CN103223074A - Wound treating capsule and preparation method - Google Patents
Wound treating capsule and preparation method Download PDFInfo
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- CN103223074A CN103223074A CN2013101912151A CN201310191215A CN103223074A CN 103223074 A CN103223074 A CN 103223074A CN 2013101912151 A CN2013101912151 A CN 2013101912151A CN 201310191215 A CN201310191215 A CN 201310191215A CN 103223074 A CN103223074 A CN 103223074A
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Abstract
The invention relates to a wound treating capsule and a preparation method, and in particular relates to a wound treating capsule. The wound treating capsule comprises the following raw materials in parts by weight: 176 parts of Korean aconite roof, 15-45 parts of rhizoma arisaematis, 5-25 parts of radix angelicae, 5-25 parts of radices sileris and 5-25 parts of notopterygium root. The invention further relates to a method for preparing the wound treating capsule. The wound treating capsule provided by the invention has good pharmaceutical properties.
Description
Technical field
The present invention relates to field of medicaments, be specifically related to a kind of wound curative capsule and method for making thereof.
Background technology
Traumatic injury is the orthopaedics commonly encountered diseases, and in the process of traumatic injury, inflammatory mediator and cytokine play an important role in inflammatory reaction and tissue repair.Traumatic injury mainly shows as degeneration, inflammatory exudation and the hypertrophy of local organization, has a large amount of cytokines or inflammatory mediator to participate in this process, as CCL5, IL-1 β, TNF-α, IL-3 etc.CCL5 plays a part in inflammatory reaction the earliest, and it attracts leukocytic chemotactic to move and activate these cells, and IL-3 is produced by the T lymphocyte in vivo, and the antagonist of IL-3 has the treatment that helps diseases associated with inflammation, and its clinical practice is still underway.TNF-α generally is considered to judge the important cytokine of inflammatory arthritis pathology process, usually by mononuclear cell, macrophage secretion.Play an important role in the cascade reaction of TNF-α pro-inflammatory cytokine, it can regulate the secretion of other preceding inflammatory cytokines.IL-1 β is called as endogenous pyrogen, except that causing fever, also plays a significant role in inflammatory reaction, is the inflammatory mediator that early occurs in the inflammatory reaction.
For the traumatic injury clinical commonly used drug is non-steroidal drug such as aspirin, indomethacin etc., and clinical research shows that taking this quasi-tradition nonsteroidal antiinflammatory drug for a long time produces multiple untoward reaction.Treatment has accumulated rich experience to Chinese medicine to traumatic injury, use wound curative capsule (the accurate word Z10920013 of traditional Chinese medicines for many years clinically, Hangzhou Zhuyangxin Pharmaceutical Co., Ltd produces) be that ancient prescription " it is diffusing to cure the wound " dosage changing form forms, effect with dispelling wind-evil and transforming calculus, reducing swelling and alleviating pain, hinder red and swollen outside being used for due to the traumatic injury, hypochondrium pain with internal injury etc., get with wind-expelling pain-stopping, eleminating phlegm and freeing channels medicine, form with Radix Aconiti Coreani, Rhizoma Arisaematis, the Radix Angelicae Dahuricae, Radix Saposhnikoviae, Rhizoma Et Radix Notopterygii prescription, wherein Radix Aconiti Coreani is a monarch drug, has dispelling pathogenic wind and eliminating phlegm, dampness analgesic effect; Rhizoma Arisaematis drying dampness to eliminate phlegm, relieving spasm to stop pain, mass dissipating and swelling eliminating; Radix Angelicae Dahuricae expelling wind and removing dampness, understand things pain-stopping, the pus that disappears row swell, and are all ministerial drug with Rhizoma Arisaematis; Radix Saposhnikoviae inducing diaphoresis to dispel wind, removing dampness to relieve pain, spasmolytic; Rhizoma Et Radix Notopterygii loose exterior cold, wind-damp dispelling, sharp joint, this two flavor is all adjuvant.All medicines share, and play dispelling wind-evil and transforming calculus altogether, the effect of reducing swelling and alleviating pain.The function of wound curative capsule is dispelling wind-evil and transforming calculus with curing mainly, reducing swelling and alleviating pain, hinder outside being used for due to the traumatic injury red and swollen, hypochondrium pain with internal injury etc.; It is generally used for clinically: traumatic injury, various soft tissue injury, strain, skin injury, internal injury; Rheumatic arthritis; The various aseptic inflammations of organizing such as scapulohumeral periarthritis, chondritis, synovitis, tenosynovitis; The pain that degeneration of joint such as hyperosteogeny, cervical spondylotic radiculopathy causes; Lumbago and skelalgia, sciatica, arthralgia, cervical vertebra pain etc.
Prior art discloses the preparation method of many wound curative capsules.For example, CN1883630A (Chinese patent application 200610051843.X, Zhu Yangxin) a kind of preparation method for the treatment of the oral medicine of traumatic injury is disclosed, get living Radix Aconiti Coreani 88～264, Radix Saposhnikoviae 7.5～22.5, Rhizoma Et Radix Notopterygii 7.5～22.5, Rhizoma Arisaematis 14.5～43.5, the Radix Angelicae Dahuricae 7.5～22.5, and with Radix Saposhnikoviae, Rhizoma Et Radix Notopterygii, Rhizoma Arisaematis, it is standby that the Radix Angelicae Dahuricae is ground into fine powder together, will give birth to Radix Aconiti Coreani again and be ground into fine powder and above-mentioned fine powder equivalent incremental method facing-up, crossing screen-aperture is 80 purpose sieves, mixing incapsulates then, and every is 0.25 gram (the 2/5th page of 7-4 reciprocal is capable referring to this description of the invention).
In addition, CN101785818A (Chinese patent application numbers 201010138372.2, Zhu Yangxin) a kind of preparation method of wound curative capsule is disclosed, be specially: the prescription medical material five tastes, according to Radix Aconiti Coreani 176g, Rhizoma Arisaematis (processed) 29g, Radix Angelicae Dahuricae 15g, Radix Saposhnikoviae 15g, the ratio of Rhizoma Et Radix Notopterygii 15g is except that giving birth to Radix Aconiti Coreani, four flavors such as all the other Radix Saposhnikoviaes are ground into fine powder, to give birth to Radix Aconiti Coreani and be ground into fine powder and above-mentioned fine powder equivalent incremental method facing-up, sieve mixing, incapsulate, make 1000, irradiation sterilization promptly gets (referring to this description of the invention [0029] section).
The wound curative capsule of making by five tastes medical material, wherein Radix Aconiti Coreani accounts for about 70% of total crude drug, and wherein comprises total alkaloids, such as following alkaloid: Guan-fubase A, Guan-fubase B, these alkaloid biologic activity are stronger, so their stability in medicine needs special concern.
CN101785818A (Chinese patent application numbers 201010138372.2, Zhu Yangxin) put down in writing the detection method of content of wound curative capsule in the prior art, for example document description [0007] section has been put down in writing " Radix Aconiti Coreani Determination of Total Alkaloid ": get the content under the wound curative capsule content uniformity item, the accurate title, decide, get about 6g, put in the tool plug conical flask, the accurate 1% hydrochloric acid solution 50ml that adds, supersound process 30 minutes, water temperature keeps below 50 ℃, puts in the centrifuge tube with 3000 rev/mins speed centrifugalize 10 minutes, and precision is measured supernatant 25ml, put in the separatory funnel, regulate pH value to 10～11 with strong ammonia solution.With chloroform extraction 5 times, each 10ml, merge extractive liquid, is put evaporate to dryness in the water-bath.Residue adds the apparent neutral ethanol 5ml of paramethyl red indicator makes dissolving, and evaporate to dryness, residue add ethanol 5ml makes dissolving, precision adds 0.01mol/L hydrochloric acid volumetric solution 10ml, shakes up, and adds 2 of the cold water 15ml that newly boiled and C.I. 13020. indicator solutions, extremely yellow with 0.01mol/L sodium hydroxide titration drop, promptly.0.01mol/L the every 1ml of hydrochloric acid volumetric solution is equivalent to the C24H31NO6 of 4.295mg.And clear and definite every of prior art wound curative capsule contains total alkaloids in Guan-fubase A (C24H31NO6), should be 1.20～2.00mg.
