CN113925846A

CN113925846A - Black plaster suitable for acute soft tissue injury and preparation method thereof

Info

Publication number: CN113925846A
Application number: CN202111230297.7A
Authority: CN
Inventors: 黄彬荣; 胡耀祖
Original assignee: Hunan Kaiyuan Museum; Yiyang Disabled Rehabilitation Hospital of Yiyang The First Hospital of Tradicional Chinese Medicine
Current assignee: Hunan Kaiyuan Museum; Yiyang Disabled Rehabilitation Hospital of Yiyang The First Hospital of Tradicional Chinese Medicine
Priority date: 2021-10-22
Filing date: 2021-10-22
Publication date: 2022-01-14

Abstract

The invention discloses a black plaster suitable for acute soft tissue injury and capable of safely and rapidly achieving effective analgesia and a preparation method thereof, and the black plaster is characterized by being prepared from Chinese angelica, dahurian angelica root, figwort root, rhubarb, red paeony root, liquoric root, myrrh, dragon's blood, yellow wax, white glue, red lead, borneol, musk, frankincense and the like which are used as raw materials in proportion; the formula and the preparation process are scientific and reasonable, and the utilization rate and the drug effect of the formula drug can be effectively improved; the minium which has the function of the adhesive can also combine the effective components in the traditional Chinese medicine with the minium to enable the effective components to be in closer contact with pores, and the effective components can quickly permeate the pores to enter local blood circulation; the external transdermal absorption has no first-pass effect and high drug utilization rate; the black plaster matrix has mild drug property, and effectively reduces skin allergy and anaphylactic reaction; the traditional Chinese medicine composition has the same analgesic effect as an oral medicine, is safer, has small side effect and greatly reduces the incidence rate of adverse reactions; can be applied to the affected part for a long time, and has lasting effect; has good analgesic and anti-inflammatory effects.

Description

Black plaster suitable for acute soft tissue injury and preparation method thereof

Technical Field

The invention relates to the technical field of traditional Chinese medicine preparations, in particular to an external plaster, and especially relates to a black plaster suitable for acute soft tissue injury and a preparation method thereof.

Background

In the past, intravenous injection is often selected by common people for the purpose of relieving symptoms and pain as quickly as possible. However, intravenous injection accounts for more than half of the incidence of adverse drug reactions. The main reason is that the medicine directly enters blood circulation from a special way of intravenous infusion, and is not filtered by a natural barrier of a human body, so that the medicine effect is exerted too fast, and the adverse reaction is quicker and more serious. Even under the most strict operation environment, the infusion process is difficult to avoid carrying particles, and the particles can accumulate in the capillaries of organs such as heart, lung, liver, kidney and the like after entering a human body, thereby causing serious diseases such as vascular embolism, pulmonary hypertension and the like, and further causing local blood supply insufficiency, tissue ischemia, hypoxia, edema, inflammation, anaphylactic reaction and the like. Adverse drug reactions caused by intravenous administration are not easy to be seen, and the body immunity can be reduced and the drug resistance of bacteria can be induced by frequent transfusion. Some treatment options such as intravenous injection waste medical resources, more than 80% of infusion prescriptions are antibiotics for resisting bacteria and diminishing inflammation, and abuse phenomena are common. Meanwhile, the price of the medicine is high, and the treatment cost is increased.

In recent years, under the advocation of 'reducing intravenous infusion' of world health organization, many provinces of China begin to implement a policy scheme of stopping infusion in outpatient service at present, so that the abuse of antibacterial drugs is gradually prevented and the occurrence of phytotoxicity is reduced. People abandon 'infusion' and select other medicines for administration when mild symptoms occur. Most of the existing medicines are oral medicines and are completed through gastrointestinal tract digestive system and liver metabolism. All oral drugs are absorbed through the gastrointestinal wall. And then into the portal vein. Some drugs have little metabolic effect, and some drugs are metabolized and eliminated widely in the gastrointestinal wall or liver. The first-pass action enhances the metabolism, reduces the amount of drug entering the systemic circulation and the absorption, resulting in a reduced therapeutic effect. Increasing the oral dosage to saturate the drug metabolism and overcome the consumption of the first-pass action is also a waste of medical resources and does not actually improve the bioavailability. And the oral medicine also has adverse reaction, and the higher the dosage, the higher the possibility of adverse reaction and the more serious the degree.

The parenteral administration route avoiding the first pass effect can be used for obtaining the medicine by percutaneous absorption except injection. Transdermal absorption of a drug refers to the process by which the drug passes through the epidermis, is absorbed by the capillaries and lymph into the systemic circulation. The transdermal absorption process of the medicine mainly comprises three stages of release, penetration and absorption into the blood circulation. Refers to the process of absorption of the drug applied to the skin through the sweat gland channel, transport through the stratum corneum and transport through the deep epidermis. Release refers to the release of the drug from the matrix and diffusion to the skin or mucosal surface. The famous medicine Xuanxi says that the property of a drug can enter into the skin and muscle from the pores, clear the meridians, or be extracted or be attacked to disperse, especially when being taken, it is said to be magical in magical way by sticking the paste to block the qi. Ancient people had a discussion of "skin separation and hair opening", which indicates that the external application of Chinese herbs can be absorbed through skin to achieve the effects of regulating qi, harmonizing yin and yang and dredging viscera. The percutaneous absorption type medicine achieves the purposes of medication and treatment through the action of skin absorption.

The plaster is one of five Chinese medicine preparations, i.e. pill, powder, ointment, pellet and soup. As the name implies, a paste is a viscous substance. The paste is a solid, semisolid or semi-fluid preparation at normal temperature. Consists of two parts of a drug and a matrix (also without the matrix). The black plaster is an external preparation for being pasted on skin, which is prepared by refining medicinal materials, edible vegetable oil and red lead into paste and spreading the paste on a backing material. It has protective, sealing and therapeutic effects, thick ointment layer, and long-lasting effect. Black plaster appears in the Wen and jin period, the preparation of Tang and Song is gradually improved and widely used, and the Mingqing period is one of the common medicines. In recent times, the use of black plaster is greatly reduced due to the development of decoction. After the rubber plaster of modern technology appeared, black plaster was almost completely disappointed from hospitals and only circulated in civilian.

