CN103223074B - Wound curative capsule and method for making - Google Patents
Wound curative capsule and method for making Download PDFInfo
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- CN103223074B CN103223074B CN201310191215.1A CN201310191215A CN103223074B CN 103223074 B CN103223074 B CN 103223074B CN 201310191215 A CN201310191215 A CN 201310191215A CN 103223074 B CN103223074 B CN 103223074B
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Abstract
The present invention relates to wound curative capsule and method for making.Specifically, the present invention relates to a kind of wound curative capsule, it is made up of the medical material of following weight proportion: Radix Aconiti Coreani 176 weight portion, Rhizoma Arisaematis 15 ~ 45 weight portion, the Radix Angelicae Dahuricae 5 ~ 25 weight portion, Radix Saposhnikoviae 5 ~ 25 weight portion, Rhizoma Et Radix Notopterygii 5 ~ 25 weight portion.The invention still further relates to the method preparing described wound curative capsule.Wound curative capsule of the present invention has Good Pharmacy character.
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 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 main manifestations is the degeneration of local organization, inflammatory exudation and hypertrophy, has a large amount of cytokines or inflammatory mediator to participate in, as CCL5, IL-1 β, TNF-α, IL-3 etc. in this process.CCL5 plays a part the earliest in inflammatory reaction, and it attracts leukocytic Chemotaxis and activates these cells, and IL-3 is produced by T lymphocyte in vivo, and the antagonist of IL-3 may contribute to the treatment to diseases associated with inflammation, and its clinical practice is still underway.TNF-α is generally considered to the important cytokine judging inflammatory arthritis pathogenesis, usually by mononuclear cell, macrophages secrete.TNF-α plays an important role in the cascade reaction of pro-inflammatory cytokines, and it can regulate the secretion of other pro-inflammatory cytokines.IL-1 β is called as endogenous pyrogen, except causing fever, also plays a significant role in inflammatory reaction, is the inflammatory mediator comparatively early occurred in inflammatory reaction.
For traumatic injury clinical commonly used drug be non-steroidal drug as aspirin, indomethacin etc., clinical research shows that this quasi-tradition nonsteroidal antiinflammatory drug of long-term taking produces multiple untoward reaction.Chinese medicine have accumulated rich experience to traumatic injury treatment, apply wound curative capsule (the accurate word Z10920013 of traditional Chinese medicines for many years clinically, Hangzhou Zhuyangxin Pharmaceutical Co., Ltd produces) be that the ancient prescription dosage changing form that " cures the wound loose " forms, there is effect of dispelling wind-evil and transforming calculus, reducing swelling and alleviating pain, red and swollen for the wound caused by 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 monarch drug, has effect of dispelling pathogenic wind and eliminating phlegm, dampness pain relieving; 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, disappear pus swollen-removing, is all ministerial drug with Rhizoma Arisaematis; Radix Saposhnikoviae inducing diaphoresis to dispel wind, removing dampness to relieve pain, spasmolytic; Rhizoma Et Radix Notopterygii falls apart exterior cold, wind-damp dispelling, sharp joint, and this two taste 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 with cure mainly as dispelling wind-evil and transforming calculus, reducing swelling and alleviating pain, red and swollen for the wound caused by traumatic injury, 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 the 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.Such as, CN1883630A (Chinese Patent Application No. 200610051843.X, Zhu Yangxin) disclose a kind of preparation method for the treatment of the oral medicine of traumatic injury, get raw 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 by Radix Saposhnikoviae, Rhizoma Et Radix Notopterygii, Rhizoma Arisaematis, it is for subsequent use that the Radix Angelicae Dahuricae is ground into fine powder together, again life Radix Aconiti Coreani is ground into fine powder and above-mentioned fine powder equal increments method facing-up, crossing screen-aperture is 80 object sieves, then mix, incapsulate, every is 0.25 gram (capable see this description of the invention the 2/5th page of 7-4 reciprocal).
In addition, CN101785818A (Chinese Patent Application No. 201010138372.2, Zhu Yangxin) disclose a kind of preparation method of wound curative capsule, 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, except raw Radix Aconiti Coreani, four tastes such as all the other Radix Saposhnikoviaes are ground into fine powder, life Radix Aconiti Coreani is ground into fine powder and above-mentioned fine powder equal increments method facing-up, sieves, mixing, incapsulate, make 1000, irradiation sterilization, obtain (see this description of the invention [0029] section).
