CN105687798A - External traditional Chinese medicinal preparation for treating stroke and preparation method of external traditional Chinese medicinal preparation - Google Patents
External traditional Chinese medicinal preparation for treating stroke and preparation method of external traditional Chinese medicinal preparation Download PDFInfo
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- 229960004418 trolamine Drugs 0.000 description 1
- 210000002700 urine Anatomy 0.000 description 1
- 210000001835 viscera Anatomy 0.000 description 1
Classifications
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- A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
- A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
- A61K9/7038—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
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- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/333—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
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Abstract
The invention relates to an external traditional Chinese medicinal preparation for treating stroke and a preparation method of the external traditional Chinese medicinal preparation. The external traditional Chinese medicinal preparation is prepared from sixteen kinds of traditional Chinese medicine such as rhizoma typhonii, agkistrodon, earthworm, scorpion and the like. The dosage form is adhesive plaster, cataplasm, ointment or plaster. The invention also provides the preparation method of the external traditional Chinese medicinal preparation. The external traditional Chinese medicinal preparation disclosed by the invention has the efficacy of dispelling wind, activating blood, and soothing meridians and activating collaterals, and can be used for treating muscular paralysis, bekhterevss symptom and generalized convulsion symptom, facial paralysis symptom, drool, stiff tongue and impeded speech, muscular numbness, arthralgia and myalgia and the like about the stroke caused by wind pathogen and apoplexy involving the collaterals; the external traditional Chinese medicinal preparation has the advantages of significant treatment effect, high safety, no side effect and convenience in use.
Description
Technical Field
The invention relates to a traditional Chinese medicine external preparation for treating apoplexy and a preparation method thereof, belonging to the technical field of traditional Chinese medicines.
Background
Apoplexy is the general name of traditional Chinese medicine for acute cerebrovascular diseases. Apoplexy is divided into exogenous wind and endogenous wind, and exogenous wind is caused by affection of exogenous wind; the stroke is a disease which is called as stroke, refers to internal wind, belongs to internal injury diseases, is also called as cerebral stroke, stroke and the like, is mainly caused by qi and blood disorder, cerebral vessel obstruction or blood overflow, is a disease which has main symptoms of sudden syncope, unconsciousness, facial distortion, language disorder, hemiplegia or sudden hemiplegia without syncope, and has the characteristics of acute onset and rapid change, such as the frequent change of wind evil and the like.
Apoplexy is also a common disease of middle-aged and old people, is one of three diseases which have the greatest harm to human beings in the world at present, and is characterized by high morbidity, high mortality, high disability rate and more complications, so the disease is also called as 'three-high one-more' disease, and seriously threatens the health of human beings. Although the stroke patients are actively treated, most of the stroke patients still have sequelae, namely stroke sequelae, which are common symptoms of paralysis and weakness of upper and lower limbs, skin incompetence, muscle numbness, facial distortion, watery mouth, sallow complexion, stiff tongue and pain of muscles and bones. If the treatment is not early, the limbs gradually spasm and stiffness, and the limb disuse rigidity and contracture are generated to cause limb deformity and function loss, so the improvement of the prevention and treatment level of the cerebral apoplexy, the reduction of the incidence and disability rate of the cerebral apoplexy, and the enhancement of the treatment and conditioning of the cerebral apoplexy sequelae are urgent.
At present, the treatment methods aiming at the apoplexy comprise food therapy, acupuncture and moxibustion, oral administration of Chinese and western patent medicines and the like. Western medicines for resisting stroke are mainly thrombolytic medicines and channel blockers, mostly have the advantages of quick response and strong pertinence, but have single action mode, mostly generate drug resistance and side effects, and are not suitable for long-term administration by patients, and the long-term treatment effect is not ideal. For example, CN105267416A discloses a Chinese medicinal composition for treating apoplexy and hemiplegia, which is prepared from the following raw material medicaments in part by weight: 3-8 parts of safflower, 7-13 parts of cortex moutan, 7-12 parts of ligusticum wallichii, 8-13 parts of radix paeoniae alba, 9-15 parts of radix rehmanniae, 12-17 parts of radix cyathulae, 22-28 parts of astragalus membranaceus, 12-18 parts of angelica sinensis, 6-10 parts of cassia twig and 15-25 parts of hawthorn. The medicine is mainly used for tonifying qi and activating blood circulation, and dredging collaterals, and the traditional Chinese medicine composition is prepared into tablets, capsules or oral liquid and is taken orally. Although a plurality of Chinese patent medicines for treating apoplexy are available in the market at present, the treatment period is longer, the medicine taking amount is larger, the cost is high, and the action mechanism is unclear.
In view of the above, the invention provides a traditional Chinese medicine for treating apoplexy, which is prepared by combining modern pharmacological research with more scientific and reasonable compatibility and process improvement according to the etiology and pathogenesis of the disease and the theory of traditional Chinese medicine and based on the traditional Chinese medicine and pharmacy theory, in order to make up the defects that the traditional Chinese medicine for treating apoplexy is mainly in an oral dosage form, facilitate the medicine use and obviously reduce the medicine use amount.
Disclosure of Invention
Aiming at the defects of the prior art, the invention provides a traditional Chinese medicine external preparation with the effects of dispelling wind, promoting blood circulation, relaxing channels and activating collaterals, which is used for treating apoplexy sequelae.
The invention also provides a preparation method of the traditional Chinese medicine external preparation for treating apoplexy.
The technical scheme of the invention is as follows:
a traditional Chinese medicine external preparation for treating apoplexy is prepared from the following raw material medicines in parts by weight:
20-100 parts of rhizoma typhonii, 10-60 parts of long-noded pit viper, 10-80 parts of earthworm, 10-80 parts of scorpion, 10-80 parts of stiff silkworm, 10-80 parts of ligusticum wallichii, 20-80 parts of angelica dahurica, 10-80 parts of angelica sinensis, 10-60 parts of rhizoma gastrodiae, 10-60 parts of red paeony root, 20-100 parts of divaricate saposhnikovia root, 20-100 parts of notopterygium root, 5-20 parts of camphor, 5-20 parts of borneol, 1-10 parts of menthol and 1-10 parts of thymol.