In addition, CN101785818A (Chinese patent application numbers 201010138372.2, Zhu Yangxin) put down in writing the method that it measures Guan-fubase B content in the preparation, for example document description [0099]～[0104] section has been put down in writing " high performance liquid chromatography (an appendix VI of Chinese Pharmacopoeia version in 2005 D) is measured Guan-fubase B content in the preparation ", and specifically: chromatographic condition and system suitability test: with octadecylsilane chemically bonded silica is filler; Acetonitrile 0.2% triethylamine 0.2% perfluoroetane sulfonic acid sodium solution is a mobile phase; The detection wavelength is 205nm; Number of theoretical plate calculates by the Guan-fubase B peak should be not less than 5000; The preparation of reference substance solution: it is an amount of that precision takes by weighing the Guan-fubase B reference substance, adds methanol and make the solution that every 1ml contains 0.04mg, promptly; The preparation of need testing solution: get the content under this product content uniformity limit, the accurate title, decide, and gets about 2g, the accurate title, decide, and puts in the tool plug conical flask, the accurate 1% hydrochloric acid solution 50ml that adds, close plug claims to decide weight, soaks 20min, supersound process 30 minutes is put coldly, weighs again, supply the weight that subtracts mistake with 1% hydrochloric acid, shake up, filter, get subsequent filtrate, promptly; Assay method: get reference substance solution and need testing solution 20ul respectively, inject chromatograph of liquid, measure, promptly.And every gram contains Guan-fubase B (C15H10O5) and must not be less than 0.6mg in the wound curative capsule that the clear and definite document provides.
As seen, the quality of wound curative capsule is controlled in the prior art attempt at least from two aspects: (a) by the titration measuring of C.I. 13020. indicator solution colour developing, determine that total alkaloids in the wound curative capsule (comprising Guan-fubase A, Guan-fubase B, hypaconitine etc.) content is 1.2～2.0mg/ grain; (b) measure by the HPLC method, determine that Guan-fubase B in the wound curative capsule (C15H10O5) content is greater than 0.6mg.
As everyone knows, it is to produce so that certain component relationship is comprehensive by numerous active component that Chinese medicine is brought into play its drug effect, for example between total alkaloids and the concrete chemical monomer thereof specific quantity relative ratio relationship is arranged in the wound curative capsule, having under the therapeutic effect of clinical verification, these quantity relative ratio relationships should not have big variation, particularly in the Long-term Storage process of for example medicine, the specific quantity relative ratio relationship between these chemical monomers does not have and changes significantly, in the hope of keeping the stability of clinical efficacy.
Therefore, those skilled in the art's expectation has a kind of new treatment traumatic injury, various soft tissue injury, strain, skin injury, internal injury; Rheumatic arthritis; The various aseptic inflammations of organizing such as scapulohumeral periarthritis, chondritis, synovitis, tenosynovitis; The pain that degeneration of joint such as hyperosteogeny, cervical spondylotic radiculopathy causes; The method of clinical diseases such as lumbago and skelalgia, sciatica, arthralgia, cervical vertebra pain or disease.Particularly expectation provides a kind of effect with dispelling wind-evil and transforming calculus, reducing swelling and alleviating pain, hinder outside can be used for due to the traumatic injury red and swollen, wound curative capsules such as hypochondrium pain with internal injury.More especially expectation provides a kind of wound curative capsule with good pharmaceutical properties.
Summary of the invention
The object of the present invention is to provide a kind of new treatment traumatic injury, various soft tissue injury, strain, skin injury, internal injury; Rheumatic arthritis; The various aseptic inflammations of organizing such as scapulohumeral periarthritis, chondritis, synovitis, tenosynovitis; The pain that degeneration of joint such as hyperosteogeny, cervical spondylotic radiculopathy causes; The method of clinical diseases such as lumbago and skelalgia, sciatica, arthralgia, cervical vertebra pain or disease.A kind of effect with dispelling wind-evil and transforming calculus, reducing swelling and alleviating pain particularly is provided, hinder outside can be used for due to the traumatic injury red and swollen, wound curative capsules such as hypochondrium pain with internal injury.A kind of wound curative capsule with good pharmaceutical properties more especially is provided.Find unexpectedly that the wound curative capsule that uses the inventive method to obtain has beat all good pharmaceutical properties.
For this reason, first aspect present invention provides a kind of wound curative capsule, and its medical material by following weight proportion is made:
Radix Aconiti Coreani 176 weight portions,
Rhizoma Arisaematis 15～45 weight portions,
The Radix Angelicae Dahuricae 5～25 weight portions,
Radix Saposhnikoviae 5～25 weight portions,
Rhizoma Et Radix Notopterygii 5～25 weight portions.
According to the described wound curative capsule of the arbitrary embodiment of first aspect present invention, its medical material by following weight proportion is made:
Radix Aconiti Coreani 176 weight portions,
Rhizoma Arisaematis 20～40 weight portions,
The Radix Angelicae Dahuricae 10～20 weight portions,
Radix Saposhnikoviae 10～20 weight portions,
Rhizoma Et Radix Notopterygii 10～20 weight portions.
According to the described wound curative capsule of the arbitrary embodiment of first aspect present invention, its medical material by following weight proportion is made:
Radix Aconiti Coreani 176 weight portions,
Rhizoma Arisaematis 25～35 weight portions,
The Radix Angelicae Dahuricae 12～18 weight portions,
Radix Saposhnikoviae 12～18 weight portions,
Rhizoma Et Radix Notopterygii 12～18 weight portions.
According to the described wound curative capsule of the arbitrary embodiment of first aspect present invention, its medical material by following weight proportion is made:
About 176 weight portions of Radix Aconiti Coreani,
About 30 weight portions of Rhizoma Arisaematis,
About 15 weight portions of the Radix Angelicae Dahuricae,
About 15 weight portions of Radix Saposhnikoviae,
About 15 weight portions of Rhizoma Et Radix Notopterygii.
According to the described wound curative capsule of the arbitrary embodiment of first aspect present invention, its medical material by following weight proportion is made:
About 176 weight portions of Radix Aconiti Coreani,
About 29 weight portions of Rhizoma Arisaematis,
About 15 weight portions of the Radix Angelicae Dahuricae,
About 15 weight portions of Radix Saposhnikoviae,
About 15 weight portions of Rhizoma Et Radix Notopterygii.
According to the described wound curative capsule of the arbitrary embodiment of first aspect present invention, its medical material by following weight proportion is made:
About 176 weight portions of Radix Aconiti Coreani,
About 31 weight portions of Rhizoma Arisaematis,
About 17 weight portions of the Radix Angelicae Dahuricae,
About 13 weight portions of Radix Saposhnikoviae,
About 15 weight portions of Rhizoma Et Radix Notopterygii.
According to the described wound curative capsule of the arbitrary embodiment of first aspect present invention, its medical material by following weight proportion is made:
About 176 weight portions of Radix Aconiti Coreani,
About 29 weight portions of Rhizoma Arisaematis,
About 16 weight portions of the Radix Angelicae Dahuricae,
About 15 weight portions of Radix Saposhnikoviae,
About 14 weight portions of Rhizoma Et Radix Notopterygii.
According to the described wound curative capsule of the arbitrary embodiment of first aspect present invention, wherein said Rhizoma Arisaematis is a Rhizoma Arisaematis (processed).Rhizoma Arisaematis (processed) is known in the art, and it for example is recorded in one one 54 pages of Chinese Pharmacopoeia versions in 2010.