According to modern pharmacological research, the black plaster is superior to the rubber plaster in absorption and curative effect. Because the manufacturing process of the black plaster is complex and the quality control is not easy to carry out, the traditional Chinese medicine external application is carried out in traditional Chinese medicine hospitals, namely, the Chinese herbal medicines are crushed and then added with matrixes such as honey, vaseline and the like to be externally applied in an ointment shape, and then the medicines are fixed by cotton paper and bandages, the medicine is changed every 24 hours, and the use cost is high. The black plaster can be used for 3 to 15 days after being pasted for a long time, and can be pasted again after being taken off, so that the curative effect is not influenced, and the cost is lower.

The transdermal absorption is adopted, and the transdermal drug delivery system has the advantages of removing the first pass effect of the liver and avoiding the chemical and biological effects of the drug on the lower gastrointestinal tract. With the rapid development of the research of Transdermal Drug Delivery System (TDDS), the application range of the external ointment is wider.

Aspirin,2- (acetoxy) benzoic acid, also known as acetylsalicylic acid. Is a white crystal or crystalline powder, has no odor or slight acetic acid odor, is slightly soluble in water, is easily soluble in ethanol, is soluble in diethyl ether and chloroform, and has acidic aqueous solution. The product is a salicylic acid derivative, and clinical application for nearly a hundred years proves that the product has better effect on relieving mild or moderate pain, such as toothache, headache, neuralgia, muscular soreness and dysmenorrheal. It is also used for treating fever due to common cold and influenza, and rheumatalgia. In recent years, aspirin has an inhibiting effect on platelet aggregation and can prevent thrombosis, and the aspirin is clinically used for preventing transient ischemic attack, myocardial infarction, artificial heart valves and venous fistula or the formation of thrombosis after other operations. Aspirin is a long-standing antipyretic analgesic. Because of easy absorption after oral administration, the aspirin oral liquid has wide tissue distribution and strong effect on the whole body, and the adverse reactions of the aspirin are gradually increased along with the wide application of the aspirin.

Gastrointestinal symptoms are the most common adverse reactions of aspirin, and the more common symptoms are nausea, vomiting, epigastric discomfort or pain and the like. Oral aspirin can directly stimulate gastric mucosa to cause epigastric discomfort, nausea and vomiting. The long-term use of the medicine is easy to cause gastric mucosa injury, gastric ulcer and gastrorrhagia. Blood images, fecal occult blood tests and necessary gastroscopy should be monitored frequently after long-term use. Aspirin is preferably taken after meal or together with antacid, and should be used with cautions or not for ulcer patients. The medicine for enhancing the barrier function of the gastric mucosa, such as misoprostol, has special effect on peptic ulcer caused by non-steroidal anti-inflammatory drugs, such as aspirin. Patients with specific physique can cause allergic reactions such as rash, angioneurotic edema and asthma after taking aspirin, and are often seen in middle-aged people or patients with rhinitis and nasal polyp. Aspirin inhibits the production of prostaglandins, and is also associated with its effects on the immune system. Most of the asthma is serious and persistent, but generally, the antiasthmatic drugs are mostly ineffective and only have good hormone effect. Classic aspirin triple (aspirin intolerance, asthma and nasal polyps) may also occur. The nervous symptoms generally appear when the dosage is large, so-called salicylic acid reaction appears, the symptoms are headache, dizziness, tinnitus and visual and audio power decline, when the dosage is too large, confusion, convulsion, even coma and the like can appear, and the symptoms can be completely recovered 2 to 3 days after the medicine is stopped. High doses may also cause central nausea and vomiting. Aspirin induced liver damage commonly occurs when applied at high doses. This lesion is not an acute effect and is characterized by the fact that it occurs several months after treatment, usually asymptomatic, with some patients presenting discomfort and tenderness to the upper right of the abdomen. Serum liver enzyme levels are elevated, but significant jaundice is not common. The damage is reversible after aspirin is stopped, serum transaminase mostly returns to normal within 1 month after the aspirin is stopped, and the liver damage is easy to occur in children with systemic rheumatoid disease compared with other two types of rheumatism. After aspirin causes liver damage, the clinical treatment method is to stop taking the medicine, and amino acid fluid infusion, VitC, inosine and other medicines are taken, so that the symptoms generally disappear after 1 week. Interstitial nephritis, renal papilla necrosis, and renal hypofunction may occur with long-term use of aspirin. After long-term administration, the product can cause oxidative phosphorylation and uncoupling, potassium escapes from renal tubular cells, so potassium deficiency and overhigh uric acid discharge in urine are caused, and protein, cells, casts and the like can appear in lower-section urine with great damage. It is believed that some renal pelvis cancers are secondary complications of abuse of analgesics such as aspirin. Aspirin does not generally change the number of white blood cells and platelets, as well as the hematocrit and hemoglobin content. But chronic aspirin use can lead to iron deficiency anemia. Therapeutic doses of aspirin have no significant direct effect on the cardiovascular system. Large doses may act directly on vascular smooth muscle, resulting in peripheral vasodilation. Toxic doses may inhibit circulation by direct and central vasomotor paralysis. Aspirin may cause rayleigh syndrome when applied to children's influenza or varicella therapy. The reich syndrome is an acute encephalopathy and liver fatty infiltration syndrome, often occurring after certain acute viral infections. The etiology is not clear, but is generally thought to be related to the following factors: such as viruses (influenza virus and varicella virus), salicylate, exogenous viruses (aflatoxin), intrinsic metabolic defect, etc., and all factors can exist together or are caused by mutual influence among all factors. Aspirin is not advocated for clinical viral colds. Cross-allergic reactions can also be caused. The product is allergic to another salicylic acid drug. However, those allergic to this product are not always allergic to nonacetylated salicylic acid drugs.

