CN116036218A - Shaolin ointment for treating rheumatism and traumatic injury - Google Patents

Abstract

The invention relates to the technical field of traditional Chinese medicines, in particular to a composition and a preparation method of Shaolin rheumatism traumatic injury emulsifiable paste. The cream with the total prescription amount of 1000g comprises the following components: 50-80 g of clear paste, 30-50 g of fluid extract, 100-300 g of white vaseline, 20-150 g of paraffin, 0-200 g of stearic acid, 50-200 g of glyceryl monostearate, 50-200 g of glycerol polyethylene glycol-75 stearate, 8g of menthol, 8g of methyl salicylate, 8g of borneol, 0-50 g of glycerol, 1-5 g of preservative, 0.1-5 g of antioxidant and water, wherein the clear paste is prepared by water extraction of 16g of common monkshood mother root, 16g of raw kusnezoff monkshood root, 16g of combined spicebush root, 16g of common bletilla tuber, 16g of dahurian angelica root, 16g of Japanese ampelopsis root, 16g of ground beetle, 16g of common floweringquince fruit, 16g of common burreed rhizome, 16g of zedoary, 16g of Chinese angelica, 16g of red paeony root, 16g of cinnamon, 32g of rhubarb and 32g of weeping forsythiae capsule, and the fluid extract is prepared by alcohol extraction of 10g of dragon's blood, 6g of frankincense (stir-fried) 6g of myrrh, 6g of sanchi and 6g of catechu. Compared with the commercial Shaolin rheumatism and traumatic injury rubber paste, the Shaolin rheumatism and traumatic injury cream prepared by the invention has the advantages of more flexible coating amount, lower skin irritation, good stability and better curative effect.

Description

Shaolin ointment for treating rheumatism and traumatic injury

Technical Field

The invention relates to the technical field of traditional Chinese medicines, in particular to a composition and a preparation method of Shaolin rheumatism traumatic injury emulsifiable paste.

Background

The shaolin rheumatism traumatic injury ointment is prepared from 22 traditional Chinese medicines such as raw radix aconiti, raw radix aconiti kusnezoffii, rheumatalgia, fructus forsythiae, pseudo-ginseng, menthol and the like, and methyl salicylate, and is mainly used for dispelling blood stasis and activating blood circulation, relaxing tendons and relieving pain, dispelling wind and dispelling cold, and is used for treating traumatic injury and rheumatalgia, wherein the symptoms are pain caused by stasis and swelling at the wounded part and lumbar limb numbness. The traditional commercial Shaolin rheumatism traumatic ointment is rubber ointment, rosin and other components contained in the prescription are adhered to the surface of skin for a long time to easily stimulate the skin, skin damage such as itching, erythema, edema or pimple is generated, partial patients are hard to feel skin damage, and local stuffiness is added after the plaster is adhered to the skin, so that skin inflammation is aggravated, the illness state of the original disease is covered, and treatment is delayed. In addition, the rubber paste has strong viscosity, physical pull injury is easily caused to human skin when the paste is uncovered, and the residual viscous substances on the surface of the human body are not easy to remove, so that the paste has small drug loading rate and long treatment course.

Disclosure of Invention

The invention aims to provide the shaolin rheumatism and traumatic injury cream which is easy to coat, flexible in coating amount, small in skin irritation, good in stability and good in curative effect.

The invention provides a Shaolin rheumatism and traumatic injury emulsifiable paste which is characterized in that the emulsifiable paste with the total prescription of 1000g comprises the following components: 50-80 g of clear paste, 30-50 g of fluid extract, 100-300 g of white vaseline, 20-150 g of paraffin, 0-200 g of stearic acid, 50-200 g of glyceryl monostearate, 50-200 g of glycerol polyethylene glycol-75 stearate, 8g of menthol, 8g of methyl salicylate, 8g of borneol, 0-50 g of glycerol, 1-5 g of preservative, 0.1-5 g of antioxidant and water, wherein the clear paste is prepared by water extraction of 16g of common monkshood mother root, 16g of raw kusnezoff monkshood root, 16g of combined spicebush root, 16g of common bletilla tuber, 16g of dahurian angelica root, 16g of Japanese ampelopsis root, 16g of ground beetle, 16g of common floweringquince fruit, 16g of common burreed rhizome, 16g of zedoary, 16g of Chinese angelica, 16g of red paeony root, 16g of cinnamon, 32g of rhubarb and 32g of weeping forsythiae capsule, and the fluid extract is prepared by alcohol extraction of 10g of dragon's blood, 6g of frankincense (stir-fried) 6g of myrrh, 6g of sanchi and 6g of catechu.

The invention provides a Shaolin ointment for treating rheumatism and traumatic injury, which is characterized in that a preservative is selected from any one of methylparaben and ethylparaben, and an antioxidant is selected from any one of dibutyl hydroxytoluene and propyl gallate.