According to the described wound curative capsule of the arbitrary embodiment of first aspect present invention, wherein said Rhizoma Arisaematis (processed) is directly pulverized the gained powder with it and is added in the described wound curative capsule.
According to the described wound curative capsule of the arbitrary embodiment of first aspect present invention, the wherein said Radix Angelicae Dahuricae is directly pulverized the gained powder with it and is added in the described wound curative capsule.
According to the described wound curative capsule of the arbitrary embodiment of first aspect present invention, wherein said Radix Saposhnikoviae is directly pulverized the gained powder with it and adds in the described wound curative capsule.
According to the described wound curative capsule of the arbitrary embodiment of first aspect present invention, wherein said Rhizoma Et Radix Notopterygii is directly pulverized the gained powder with it and adds in the described wound curative capsule.
According to the described wound curative capsule of the arbitrary embodiment of first aspect present invention, wherein said Radix Aconiti Coreani is to give birth to Radix Aconiti Coreani.
According to the described wound curative capsule of the arbitrary embodiment of first aspect present invention, wherein said living Radix Aconiti Coreani adds in the described wound curative capsule after extracting.
According to the described wound curative capsule of the arbitrary embodiment of first aspect present invention, wherein said living Radix Aconiti Coreani is that gained Radix Aconiti Coreani extract adds in the described wound curative capsule after being selected from following solvent extraction: water, aquiferous ethanol, ethanol.In one embodiment, wherein said aquiferous ethanol is the ethanol of concentration 10～90%.In one embodiment, wherein said aquiferous ethanol is the ethanol of concentration 25～80%.In one embodiment, wherein said aquiferous ethanol is the ethanol of concentration 50～75%.In one embodiment, wherein said aquiferous ethanol is concentration 50～75% ethanol and wherein contains 1～5mmol hydrochloric acid, for example contains 1～3mmol hydrochloric acid, contains 1～2mmol hydrochloric acid.In one embodiment, the following basically mode of wherein said Radix Aconiti Coreani extract prepares: will give birth to Radix Aconiti Coreani with the extraction solvent soaking of 5～10 times of amounts 1～3 hour, then reflux, extract, is 1～3 hour; Filtering residue is with the extraction solvent of 5～10 times of amounts reflux, extract, 1～3 hour once more; Merge extracted twice gained extracting solution, concentrate, be dried to moisture, get powder and be the Radix Aconiti Coreani extract below 5%.As well known to those skilled in the art, under the situation of having determined the extraction solvent, concrete extraction process can be treated according to those skilled in the art's experience or the present invention and be hindered capsular concrete condition and do suitable adjustment, and therefore above-mentioned concrete extraction process only is a preferred embodiment of the present invention.Unexpectedly find, use specific solvent to extract gained and not only have higher alkaloid, and wherein crucial alkaloidal quantity relative ratio relationship can keep than stable status well, and prior art does not have any instruction or theoretically can set forth the relevant property with the extraction process condition of stability of quantity relative ratio relationship.
According to the described wound curative capsule of the arbitrary embodiment of first aspect present invention, wherein can also comprise the pharmacy acceptable auxiliary.The selection of pharmaceutic adjuvant and addition are that those skilled in the art rule of thumb prepare demand with capsule and determine easily.Schematically pharmaceutic adjuvant has diluent or filler, binding agent, lubricants, flavoring agent etc.Diluent or filler are mainly used in the weight or volume of adjusting medicament, so that make active component can be prepared into the pharmaceutical preparation of suitable clinical use; Typical diluent or filler be for example sucrose, glucose, lactose etc. of saccharide for example, and starch and derivant thereof be corn starch, modified starch, amylum pregelatinisatum, dextrin etc. for example, and cellulose family is microcrystalline Cellulose for example; Typical binding agent is aqueous solution/suspension of being mixed with such as starch slurry, PVP, HPMC for example, can also make water or aquiferous ethanol as wetting agent to obtain the effect of binding agent; Lubricants helps to improve particulate flowability so that formulation preparation, and exemplary lubricants comprises magnesium stearate, Pulvis Talci, silicon dioxide, micropowder silica gel etc.; Flavoring agent can be used for improving medicine mouthfeel, for example aspartame, stevioside etc.
According to the described wound curative capsule of the arbitrary embodiment of first aspect present invention, it prepares according to following method basically: get Rhizoma Arisaematis, the Radix Angelicae Dahuricae, Radix Saposhnikoviae and Rhizoma Et Radix Notopterygii, pulverize separately becomes fine powder standby; Radix Aconiti Coreani is obtained the Radix Aconiti Coreani extract with being selected from following solvent extraction: water, aquiferous ethanol, ethanol; The fine powder of Radix Aconiti Coreani extract and other four Chinese medicine material and optional pharmacy acceptable auxiliary are mixed, make powder or granule, incapsulate in the shell, promptly.
According to the described wound curative capsule of the arbitrary embodiment of first aspect present invention, it prepares according to following method basically: get Rhizoma Arisaematis, the Radix Angelicae Dahuricae, Radix Saposhnikoviae and Rhizoma Et Radix Notopterygii, pulverize separately becomes fine powder standby; Radix Aconiti Coreani extracted with 10～90% ethanol (for example 25～80% ethanol, for example 50～75% ethanol for example contain 1～5mmol hydrochloric acid in this ethanol, for example contain 1～3mmol hydrochloric acid, contain 1～2mmol hydrochloric acid) obtain the Radix Aconiti Coreani extract; The fine powder of Radix Aconiti Coreani extract and other four Chinese medicine material and optional pharmacy acceptable auxiliary are mixed, make powder or granule, incapsulate in the shell, promptly.
According to the described wound curative capsule of the arbitrary embodiment of first aspect present invention, it prepares according to following method basically: get Rhizoma Arisaematis, the Radix Angelicae Dahuricae, Radix Saposhnikoviae and Rhizoma Et Radix Notopterygii, pulverize separately becomes fine powder standby; With giving birth to Radix Aconiti Coreani, follow reflux, extract, 1～3 hour with the extraction solvent soaking of 5～10 times of amounts 1～3 hour; Filtering residue is with the extraction solvent of 5～10 times of amounts reflux, extract, 1～3 hour once more; Merge extracted twice gained extracting solution, concentrate, be dried to moisture below 5%, getting powder is the Radix Aconiti Coreani extract; The fine powder of Radix Aconiti Coreani extract and other four Chinese medicine material and optional pharmacy acceptable auxiliary are mixed, make powder or granule, incapsulate in the shell, promptly.
Second aspect present invention provides a kind of for example method of each described wound curative capsule of first aspect present invention of wound curative capsule for preparing, and this method may further comprise the steps: get Rhizoma Arisaematis, the Radix Angelicae Dahuricae, Radix Saposhnikoviae and Rhizoma Et Radix Notopterygii, pulverize separately becomes fine powder standby; Radix Aconiti Coreani is obtained the Radix Aconiti Coreani extract with being selected from following solvent extraction: water, aquiferous ethanol, ethanol; The fine powder of Radix Aconiti Coreani extract and other four Chinese medicine material and optional pharmacy acceptable auxiliary are mixed, make powder or granule, incapsulate in the shell, promptly.
According to the described method of the arbitrary embodiment of second aspect present invention, the weight proportion of wherein said five kinds of medical materials is:
Radix Aconiti Coreani 176 weight portions,
Rhizoma Arisaematis 15～45 weight portions,
The Radix Angelicae Dahuricae 5～25 weight portions,
Radix Saposhnikoviae 5～25 weight portions,
Rhizoma Et Radix Notopterygii 5～25 weight portions.
According to the described method of the arbitrary embodiment of second aspect present invention, the weight proportion of wherein said five kinds of medical materials is:
Radix Aconiti Coreani 176 weight portions,
Rhizoma Arisaematis 20～40 weight portions,
The Radix Angelicae Dahuricae 10～20 weight portions,
Radix Saposhnikoviae 10～20 weight portions,
Rhizoma Et Radix Notopterygii 10～20 weight portions.