In the scheme, the raw material medicines are preferably as follows in parts by weight:
20-80 parts of rhizoma typhonii, 10-40 parts of long-noded pit viper, 20-60 parts of earthworm, 10-60 parts of scorpion, 10-60 parts of stiff silkworm, 20-60 parts of ligusticum wallichii, 20-60 parts of angelica dahurica, 10-50 parts of angelica, 10-50 parts of rhizoma gastrodiae, 10-50 parts of red paeony root, 20-70 parts of divaricate saposhnikovia root, 20-70 parts of notopterygium root, 5-15 parts of camphor, 5-15 parts of borneol, 2-10 parts of menthol and 2-10 parts of thymol.
According to the invention, a preferred embodiment is a traditional Chinese medicine external preparation for treating stroke, which is prepared from the following raw material medicines in parts by weight:
50 parts of giant typhonium rhizome, 20 parts of long-noded pit viper, 30 parts of earthworm, 50 parts of scorpion, 50 parts of stiff silkworm, 40 parts of szechuan lovage rhizome, 40 parts of dahurian angelica root, 40 parts of Chinese angelica, 30 parts of tall gastrodia tuber, 20 parts of red paeony root, 30 parts of divaricate saposhnikovia root, 20 parts of incised notopterygium rhizome, 10 parts of camphor, 10 parts of borneol, 5 parts of menthol and 5 parts of thymol.
According to another preferred embodiment of the invention, the traditional Chinese medicine external preparation for treating stroke is prepared from the following raw material medicines in parts by weight:
60 parts of rhizoma typhonii, 15 parts of long-noded pit viper, 40 parts of earthworm, 50 parts of scorpion, 50 parts of stiff silkworm, 50 parts of ligusticum wallichii, 40 parts of radix angelicae, 40 parts of angelica, 20 parts of rhizoma gastrodiae, 30 parts of red paeony root, 20 parts of radix sileris, 30 parts of notopterygium root, 5 parts of camphor, 10 parts of borneol, 10 parts of menthol and 5 parts of thymol.
According to another preferred embodiment of the invention, the traditional Chinese medicine external preparation for treating stroke is prepared from the following raw material medicines in parts by weight:
55 parts of giant typhonium rhizome, 15 parts of long-noded pit viper, 40 parts of earthworm, 50 parts of scorpion, 60 parts of stiff silkworm, 30 parts of szechuan lovage rhizome, 30 parts of dahurian angelica root, 30 parts of Chinese angelica, 30 parts of tall gastrodia tuber, 30 parts of red paeony root, 40 parts of divaricate saposhnikovia root, 30 parts of incised notopterygium rhizome, 10 parts of camphor, 5 parts of borneol, 10 parts of menthol and 5 parts of thymol.
The components are as follows:
rhizoma Typhonii is dried tuber of Typhonium giganteum Engl. of Typhonium giganteum of Araceae. Has effects in expelling pathogenic wind and phlegm, arresting convulsion, removing toxic materials, dispersing pathogen accumulation, and relieving pain.
Agkistrodon acutus (Agkistrodon acutus) is dried whole body of Agkistrodon acutus (Agnther) with viscera removed. Has the functions of dispelling wind, activating collaterals and arresting convulsion.
Pheretima, which is a dried body of Pheretima aspergillum (E.Perrier), PheretimimavagalgarisChen, Pheretimimagillus weberianulus weberi, Pheretimagallelmili (Michaelsen), or Pheretimimafelina pectinei (Michaelsen), or Pheretima aspergillum Michelsen, belonging to the family Pheretima. Has the effects of clearing heat, arresting convulsion, dredging collaterals, relieving asthma and promoting urination.
Scorpio is dried body of Buthus martensii Karsch of Buthidae. Has the effects of calming endogenous wind, relieving spasm, dredging collaterals, relieving pain, counteracting toxic substances and resolving hard mass.
Bombyx Batryticatus is a dried body of Bombyx mori Linnaeus 4-5 instar larva of Bombyxmori Linnaeus, Bombycidae, which is lethal after infecting (or artificially inoculating) Beauveria assiana (Bals.) Vuillant. Has the effects of calming endogenous wind, relieving spasm, dispelling pathogenic wind, relieving pain, eliminating phlegm, and resolving masses.
Rhizoma Ligustici Chuanxiong is dried rhizome of Ligusticum chuanhianxiong Hort of Umbelliferae. Has the effects of promoting blood circulation, activating qi-flowing, dispelling pathogenic wind and relieving pain.
Angelica dahurica is dried root of Angelica dahurica Angelica Dahurica (Fisch. ex Hoffm.) Benth.et Hook.f. or Angelica dahurica Angelica Dahurica (Fisch. ex Hoffm.) Benth.et Hook.f. var. fortmosana (Boiss.) ShanetYuan. Has the effects of relieving exterior syndrome, dispelling cold, dispelling pathogenic wind, relieving pain, dredging nasal orifice, eliminating dampness, stopping leukorrhagia, and relieving swelling and pus discharge.
Angelica sinensis (Oliv.) Diels is dried root of Angelica gigas nakai (Angelica gigas nakai) of Umbelliferae. Has the effects of enriching blood, promoting blood circulation, regulating menstruation, relieving pain, moistening intestines and relaxing bowels.
Gastrodia elata is dried tuber of Gastrodia elata B1. of Orchidaceae. Has the effects of extinguishing wind, relieving spasm, calming liver-yang, dispelling wind and dredging collaterals.
Radix Paeoniae Rubra is dried root of Paeoniacalara pall or Paeoniavavieticilynch of Ranunculaceae. Has the effects of clearing heat and cooling blood, and removing blood stasis and relieving pain.
Ledebouriella root, a dried root of Saposhnikoviadivaricata (Turcz.) Schischk. Dispel wind and relieve exterior syndrome, subdue dampness and alleviate pain, stop spasm.