The wound curative capsule be made up of gomi herbs, 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 comparatively strong, and therefore their stability in medicine needs special concern.
CN101785818A (Chinese Patent Application No. 201010138372.2, Zhu Yangxin) describe the detection method of content of wound curative capsule in prior art, such as document description [0007] section describes " Radix Aconiti Coreani Determination of Total Alkaloid ": get the content under wound curative capsule content uniformity item, accurately weighed, get about 6g, put in tool plug conical flask, precision adds 1% hydrochloric acid solution 50ml, supersound process 30 minutes, water temperature keeps less than 50 DEG C, put in centrifuge tube and be separated 10 minutes with the centrifugation of 3000 revs/min, precision measures supernatant 25ml, put in separatory funnel, with strong ammonia solution adjust ph to 10 ~ 11.With chloroform extraction 5 times, each 10ml, merge extractive liquid, puts evaporate to dryness in water-bath.Residue adds paramethyl red indicator and shows neutral ethanol 5ml and make dissolving, evaporate to dryness, and residue adds ethanol 5ml makes dissolving, precision adds 0.01mol/L HCI liquid 10ml, shakes up, and adds the cold water 15ml and C.I. 13020. indicator solution 2 that newly boiled, with 0.01mol/L sodium hydroxide titration drop to yellow, to obtain final product.The every 1ml of 0.01mol/L HCI liquid is equivalent to the C24H31NO6 of 4.295mg.And specify that prior art wound curative capsule every contains total alkaloids in Guan-fubase A (C24H31NO6), should be 1.20 ~ 2.00mg.
In addition, CN101785818A (Chinese Patent Application No. 201010138372.2, Zhu Yangxin) record the method that it measures Guan-fubase B content in preparation, such as document description [0099] ~ [0104] section describes " high performance liquid chromatography (China's coastal port annex VI D) measures Guan-fubase B content in preparation ", specifically: chromatographic condition and system suitability: be filler with octadecylsilane chemically bonded silica; Acetonitrile 0.2% triethylamine 0.2% octane sulfonate sodium solution is mobile phase; Determined wavelength is 205nm; Number of theoretical plate calculates should be not less than 5000 by Guan-fubase B peak; The preparation of reference substance solution: it is appropriate that precision takes Guan-fubase B reference substance, adds methanol and makes the solution of every 1ml containing 0.04mg, to obtain final product; The preparation of need testing solution: get the content under this product content uniformity limit, accurately weighed, get about 2g, accurately weighed, put in tool plug conical flask, precision adds 1% hydrochloric acid solution 50ml, close plug, weighed weight, soaks 20min, supersound process 30 minutes, lets cool, then weighs, supply the weight of less loss with 1% hydrochloric acid, shake up, filter, get subsequent filtrate, to obtain final product; Assay method: get reference substance solution and need testing solution 20ul respectively, injection liquid chromatography, measures, to obtain final product.And every gram must not be less than 0.6mg containing Guan-fubase B (C15H10O5) in specify that the wound curative capsule that the document provides.
Visible, prior art attempt at least controls the quality of wound curative capsule from two aspects: the titration measuring that (a) is developed the color by C.I. 13020. indicator solution, determines that total alkaloids in wound curative capsule (comprising Guan-fubase A, Guan-fubase B, hypaconitine etc.) content is 1.2 ~ 2.0mg/ grain; B () is measured by HPLC method, determine that Guan-fubase B in wound curative capsule (C15H10O5) content is greater than 0.6mg.
As everyone knows, it is comprehensively produced with certain component relationship by numerous active component that Chinese medicine plays its drug effect, such as, between total alkaloids and concrete chemical monomer thereof, there is specific quantity relative ratio relationship in wound curative capsule, existing under the therapeutic effect of clinical verification, these quantity relative ratio relationships should not have large change, particularly in the Long-term Storage process of such as medicine, the specific quantity relative ratio relationship between these chemical monomers does not have and changes significantly, to maintaining the stability of clinical efficacy.