Disclosure of Invention

The invention aims to provide a black plaster which can safely and quickly achieve effective analgesic effect and is suitable for acute soft tissue injury and a preparation method thereof.

The invention adopts the following technical scheme to realize the aim, and the black plaster suitable for acute soft tissue injury is prepared from the following raw materials in parts by weight:

the formula I is as follows: 25 to 35g of angelica, 25 to 35g of angelica dahurica, 25 to 35g of radix scrophulariae, 25 to 35g of rhubarb, 25 to 35g of red peony root and 25 to 35g of liquorice;

and the formula II comprises: 150 to 250g of myrrh, 150 to 250g of dragon's blood, 150 to 250g of yellow wax, 150 to 250g of white glue and 200 to 300g of red lead;

the formula III is as follows: 40 to 60g of borneol, 40 to 60g of musk, 40 to 60g of frankincense, 40 to 60g of myrrh and 40 to 60g of rush;

600-700 g of sesame oil.

The black plaster suitable for acute soft tissue injury comprises the following raw materials in parts by weight:

the formula I is as follows: 30 to 35g of angelica, 25 to 30g of angelica dahurica, 30 to 35g of radix scrophulariae, 25 to 30g of rhubarb, 30 to 35g of red peony root and 25 to 30g of liquorice;

and the formula II comprises: 200 to 250g of myrrh, 180 to 200g of dragon's blood, 200 to 250g of yellow wax, 220 to 250g of white glue and 200 to 250g of red lead;

the formula III is as follows: 45 to 55g of borneol, 45 to 50g of musk, 50 to 60g of frankincense, 50 to 60g of myrrh and 50 to 60g of rush;

630-700 g of sesame oil.

Preferably, the black plaster for acute soft tissue injury comprises the following raw materials in parts by weight:

the formula I is as follows: 30g of angelica, 30g of angelica dahurica, 30g of radix scrophulariae, 25g of rhubarb, 30g of red peony root and 25g of liquorice;

and the formula II comprises: 200g of myrrh, 200g of dragon's blood, 250g of yellow wax, 250g of white glue and 200g of red lead;

the formula III is as follows: 50g of borneol, 45g of musk, 60g of frankincense, 60g of myrrh and 50g of juncus effuses;

700g of sesame oil.

The rhubarb of the invention is raw rhubarb.

The preparation method of the black plaster suitable for acute soft tissue injury comprises the following steps:

the technical scheme includes that the first-component raw material medicines (Chinese angelica, dahurian angelica root, figwort root, raw rhubarb, red paeony root and liquoric root) are crushed and mixed according to a ratio, and an obtained first-component medicine mixture is put into sesame oil in a container and is uniformly stirred;

heating the oil-medicine mixture in the container and heating the oil-medicine mixture in the container, and continuously stirring the mixture to ensure that the composition-medicine mixture in the sesame oil is heated uniformly and fried to be withered and yellow (the oil color is dark brown, the inner part is scorched and the oil is not carbonized), and filtering dregs of the medicine to obtain filtered oil;

thirdly, adding the second raw material medicine (myrrh, dragon's blood, yellow wax and white glue) into the oil filter obtained in the second step according to the proportion, heating to 300-330 ℃ (320 ℃) and decocting to form water dripping beading to obtain medicinal oil;

fourthly, the medicinal oil is continuously heated for 5-10 minutes and is continuously stirred, so that oxides generated by the medicinal oil and the medicinal mixture of the second formula are promoted to be evaporated, impurities in the medicinal oil are reduced to the minimum extent, and the quality of the ointment is improved; then, the mixture is taken out of the fire when the temperature is between 300 and 360 ℃, lead is evenly sieved when the oil temperature is reduced to between 250 and 270 ℃, and the mixture is stirred along one direction, so that the lead is combined with the medicinal oil, and the lead is prevented from floating on the oil surface or being deposited on the bottom of grains, and the full reaction is carried out;

fifthly, pouring the obtained ointment into water for soaking for removing fire toxin, avoiding skin irritation, erythema, pruritus and even blistering ulcer, and condensing for later use;

sixthly, crushing the three raw materials (borneol, musk, frankincense, myrrh and juncus effusus) into fine powder, mixing uniformly, and sieving, wherein the condensed ointment obtained in the step is divided according to the parts by weight for later use;

taking the ointment out of the water, heating and melting the ointment to remove water vapor, cooling the ointment to 70-80 ℃, adding the ointment into the medicinal powder obtained in the step sixteenth according to the proportion, and uniformly stirring the ointment; spreading and coating to obtain the finished product.

The method comprises the following steps of: 25 to 35g of angelica, 25 to 35g of angelica dahurica, 25 to 35g of radix scrophulariae, 25 to 35g of rhubarb, 25 to 35g of red peony root, 25 to 35g of liquorice and 600 to 700g of sesame oil; the formula II in the step III comprises 150-250 g of myrrh, 150-250 g of dragon's blood, 150-250 g of yellow wax, 150-250 g of white glue and 200-300 g of red lead; the formula III in the step VI is prepared from 40g to 60g of borneol, 40g to 60g of musk, 40g to 60g of frankincense, 40g to 60g of myrrh and 40g to 60g of rush.

In the steps, sesame oil is preheated to 40-80 ℃ before a medicine mixture in a composition is put into the sesame oil; after the composition I medicine mixture is put into sesame oil, soaking for 1 to 1.5 hours at the temperature of between 90 and 100 ℃ in a heat preservation way, namely heating the container and the oil-medicine mixture in the container in a water bath, and avoiding the situation that hard parts in the composition I medicine mixture are not penetrated and the medicine effect cannot be fully exerted; heating the sesame oil to 220-240 ℃ (230 ℃) for 1-3.5 hours.

The step of the invention comprises soaking the Chinese medicinal paste in water for 24 hours; the temperature for heating and melting the stephania ointment is not more than 100 ℃.