Notopterygium incisum (Notopterygium incisum) of Umbelliferae is dried rhizome and root of Notopterygium incisum (Notopterygium franchetii) or Notopterygium forbesii (Notopterygium franchetii) of Umbelliferae. Has the effects of relieving exterior syndrome, dispelling cold, dispelling pathogenic wind, removing dampness, and relieving pain.
Camphor, chemical name (1R,4R) -1,7, 7-trimethylbicyclo [2.2.1] heptane-2-one, is extracted from Lauraceae plant. This herb is a skin irritant.
Borneol, as synthetic borneol, has the effects of inducing resuscitation, refreshing mind, clearing heat and relieving pain. Can be used for treating fever unconsciousness, convulsion, apoplexy with phlegm syncope, qi stagnation and sudden syncope, central nausea and coma, thoracic obstruction, cardialgia, conjunctival congestion, aphtha, sore throat, and purulence in ear canal.
Menthol is a saturated cyclic alcohol obtained by steam distillation, freezing and recrystallization of fresh stems and leaves of Mentha haphallocalyxBriq.of Labiatae, and has chemical name of l-1-methyl-4-isopropylcyclohexanol-3.
Thymol, chemical name is 5-methyl-2-isopropylphenol. The product is a disinfectant and antiseptic medicine, and is mainly used for treating mycotic infection.
According to the present invention, the pharmaceutical external preparation is preferably in the form of a rubber plaster, a cataplasm, an ointment or a plaster.
According to the invention, the preparation method of the traditional Chinese medicine external preparation for treating stroke comprises the following steps:
(1) weighing the raw material components in proportion, and crushing; mixing rhizoma Typhonii, Agkistrodon, Lumbricus, Scorpio, Bombyx Batryticatus, rhizoma Ligustici Chuanxiong, radix Angelicae Dahuricae, radix Angelicae sinensis, rhizoma Gastrodiae, radix Paeoniae Rubra, radix Saposhnikoviae, and Notopterygii rhizoma, extracting the obtained mixed medicinal powder with ethanol solvent, concentrating, and making into Chinese medicinal fluid extract;
(2) and (3) taking a paste substrate, adding the traditional Chinese medicine fluid extract obtained in the step (1), camphor, borneol, menthol and thymol, refining and preparing into a paste.
According to the preparation method of the traditional Chinese medicine external preparation for treating the apoplexy, when the preparation form is rubber paste, cataplasm or plaster, the preparation method further comprises the steps of (3) coating the rubber paste prepared in the step (2) on a back lining cloth, cutting into sections, covering a lining (an isolation layer), slicing and packaging.
In the step (2), the plaster base is a rubber plaster base, a cataplasm base, an ointment base or a plaster base. The material composition of the matrix shown is as is known in the art. The following substrates are preferred in the present invention:
a. rubber paste matrix: a blend of rubber, rosin, zinc oxide and petrolatum and/or lanolin;
b. cataplasm base: sodium polyacrylate, sodium carboxymethylcellulose, citric acid, povidone, glycerol and silica gel micropowder;
c. ointment base: stearic acid, glyceryl monostearate, glycerol, polysorbate and triethanolamine soaps;
d. plaster matrix comprises oleum Sesami and Plumbum Preparatium.
According to the preparation method of the external traditional Chinese medicine composition preparation of the present invention, preferably, the extraction with ethanol as a solvent in the step (1) is a percolation method, a percolation liquid is collected, reduced pressure concentration is performed, ethanol is recovered, and a traditional Chinese medicine fluid extract is prepared. Further preferred is:
the volume dosage of the ethanol solvent is 1-1.5 times of the total mass of the mixed medicinal powder (the volume: weight ratio unit is milliliter/gram), the mixed medicinal powder and the ethanol solvent are stirred uniformly, and then the mixture is placed in a closed state for soaking for 1-3 hours, so that the medicinal materials are fully expanded; and then filling the soaked mixed medicinal powder into a percolator, adding an ethanol solvent, continuously placing in a closed state for soaking for 24-48 hours to ensure that the solvent is fully permeated and diffused, and then starting percolation.
Preferably, when the infiltrated mixed powder is filled into a percolator, the mixed powder is uniformly filled into the percolator (with proper tightness) in a plurality of times; opening the lower opening of the percolator, slowly adding ethanol solvent from the upper part, closing the lower opening when liquid flows out from the lower opening to remove air in the gaps between the medicinal powders, and continuously adding ethanol solvent until the upper surface of the medicinal powders is 1-10 cm higher than the upper surface of the medicinal powders.
Preferably, when the percolation is started, the percolation speed is controlled, the per hour effluent liquid is equal to 1/48-1/24 of the effective volume of the percolator, and the ethanol solvent is continuously added from the upper part, so that the liquid level of the solvent is kept higher than the upper surface of the mixed powder. Collecting the volume of the percolate which is 5-6 times of the total mass of the mixed medicinal powder, wherein the volume/mass unit is as follows: ml/g.
According to the preparation method of the external traditional Chinese medicine composition preparation, in the step (1), the concentration temperature is preferably 50-85 ℃. The relative density of the traditional Chinese medicine fluid extract is 1.05-1.10, the reference density is water, and the temperature is measured at 50-65 ℃.
According to the preparation method of the external traditional Chinese medicine composition preparation of the present invention, preferably, in the step (1), the ethanol solvent is ethanol with a volume fraction of 70-90%, and more preferably ethanol with a volume fraction of 85%.
According to the preparation method of the external traditional Chinese medicine composition preparation, preferably, in the step (1), the raw material medicines are crushed into coarse powder, and the coarse powder is completely sieved by a 24-mesh sieve, wherein the mass of the coarse powder which can be sieved by a 65-mesh sieve is not more than 40% of the total mass of the coarse powder.