According to the described method of the arbitrary embodiment of second aspect present invention, the weight proportion of wherein said five kinds of medical materials is:
Radix Aconiti Coreani 176 weight portions,
Rhizoma Arisaematis 25～35 weight portions,
The Radix Angelicae Dahuricae 12～18 weight portions,
Radix Saposhnikoviae 12～18 weight portions,
Rhizoma Et Radix Notopterygii 12～18 weight portions.
According to the described method of the arbitrary embodiment of second aspect present invention, the weight proportion of wherein said five kinds of medical materials is:
About 176 weight portions of Radix Aconiti Coreani,
About 30 weight portions of Rhizoma Arisaematis,
About 15 weight portions of the Radix Angelicae Dahuricae,
About 15 weight portions of Radix Saposhnikoviae,
About 15 weight portions of Rhizoma Et Radix Notopterygii.
According to the described method of the arbitrary embodiment of second aspect present invention, the weight proportion of wherein said five kinds of medical materials is:
About 176 weight portions of Radix Aconiti Coreani,
About 29 weight portions of Rhizoma Arisaematis,
About 15 weight portions of the Radix Angelicae Dahuricae,
About 15 weight portions of Radix Saposhnikoviae,
About 15 weight portions of Rhizoma Et Radix Notopterygii.
According to the described method of the arbitrary embodiment of second aspect present invention, the weight proportion of wherein said five kinds of medical materials is:
About 176 weight portions of Radix Aconiti Coreani,
About 31 weight portions of Rhizoma Arisaematis,
About 17 weight portions of the Radix Angelicae Dahuricae,
About 13 weight portions of Radix Saposhnikoviae,
About 15 weight portions of Rhizoma Et Radix Notopterygii.
According to the described method of the arbitrary embodiment of second aspect present invention, the weight proportion of wherein said five kinds of medical materials is:
About 176 weight portions of Radix Aconiti Coreani,
About 29 weight portions of Rhizoma Arisaematis,
About 16 weight portions of the Radix Angelicae Dahuricae,
About 15 weight portions of Radix Saposhnikoviae,
About 14 weight portions of Rhizoma Et Radix Notopterygii.
According to the described method of the arbitrary embodiment of second aspect present invention, wherein said Rhizoma Arisaematis is a Rhizoma Arisaematis (processed).Rhizoma Arisaematis (processed) is known in the art, and it for example is recorded in one one 54 pages of Chinese Pharmacopoeia versions in 2010.
According to the described method of the arbitrary embodiment of second aspect present invention, wherein said aquiferous ethanol is the ethanol of concentration 10～90%.In one embodiment, wherein said aquiferous ethanol is the ethanol of concentration 25～80%.In one embodiment, wherein said aquiferous ethanol is the ethanol of concentration 50～75%.In one embodiment, wherein said aquiferous ethanol is concentration 50～75% ethanol and wherein contains 1～5mmol hydrochloric acid, for example contains 1～3mmol hydrochloric acid, contains 1～2mmol hydrochloric acid.In one embodiment, the following basically mode of wherein said Radix Aconiti Coreani extract prepares: will give birth to Radix Aconiti Coreani with the extraction solvent soaking of 5～10 times of amounts 1～3 hour, then reflux, extract, is 1～3 hour; Filtering residue is with the extraction solvent of 5～10 times of amounts reflux, extract, 1～3 hour once more; Merge extracted twice gained extracting solution, concentrate, be dried to moisture, get powder and be the Radix Aconiti Coreani extract below 5%.As well known to those skilled in the art, under the situation of having determined the extraction solvent, concrete extraction process can be treated according to those skilled in the art's experience or the present invention and be hindered capsular concrete condition and do suitable adjustment, and therefore above-mentioned concrete extraction process only is a preferred embodiment of the present invention.Unexpectedly find, use specific solvent to extract gained and not only have higher alkaloid, and wherein crucial alkaloidal quantity relative ratio relationship can keep than stable status well, and prior art does not have any instruction or theoretically can set forth the relevant property with the extraction process condition of stability of quantity relative ratio relationship.
According to the described wound curative capsule of the arbitrary embodiment of first aspect present invention, it prepares according to following method basically: get Rhizoma Arisaematis, the Radix Angelicae Dahuricae, Radix Saposhnikoviae and Rhizoma Et Radix Notopterygii, pulverize separately becomes fine powder standby; With Radix Aconiti Coreani with 10～90% ethanol (25～80% ethanol for example, 50～75% ethanol for example, for example contain 1～5mmol hydrochloric acid in this ethanol, for example contain 1～3mmol hydrochloric acid, contain 1～2mmol hydrochloric acid) extract and to obtain the Radix Aconiti Coreani extract: water, aquiferous ethanol, ethanol; The fine powder of Radix Aconiti Coreani extract and other four Chinese medicine material and optional pharmacy acceptable auxiliary are mixed, make powder or granule, incapsulate in the shell, promptly.
According to the described wound curative capsule of the arbitrary embodiment of first aspect present invention, it prepares according to following method basically: get Rhizoma Arisaematis, the Radix Angelicae Dahuricae, Radix Saposhnikoviae and Rhizoma Et Radix Notopterygii, pulverize separately becomes fine powder standby; With giving birth to Radix Aconiti Coreani, follow reflux, extract, 1～3 hour with the extraction solvent soaking of 5～10 times of amounts 1～3 hour; Filtering residue is with the extraction solvent of 5～10 times of amounts reflux, extract, 1～3 hour once more; Merge extracted twice gained extracting solution, concentrate, be dried to moisture below 5%, getting powder is the Radix Aconiti Coreani extract; The fine powder of Radix Aconiti Coreani extract and other four Chinese medicine material and optional pharmacy acceptable auxiliary are mixed, make powder or granule, incapsulate in the shell, promptly.
Arbitrary technical characterictic that arbitrary embodiment had of either side of the present invention or this either side is suitable for arbitrary embodiment of other arbitrary embodiment or other either side equally, as long as they can be not conflicting, certainly at where applicable each other, necessary words can be done suitably to modify to individual features.Be further described with characteristics to various aspects of the present invention below.
All documents that the present invention quoted from, their full content is incorporated this paper by reference into, and if the expressed implication of these documents and the present invention when inconsistent, be as the criterion with statement of the present invention.In addition, various terms and phrase that the present invention uses have the general sense of well known to a person skilled in the art, nonetheless, the present invention still wishes at this more detailed description and interpretation to be made in these terms and phrase, term of mentioning and phrase are as the criterion with the implication that the present invention was explained if any inconsistent with known implication.
Existing wound curative capsule is on the basis of ancient prescription " Yuzhen San ", to various medical materials in the prescription, according to the different screenings meticulously of its property of medicine, effect, carries out that rational formula makes.Thereby many shortcomings such as the numb tongue, bitter in the mouth, the dosage that have overcome original dosage form are inaccurate.Wound curative capsule, damages soft tissue injury through a large amount of clinical verifications, and diseases such as rheumatism, rheumatoid bone injury have unique curative effect; Also fine to associated conditions effects such as hypochondrium pain with internal injury, lumbar muscle strain, scapulohumeral periarthritis, arthralgia, be a kind of efficient, safe, ideal pure Chinese medicinal preparation.Treatment with dispelling wind-evil and transforming calculus, reducing swelling and alleviating pain effect is hindered capsule and is hindered red and swollen, hypochondrium pain with internal injury outside being used for due to the traumatic injury, and its pharmacological action comprises: it is illusory 1, to regulate whole body or local blood, to improve the metabolism status of diseased region; 2, regulate the function of blood coagulation and anticoagulation system, have dual regulation; 3, suppress inflammatory reaction, reduce the generation that inflammatory ends and cause the pain factor, slow down pain; 4, promote pathological changes reparation and tissue regeneration.