Angelica sinensis is dried root of Angelica sinensis (Oliv.) Diels of Umbelliferae. The root of the whole angelica is slightly cylindrical and is divided into three parts by people, wherein the head part at the upper end of the root is called 'the head part', the main root at the middle part is called 'the body part' or 'the cun body', the branch root at the tail part is called 'the tail part' or 'the leg part', and the whole is called 'the whole body'. Whole Chinese angelica root, radix Angelicae sinensis can nourish blood and promote blood circulation. It is often used for treating blood deficiency, sallow complexion, giddiness, palpitation, menoxenia, amenorrhea, dysmenorrhea, asthenia cold, abdominal pain, constipation due to intestinal dryness, rheumatalgia, traumatic injury, superficial infection, pyocutaneous disease.

Radix Angelicae Dahuricae is dried root of Angelica dahurica or Angelica dahurica of Umbelliferae. Pungent flavor and warm nature. It enters lung, spleen and stomach meridians. Has the functions of relieving exterior syndrome, dispelling cold, dispelling pathogenic wind, relieving pain, dredging nasal orifice, eliminating disease, removing dampness, eliminating dampness, stopping leukorrhagia, dispelling pathogenic wind, relieving itching, relieving swelling, expelling pus, promoting granulation, promoting blood circulation, relieving pain, etc. Can be used for treating wind-cold type common cold, headache, rhinitis, and toothache. Rheumatic arthralgia, nasosinusitis, leucorrhea with reddish discharge, pain, furuncle, and pyogenic infections.

Radix scrophulariae is root of Scrophularia ningpoensis Fisch of Scrophulariaceae. Alias: radix scrophulariae, and radix scrophulariae. Is bitter and salty in taste. Slightly cold in nature. Is nontoxic. The main treatment is as follows: fever, nutritional blood, fever, polydipsia, crimson tongue, macula, bone-steaming, overstrain cough, restlessness, constipation due to body fluid deficiency, dryness and dim eyesight, sore throat, scrofula, subcutaneous nodule, superficial infection and sore toxicity.

The radix et rhizoma Rhei is dried root and rhizome of Rheum palmatum L, Rheum tanguticum Maxim. ex Baif. or Rheum officinale Baill. of Polygonaceae. Collecting and digging stems and leaves at late autumn or before germination in spring, removing thin roots, scraping outer skin, cutting into sections or segments, stringing, and drying or directly drying. Nature and taste: bitter and cold. Has the functions of purging excess heat, promoting the flow of food retention, removing blood stasis and removing toxic material. Can be used for treating excessive heat constipation, abdominal pain due to stagnation, jaundice due to damp-heat pathogen, acute appendicitis, incomplete intestinal obstruction, amenorrhea due to blood stasis, carbuncle, furuncle, suppurative dermatoses, burn, and scald. Raw rhubarb refers to decoction pieces of crude medicinal materials. Has the main functions of removing food retention and relieving constipation, and is used for treating excess heat in stomach and intestine and constipation.

The radix Paeoniae Rubra is dried root of Paeonia lactiflora pall or Paeonia veitchii Schott of Ranunculaceae. Bitter in taste and slightly cold in nature. It enters liver meridian. Has the effects of clearing heat, cooling blood, promoting blood circulation and removing blood stasis. Can be used for treating heat entering nutrient-blood, toxic heat macula, hematemesis and epistaxis, conjunctival congestion, swelling and pain, liver depression, hypochondriac pain, amenorrhea, dysmenorrhea, abdominal pain, traumatic injury, carbuncle, swelling, and pyocutaneous disease.

The Glycyrrhrizae radix is dried root and rhizome of Glycyrrhiza uralensis Fisch, Glycyrrhiza inflata Bat, or Glycyrrhiza glabra L. Sweet in flavor and neutral in nature. Has the effects of invigorating spleen and replenishing qi, clearing away heat and toxic materials, eliminating phlegm and stopping cough, relieving spasm and pain, and harmonizing the medicines. It is indicated for spleen and stomach deficiency, lassitude and hypodynamia, palpitation and shortness of breath, cough with profuse sputum, spasm and pain of abdomen and limbs, carbuncle and sore, and to relieve toxicity and strong action of drugs.

The Olibanum is resin exuded from bark of Boswellia carterii Birdw of Burseraceae and Boswellia bhauradaijiana Birdw of the same genus. The product is in the form of long oval emulsion, round-like granule or irregular block with different sizes. The major ones are up to 2cm (Boswellia carterii bead) or 5cm (Boswellia carterii). The surface is yellowish white and semitransparent, and is darkened after long-term storage by yellowish white powder. It is brittle and softened by heat. The fracture surface has a glass-like or wax-like luster. Has special fragrance and slightly bitter taste. It is usually processed by vinegar-moxibustion. Pungent, bitter and warm in nature. Has effects of promoting blood circulation, activating qi-flowing, relieving pain, eliminating swelling and promoting granulation. Can be used for treating thoracic obstruction, cardialgia, epigastralgia, dysmenorrhea, amenorrhea, puerperal blood stasis, abdominal pain, rheumatic arthralgia, spasm of muscles and tendons, traumatic injury, carbuncle, swelling, and pyocutaneous disease.

The Myrrha is dried resin of Commiphora myrrha Engl. or Commiphora molmol Engl. of Burseraceae. Is divided into natural myrrh and colloid myrrh. Pungent and bitter in flavor and mild in nature. Has the effects of removing blood stasis, relieving pain, eliminating swelling and promoting granulation. It is often used for treating thoracic obstruction, heart pain, epigastric pain, dysmenorrhea, amenorrhea, postpartum stasis, abdominal mass, rheumatic arthralgia, traumatic injury, carbuncle, swelling, sore and ulcer.

Sanguis Draxonis is resin exuded from fruit of daemonorops draco of Palmaceae. Sweet, salty and neutral in nature. Has effects of promoting blood circulation, relieving pain, removing blood stasis, stopping bleeding, promoting granulation, and healing sore. Can be used for treating traumatic injury, heart and abdomen blood stasis and pain, traumatic hemorrhage, and unhealed skin and external diseases.