The invention provides a preparation method of Shaolin rheumatism and traumatic injury cream, which is characterized in that the preparation method of the cream comprises the following steps:

1) Preparing clear paste: adding water which is 16g of common monkshood mother root, 16g of raw kusnezoff monkshood root, 16g of combined spicebush root, 16g of common bletilla tuber, 16g of dahurian angelica root, 16g of Japanese ampelopsis root, 16g of ground beetle, 16g of common floweringquince fruit, 16g of common burreed rhizome, 16g of zedoary, 16g of Chinese angelica, 16g of red paeony root, 16g of cassia bark, 32g of rhubarb, 32g of weeping forsythiae capsule and 6-8 times of the mass of the 15 medicinal materials into an extraction pot, heating for 3 hours to obtain dregs and primary liquid medicine, continuously adding water to carry out twice water extraction on the dregs for 3 hours and 2 hours respectively, mixing the liquid medicine obtained by the twice water extraction and the primary liquid medicine, and concentrating the liquid medicine under reduced pressure at 80 ℃ to obtain clear paste with the relative density of 1.25-1.30;

2) Preparing fluid extract: preparing 10g of dragon's blood, 6g of frankincense (stir-fried), 6g of myrrh (stir-fried), 6g of pseudo-ginseng and 6g of catechu into coarse powder in a pulverizer, and preparing a fluid extract with the relative density of 1.03-1.07 by 90% ethanol;

3) Preparing a emulsifiable paste: heating, melting and mixing the fluid extract, white vaseline, paraffin, stearic acid, glyceryl monostearate, glyceryl distearate, glycerol polyethylene glycol-75 stearate and antioxidant at 75-80 ℃ to obtain a phase I; heating menthol, borneol and methyl salicylate at 50-60 deg.c to mix homogeneously to form phase II; heating and mixing the clear paste, glycerol, preservative and water at 75-80 ℃ uniformly to obtain a phase III; adding phase II and phase III into phase I at 75-80 ℃, stirring and mixing uniformly at 2000-3000 rpm, and cooling to room temperature to form the cream.

Compared with the prior art, the invention has the following advantages: the self-made Shaolin rheumatism and traumatic injury cream effectively solves the problems that the air permeability of the commercial rubber cream is poor, sticky substances are easy to remain, pain, itching or physical strain of a patient are easy to occur when the cream is uncovered, allergic reactions such as erythema and edema are easy to occur on the skin, the drug loading rate is small, the course of treatment is long, the effect is slow, and the like in the use process, and the prepared cream is uniform and fine, easy to coat, flexible in coating amount, good in skin feel, easy to absorb, good in stability, low in irritation, curative effect, safety and better in patient medication compliance.

Detailed Description

Example preparation of Mirabilin ointment for treating rheumatism and traumatic injury

1.1 preparation of fluid extract

Weighing 16g of radix aconiti, 16g of raw kusnezoff monkshood root, 16g of combined spicebush root, 16g of rhizoma bletillae, 16g of dahurian angelica root, 16g of Japanese ampelopsis root, 16g of ground beetle, 16g of papaya, 16g of common burreed rhizome, 16g of zedoary, 16g of Chinese angelica, 16g of red paeony root, 16g of cinnamon, 32g of rhubarb, 32g of weeping forsythiae capsule and 1904g of water, heating for 3 hours to obtain dregs and primary liquid medicine, continuously adding 1088g of water, respectively carrying out water extraction for 3 hours and 2 hours twice, mixing the liquid medicine obtained by the water extraction for two times and the primary liquid medicine, concentrating under reduced pressure at 80 ℃ to obtain clear paste with the relative density of 1.25-1.30, wherein the amount of the clear paste is 67.3g.

1.2 preparation of fluid extract

Weighing 10g of dragon's blood, 6g of frankincense (stir-fried), 6g of myrrh (stir-fried), 6g of pseudo-ginseng and 6g of catechu, preparing coarse powder in a pulverizer, adding the coarse powder into an extraction pot, respectively adding 136g of 90% ethanol twice, respectively extracting for 3 hours under heating and refluxing, mixing the extracting solutions, filtering, and concentrating under reduced pressure at 70-80 ℃ to obtain fluid extract with the relative density of 1.03-1.07, wherein the fluid extract amount is 46.1g.