Radix Aconiti Coreani of the present invention is dry daughter root and the parent root of cohosh Aconitum carmichjaelii Debx. Aconitum coreanum (Levl.) Raip, and nature and flavor are hot, goes into the heart, spleen, kidney channel; Has recuperating depleted YANG and rescuing the patient from collapse, dispelling cold by warming the meridian, analgesic function.
Rhizoma Arisaematis of the present invention is the dry tuber of herbaceos perennial Rhizoma Arisaematis Arisaema erubescens (Wall.) Schott., Arisaema heterophyllum B1. Arisaema heterophyllum BL., arisaema amurense Maxim Arisaema amurense Maxim. or Rhizoma pinelliae pedatisectae Pinellia pedaeisecta Schott, nature and flavor hardship, suffering, temperature, return liver, spleen channel: have drying dampness to eliminate phlegm, expelling wind for relieving convulsion, the dispersing swelling and dissipating binds pain-relieving functions.
The Radix Angelicae Dahuricae of the present invention is the dry root of samphire Radix Angelicae Dahuricae Angelica dahurica (Fishch.ex Hoffm.) Benth.ethook.f. or Radix angelicae dahuricae, and nature and flavor suffering, temperature attach to the lung and stomach meridians; Has dispeiling pathogenic wind and removing dampness, the function of reducing swelling and alleviating pain.As usually join Rhizoma Et Radix Notopterygii, Radix Saposhnikoviae with wind-expelling pain-stopping.
Radix Saposhnikoviae of the present invention is umbelliferae Saposhnikovia divaricata Saposhnikovia divaricata (Turcz.) Schischk. dry root, nature and flavor suffering, sweet, and temperature is returned bladder, lung, spleen channel; Has expelling pathogenic wind from the body surface, the function of removing dampness to relieve pain.
Rhizoma Et Radix Notopterygii of the present invention is dry rhizome and the root of samphire Rhizoma Et Radix Notopterygii Notopterygium incisum TingexH.T.Chang or broad-leaved Rhizoma Et Radix Notopterygii Notopterygium forbesii Boiss., nature and flavor suffering, hardship, and temperature is returned bladder, Liver Channel; Have and induce sweat, cold expelling, wind-damp dispelling, the analgesic function is used for exterior syndrome due to wind-cold, anemofrigid-damp arthralgia, diseases such as arthralgia.
In a word, the present invention can be used for treating in the capsule of traumatic injury living Radix Aconiti Coreani with the warming the interior cold expelling can all over the body sun of temperature, dispelling cold and dampness, thereby can be used for cold-evil's invasion, disease due to cold-damp wins partially, and the Radix Saposhnikoviae of expelling wind and cold (containing volatile oil), the Radix Angelicae Dahuricae (containing Radix Angelicae Dahuricae element), Rhizoma Et Radix Notopterygii (containing volatile oil), warming for resolving cold-phlegm class medicine system Pu star (the main benzoic acid that contains) are ministerial drug, but wind-damp dispelling, stopping numbness pain, relieving convulsion, the detumescence function of the Radix Angelicae Dahuricae are more so, and Rhizoma Arisaematis (processed) eliminates the phlegm, dampness, antidotal effect.Whole prescription the monarch and his subjects help mutually, and expectorant has the merit of blood stasis dispelling, and the medicine that dispels the wind also has the effect of circulation of qi promoting; But its Radix Saposhnikoviae, Rhizoma Et Radix Notopterygii priming again can make the property of medicine whole body of leading to.So for soft tissue injury, the aseptic inflammation of various tissues such as rheumatism, rheumatoid disease, bone injury, scapulohumeral periarthritis, and all kinds of blood stasis are pain caused all effective in cure.
The specific embodiment
Further specify the present invention below by specific embodiment/experimental example, still, should be understood to, these embodiment and experimental example are only used for the more detailed usefulness that specifically describes, and are used for limiting in any form the present invention and should not be construed as.
The present invention carries out generality and/or concrete description to the material and the test method that are used in the test.Though for realizing that employed many materials of the object of the invention and operational approach are well known in the art, the present invention still does to describe in detail as far as possible at this.It will be apparent to those skilled in the art that hereinafter, if do not specify that material therefor of the present invention and operational approach are well known in the art.
When the present invention hereinafter prepares capsule; the living Radix Aconiti Coreani crude drug amount that comprises during every batch of material feeds intake is 1.76kg; other medical material is determined with the proportionate relationship between them as the case may be; and when the preparation capsule, add appropriate amount of auxiliary materials; the dose that comprises among institute's gained total particle or the total every 250mg of powder is counted 176mg by giving birth to Radix Aconiti Coreani crude drug amount; every capsules loading amount is counted 250mg with total particle or total powder, and the dose that comprises in promptly every capsules is counted 176mg by giving birth to Radix Aconiti Coreani crude drug amount.In the instantiation, Radix Aconiti Coreani is given birth to by system when mentioning Radix Aconiti Coreani, is Rhizoma Arisaematis (processed) when mentioning Rhizoma Arisaematis hereinafter.
Preparation example 1: prepare wound curative capsule of the present invention
Prescription: Radix Aconiti Coreani 176 weight portions, Rhizoma Arisaematis 30 weight portions, the Radix Angelicae Dahuricae 15 weight portions, Radix Saposhnikoviae 15 weight portions, Rhizoma Et Radix Notopterygii 15 weight portions.
Method for making: get Rhizoma Arisaematis, the Radix Angelicae Dahuricae, Radix Saposhnikoviae and Rhizoma Et Radix Notopterygii, pulverize separately becomes fine powder standby; Radix Aconiti Coreani was soaked 2 hours with 8 times of amount 50% ethanol (wherein being added with 2mmol hydrochloric acid), and then reflux, extract, is 2 hours; Filtering residue is with the aforementioned extraction solvent of 6 times of amounts reflux, extract, 2 hours once more; Merge extracted twice gained extracting solution, concentrate, be dried to moisture below 5%, getting powder is the Radix Aconiti Coreani extract; With Radix Aconiti Coreani extract and the fine powder mixing of four Chinese medicine material in addition, add an amount of dextrin and make the medical material that comprises in the total powder of every 250mg count 176mg with Radix Aconiti Coreani crude drug amount, fully mix, make powder, in the hungry area softgel shell of packing into, promptly.
Preparation example 2: prepare wound curative capsule of the present invention
Prescription: Radix Aconiti Coreani 176 weight portions, Rhizoma Arisaematis 29 weight portions, the Radix Angelicae Dahuricae 15 weight portions, Radix Saposhnikoviae 15 weight portions, Rhizoma Et Radix Notopterygii 15 weight portions.
Method for making: get Rhizoma Arisaematis, the Radix Angelicae Dahuricae, Radix Saposhnikoviae and Rhizoma Et Radix Notopterygii, pulverize separately becomes fine powder standby; Radix Aconiti Coreani was soaked 3 hours with 10 times of amount 65% ethanol (wherein being added with 1.5mmol hydrochloric acid), and then reflux, extract, is 3 hours; Filtering residue is with the aforementioned extraction solvent of 5 times of amounts reflux, extract, 1 hour once more; Merge extracted twice gained extracting solution, concentrate, be dried to moisture below 5%, getting powder is the Radix Aconiti Coreani extract; With Radix Aconiti Coreani extract and the fine powder mixing of four Chinese medicine material in addition, add an amount of sucrose and make the medical material that comprises in the total powder of every 250mg count 176mg with Radix Aconiti Coreani crude drug amount, fully mix, make powder, in the hungry area softgel shell of packing into, promptly.
Preparation example 3: prepare wound curative capsule of the present invention
Prescription: Radix Aconiti Coreani 176 weight portions, Rhizoma Arisaematis 31 weight portions, the Radix Angelicae Dahuricae 17 weight portions, Radix Saposhnikoviae 13 weight portions, Rhizoma Et Radix Notopterygii 15 weight portions.