The Plumbum Preparatium is prepared from pure lead. Pungent flavor and slightly cold in nature. Has the effects of removing toxic substances and putrefaction, astringing dampness and promoting wound healing, eliminating phlegm and relieving convulsion. It is commonly used for abscess, deep-rooted carbuncle, sores and ulcers, external hemorrhoid, eczema, burn and scald.

The beeswax is prepared by squeezing dried honey from honeycomb constructed by worker bee, and decocting in water. Contains a large amount of active ingredients and acidic substances. Has astringent, sore healing, granulation promoting, and analgesic effects. It is indicated for unhealed ulcer, wound, burn and scald.

The white gum is white gum incense, and is resin of resina Liquidambaris of Hamamelidaceae. The main functional indications are as follows: promoting blood circulation, cooling blood, removing toxic substance and relieving pain. It is indicated for abscess, deep-rooted carbuncle, sores and scabies, urticaria, scrofula, incised sores, toothache, hematemesis and epistaxis.

Borneolum, named as Borneolum, pericarpium Citri Tangerinae, folium Artemisiae Argyi, Borneolum Syntheticum, Serissa, Borneolum Syntheticum, and Borneolum Syntheticum, is prepared from stems and leaves of blumea balsamifera of Compositae or branches and leaves of Cinnamomum camphora of Lauraceae by steam distillation and recrystallization. Pungent, bitter and slightly cold in flavor; heart, liver and lung meridians entered; the product has effects of inducing resuscitation, refreshing mind, clearing heat, removing toxic substance, improving eyesight, and removing nebula, and can be used for treating fever, hyperpyrexia, coma, apoplexy, phlegm syncope, convulsion, summer-heat dampness covering resuscitation, pharyngitis, deafness, aphtha, swelling of teeth, skin ulcer, carbuncle, malnutritional hemorrhoid, conjunctival congestion, swelling and pain, nebula, and eye covering. For phlegm-fire stagnation, throat impediment, hoarseness, or heat accumulation, mouth sores and swollen teeth, borneol can be combined with cinnabar, borax and glauber salt to blow on the affected part to dissipate fire and remove toxicity. For coma due to heat block, Bing pian can be combined with she Xiang, niu Huang, Huang Lian and Yu jin to clear heat and induce resuscitation. For sudden fire or pterygium, Bing pian can be combined with Lian Gao Shi, Xuan Ming powder and Borax to make eyes in powder.

The Moschus is dry secretion of mature male sachet of forest musk deer moschus berezovski Flerov, horse musk deer M.sifanicus Przewalski or original musk deer M.moscheffersus Linnaeus. Has effects of inducing resuscitation, refreshing mind, promoting blood circulation, dredging channels, and relieving swelling and pain. It can be used for treating block syndrome of unconsciousness, pyocutaneous disease, toxic swelling, scrofula, subcutaneous nodule, sore throat, amenorrhea due to blood stasis, abdominal mass, heart and abdomen pain, headache, traumatic injury, arthralgia due to wind-cold-dampness, dystocia, dead fetus, and retained afterbirth.

Medulla Junci is dry stem pith of Juncus effusus L. of Juncus of Juncaceae, and is used for extracting core or air drying and cutting into pieces. Sweet and bland in flavor, slightly cold in nature. Has effects of clearing heart fire and promoting urination. Can be used for treating vexation, insomnia, oliguria, odynuria, aphtha of the mouth and tongue

The sesame oil is sesame oil, which is fatty oil extracted from seed of semen Sesami of Pedaliaceae. The main functional indications are as follows: moisten dryness and relax bowels, remove toxicity and promote tissue regeneration. Sweet taste and cool nature. Has effects in moistening dryness, relieving constipation, removing toxic materials, and promoting granulation. It is indicated for constipation due to intestinal dryness, ascarid, abdominal pain due to dyspepsia, sore, ulcer, scabies, tinea, and chapped skin. Rihuazi Bencao: the old oil is decocted into paste, promotes tissue regeneration and flesh growth, relieves pain, eliminates carbuncle and swelling, and tonifies skin cracks.

By adopting the technical scheme, the invention better realizes the aim of the invention, has scientific and reasonable formula and preparation process, supplements each other, and can effectively improve the utilization rate and the drug effect of the formula; the minium which has the function of the adhesive can also combine the effective components in the traditional Chinese medicine with the minium to enable the effective components to be in closer contact with pores, and the effective components can quickly permeate the pores to enter local blood circulation; the external transdermal absorption has no first-pass effect and high drug utilization rate; the black plaster matrix has mild drug property, and effectively reduces skin allergy and anaphylactic reaction; the traditional Chinese medicine composition has the same analgesic effect as the oral medicine, is safer, has small side effect and greatly reduces the incidence rate of adverse reactions; can be applied to the affected part for a long time, and has lasting effect; has good analgesic and anti-inflammatory effects.

Detailed Description

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

Example 1:

a black plaster suitable for acute soft tissue injury is prepared from the following raw materials in parts by weight:

600-700 g of sesame oil (in the embodiment, the first formula comprises 30g of angelica sinensis, 30g of angelica dahurica, 30g of radix scrophulariae, 25g of rheum officinale, 30g of red peony root and 25g of liquorice, the second formula comprises 200g of myrrh, 200g of dragon's blood, 250g of yellow wax, 250g of white glue and 200g of red lead, and the third formula comprises 50g of borneol, 45g of musk, 60g of frankincense, 60g of myrrh, 50g of juncus effuses and 700g of sesame oil).

The rhubarb of the invention is raw rhubarb.

thirdly, adding the second raw material medicine (myrrh, dragon's blood, yellow wax and white glue) into the oil filter obtained in the second step according to the proportion, and decocting to obtain the medicinal oil;

fourthly, the medicinal oil is continuously heated and continuously stirred to promote the evaporation of the oxides generated by the medicinal oil in the step three and the medicinal mixture in the formula two, so that impurities in the medicinal oil are reduced to the minimum extent, and the quality of the ointment is improved; then, the lead is separated from the fire, evenly sieved and stirred along one direction, so that the lead is combined with the medicinal oil, and the lead is prevented from floating on the oil surface or precipitating at the bottom, and fully reacts;

taking the ointment out of the water, heating and melting the ointment to remove water vapor, adding the ointment into the medicinal powder obtained in the step sixteenth according to the ratio, and uniformly stirring; spreading and coating to obtain the finished product.