1.3 preparation of cream

1.3.1 emulsifier screening

Prescription composition:

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the preparation method comprises the following steps: weighing the liquid extract, white vaseline, paraffin, stearic acid, glyceryl monostearate, glyceryl polyethylene glycol-75 stearate or polyethylene glycol-7 stearate, and dibutyl hydroxytoluene with the formula amount, heating at 80deg.C, melting, and mixing to obtain phase I; heating menthol, borneol and methyl salicylate at 50-60 deg.c to mix homogeneously to form phase II; heating and mixing the fluid extract, polysorbate 80, glycerol, ethyl hydroxybenzoate and water at 80deg.C to obtain phase III; adding phase II and phase III into phase I at 80 ℃, stirring and mixing for 30min at 2200-2500 rpm, and cooling to room temperature to form the cream.

1.3.2 stability investigation

Cream samples 1 to 6 were prepared according to the recipe process listed in example one, and the stability of the samples under different conditions was examined, with the following results:

the results show that when the emulsifier selects glycerol polyethylene glycol-75 stearate, the stability of the cream is good and is obviously better than that of polyethylene glycol-7 stearate or polysorbate 80, and the glycerol polyethylene glycol-75 stearate is determined to be used as the emulsifier in self-made cream.

Example two skin irritation and allergy test

2.1 sample preparation and dosing

2.2 skin irritation test

Intact skin: experimental animals: guinea pigs, 300-400 g, male and female halves, are randomly divided into 4 groups of 10 animals each. The back and spine of each guinea pig were shaved symmetrically at two sides and each side was about 20cm in area prior to administration ² 24 hours after dehairing, it was examined whether the dehaired skin was injured, and if injured skin was not suitable for the test.

Dosing method and observations: the experiment adopts the comparison of the guinea pig body left and right, the left dehairing area respectively takes the cream 2 sample of the low dose, the medium dose and the high dose group and the rubber plaster of the commercial drug group, and the corresponding drug administration dose is evenly smeared or stuck on the left bare skin 19cm of the guinea pig ² The blank cream samples of the blank group taken from the right side are uniformly smeared on the right naked skin 19cm of the guinea pig according to the corresponding administration dosage ² As a control, administration was for 24 hoursAfter that, the plaster is removed, the residual medicine is removed by warm water, and the skin condition is observed and recorded at 1h, 24h, 48h and 72h after the medicine is removed.

Broken skin: experimental animals: guinea pigs, 300-400 g, male and female halves, are randomly divided into 4 groups of 10 animals each. The back and spine of each guinea pig were shaved symmetrically at two sides and each side was about 20cm in area prior to administration ² 24 hours after dehairing, it was examined whether the dehaired skin was injured, and if injured skin was not suitable for the test. The 7# syringe needle was used to scratch "#" type lesions on the haired skin of guinea pigs, and the same method as that of intact skin was immediately used for administration and observation until mild bleeding occurred in the skin.

Complete skin irritation results:

the results show that with intact skin administration, the self-made cream was almost free of skin irritation, the commercial rubber cream was slightly irritating, and after 3 days, some guinea pigs showed weak erythema.

Broken skin irritation results:

the results show that when the damaged skin is administrated, the self-made cream has no skin irritation in the middle-dose group and the low-dose group, the high-dose group has light skin irritation, the skin symptoms subside after 2 days, the commercial rubber paste has light to moderate irritation, part of guinea pig erythema still does not subside after 3 days, and the overall skin irritation of the self-made cream is superior to that of the commercial medicine.

2.3 skin allergy test

Experimental animals: guinea pigs, 300-400 g, male and female halves, are randomly divided into 6 groups of 10 animals each. Before administration at eachHairing is carried out on two symmetrical positions of the back spine of the guinea pig, and the area of each side is about 20cm ² 24 hours after dehairing, it was checked whether the dehaired skin was injured, e.g. injured skin was not suitable for testing.

Dosing method and observations:

sensitization contact: respectively taking low dose, medium dose, high dose, blank group of cream samples, commercially available drug group rubber plaster, and 1% positive control group of cream samples, and uniformly applying or pasting on the left side dehairing zone (19 cm) of guinea pig according to corresponding dosage ² ) Drug removal was performed 6 hours after administration, and 1 and 3 times in the same manner were repeated for 7 days and 14 days.

Excitation contact: at 14 days after the final sensitization, respectively taking low dose, medium dose, high dose, blank group cream samples, commercially available medicine group rubber paste, 0.1% positive control group cream samples, and uniformly applying or pasting the cream samples on the right side dehairing zone (19 cm) of corresponding guinea pigs according to the corresponding administration dosage ² ) After 6 hours, the medicines are removed, and the skin conditions are observed and recorded at 0h, 24h, 48h and 72h respectively.

The results showed that the positive control group had all allergic reactions (sensitization rate 100%), the self-made cream did not have allergic reactions (sensitization rate 0%) in the low, medium and high dose groups and the blank group, the sensitization rate was 50% in the commercial group, and the allergic reactions subsided after 3 days.