Method for making: get Rhizoma Arisaematis, the Radix Angelicae Dahuricae, Radix Saposhnikoviae and Rhizoma Et Radix Notopterygii, pulverize separately becomes fine powder standby; Radix Aconiti Coreani was soaked 1 hour with 5 times of amount 75% ethanol (wherein being added with 1mmol hydrochloric acid), and then reflux, extract, is 1 hour; Filtering residue is with the aforementioned extraction solvent of 10 times of amounts reflux, extract, 3 hours once more; Merge extracted twice gained extracting solution, concentrate, be dried to moisture below 5%, getting powder is the Radix Aconiti Coreani extract; With Radix Aconiti Coreani extract and the fine powder mixing of four Chinese medicine material in addition, add an amount of dextrin and make the medical material that comprises in the total powder of every 250mg count 176mg with Radix Aconiti Coreani crude drug amount, fully mix, make powder, in the hungry area softgel shell of packing into, promptly.
Preparation example 4: prepare wound curative capsule of the present invention
Prescription: Radix Aconiti Coreani 176 weight portions, Rhizoma Arisaematis 29 weight portions, the Radix Angelicae Dahuricae 16 weight portions, Radix Saposhnikoviae 15 weight portions, Rhizoma Et Radix Notopterygii 14 weight portions.
Method for making: get Rhizoma Arisaematis, the Radix Angelicae Dahuricae, Radix Saposhnikoviae and Rhizoma Et Radix Notopterygii, pulverize separately becomes fine powder standby; Radix Aconiti Coreani was soaked 2 hours with 6 times of amount 60% ethanol (wherein being added with 1.3mmol hydrochloric acid), and then reflux, extract, is 2 hours; Filtering residue is with the aforementioned extraction solvent of 8 times of amounts reflux, extract, 2 hours once more; Merge extracted twice gained extracting solution, concentrate, be dried to moisture below 5%, getting powder is the Radix Aconiti Coreani extract; With Radix Aconiti Coreani extract and the fine powder mixing of four Chinese medicine material in addition, add an amount of dextrin and make the medical material that comprises in the total powder of every 250mg count 176mg with Radix Aconiti Coreani crude drug amount, fully mix, make powder, in the hungry area softgel shell of packing into, promptly.
Preparation example 5: prepare wound curative capsule of the present invention
Prescription: Radix Aconiti Coreani 176 weight portions, Rhizoma Arisaematis 20 weight portions, the Radix Angelicae Dahuricae 20 weight portions, Radix Saposhnikoviae 10 weight portions, Rhizoma Et Radix Notopterygii 20 weight portions.
Method for making: get Rhizoma Arisaematis, the Radix Angelicae Dahuricae, Radix Saposhnikoviae and Rhizoma Et Radix Notopterygii, pulverize separately becomes fine powder standby; Radix Aconiti Coreani was soaked 2 hours with 6 times of amount 60% ethanol (wherein being added with 1.5mmol hydrochloric acid), and then reflux, extract, is 2 hours; Filtering residue is with the aforementioned extraction solvent of 8 times of amounts reflux, extract, 2 hours once more; Merge extracted twice gained extracting solution, concentrate, be dried to moisture below 5%, getting powder is the Radix Aconiti Coreani extract; With Radix Aconiti Coreani extract and the fine powder mixing of four Chinese medicine material in addition, add an amount of dextrin and make the medical material that comprises in the total powder of every 250mg count 176mg with Radix Aconiti Coreani crude drug amount, fully mix, make powder, in the hungry area softgel shell of packing into, promptly.
Preparation example 6: prepare wound curative capsule of the present invention
Prescription: Radix Aconiti Coreani 176 weight portions, Rhizoma Arisaematis 40 weight portions, the Radix Angelicae Dahuricae 10 weight portions, Radix Saposhnikoviae 20 weight portions, Rhizoma Et Radix Notopterygii 10 weight portions.
Method for making: get Rhizoma Arisaematis, the Radix Angelicae Dahuricae, Radix Saposhnikoviae and Rhizoma Et Radix Notopterygii, pulverize separately becomes fine powder standby; Radix Aconiti Coreani was soaked 2 hours with 6 times of amount 60% ethanol (wherein being added with 1.3mmol hydrochloric acid), and then reflux, extract, is 2 hours; Filtering residue is with the aforementioned extraction solvent of 8 times of amounts reflux, extract, 2 hours once more; Merge extracted twice gained extracting solution, concentrate, be dried to moisture below 5%, getting powder is the Radix Aconiti Coreani extract; With Radix Aconiti Coreani extract and the fine powder mixing of four Chinese medicine material in addition, add an amount of dextrin and make the medical material that comprises in the total powder of every 250mg count 176mg with Radix Aconiti Coreani crude drug amount, fully mix, make powder, in the hungry area softgel shell of packing into, promptly.
Preparation example 7: prepare wound curative capsule of the present invention
Prescription: Radix Aconiti Coreani 176 weight portions, Rhizoma Arisaematis 25 weight portions, the Radix Angelicae Dahuricae 18 weight portions, Radix Saposhnikoviae 12 weight portions, Rhizoma Et Radix Notopterygii 18 weight portions.
Method for making: get Rhizoma Arisaematis, the Radix Angelicae Dahuricae, Radix Saposhnikoviae and Rhizoma Et Radix Notopterygii, pulverize separately becomes fine powder standby; Radix Aconiti Coreani was soaked 2 hours with 6 times of amount 60% ethanol (wherein being added with 1.5mmol hydrochloric acid), and then reflux, extract, is 2 hours; Filtering residue is with the aforementioned extraction solvent of 8 times of amounts reflux, extract, 2 hours once more; Merge extracted twice gained extracting solution, concentrate, be dried to moisture below 5%, getting powder is the Radix Aconiti Coreani extract; With Radix Aconiti Coreani extract and the fine powder mixing of four Chinese medicine material in addition, add an amount of dextrin and make the medical material that comprises in the total powder of every 250mg count 176mg with Radix Aconiti Coreani crude drug amount, fully mix, make powder, in the hungry area softgel shell of packing into, promptly.
Preparation example 8: prepare wound curative capsule of the present invention
Prescription: Radix Aconiti Coreani 176 weight portions, Rhizoma Arisaematis 35 weight portions, the Radix Angelicae Dahuricae 12 weight portions, Radix Saposhnikoviae 18 weight portions, Rhizoma Et Radix Notopterygii 12 weight portions.
Method for making: get Rhizoma Arisaematis, the Radix Angelicae Dahuricae, Radix Saposhnikoviae and Rhizoma Et Radix Notopterygii, pulverize separately becomes fine powder standby; Radix Aconiti Coreani was soaked 2 hours with 6 times of amount 60% ethanol (wherein being added with 1.3mmol hydrochloric acid), and then reflux, extract, is 2 hours; Filtering residue is with the aforementioned extraction solvent of 8 times of amounts reflux, extract, 2 hours once more; Merge extracted twice gained extracting solution, concentrate, be dried to moisture below 5%, getting powder is the Radix Aconiti Coreani extract; With Radix Aconiti Coreani extract and the fine powder mixing of four Chinese medicine material in addition, add an amount of dextrin and make the medical material that comprises in the total powder of every 250mg count 176mg with Radix Aconiti Coreani crude drug amount, fully mix, make powder, in the hungry area softgel shell of packing into, promptly.
Reference examples 1: preparation wound curative capsule
With reference to preparation example 2 above, different is, and wherein to make water be to extract solvent, makes capsule.
Reference examples 2: preparation wound curative capsule
Reference is preparation example 2 above, and different is wherein to make water (wherein being added with 1.5mmol hydrochloric acid) for extracting solvent, makes capsule.
Reference examples 3: preparation wound curative capsule
Reference is preparation example 2 above, and different is wherein to use 15% ethanol (wherein being added with 1.5mmol hydrochloric acid) for extracting solvent, makes capsule.