The first bulk drug of the composition is prepared from 25-35 g of Chinese angelica, 25-35 g of angelica dahurica, 25-35 g of radix scrophulariae, 25-35 g of rheum officinale, 25-35 g of red peony roots, 25-35 g of liquorice and 600-700 g of sesame oil (in the embodiment, 30g of Chinese angelica, 30g of angelica dahurica, 30g of radix scrophulariae, 25g of rheum officinale, 30g of red peony roots, 25g of liquorice and 700g of sesame oil); the formula II in the step III comprises 150-250 g of myrrh, 150-250 g of dragon's blood, 150-250 g of beeswax, 150-250 g of white glue and 200-300 g of red lead (200 g of myrrh, 200g of dragon's blood, 250g of beeswax, 250g of white glue and 200g of red lead in the embodiment); the formula III in the step VI is prepared from 40g to 60g of borneol, 40g to 60g of musk, 40g to 60g of frankincense, 40g to 60g of myrrh and 40g to 60g of rush (in the embodiment, 50g of borneol, 45g of musk, 60g of frankincense, 60g of myrrh and 50g of rush).

In the steps, sesame oil is preheated to 40-80 ℃ before a medicine mixture in a composition is put into the sesame oil; after the composition I medicine mixture is put into sesame oil, soaking for 1 hour to 1.5 hours (1.5 hours in the embodiment) under the condition of 90 ℃ to 100 ℃ (90 ℃ in the embodiment), wherein the heat preservation mode is to heat the container and the oil-medicine mixture in the container in a water bath manner, so that the situation that hard parts in the composition I medicine mixture are not penetrated and the medicine effect cannot be fully exerted is avoided; heating the sesame oil to 220-240 ℃ (230 ℃ in the embodiment) for 1-3.5 hours (3 hours in the embodiment).

The step of the invention comprises soaking the Chinese medicinal paste in water for 24 hours; the melting temperature of the stephania ointment is not more than 100 ℃ (70 ℃ in the embodiment).

Example 2:

630-700 g of sesame oil (in the embodiment, 35g of angelica, 25g of angelica dahurica, 35g of radix scrophulariae, 30g of rhubarb, 35g of red peony root and 30g of liquorice, 250g of myrrh, 180g of dragon's blood, 200g of beeswax, 220g of white glue and 250g of red lead, and third formula, 55g of borneol, 50g of musk, 50g of frankincense, 50g of myrrh, 60g of rush and 630g of sesame oil).

According to the preparation method of the black plaster suitable for acute soft tissue injury, the first raw material of the formula in the step is prepared from 25-35 g of angelica, 25-35 g of angelica dahurica, 25-35 g of radix scrophulariae, 25-35 g of rheum officinale, 25-35 g of red peony roots, 25-35 g of liquorice and 600-700 g of sesame oil (in the embodiment, 35g of angelica, 25g of angelica dahurica, 35g of radix scrophulariae, 30g of rheum officinale, 35g of red peony roots, 30g of liquorice and 630g of sesame oil); the formula II in the step III comprises 150-250 g of myrrh, 150-250 g of dragon's blood, 150-250 g of beeswax, 150-250 g of white glue and 200-300 g of red lead (in this embodiment, 250g of myrrh, 180g of dragon's blood, 200g of beeswax, 220g of white glue and 250g of red lead); the formula III in the step VI is prepared from 40g to 60g of borneol, 40g to 60g of musk, 40g to 60g of frankincense, 40g to 60g of myrrh and 40g to 60g of rush (in the embodiment, 55g of borneol, 50g of musk, 50g of frankincense, 50g of myrrh and 60g of rush).

In the steps, sesame oil is preheated to 40-80 ℃ before a medicine mixture in a composition is put into the sesame oil; after the composition I medicine mixture is put into sesame oil, soaking for 1 hour to 1.5 hours (1.5 hours in the embodiment) under the condition of 90 ℃ to 100 ℃ (95 ℃ in the embodiment), wherein the heat preservation mode is to heat the container and the oil-medicine mixture in the container in a water bath manner, so that the situation that hard parts in the composition I medicine mixture are not penetrated and the medicine effect cannot be fully exerted is avoided; heating the sesame oil to 220-240 ℃ (220 ℃ in the embodiment) for 1-3.5 hours (3.5 hours in the embodiment).

The step of the invention comprises soaking the Chinese medicinal paste in water for 24 hours; the melting temperature of the stephania ointment is not more than 100 ℃ (80 ℃ in the embodiment).

The same as in example 1.

Example 3:

630-700 g of sesame oil (in this embodiment, 25g of angelica, 35g of angelica dahurica, 25g of radix scrophulariae, 35g of rhubarb, 25g of red peony root and 35g of liquorice, 150g of myrrh, 150g of dragon's blood, 150g of beeswax, 150g of white glue and 200g of red lead, and third formula, 40g of borneol, 40g of musk, 40g of frankincense, 40g of myrrh, 40g of rush and 600g of sesame oil).

According to the preparation method of the black plaster suitable for acute soft tissue injury, the first raw material of the formula in the step is prepared from 25-35 g of angelica, 25-35 g of angelica dahurica, 25-35 g of radix scrophulariae, 25-35 g of rheum officinale, 25-35 g of red peony roots, 25-35 g of liquorice and 600-700 g of sesame oil (in the embodiment, 25g of angelica, 35g of angelica dahurica, 25g of radix scrophulariae, 35g of rheum officinale, 25g of red peony roots, 35g of liquorice and 600g of sesame oil); the formula II in the step III comprises 150-250 g of myrrh, 150-250 g of dragon's blood, 150-250 g of beeswax, 150-250 g of white glue and 200-300 g of red lead (in this embodiment, 150g of myrrh, 150g of dragon's blood, 150g of beeswax, 150g of white glue and 200g of red lead); the formula III in the step VI is prepared from 40g to 60g of borneol, 40g to 60g of musk, 40g to 60g of frankincense, 40g to 60g of myrrh and 40g to 60g of rush (in the embodiment, 40g of borneol, 40g of musk, 40g of frankincense, 40g of myrrh and 40g of rush).