The granularity of the raw material medicine powder is particularly required, and the raw material medicine powder is most suitably ground into coarse powder, wherein the coarse powder can completely pass through a 24-mesh sieve, but a small amount of fine powder which can pass through a 65-mesh sieve is mixed, and the total amount of the fine powder is not more than 40%. If the medicinal powder is too coarse, the medicinal powder is not easy to compress when being filled in a percolator (cylinder), the consumption of the solvent is high during percolation, the leaching components are incomplete, and the leaching effect is poor; if the medicinal powder is too fine, the percolator is easy to block, the percolation speed is influenced, and the extraction efficiency is low.
The percolation method and the method for preparing the traditional Chinese medicine fluid extract by decompressing and concentrating have special requirements on the soaking and percolation operation of the medicinal powder, the moderately crushed medicinal materials are placed in the percolator, the solvent is continuously added from the upper part, and the solvent permeates through the medicinal material layer and leaches the medicinal material components in the downward flowing process, so that the dynamic leaching extraction is realized, the solvent utilization rate is high, the effective components are completely leached, and the leachate can be directly collected; the traditional Chinese medicine fluid extract is prepared by reduced pressure concentration, the heating temperature is low when the percolate is concentrated, the heating time is short, the damage to the effective components is less, the retention is more, the curative effect is kept, and the volume of the finished product can be reduced. The key points of the technological parameters of medicinal powder infiltration, charging, impregnation and percolation are as follows: 1. soaking the medicinal powder: the medicinal powder is wetted by a proper amount of solvent to fully expand, so that blockage caused by expansion of the medicinal powder in a percolator is avoided; 2. charging: filling the wetted and expanded medicinal powder into a percolator in a plurality of times, and uniformly flattening; when adding the solvent, the lower opening of the percolator is opened, the solvent is added from the upper part of the medicinal powder until the percolate flows out from the outlet, the air in the gaps among the medicinal powder is removed, the solvent is continuously added to immerse the surface of the medicinal powder for several centimeters, and the percolate outlet is closed. 3. Dipping the medicinal powder: and soaking in a percolator for 24-48 h to ensure that the solvent is fully permeated and diffused, so that leaching of effective components during percolation is facilitated. 4. Percolation speed: during percolation, the percolation speed is controlled, the percolation speed is too high, the leaching components are incomplete, and the solvent consumption is large; the speed is too slow, which affects the extraction efficiency.
When the external traditional Chinese medicine composition and the preparation thereof are used for external medicines for treating the stroke sequela diseases, the preparation such as rubber paste, cataplasm, ointment or plaster is pasted or coated on the relevant acupuncture points on the affected side. Before application, the relevant acupuncture points are cleaned with warm water or disinfected with alcohol. The medicine can be used for treating facial distortion, watery saliva, speech difficulty, muscle numbness, and arthralgia and myalgia due to apoplexy caused by pathogenic wind and collateral obstruction, and has advantages of remarkable therapeutic effect, high safety, no adverse side effect, convenient use, and low cost. The traditional Chinese medicines of the invention are reasonably compatible, complementary and synergistic, and have dialectical treatment, thereby having good curative effect on various symptoms of apoplexy sequelae and overcoming the defects of the existing medicines for treating apoplexy. Experimental research shows that the medicine has scientific and reasonable compatibility, not only can achieve the synergistic enhancement effect of the medicine effect, but also can obviously reduce the using amount of the medicine.
The invention has the beneficial effects that:
1. the Chinese medicinal composition is a natural pure Chinese medicinal preparation, has the effects of dispelling wind, activating blood circulation, dredging channels and activating collaterals, can be used for treating muscular paralysis, facial paralysis and channel contracture symptoms of stroke caused by wind evil collateral, and has the symptoms of facial paralysis, watery mouth, stiff tongue, muscle numbness, muscle and bone pain and the like, and has remarkable treatment effect. At present, oral medicines such as prednisone and acupuncture are mostly adopted for treating the disease, so that the medicine is inconvenient to take, has large side effect and is not suitable for long-term use. The rubber ointment is applied to acupuncture points and local parts of affected parts for medication, and the treatment effect is achieved by regulating the channels and collaterals through transdermal absorption, and the rubber ointment has the advantages of high safety, no side effect and convenience in use.
2. The traditional Chinese medicine composition contains a plurality of medicine components, achieves the treatment effect by being applied to relevant acupuncture points of a patient, percutaneous absorption and meridian regulation, has a plurality of action targets, such as being applied to acupuncture points of Sibai, Ying Xiang, Taiyang, Xiaguan, Zhongzhong and the like to treat facial distortion, being applied to acupuncture points of Zhangze, Hegu, Zusanli, Yanglingquan and the like to treat muscle numbness, being applied to Ashi acupuncture points to treat muscle and bone pain and the like. Compared with the existing traditional Chinese medicine, the traditional Chinese medicine has the advantages of quick response and wide action range. Pharmacodynamic tests show that: the medicine can be absorbed through skin, and has effects of dilating local blood vessel, increasing blood flow, and affecting local muscle physiological property. Animal experiments prove that the product can increase the conduction speed of sciatic nerve movement of rabbits and shorten the latent period; the action time of the evoked potential can be shortened; can increase the amplitude of evoked potential, so that it can accelerate nerve conduction speed and improve excitability.
3. The preparation method of the traditional Chinese medicine preparation combines the percolation method and the decompression concentration preferably, the preparation of the traditional Chinese medicine preparation is a complex system, and particularly, the process parameters in the extraction and the concentration are different, so that the obtained medicine components are different, and the generated effects are also different. The effective components of the components are fully considered, a large number of experimental researches are carried out to reserve the effective components to the maximum extent, and meanwhile, the advanced technology is adopted, so that the production efficiency is improved, the working hours are shortened, and the energy consumption is reduced.
Detailed Description
The technical solution of the present invention is further described with reference to the following examples, but the scope of the present invention is not limited thereto.
Example 1
A traditional Chinese medicine external preparation for treating apoplexy comprises the following components in parts by weight:
50 parts of giant typhonium rhizome, 20 parts of long-noded pit viper, 30 parts of earthworm, 50 parts of scorpion, 50 parts of stiff silkworm, 40 parts of szechuan lovage rhizome, 40 parts of dahurian angelica root, 40 parts of Chinese angelica, 30 parts of tall gastrodia tuber, 20 parts of red paeony root, 30 parts of divaricate saposhnikovia root, 20 parts of incised notopterygium rhizome, 10 parts of camphor, 10 parts of borneol, 5 parts of menthol and 5 parts of thymol.