Therefore, those skilled in the art expect have 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 the degeneration of joint such as hyperosteogeny, cervical spondylotic radiculopathy causes; The method of the clinical diseases such as lumbago and skelalgia, sciatica, arthralgia, cervical vertebra pain or disease.Particularly expect to provide one to have effect of dispelling wind-evil and transforming calculus, reducing swelling and alleviating pain, can be used for the caused wound of traumatic injury red and swollen, the wound curative capsules such as hypochondrium pain with internal injury.More especially expect to provide 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 the degeneration of joint such as hyperosteogeny, cervical spondylotic radiculopathy causes; The method of the clinical diseases such as lumbago and skelalgia, sciatica, arthralgia, cervical vertebra pain or disease.Particularly provide one to have effect of dispelling wind-evil and transforming calculus, reducing swelling and alleviating pain, can be used for the caused wound of traumatic injury red and swollen, the wound curative capsules such as hypochondrium pain with internal injury.A kind of wound curative capsule with good pharmaceutical properties is more especially provided.Have been surprisingly found that, the wound curative capsule using the inventive method to obtain has beat all Good Pharmacy character.
For this reason, first aspect present invention provides a kind of wound curative capsule, and it is made up of the medical material of following weight proportion:
Radix Aconiti Coreani 176 weight portion,
Rhizoma Arisaematis 15 ~ 45 weight portion,
The Radix Angelicae Dahuricae 5 ~ 25 weight portion,
Radix Saposhnikoviae 5 ~ 25 weight portion,
Rhizoma Et Radix Notopterygii 5 ~ 25 weight portion.
Wound curative capsule according to a first aspect of the present invention described in arbitrary embodiment, it is made up of the medical material of following weight proportion:
Radix Aconiti Coreani 176 weight portion,
Rhizoma Arisaematis 20 ~ 40 weight portion,
The Radix Angelicae Dahuricae 10 ~ 20 weight portion,
Radix Saposhnikoviae 10 ~ 20 weight portion,
Rhizoma Et Radix Notopterygii 10 ~ 20 weight portion.
Wound curative capsule according to a first aspect of the present invention described in arbitrary embodiment, it is made up of the medical material of following weight proportion:
Radix Aconiti Coreani 176 weight portion,
Rhizoma Arisaematis 25 ~ 35 weight portion,
The Radix Angelicae Dahuricae 12 ~ 18 weight portion,
Radix Saposhnikoviae 12 ~ 18 weight portion,
Rhizoma Et Radix Notopterygii 12 ~ 18 weight portion.
Wound curative capsule according to a first aspect of the present invention described in arbitrary embodiment, it is made up of the medical material of following weight proportion:
Radix Aconiti Coreani about 176 weight portion,
Rhizoma Arisaematis about 30 weight portion,
The Radix Angelicae Dahuricae about 15 weight portion,
Radix Saposhnikoviae about 15 weight portion,
Rhizoma Et Radix Notopterygii about 15 weight portion.
Wound curative capsule according to a first aspect of the present invention described in arbitrary embodiment, it is made up of the medical material of following weight proportion:
Radix Aconiti Coreani about 176 weight portion,
Rhizoma Arisaematis about 29 weight portion,
The Radix Angelicae Dahuricae about 15 weight portion,
Radix Saposhnikoviae about 15 weight portion,
Rhizoma Et Radix Notopterygii about 15 weight portion.
Wound curative capsule according to a first aspect of the present invention described in arbitrary embodiment, it is made up of the medical material of following weight proportion:
Radix Aconiti Coreani about 176 weight portion,
Rhizoma Arisaematis about 31 weight portion,
The Radix Angelicae Dahuricae about 17 weight portion,
Radix Saposhnikoviae about 13 weight portion,
Rhizoma Et Radix Notopterygii about 15 weight portion.
Wound curative capsule according to a first aspect of the present invention described in arbitrary embodiment, it is made up of the medical material of following weight proportion:
Radix Aconiti Coreani about 176 weight portion,
Rhizoma Arisaematis about 29 weight portion,
The Radix Angelicae Dahuricae about 16 weight portion,
Radix Saposhnikoviae about 15 weight portion,
Rhizoma Et Radix Notopterygii about 14 weight portion.
Wound curative capsule according to a first aspect of the present invention described in arbitrary embodiment, wherein said Rhizoma Arisaematis is Rhizoma Arisaematis (processed).Rhizoma Arisaematis (processed) is known in the art, and it is such as recorded in Chinese Pharmacopoeia version in 2010 54 pages.