In the steps, sesame oil is preheated to 40-80 ℃ before a medicine mixture in a composition is put into the sesame oil; after the composition I medicine mixture is put into sesame oil, soaking for 1 hour to 1.5 hours (1 hour in the embodiment) at the temperature of 90 ℃ to 100 ℃ (100 ℃ in the embodiment), wherein the heat preservation mode is to heat the container and the oil-medicine mixture in the container in a water bath manner, so that hard parts in the composition I medicine mixture are prevented from being not penetrated, and the medicine effect cannot be fully exerted; heating the sesame oil to 220-240 ℃ (240 ℃ in the embodiment) for 1-3.5 hours (1 hour in the embodiment).

The same as in example 1.

Example 4:

630-700 g of sesame oil (35 g of angelica sinensis, 35g of angelica dahurica, 35g of radix scrophulariae, 30g of rheum officinale, 35g of red peony root and 35g of liquorice in the embodiment), 250g of myrrh, 250g of dragon's blood, 250g of beeswax, 250g of white glue and 300g of red lead in the formula II, 60g of borneol, 60g of musk, 60g of frankincense, 60g of myrrh, 55g of juncus effuses and 650g of sesame oil in the formula III).

According to the preparation method of the black plaster suitable for acute soft tissue injury, the first raw material of the formula in the step is prepared from 25-35 g of angelica, 25-35 g of angelica dahurica, 25-35 g of radix scrophulariae, 25-35 g of rheum officinale, 25-35 g of red peony roots, 25-35 g of liquorice and 600-700 g of sesame oil (in the embodiment, 35g of angelica dahurica, 35g of radix scrophulariae, 30g of rheum officinale, 35g of red peony roots, 35g of liquorice and 650g of sesame oil); the formula II in the step III comprises 150-250 g of myrrh, 150-250 g of dragon's blood, 150-250 g of beeswax, 150-250 g of white glue and 200-300 g of red lead (in this embodiment, 250g of myrrh, 250g of dragon's blood, 250g of beeswax, 250g of white glue and 300g of red lead); the formula III in the step VI is prepared from 40g to 60g of borneol, 40g to 60g of musk, 40g to 60g of frankincense, 40g to 60g of myrrh and 40g to 60g of rush (in the embodiment, 60g of borneol, 60g of musk, 60g of frankincense, 60g of myrrh and 55g of rush).

In the steps, sesame oil is preheated to 40-80 ℃ before a medicine mixture in a composition is put into the sesame oil; after the composition I medicine mixture is put into sesame oil, soaking for 1 hour to 1.5 hours (1.5 hours in the embodiment) under the condition of 90 ℃ to 100 ℃ (95 ℃ in the embodiment), wherein the heat preservation mode is to heat the container and the oil-medicine mixture in the container in a water bath manner, so that the situation that hard parts in the composition I medicine mixture are not penetrated and the medicine effect cannot be fully exerted is avoided; heating the sesame oil to 220-240 ℃ (230 ℃ in the embodiment) for 1-3.5 hours (2.5 hours in the embodiment).

The same as in example 3.

Test examples

1 Material

1.1 animals

30 ICR mice, each half weight (180. + -.20) g, were purchased from Tianqin laboratory animals Co., Ltd, Hunan. Feeding in cage under light/dark cycle of 12h/12h (illumination time of 7: 00-19: 00), and freely obtaining feed and drinking water. License of experimental animal: SYKX 2020 (Xiang) 0008.

1.2 drugs and reagents

Raw medicinal powder provided by a preparation room of the institute of traditional Chinese medicine of Hunan province is prepared according to the proportion of example 1, and the production batch number is as follows: 20210902, respectively;

positive control group drug, aspirin tablet, beijing nova pharmaceuticals ltd, national drug standard H10980297, lot No. 20210127;

glacial acetic acid.

1.3 instruments

A hot plate apparatus;

model ME-202 electronic balance.

2 method of experiment

2.1 Hot plate analgesia test

2.1.1 preselection of animals

The mice are placed in a hot plate instrument, the temperature is set to be 55 +/-0.5 ℃, the pain threshold value of the mice is measured for 2 times, the feet of the mice after licking are used as an observation index, and the mice with pain reaction within 30s are preselected.

2.1.2 grouping and administration

30 mice that were eligible for preselection were selected and randomly divided into 3 groups: blank control group and positive control group (aspirin 0.11 g.kg)^-1) And plaster prescription (plaster prescription 0.90. kg)^-1）；

Removing the back rat hair of all mice by adopting a 10% sodium sulfide solution, and using an aspirin tablet water solution for positive control group; plaster formula of 2 x 2cm for external application²Gavage distilled water for 1 time and d for blank control group^-1And continuously administering for 3 d.

2.1.3 pain threshold determination

After the last administration for 1h, the animals were placed in a hotplate apparatus and the time for the mice to lick the hindpaw was recorded, and if the mice did not have a painful reaction within 60s, the animals were immediately removed and counted for 60 s.

2.1.4 pain threshold calculation

After the test was completed, the pain threshold (hot pain response time) and the pain threshold increase percentage of each group of mice were calculated.

2.2 acetic acid writhing method

2.1.2 grouping and administration

30 mice that were eligible for preselection were selected and randomly divided into 3 groups: model control group and positive control group (aspirin 0.11 g.kg)^-1) And plaster prescription (plaster prescription 0.90 g.kg)^-1）；

Positive control group gastric perfusion aspirin tablet water solution; plaster formula of 2 x 2cm for external application²Gavage distilled water for 1 time and d for blank control group^-1And continuously administering for 3 d.

