balance

3. Test method

(1) Grouping and dosing

After the mice are adaptively fed for three days, the mice are randomly divided into 7 groups, each group comprises 10 mice, the tested drug group is a group for administering 3 different extracted substances, and 3ml/kg of volatile oil, 3g/kg of medicinal powder and 3ml/kg of volatile oil and 3g/kg of medicinal powder are respectively administered; 0.04g/kg of diclofenac sodium sustained-release tablets are given to the positive control drug group 1, and 0.3g/kg of compound acetaminophen tablets are given to the positive control drug group 2; 1.2g/kg of stauntonia chinensis slices are given to a traditional Chinese medicine control group; the blank group was given 1ml of physiological saline.

The above groups were administered by intragastric administration 1 time per day.

(2) Dosing and post-inflammatory swelling determination

Determining the dosage (0.1ml/10g) according to the weight of the mouse, carrying out intragastric administration for 1 time per day for each group, continuously administering for 7 days, carrying out administration for 30min after the last administration, smearing dimethylbenzene on the right ear to cause inflammation, taking the left ear as a control, removing the cervical vertebra to kill after half an hour, cutting the same area of the two ears of the mouse by a 7mm puncher, analyzing a balance for weighing, calculating the weight difference of the two ears, namely the swelling degree, and calculating the swelling inhibition rate (%).

(3) Calculation by statistical method

All the data are used

Figure BDA0002327478190000101

Statistical analysis was performed using SPSS 20.0.

5. Test results (see Table 2)

TABLE 2 influence of different substances of the herbs on acute auricle swelling of mice caused by xylene

Figure BDA0002327478190000102

Note: denotes P <0.05(P is probability)

As can be seen from Table 2, the alcohol-soluble part group has a significant inhibitory effect on ear swelling of mice caused by xylene (P < 0.05); the volatile oil and alcohol-soluble part group can also inhibit ear swelling of mice caused by xylene, namely has anti-inflammatory effect, so that the emplastrum prepared by adding the volatile oil into the ointment in the step S08 can achieve the anti-inflammatory effect.

In conclusion, the mixture of the volatile oil and the medicinal powder can relieve ear swelling to play a remarkable role in resisting inflammation and diminishing swelling, has a definite analgesic effect, can effectively relieve pain caused by the diseases, and shows that the medicinal composition can be used for treating and preventing bone rheumatism such as scapulohumeral periarthritis, rheumatic arthritis and the like.

Thirdly, the clinical curative effect of the invention is as follows:

1. sample information

From 2016, month 1 to 18, month 12, 970 patients treated by the present invention were outpatients, wherein 407 men, 563 women, 88 years of age with the greatest age, and 13 years of age with the smallest. The clinical data was accumulated as follows (see table 3):

TABLE 3 number of cases of different arthralgia types and their healing

Arthralgia syndrome type Number of cases Recovery method Is remarkable in that Is basically effective Invalidation High efficiency
Scapulohumeral periarthritis 33 32 1 0 0 100%
Cervical spondylosis of cervical vertebra 177 110 42 11 14 92.09%
Prolapse of lumbar intervertebral disc 363 193 89 55 26 92.84%
Stenosis of lumbar spinal canal 152 78 29 25 20 86.84%
Primary double knee osteoarthritis 155 80 33 29 13 91.61%
Falling pillow 41 32 7 1 1 97.56%
Gout 49 22 17 5 5 89.80%

2. Diagnostic criteria

The specific diagnosis standard of each classification of the arthralgia syndrome in traditional Chinese medicine is taken as a confirmation standard.

3. Standard therapeutic effect (see Table 3)

And (3) healing: clinical symptoms disappear, and the disease does not relapse within one year;

remarkably: symptoms and physical signs are improved, clinical symptoms disappear, but the effect duration is limited, and the symptoms recur within one year;

basically, the method is effective: the symptoms and physical signs are mostly improved, the pain degree is obviously relieved, the pain frequency is reduced, and the pain time is shortened;

and (4) invalidation: the pain symptoms and signs did not change.

4. Method of treatment

The plaster prepared by the invention is externally stuck on a painful part or a corresponding acupuncture point, and can be replaced at proper time according to the disease improvement condition once in 7 to 10 days. During application, if bathing is needed, the patch can be temporarily taken off, the skin is wiped dry after bathing, and the patch is slightly heated and then applied to the original place without reducing the drug effect.

5. Typical cases

Case 1: tan Yufang, 50 years old, retired workers, scapulohumeral periarthritis diagnosed in hospitals, pain appears after a left shoulder is directly blown by cold air of an air conditioner when a patient goes out for 1 week, the left shoulder joint is limited in activity, numbness of upper limbs and dizziness do not exist, symptoms are slightly relieved after self hot compress and physical therapy, the left shoulder joint is still limited in activity and cannot comb one head by self, wind-cold-damp evil qi obstruction of shoulder channels and obstruction of channels and collaterals after the patient is cooled are considered, the plaster prepared by the invention is applied externally, the pain is obviously relieved on the same day, the pain disappears after one treatment course, the shoulder joint activity is obviously improved, and the symptoms are not relapsed after two treatment courses are continuously used.

Case 2: the plaster patch prepared by the invention is externally applied to a bilateral air reservoir and a left shoulder well of a patient after treatment for one course of treatment, the symptoms are obviously relieved, and the patient feels no relapse after continuous use for three courses of treatment by considering the nerve root type cervical spondylosis of the patient.

Case 3: zhou prefecture, age 34, official, hospital diagnosis is prolapse of lumbar intervertebral disc, patient appears lumbago after sitting for a long time, accompanied left lower limb radio-induced pain, numbness and weakness, the symptom is obviously aggravated after catching a cold, it is difficult to stand up, the symptom can be alleviated after lying in bed and rest, because work is busy and has not been treated systematically all the time, buy the external application of GU TONG plaster by oneself, oral analgesic drug therapy, the symptom can be alleviated after treating, but still can't sit for a long time and carry heavy object, attack occasionally, the patient carries out the suggestion of lumbar vertebra CT examination: lumbar disc 4-5 is herniated, and the nerve roots on the left side are obviously compressed. The plaster patch is applied to the lumbar yang-yang deficiency and the kidney-yang deficiency at both sides of a patient after the patient is tired and cooled, the pain symptoms of the waist and the legs are obviously relieved after two treatment courses, and the patient is continuously advised to completely disappear after one treatment course.

The clinical curative effect shows that the traditional Chinese medicine composition can effectively treat the bone rheumatism and has obvious curative effect.

While the invention has been described with reference to a preferred embodiment, it will be understood by those skilled in the art that various changes in form and detail may be made therein without departing from the spirit and scope of the invention.

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