Example three self-made Shaolin rheumatism and Dieda cream treatment effect test

Test population: 50 volunteers with the age of 25-60 years and the body with bruises and pains are selected as trial subjects, wherein 22 men and 28 women are randomly divided into 2 groups of 25 persons.

Dosing method and observations: from pharmaceutical group: a shaolin rheumatism and traumatic injury cream sample was prepared by the method of example 2 at 1.87g/100cm ² The administration dose of the medicine is uniformly smeared on the pain parts of the stasis and swelling on the volunteers, and the medicine is used for 3 days once a day; commercial drug group: a plaster containing xiaolin for treating rheumatism and traumatic injuryThe amount is as follows: 1.87g/100cm ² ) Cutting into pieces, and applying onto the pain parts of volunteers with swelling and pain parts for 3 days. The administration areas from the pharmaceutical and commercial drug groups should cover the pain sites of the volunteers and the administration areas of both should be consistent. Both groups of volunteers self-described the effect of use and scored 3 days after dosing.

The scoring criteria and results were as follows:

group of	Scoring results
		Self-pharmacy group	4.4
Commercial medicine group	2.9

The results show that compared with the commercially available rubber paste, the self-made cream has better skin feel, quicker response, better curative effect and lower incidence of adverse reaction.

Claims (3)

1. A Shaolin ointment for treating rheumatism and traumatic injury is characterized in that the ointment with the total prescription of 1000g comprises the following components: 50-80 g of clear paste, 30-50 g of fluid extract, 100-300 g of white vaseline, 20-150 g of paraffin, 0-200 g of stearic acid, 50-200 g of glyceryl monostearate, 50-200 g of glycerol polyethylene glycol-75 stearate, 8g of menthol, 8g of methyl salicylate, 8g of borneol, 0-50 g of glycerol, 1-5 g of preservative, 0.1-5 g of antioxidant and water, wherein the clear paste is prepared by water extraction of 16g of common monkshood mother root, 16g of raw kusnezoff monkshood root, 16g of combined spicebush root, 16g of common bletilla tuber, 16g of dahurian angelica root, 16g of Japanese ampelopsis root, 16g of ground beetle, 16g of common floweringquince fruit, 16g of common burreed rhizome, 16g of zedoary, 16g of Chinese angelica, 16g of red paeony root, 16g of cinnamon, 32g of rhubarb and 32g of weeping forsythiae capsule, and the fluid extract is prepared by alcohol extraction of 10g of dragon's blood, 6g of frankincense (stir-fried) 6g of myrrh, 6g of sanchi and 6g of catechu.

2. The selinum rheumaticum traumatic injury cream according to claim 1, wherein the preservative is selected from any one of methylparaben and ethylparaben, and the antioxidant is selected from any one of dibutylhydroxytoluene and propyl gallate.

3. The shaolin rheumatism traumatic cream as claimed in claim 1, wherein the preparation method of the cream comprises the following steps:

1) Preparing clear paste: adding water which is 16g of common monkshood mother root, 16g of raw kusnezoff monkshood root, 16g of combined spicebush root, 16g of common bletilla tuber, 16g of dahurian angelica root, 16g of Japanese ampelopsis root, 16g of ground beetle, 16g of common floweringquince fruit, 16g of common burreed rhizome, 16g of zedoary, 16g of Chinese angelica, 16g of red paeony root, 16g of cassia bark, 32g of rhubarb, 32g of weeping forsythiae capsule and 6-8 times of the mass of the 15 medicinal materials into an extraction pot, heating for 3 hours to obtain dregs and primary liquid medicine, continuously adding water to carry out twice water extraction on the dregs for 3 hours and 2 hours respectively, mixing the liquid medicine obtained by the twice water extraction and the primary liquid medicine, and concentrating the liquid medicine under reduced pressure at 80 ℃ to obtain clear paste with the relative density of 1.25-1.30;

2) Preparing fluid extract: preparing 10g of dragon's blood, 6g of frankincense (stir-fried), 6g of myrrh (stir-fried), 6g of pseudo-ginseng and 6g of catechu into coarse powder in a pulverizer, and preparing a fluid extract with the relative density of 1.03-1.07 by 90% ethanol;

3) Preparing a emulsifiable paste: heating, melting and mixing the fluid extract, white vaseline, paraffin, stearic acid, glyceryl monostearate, glyceryl distearate, glycerol polyethylene glycol-75 stearate and antioxidant at 75-80 ℃ to obtain a phase I; heating menthol, borneol and methyl salicylate at 50-60 deg.c to mix homogeneously to form phase II; heating and mixing the clear paste, glycerol, preservative and water at 75-80 ℃ uniformly to obtain a phase III; adding phase II and phase III into phase I at 75-80 ℃, stirring and mixing uniformly at 2000-3000 rpm, and cooling to room temperature to form the cream.