2.1.3 Observation index

After the last administration for 1h, all animals were injected with 0.4ml of 0.6% glacial acetic acid solution in the abdominal cavity, and the number of animals with writhing reaction within 15min, the number of writhing times and the percentage of analgesia were recorded as evaluation indexes.

Percent analgesia (P) = (number of animals with no writhing response in experimental group-number of animals with no writhing response in control group)/number of animals with writhing response in control group 100.

3 statistical treatment

The data analysis uses statistical software SPSS17.0, all measured data with (

S) between groups, One-way-ANOVA, t-test, two-sided test, pairwise comparison, P<0.05 is significant in difference and has statistical significance.

4 results

4.1 Effect of the ointment formulation on the response to thermal pain in ICR mice

Compared with a blank control group, the pain threshold values of mice in the positive control group and the plaster prescription group are obviously increased, and the difference is shown by the statistical significance: (PLess than 0.01), the pain threshold increasing percentage of the positive control group and the plaster prescription group are respectively 26.1 percent and 25.7 percent.

TABLE 1 Effect of the ointment formulation on the response to thermal pain in ICR mice: (

±s）

Compared with blank group，^* P ＜0.05，^** P ＜0.01

4.2 Effect of the invention on ICR mouse Acetowrithing experiments: (

±s）

Compared with the model control group, the torsion rates of the positive control group and the plaster prescription group of the mice are respectively 80%, 30% and 50%, and the pain rates of the positive control group and the plaster prescription group are respectively 62% and 38%. Compared with the model control group, the times of torsion of the positive control group and the plaster square group mice are obviously reduced, and the difference is statistically significant (P< 0.05), the results are shown in Table 2.

TABLE 2 Effect of the ointment formulation on the acetic acid writhing test in ICR mice: (

±s）

Compared with model group，^# P ＜0.05，^## P ＜0.01

5 conclusion

The invention can obviously increase the thermal pain threshold of a mouse, and the pain threshold is increased by 25.7 percent and is similar to the analgesic effect of the positive control drug aspirin by 26.1 percent. The plaster formula can reduce the body twisting rate and the body twisting times of a mouse in an acetic acid body twisting experiment.

In conclusion, the invention has better analgesic effect.

Claims

1. The black plaster for acute soft tissue injury is characterized by being prepared from the following raw materials in parts by weight:

600-700 g of sesame oil.

2. The black plaster for acute soft tissue injury according to claim 1, wherein the raw materials in the ratio are:

630-700 g of sesame oil.

3. The black plaster for acute soft tissue injury according to claim 1 or 2, wherein the raw materials in the ratio are:

700g of sesame oil.

4. A black plaster for acute soft tissue injury according to claim 1 or 2, wherein the rhubarb is raw rhubarb.

5. A black plaster for acute soft tissue injury according to claim 3, wherein the rhubarb is raw rhubarb.

6. A preparation method of a black plaster suitable for acute soft tissue injury is characterized by comprising the following steps:

the technical scheme includes that the first group of raw material medicines are crushed and mixed according to a ratio, and an obtained first group of medicine mixture is put into sesame oil and stirred uniformly;

heating and raising the temperature, continuously stirring, frying the composition-medicine mixture in the sesame oil to be withered and yellow, and filtering out dregs of a decoction to obtain filtered oil;

the second raw material medicine is added into the oil filter obtained in the step II according to the proportion, and the mixture is decocted into dripping pills to obtain medicinal oil;

fourthly, the medicinal oil is continuously heated and continuously stirred to reduce impurities in the medicinal oil, then the medicinal oil is separated from fire, lead is uniformly sieved in the medicinal oil, and the medicinal oil is stirred in one direction to fully react;

pouring the ointment obtained after the reaction is finished into water for soaking, condensing and dividing for later use;

sixthly, crushing the three raw materials of the formula into fine powder, uniformly mixing the fine powder and the fine powder, and dividing the mixture into parts according to the proportion for later use;

taking the ointment out of the water, heating and melting the ointment, adding the ointment into the medicinal powder obtained in the step sixteenth according to the ratio, and uniformly stirring the mixture; spreading and coating to obtain the finished product.

7. The preparation method of a black plaster suitable for acute soft tissue injury according to claim 6, characterized in that the first raw material medicine in the step is prepared from 25 to 35g of angelica sinensis, 25 to 35g of angelica dahurica, 25 to 35g of radix scrophulariae, 25 to 35g of rheum officinale, 25 to 35g of red peony root, 25 to 35g of licorice root, and 600 to 700g of sesame oil; the formula II in the step III comprises 150-250 g of myrrh, 150-250 g of dragon's blood, 150-250 g of yellow wax, 150-250 g of white glue and 200-300 g of red lead; the formula III in the step VI is prepared from 40g to 60g of borneol, 40g to 60g of musk, 40g to 60g of frankincense, 40g to 60g of myrrh and 40g to 60g of rush.

8. A preparation method of a black plaster suitable for acute soft tissue injury according to claim 6, characterized in that in the step of first, before a medicine mixture of a composition is put in, sesame oil is preheated to 40-80 ℃; the formula I medicine mixture is put into sesame oil and then is soaked for 1 to 1.5 hours at the temperature of between 90 and 100 ℃, and the heat preservation mode is water bath heating.

9. A method for preparing a black plaster suitable for acute soft tissue injury according to claim 7, wherein in the step of adding a composition-a drug mixture, sesame oil is preheated to 40 ℃ to 80 ℃; the formula I medicine mixture is put into sesame oil and then is soaked for 1 to 1.5 hours at the temperature of between 90 and 100 ℃, and the heat preservation mode is water bath heating.

10. The preparation method of the black plaster for acute soft tissue injury according to claim 6, 7, 8 or 9, characterized in that the step of soaking the Chinese medicinal plaster in water for 24 hours; the temperature for heating and melting the stephania ointment is not more than 100 ℃.