The formula traditional Chinese medicine external preparation is rubber paste, and the preparation steps are as follows:
1. weighing the traditional Chinese medicines according to the parts by weight, wherein part of the traditional Chinese medicines comprise rhizoma typhonii, long-noded pit viper, earthworm, scorpion, stiff silkworm, ligusticum wallichii, radix angelicae, angelica sinensis, rhizoma gastrodiae, radix paeoniae rubra, radix sileris and notopterygium root, and crushing into coarse powder for later use;
2. uniformly mixing the coarse powder, adding 85% ethanol (the volume of the ethanol is equal to the weight of the coarse powder, and the proportion unit of the volume of the ethanol to the weight of the coarse powder is milliliter/gram), uniformly stirring, and standing and soaking for 2-3 hours in a closed manner; then evenly loading the soaked medicinal coarse powder into a percolator in a grading manner to ensure proper tightness; opening the lower opening switch of the percolator, slowly adding 85% ethanol from the upper part, closing the switch when the liquid flows out from the lower opening, continuously adding the solvent to the powder with a plurality of centimeters above the lower opening, soaking for 48 hours in a sealed state, percolating, controlling the percolation speed to be that the effluent per hour is about equal to 1/24 of the effective container of the percolator, and continuously adding the solvent from the upper part to keep the volume higher than the upper surface of the powder. Collecting percolate with volume 5 times of the total mass of the mixed medicinal powder, wherein the volume/mass unit is as follows: stopping percolation at ml/g. Concentrating the collected percolate under reduced pressure, recovering ethanol, controlling the concentration temperature to 50-85 deg.C, and concentrating to obtain Chinese medicinal fluid extract with relative density of 1.07-1.10 (measured at 50 deg.C, reference density is water).
3. Pretreating rubber, plasticating into a reticular sheet in a rubber mixing mill, and then mixing with rosin, zinc oxide, vaseline and lanolin to obtain the rubber matrix.
4. And (3) taking the mixed rubber substrate, adding the crushed camphor, borneol, menthol, thymol and the traditional Chinese medicine fluid extract prepared in the step (2), refining and preparing into the rubber paste.
5. Coating the adhesive paste on a backing cloth, cutting into sections, covering the backing cloth with a liner (isolation layer), cutting into small pieces, and packaging.
Embodiment 2, a traditional Chinese medicine external preparation for treating apoplexy, which comprises the following components in parts by weight:
60 parts of rhizoma typhonii, 15 parts of long-noded pit viper, 40 parts of earthworm, 50 parts of scorpion, 50 parts of stiff silkworm, 50 parts of ligusticum wallichii, 40 parts of radix angelicae, 40 parts of angelica, 20 parts of rhizoma gastrodiae, 30 parts of red paeony root, 20 parts of radix sileris, 30 parts of notopterygium root, 5 parts of camphor, 10 parts of borneol, 10 parts of menthol and 5 parts of thymol.
The formula traditional Chinese medicine external preparation is rubber paste, and the preparation steps are as follows:
1. weighing the traditional Chinese medicines according to the parts by weight, wherein part of the traditional Chinese medicines comprise rhizoma typhonii, long-noded pit viper, earthworm, scorpion, stiff silkworm, ligusticum wallichii, radix angelicae, angelica sinensis, rhizoma gastrodiae, radix paeoniae rubra, radix sileris and notopterygium root, and crushing into coarse powder for later use;
2. uniformly mixing the coarse powder, adding 70% ethanol (the volume of the ethanol is equal to the weight of the coarse powder, and the proportion unit of the volume of the ethanol to the weight of the coarse powder is milliliter/gram), uniformly stirring, and standing and soaking for 1-2 hours in a closed manner; then evenly loading the soaked medicinal coarse powder into a percolator in a grading manner to ensure proper tightness; opening the lower opening switch of the percolator, slowly adding 70% ethanol from the upper part, closing the switch when the liquid flows out from the lower opening, continuously adding the solvent to the powder with a plurality of centimeters above the lower opening, soaking for 24 hours in a sealed condition, percolating, controlling the percolation speed to be that the effluent per hour is about equal to 1/48 of the effective volume of the percolator, and continuously adding the solvent from the upper part to keep the volume higher than the upper surface of the powder. Collecting the percolate with the volume being 6 times of the total mass of the mixed medicinal powder, wherein the volume/mass unit is as follows: ml/g. Concentrating the collected percolate under reduced pressure, recovering ethanol, controlling the concentration temperature to 50-85 deg.C, and concentrating to obtain Chinese medicinal fluid extract with relative density of 1.05-1.08 (measured at 65 deg.C, reference density is water).
3. Pretreating rubber, plasticating into a reticular sheet in a rubber mixing mill, and then mixing with rosin, zinc oxide, vaseline and lanolin to obtain the rubber matrix.
4. And (3) taking the mixed rubber substrate, adding the crushed camphor, borneol, menthol, thymol and the traditional Chinese medicine fluid extract prepared in the step (2), refining and preparing into the rubber paste.
5. Coating the adhesive paste on a backing cloth, cutting into sections, covering the backing cloth with a liner (isolation layer), cutting into small pieces, and packaging.
Example 3, a traditional Chinese medicine external preparation for treating stroke, which comprises the following components in parts by weight:
55 parts of giant typhonium rhizome, 15 parts of long-noded pit viper, 40 parts of earthworm, 50 parts of scorpion, 60 parts of stiff silkworm, 30 parts of szechuan lovage rhizome, 30 parts of dahurian angelica root, 30 parts of Chinese angelica, 30 parts of tall gastrodia tuber, 30 parts of red paeony root, 40 parts of divaricate saposhnikovia root, 30 parts of incised notopterygium rhizome, 10 parts of camphor, 5 parts of borneol, 10 parts of menthol and 5 parts of thymol.