Reference examples 4: preparation wound curative capsule
Reference is preparation example 2 above, and different is wherein to use 40% ethanol (wherein being added with 1.5mmol hydrochloric acid) for extracting solvent, makes capsule.
Reference examples 5: preparation wound curative capsule
Reference is preparation example 2 above, and different is wherein to use 85% ethanol (wherein being added with 1.5mmol hydrochloric acid) for extracting solvent, makes capsule.
Reference examples 6: preparation wound curative capsule
Reference is preparation example 2 above, and different is wherein to use 95% ethanol (wherein being added with 1.5mmol hydrochloric acid) for extracting solvent, makes capsule.
Reference examples 7: preparation wound curative capsule
Reference is preparation example 2 above, and different is wherein to use 65% ethanol (not adding hydrochloric acid) for extracting solvent, makes capsule.
Reference examples 8: preparation wound curative capsule
Reference is preparation example 2 above, and different is wherein to use 65% ethanol (wherein being added with 0.5mmol hydrochloric acid) for extracting solvent, makes capsule.
Reference examples 9: preparation wound curative capsule
According to CN101785818A (Chinese patent application numbers 201010138372.2, the Zhu Yangxin) method preparation of description [0029] section record, capsule.
Reference examples 10: wound curative capsule
Commercially available product wound curative capsule (the accurate word Z10920013 of traditional Chinese medicines), the tolerant 250mg of every intragranular, Radix Aconiti Coreani crude drug wherein is 176mg.
Test example 1: measure total alkaloid content and Guan-fubase B content in each capsule
Hinder capsule (every kind prepares 3 Lot samples, measures their results separately, with meansigma methods or their residing scope ecbatics) at the treatment of above-mentioned each preparation example and reference examples, measure total alkaloid content and Guan-fubase B content in each capsule.
According to CN101785818A (Chinese patent application numbers 201010138372.2; Zhu Yangxin) method of description [0007] section record is measured the Radix Aconiti Coreani total alkaloid content; and provide the result (the prior art record is generally total alkaloids 1.20～2.00mg/ grain) with total alkaloids contained in every capsules content granule or the powder (with Guan-fubase A (C24H31NO6) expression, unit is the mg/ grain).
According to CN101785818A (Chinese patent application numbers 201010138372.2; Zhu Yangxin) description [0099]～[a 0104] section HPLC method is measured Guan-fubase B content in the capsule, and provides the result (the prior art record is generally Guan-fubase B〉0.15mg/ grain) with Guan-fubase B contained in every capsules content granule or the powder (unit is the mg/ grain).
The result: preparation example 1～8 capsule total alkaloid content is all in 1.40～1.80mg/ grain scope; Guan-fubase B is all in 0.25～0.35mg/ grain scope; And the total alkaloids/Guan-fubase B ratio (ratio of total alkaloid content that records in every capsules and Guan-fubase B content, this value can be described as " total heptan than " in the present invention) all in 3.5～7.5 scopes, particularly in 4.0～7.0 scopes (8 preparation example capsules are all in this scope).For example preparation example 1 capsule total alkaloid content is the 1.66mg/ grain, and Guan-fubase B content is the 0.31mg/ grain, and always heptan, ratio was 5.35.
Each reference examples sample measurement result is as follows:
| Test sample: extract solvent | Total alkaloids (mg/ grain) | Guan-fubase B (mg/ grain) | Total heptan ratio |
| Reference examples 1: water | 0.50～0.80 | 0.05～0.08 | 3.5～7.5 |
| Reference examples 2: water (1.5M hydrochloric acid) | 0.50～0.80 | 0.05～0.08 | 3.5～7.5 |
| Reference examples 3:15% ethanol (1.5M hydrochloric acid) | 0.50～0.80 | 0.05～0.08 | 3.5～7.5 |
| Reference examples 4:40% ethanol (1.5M hydrochloric acid) | 0.60～0.80 | 0.05～0.08 | 3.5～7.5 |
| Reference examples 5:85% ethanol (1.5M hydrochloric acid) | 1.60～2.10 | 0.10～0.14 | 14～18 |
| Reference examples 6:95% ethanol (1.5M hydrochloric acid) | 1.60～2.10 | 0.10～0.14 | 14～18 |
| Reference examples 7:65% ethanol (no hydrochloric acid) | 0.50～0.80 | 0.20～0.25 | 1～3 |
| Reference examples 8:65% ethanol (0.5M hydrochloric acid) | 0.50～0.80 | 0.20～0.25 | 1～3 |
| Reference examples 9:CN201010138372.2 | 1.30～1.80 | 0.20～0.30 | 3.5～7.5 |
| Reference examples 10: commercially available wound curative capsule | 1.30～1.80 | 0.20～0.30 | 3.5～7.5 |
From table the result as seen, when making water or containing acid extraction, and working concentration is suitable with the prior art capsule with capsule of the present invention although compare total heptan when being lower than/equaling 40% ethanol extraction, but total alkaloids and Guan-fubase B are all obviously on the low side.But when determining alcohol greater than/when equaling 85%, though total alkaloid content and capsule of the present invention are suitable with the prior art capsule, Guan-fubase B content is on the low side, and total heptan is than much larger than capsule of the present invention and prior art capsule.In addition, when using when not containing acid or the lower ethanol water of acid content and extracting, although Guan-fubase B content is suitable with the prior art capsule with capsule of the present invention in the product, total alkaloid content is on the low side, and always heptan than on the low side.
Test example 2: measure each capsular stability
Each capsule of preparation example of the present invention and reference examples is packed, place May down in 45 ° of C, measure the ratio in total heptan in 0 month (when high-temperature treatment begins) and May in each sample (when high-temperature treatment finishes) respectively, calculate total heptan than percent change with following formula: total heptan is than percent change=[(total heptan in May than-0 month total heptan than) ÷ 0 month total heptan ratio] * 100%.
The result shows, preparation example 1～8 each capsule of the present invention total heptan all in 15～35% scopes, shows that Guan-fubase B content has reduction slightly for total alkaloid content than percent change, and for example 1 total heptan of preparation example is 22% than percent change.Beat allly be, reference examples 9 and reference examples 10, reference examples 1～4, reference examples 7～8 each capsule total heptan than percent change all in 95～150% scopes, show that Guan-fubase B content has obvious reduction for total alkaloid content, for example 1 total heptan of reference examples is 132% than percent change.These results show that the ethanol water that uses the present invention to comprise appropriate amount of acid extracts the stability that wound curative capsule that Radix Aconiti Coreani makes has good chemical composition relation, and the wound curative capsule of prior art and make water or ethanol water that acid content is lower extracts the stability that wound curative capsule that Radix Aconiti Coreani makes shows unsafty chemical composition relation.
Test example 3: the biologic activity of measuring wound curative capsule
Reagent: preparation example 1,2 capsules and reference examples 9,10 capsules, dosage is all used each capsule particle or powder 1.5g with every kg the weight of animals.Negative control group and positive controls are pressed the literature method setting respectively.
With reference to CN1883630A (Chinese patent application 200610051843.X, Zhu Yangxin) the mice auricle swelling test (test one) in the Instructions Page 2 test 1, test the influence that each reagent xylol causes mice auricle swelling, suppress percent in swelling, that is, swelling suppresses percent=[the negative contrast groups swelling of (negative contrast groups swelling degree-administration group swelling degree) ÷ degree] * 100%.The result shows, preparation example 1,2 capsules and reference examples 9,10 capsular swelling suppress the percentage number average in 47～56% scopes, and more all there were significant differences with negative contrast groups, p＜0.01, and it is 53% that preparation example 1 capsular swelling for example of the present invention suppresses percent.
With reference to CN1883630A (Chinese patent application 200610051843.X, Zhu Yangxin) the method in the description page 4 test 2, test the influence of each reagent to the mice autonomic activities, the computational activity number of times reduces percent, and promptly movable number of times reduces percent=[the negative contrast groups activity of (negative contrast groups activity number of times-administration group activity number of times) ÷ number of times] * 100%.The result shows, preparation example 1,2 capsules and reference examples 9,10 capsular movable number of times reduce the percentage number average in 22～27% scopes, and more all there were significant differences with negative contrast groups, p＜0.01, and it is 24% that preparation example 2 capsular movable number of times for example of the present invention reduce percent.