The formula traditional Chinese medicine external preparation is rubber paste, and the preparation steps are as follows:
1. same as step 1 of example 1;
2. uniformly mixing the coarse powder, adding 80% ethanol (the volume of the ethanol is equal to the weight of the coarse powder, and the proportion unit of the volume of the ethanol to the weight of the coarse powder is milliliter/gram), uniformly stirring, and standing and soaking for 2-3 hours in a closed manner; then evenly loading the soaked medicinal coarse powder into a percolator in a grading manner to ensure proper tightness; opening the lower opening switch of the percolator, slowly adding 80% ethanol from the upper part, closing the switch when the liquid flows out from the lower opening, continuously adding the solvent to the powder with a plurality of centimeters above the lower opening, soaking for 36 hours in a sealed condition, percolating, controlling the percolation speed to be that the effluent per hour is about equal to 1/36 of the effective container of the percolator, and continuously adding the solvent from the upper part to keep the volume higher than the upper surface of the powder. Collecting percolate with volume 5.5 times of the total mass of the mixed medicinal powder, wherein the volume/mass unit is as follows: ml/g; concentrating the collected percolate under reduced pressure, recovering ethanol, controlling the concentration temperature to 50-85 deg.C, and concentrating to obtain Chinese medicinal fluid extract with relative density of 1.06-1.09 (measured at 60 deg.C, reference density is water).
3. Mixing sodium polyacrylate, sodium carboxymethylcellulose, citric acid, polyvidone, glycerol and silica gel micropowder matrix material, and making into uniform cataplasma matrix.
4. And (3) taking the mixed cataplasm matrix, adding the crushed camphor, borneol, menthol, thymol and the traditional Chinese medicine fluid extract prepared in the step (2), refining and preparing the mixture into the plaster.
5. Coating the adhesive paste on a backing cloth, cutting into sections, covering the backing cloth with a liner (an isolation layer), slicing, and packaging.
Experimental example 1 skin test
The test drugs are: the external Chinese medicinal composition preparation of embodiments 1 to 3 of the present invention
1. Skin irritation test: the test animal is rabbit.
The test method comprises the following steps: 24 rabbits (8 rabbits are used in each experiment of each embodiment) are taken, the weight of the rabbits is 2.0-2.3 kg, the rabbits and the male rabbits are used as both male and female rabbits, the two sides of the spinal column of the animal are unhaired 24 hours before administration, the administration is carried out twice every day, the administration area on the left side and the blank matrix control area on the right side are carried out, the skin reaction condition is continuously observed for 7 days every day, the existence of erythema, edema, swelling, eschar formation and the like is carefully observed, and the observation is continuously carried out for 3 days after the medicine is stopped.
And (3) test results: after 7 days of continuous administration, the skin of the application part of the rabbit does not turn red, does not have irritation symptoms such as erythema, edema and the like, has no obvious difference compared with a blank matrix control area, and does not have erythema, edema, pigmentation and the like 72 hours after the skin of all the rabbits stops administration. The rabbit has no abnormal symptoms such as mental state, activity, respiration, food intake, weight, appearance, shape and color of urine, back hair, skin color and the like, and has no abnormal secretion in nose, eyes and oral cavity, thereby proving that the test drug has no skin irritation reaction.
2. Skin allergy test: the test animals were white guinea pigs.
White guinea pigs are taken, half male and female parts are respectively taken, the weight is 290-320 g, and hairs on two sides of the spinal column of the back of the guinea pigs are removed 24 hours before administration. The test animals were randomly divided into 5 groups of 10 animals each (male and female halves), each group was coated with the test substance (first, second and third groups were examples 1, 2 and 3, respectively), blank matrix (fourth group), 1% 2.4-dinitrochlorobenzene (fifth group, positive control group) once every 2 hours, after 6 hours the coated substance was washed off with clean water, all animals were housed in cages, repeated on days 7 and 14, the test was initiated on day 28, the test substance, blank matrix, 0.1% 2.4-dinitrochlorobenzene were applied to the other side of the spine of the test animal, after 6 hours the coated substance was removed, the skin allergy was observed, and then the allergy was observed again at 24 hours, 48 hours and 72 hours, and the skin reaction score was referenced to observe whether erythema, edema, animal standing, asthma, and/or not, Shock, and the like. Results of skin allergy test: the administration groups (the first group, the second group and the third group) and the blank substrate (the fourth group) have no anaphylactic reaction such as erythema, edema, unstable animal standing, asthma, shock and the like, and the sensitization rate of the positive control group (the fifth group) reaches 100 percent, which proves that the tested medicine has no skin anaphylactic reaction.
Experimental example 2, clinical test
The treatment method comprises the following steps: the plaster is used for treating apoplexy sequela by external application and is applied to the related acupuncture points on the affected side. Before application, the relevant acupuncture points are cleaned with warm water or disinfected with alcohol.
Diagnosis criteria for stroke sequelae:
1. the main symptoms are: hemiplegia, facial distortion, cloudiness, stiff tongue, aphasia, and hemianesthesia;
2. acute onset of disease;
3. the disease is induced by a plurality of factors, and the premonitory symptoms are usually found before the disease is initiated;
4. the age of good hair is more than 40 years old;
the diagnosis can be determined by combining the characteristics of tongue, pulse, inducement, aura, age and the like, and can be determined by combining the results of the imaging examination without the above conditions.
Staging standard:
1. in the acute stage: within 2 weeks after onset. The longest period of the middle zang-fu organs is 1 month.
2. A recovery period: the disease is developed within 2 weeks or 1 month to half a year.
3. In the sequela stage: the disease is more than half a year.
The evaluation standard of the curative effect of the apoplexy sequelae is as follows:
adopting a scoring method: the recovery degree of the mind, language and motor functions is focused.
The scoring method comprises the following steps:
1. mental state: 4 points for refreshing; absentmindedness (mind can be liked to human after sleep and awakening) for 3 minutes; mental confusion (unconsciousness of the response to sleepiness and exhaling) 2 points; coma 1 point; muddlehead (coma accompanied by withdrawal) score 0.