(Chinese patent application 200610051843.X, Zhu Yangxin) method in the description page 4 test 3 is tested the influence that each reagent Dichlorodiphenyl Acetate causes the mouse writhing number of times, calculates the analgesia percentage rate with reference to CN1883630A.The result shows, preparation example 1,2 capsules and reference examples 9,10 capsular analgesia percentage rate all in 36～41% scopes, and with negative contrast groups more all there were significant differences, p＜0.01, preparation example 2 capsular analgesia percentage rate for example of the present invention are 38%.
More than three biological test results show that capsule of the present invention is the same with existing product all to have good biologic activity, is applicable to clinical treatment traumatic injury, various soft tissue injury, strain, skin injury, internal injury; Rheumatic arthritis; The various aseptic inflammations of organizing such as scapulohumeral periarthritis, chondritis, synovitis, tenosynovitis; The pain that degeneration of joint such as hyperosteogeny, cervical spondylotic radiculopathy causes; Lumbago and skelalgia, sciatica, arthralgia, cervical vertebra pain.
Claims (10)
1. wound curative capsule, its medical material by following weight proportion is made: Radix Aconiti Coreani 176 weight portions, Rhizoma Arisaematis 15～45 weight portions, the Radix Angelicae Dahuricae 5～25 weight portions, Radix Saposhnikoviae 5～25 weight portions, Rhizoma Et Radix Notopterygii 5～25 weight portions.
2. according to the wound curative capsule of claim 1, its medical material by following weight proportion is made: Radix Aconiti Coreani 176 weight portions, Rhizoma Arisaematis 20～40 weight portions, the Radix Angelicae Dahuricae 10～20 weight portions, Radix Saposhnikoviae 10～20 weight portions, Rhizoma Et Radix Notopterygii 10～20 weight portions; Perhaps, its medical material by following weight proportion is made: Radix Aconiti Coreani 176 weight portions, Rhizoma Arisaematis 25～35 weight portions, the Radix Angelicae Dahuricae 12～18 weight portions, Radix Saposhnikoviae 12～18 weight portions, Rhizoma Et Radix Notopterygii 12～18 weight portions.
3. according to the wound curative capsule of claim 1, its medical material by following weight proportion is made:
About 176 weight portions of Radix Aconiti Coreani, about 30 weight portions of Rhizoma Arisaematis, about 15 weight portions of the Radix Angelicae Dahuricae, about 15 weight portions of Radix Saposhnikoviae, about 15 weight portions of Rhizoma Et Radix Notopterygii; Perhaps, its medical material by following weight proportion is made:
About 176 weight portions of Radix Aconiti Coreani, about 29 weight portions of Rhizoma Arisaematis, about 15 weight portions of the Radix Angelicae Dahuricae, about 15 weight portions of Radix Saposhnikoviae, about 15 weight portions of Rhizoma Et Radix Notopterygii; Perhaps, its medical material by following weight proportion is made:
About 176 weight portions of Radix Aconiti Coreani, about 31 weight portions of Rhizoma Arisaematis, about 17 weight portions of the Radix Angelicae Dahuricae, about 13 weight portions of Radix Saposhnikoviae, about 15 weight portions of Rhizoma Et Radix Notopterygii; Perhaps, its medical material by following weight proportion is made:
About 176 weight portions of Radix Aconiti Coreani, about 29 weight portions of Rhizoma Arisaematis, about 16 weight portions of the Radix Angelicae Dahuricae, about 15 weight portions of Radix Saposhnikoviae, about 14 weight portions of Rhizoma Et Radix Notopterygii.
4. according to the wound curative capsule of claim 1, wherein said Rhizoma Arisaematis is a Rhizoma Arisaematis (processed); Perhaps, wherein said Rhizoma Arisaematis (processed) adds in the described wound curative capsule with its direct gained powder of pulverizing; Perhaps, the wherein said Radix Angelicae Dahuricae adds in the described wound curative capsule with its direct gained powder of pulverizing; Perhaps, wherein said Radix Saposhnikoviae is added in the described wound curative capsule with its direct gained powder of pulverizing; Perhaps,, wherein said Rhizoma Et Radix Notopterygii is directly pulverized the gained powder with it and adds in the described wound curative capsule; Perhaps, wherein said Radix Aconiti Coreani is to give birth to Radix Aconiti Coreani; Perhaps, wherein said living Radix Aconiti Coreani adds in the described wound curative capsule after extracting.
5. according to the wound curative capsule of claim 1, wherein said living Radix Aconiti Coreani is that gained Radix Aconiti Coreani extract adds in the described wound curative capsule after being selected from following solvent extraction: water, aquiferous ethanol, ethanol; Perhaps, wherein said aquiferous ethanol is concentration 50～75% ethanol and wherein contains 1～5mmol hydrochloric acid; Perhaps, the following basically mode of wherein said Radix Aconiti Coreani extract prepares: will give birth to Radix Aconiti Coreani with the extraction solvent soaking of 5～10 times of amounts 1～3 hour, then reflux, extract, is 1～3 hour; Filtering residue is with the extraction solvent of 5～10 times of amounts reflux, extract, 1～3 hour once more; Merge extracted twice gained extracting solution, concentrate, be dried to moisture, get powder and be the Radix Aconiti Coreani extract below 5%.
6. according to the wound curative capsule of claim 1, wherein the pharmacy acceptable auxiliary be can also comprise, diluent or filler, binding agent, lubricants, flavoring agent etc. are selected from.
7. according to the wound curative capsule of claim 1, it prepares according to following method basically: get Rhizoma Arisaematis, the Radix Angelicae Dahuricae, Radix Saposhnikoviae and Rhizoma Et Radix Notopterygii, pulverize separately becomes fine powder standby; Radix Aconiti Coreani is obtained the Radix Aconiti Coreani extract with being selected from following solvent extraction: water, aquiferous ethanol, ethanol; The fine powder of Radix Aconiti Coreani extract and other four Chinese medicine material and optional pharmacy acceptable auxiliary are mixed, make powder or granule, incapsulate in the shell, promptly.
8. according to the wound curative capsule of claim 1, it prepares according to following method basically: get Rhizoma Arisaematis, the Radix Angelicae Dahuricae, Radix Saposhnikoviae and Rhizoma Et Radix Notopterygii, pulverize separately becomes fine powder standby; Radix Aconiti Coreani is obtained the Radix Aconiti Coreani extract with 10～90% ethanol (for example for example containing 1～5mmol hydrochloric acid in this ethanol) extraction; The fine powder of Radix Aconiti Coreani extract and other four Chinese medicine material and optional pharmacy acceptable auxiliary are mixed, make powder or granule, incapsulate in the shell, promptly.
9. the method for preparing wound curative capsule, this method may further comprise the steps: get Rhizoma Arisaematis, the Radix Angelicae Dahuricae, Radix Saposhnikoviae and Rhizoma Et Radix Notopterygii, pulverize separately becomes fine powder standby; Radix Aconiti Coreani is obtained the Radix Aconiti Coreani extract with being selected from following solvent extraction: water, aquiferous ethanol, ethanol; The fine powder of Radix Aconiti Coreani extract and other four Chinese medicine material and optional pharmacy acceptable auxiliary are mixed, make powder or granule, incapsulate in the shell, promptly.
10. according to the method for claim 9, wherein said aquiferous ethanol is the ethanol of concentration 10～90%; Further, contain 1～5mmol hydrochloric acid in this ethanol.
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| 张志文: "盐酸关附甲素注射液的生产工艺改进研究", 《中国优秀硕士学位论文全文数据库》, 31 December 2007 (2007-12-31) * |
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