2. Language expression: 4, normal score; general expression, naming can not be divided into 3 points; uttering into sentences but not expressing fully for 2 points; the word and phrase 1 can not be spoken; the language cannot or cannot substantially be 0 points.
3. Upper limb shoulder joint: 4, normal score; the whole uplift and the muscle strength difference are 3 points; lifting the flat shoulder or skipping the shoulder for 2 minutes; lifting the shoulder for 1 minute; cannot move or slightly swing back and forth for 0 minute.
4. Upper limb finger joint: 4, normal score; the fingers act effectively respectively and the muscle strength difference is 3 minutes; the fist is clenched and the fingers are stretched for 2 minutes; the fingers are bent, the fist cannot be made, and the fingers cannot stretch for 1 minute; will not move for 0 minutes.
5. Lower limb hip joints: 4, normal score; lifting for 3 minutes above 45 degrees; less than 45 degrees and 2 minutes; the swing can translate for 1 minute; the power is not 0 minutes.
6. Lower limb toe joints: 4, normal score; freely stretched and flexed, weak force for 3 minutes; incomplete extension and flexion 2 points; slightly moving for 1 minute; will not move for 0 minutes.
7. Comprehensive functions are as follows: the life can be self-care, and the conversation is freely divided into 4 points; the independent life is simple, the labor is simple, and partial functions are not complete for 3 points; the walking can be realized, partial self-care is realized, and people are required to assist for 2 minutes; the person can take a step immediately and needs to take care of 1 minute at any time; 0 minute for bedridden.
Secondly, evaluating the curative effect:
the full score is 28 points, the maximum starting point score is not more than 18 points, and the curative effect evaluation is as follows:
1. deterioration: patients with decreased exacerbation score or death;
2. and (4) invalidation: the integral is increased by less than 4 points;
3. the method has the following advantages: the integral is increased by more than 4 points;
4. the effect is shown: the integral is increased by more than 10 points;
5. the basic cure is as follows: the integral reaches more than 24 points.
Thirdly, clinical tests:
1. treatment groups:
A. the external traditional Chinese medicine composition preparation of the embodiment 1 of the invention is applied to the relevant acupuncture points on the affected side for treating the sequela of apoplexy, and the treatment period is three months. In 385 patients with post-stroke symptoms, 239 male patients and 146 female patients are treated, and the age is between 40 and 75 years. 69 cases are basically cured, and the cure rate is 17.9%; 191 cases of significant effect are achieved, and the significant effect rate is 49.6%; 351 effective cases, and the effective rate is 91.2%; 34 cases of the cases are invalid, the inefficiency is 8.8%, and the deterioration is 0 case. The total effective rate is 91.2%.
B. The external traditional Chinese medicine composition preparation for treating the apoplexy sequelae is applied to the relevant acupuncture points on the affected side, and the treatment period is three months. In total, 214 patients with post-stroke symptoms were treated, 159 in male patients and 55 in female patients, with the age between 40 and 75 years. 37 cases are basically cured, and the cure rate is 17.3 percent; 107 cases of significant effect, 50.0 percent of significant effect; 191 effective cases, 89.3% effective rate; the efficiency was 10.7% in the case of 23 cases of no effect, and the case was 0% in the case of no effect. The total effective rate is 89.3%.
C. The external traditional Chinese medicine composition preparation for treating the apoplexy sequelae is applied to the relevant acupuncture points on the affected side, and the treatment period is three months. In total 327 patients with post-stroke symptoms were treated, including 210 male patients and 117 female patients, with the age between 40 and 70 years. 60 cases are basically cured, and the cure rate is 18.4%; 162 cases of significant effect, 49.5 percent of significant effect; 295 effective cases, and the effective rate is 90.2%; the efficiency was 9.8% in 32 cases of failure, and the quality was 0 case of failure. The total effective rate is 90.2%.
2. Control group: 81 patients with apoplexy sequelae in the same region are selected, and the age is between 40 and 75 years old. 60 male patients and 21 female patients are treated by using traditional Chinese and western medicines in hospitals for three months as a treatment period. The 10 cases are basically cured, and the cure rate is 12.3 percent; 33 cases of significant effect are shown, and the significant effect rate is 40.7%; 67 effective cases, the effective rate is 82.7%; the efficiency was 17.3% in 14 cases of no effect, and the efficiency was 0 case of no effect. The total effective rate is 82.7%.
The statistical results show that: the treated group and the control group differed significantly. Clinical trials show that: the traditional Chinese medicine composition is a traditional Chinese medicine preparation with the effects of dispelling wind, activating blood circulation, dredging channels and activating collaterals, is reasonably compatible, complementary and synergistic, dialectical in treatment, can be used for treating muscular paralysis, facial paralysis and channel contracture of stroke caused by collateral channels of wind evil, and has obvious effects of treating facial paralysis, watery mouth, stiff tongue, muscle numbness, arthralgia and myalgia and the like.
Claims (10)
1. A traditional Chinese medicine external preparation for treating apoplexy is characterized by being prepared from the following raw material medicines in parts by weight:
20-100 parts of rhizoma typhonii, 10-60 parts of long-noded pit viper, 10-80 parts of earthworm, 10-80 parts of scorpion, 10-80 parts of stiff silkworm, 10-80 parts of ligusticum wallichii, 20-80 parts of angelica dahurica, 10-80 parts of angelica sinensis, 10-60 parts of rhizoma gastrodiae, 10-60 parts of red paeony root, 20-100 parts of divaricate saposhnikovia root, 20-100 parts of notopterygium root, 5-20 parts of camphor, 5-20 parts of borneol, 1-10 parts of menthol and 1-10 parts of thymol.
2. The traditional Chinese medicine external preparation for treating stroke as claimed in claim 1, wherein the raw material medicines are as follows in parts by weight: 20-80 parts of rhizoma typhonii, 10-40 parts of long-noded pit viper, 20-60 parts of earthworm, 10-60 parts of scorpion, 10-60 parts of stiff silkworm, 20-60 parts of ligusticum wallichii, 20-60 parts of angelica dahurica, 10-50 parts of angelica, 10-50 parts of rhizoma gastrodiae, 10-50 parts of red paeony root, 20-70 parts of divaricate saposhnikovia root, 20-70 parts of notopterygium root, 5-15 parts of camphor, 5-15 parts of borneol, 2-10 parts of menthol and 2-10 parts of thymol.
3. The traditional Chinese medicine external preparation for treating stroke as claimed in claim 1, which is prepared from the following raw material medicines in parts by weight:
50 parts of giant typhonium rhizome, 20 parts of long-noded pit viper, 30 parts of earthworm, 50 parts of scorpion, 50 parts of stiff silkworm, 40 parts of szechuan lovage rhizome, 40 parts of dahurian angelica root, 40 parts of Chinese angelica, 30 parts of tall gastrodia tuber, 20 parts of red paeony root, 30 parts of divaricate saposhnikovia root, 20 parts of incised notopterygium rhizome, 10 parts of camphor, 10 parts of borneol, 5 parts of menthol and 5 parts of thymol; or,
60 parts of rhizoma typhonii, 15 parts of long-noded pit viper, 40 parts of earthworm, 50 parts of scorpion, 50 parts of stiff silkworm, 50 parts of ligusticum wallichii, 40 parts of angelica dahurica, 40 parts of angelica, 20 parts of gastrodia elata, 30 parts of red paeony root, 20 parts of divaricate saposhnikovia root, 30 parts of notopterygium root, 5 parts of camphor, 10 parts of borneol, 10 parts of menthol and 5 parts of thymol; or,
55 parts of giant typhonium rhizome, 15 parts of long-noded pit viper, 40 parts of earthworm, 50 parts of scorpion, 60 parts of stiff silkworm, 30 parts of szechuan lovage rhizome, 30 parts of dahurian angelica root, 30 parts of Chinese angelica, 30 parts of tall gastrodia tuber, 30 parts of red paeony root, 40 parts of divaricate saposhnikovia root, 30 parts of incised notopterygium rhizome, 10 parts of camphor, 5 parts of borneol, 10 parts of menthol and 5 parts of thymol.
4. The topical Chinese medicinal composition preparation according to any one of claims 1 to 3, characterized in that the formulation is a rubber paste, a cataplasma, an ointment or a plaster.
5. A method for preparing an external preparation of the Chinese medicinal composition of any one of claims 1 to 3, comprising the steps of:
(1) weighing the raw material components in proportion, and crushing; mixing rhizoma Typhonii, Agkistrodon, Lumbricus, Scorpio, Bombyx Batryticatus, rhizoma Ligustici Chuanxiong, radix Angelicae Dahuricae, radix Angelicae sinensis, rhizoma Gastrodiae, radix Paeoniae Rubra, radix Saposhnikoviae, and Notopterygii rhizoma, extracting the obtained mixed medicinal powder with ethanol solvent, concentrating, and making into Chinese medicinal fluid extract;
(2) taking paste matrix, adding the traditional Chinese medicine fluid extract in the step (1), camphor, borneol, menthol and thymol, refining and preparing into paste;
preferably, the plaster base is a rubber plaster base, a cataplasm base, an ointment base or a plaster base.
6. The method for preparing an external preparation of a Chinese medicinal composition as claimed in claim 5, wherein the extracting with ethanol as a solvent in step (1) is carried out by percolating, collecting the percolate, concentrating under reduced pressure, recovering ethanol, and making into Chinese medicinal fluid extract.
7. The method for preparing an external preparation of a Chinese medicinal composition as claimed in claim 5 or 6, wherein the volume of the ethanol solvent is 1-1.5 times of the total mass of the mixed medicinal powder, and the volume: the unit of mass ratio is milliliter/gram or liter/kilogram; mixing the mixed medicinal powder with ethanol solvent, stirring, sealing, standing, and soaking for 1-3 hr to make the medicinal materials fully expand; and then filling the soaked mixed medicinal powder into a percolator, adding an ethanol solvent, continuously placing in a closed state for soaking for 24-48 hours to ensure that the solvent is fully permeated and diffused, and then starting percolation.
8. The method for preparing an external preparation of a Chinese medicinal composition according to claim 7, wherein, when the infiltrated mixed powder is loaded into a percolator, the mixed powder is evenly loaded into the percolator in several times; opening the lower opening of the percolator, slowly adding ethanol solvent from the upper part, closing the lower opening when liquid flows out from the lower opening to remove air in the gaps between the medicinal powders, and continuously adding ethanol solvent until the upper surface of the medicinal powders is 1-10 cm higher than the upper surface of the medicinal powders.
9. The method for preparing an external preparation of a Chinese medicinal composition according to claim 7, wherein, when starting percolation, the percolation speed is controlled so that the effluent per hour is 1/48-1/24 of the effective volume of the percolator, and the ethanol solvent is continuously added from the upper part so as to keep the liquid level of the solvent higher than the upper surface of the mixed medicinal powder; collecting the volume of the percolate which is 5-6 times of the total mass of the mixed medicinal powder, wherein the unit is as follows: ml/g, or l/kg.
10. The method for preparing the external preparation of the Chinese medicinal composition according to claim 7, wherein in the step (1), the concentration temperature is 50-85 ℃;
the relative density of the traditional Chinese medicine fluid extract is 1.05-1.10, the reference density is water, and the temperature is measured at 50-65 ℃;
the ethanol solvent is ethanol with the volume fraction of 70-90;
the raw material medicines are crushed into coarse powder, and the coarse powder is completely sieved by a 24-mesh sieve, wherein the mass of the coarse powder which can be sieved by a 65-mesh sieve is not more than 40% of the total mass of the coarse powder.
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| CN110237163A (en) * | 2019-07-03 | 2019-09-17 | 亳州职业技术学院 | A kind of Dahurian angelica root collaterals-dredgingdrink powder and preparation method thereof |
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