Wound curative capsule according to a first aspect of the present invention described in arbitrary embodiment, wherein said Rhizoma Arisaematis (processed) is directly pulverized gained powder with it and is added in described wound curative capsule.
Wound curative capsule according to a first aspect of the present invention described in arbitrary embodiment, the wherein said Radix Angelicae Dahuricae is directly pulverized gained powder with it and is added in described wound curative capsule.
Wound curative capsule according to a first aspect of the present invention described in arbitrary embodiment, wherein said Radix Saposhnikoviae is directly pulverized gained powder with it and adds in described wound curative capsule.
Wound curative capsule according to a first aspect of the present invention described in arbitrary embodiment, wherein said Rhizoma Et Radix Notopterygii is directly pulverized gained powder with it and adds in described wound curative capsule.
Wound curative capsule according to a first aspect of the present invention described in arbitrary embodiment, wherein said Radix Aconiti Coreani is raw Radix Aconiti Coreani.
Wound curative capsule according to a first aspect of the present invention described in arbitrary embodiment, wherein said raw Radix Aconiti Coreani adds in described wound curative capsule after extracting.
Wound curative capsule according to a first aspect of the present invention described in arbitrary embodiment, wherein said raw Radix Aconiti Coreani adds in described wound curative capsule through being selected from gained Radix Aconiti Coreani extract after 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 containing 1 ~ 5mmol hydrochloric acid, such as, contains 1 ~ 3mmol hydrochloric acid, containing 1 ~ 2mmol hydrochloric acid.In one embodiment, wherein said Radix Aconiti Coreani extract is substantially as prepared by under type: soaked 1 ~ 3 hour by the Extraction solvent of raw Radix Aconiti Coreani by 5 ~ 10 times amount, then reflux, extract, 1 ~ 3 hour; The filtering residue Extraction solvent of 5 ~ 10 times amount reflux, extract, 1 ~ 3 hour again; Merge extracted twice gained extracting solution, concentrated, be dried to moisture below 5%, obtain powder and be Radix Aconiti Coreani extract.As well known to those skilled in the art, when determining Extraction solvent, concrete extraction process can be treated the concrete condition of hindering capsule according to the experience of those skilled in the art or the present invention and be done suitable adjustment, and therefore above-mentioned concrete extraction process is only a preferred embodiment of the present invention.Have been surprisingly found that, use specific solvent to extract gained and not only there is higher alkaloid, and the quantity relative ratio relationship of wherein key organism alkali can keep more stable state well, and prior art can set forth the stability property relevant to extracting factor of quantity relative ratio relationship without any instruction or theory.
Wound curative capsule according to a first aspect of the present invention described in arbitrary embodiment, wherein can also comprise the acceptable adjuvant of pharmacy.The selection of pharmaceutic adjuvant and addition are that those skilled in the art rule of thumb prepare demand with capsule and easily determine.Schematic pharmaceutic adjuvant has diluent or filler, binding agent, lubricants/glidants, flavoring agent etc.Diluent or filler are mainly used in the weight or volume adjusting medicament, to enable active component be prepared into the pharmaceutical preparation of suitable Clinical practice; Typical diluent or filler be saccharide such as sucrose, glucose, lactose etc. such as, and starch and derivant thereof be corn starch, modified starch, amylum pregelatinisatum, dextrin etc. such as, cellulose family such as microcrystalline Cellulose; Aqueous solution/suspension that typical binding agent such as starch slurry, PVP, HPMC etc. are mixed with, can also use water or aquiferous ethanol as wetting agent to obtain the effect of binding agent; Lubricants/glidants contributes to improving the mobility of granule so that preparation preparation, and exemplary lubricants/glidants comprises magnesium stearate, Pulvis Talci, silicon dioxide, micropowder silica gel etc.; Flavoring agent can be used for improving medicine mouthfeel, such as aspartame, stevioside etc.
Wound curative capsule according to a first aspect of the present invention described in arbitrary embodiment, it prepares according to following method substantially: get Rhizoma Arisaematis, the Radix Angelicae Dahuricae, Radix Saposhnikoviae and Rhizoma Et Radix Notopterygii, be ground into fine powder respectively for subsequent use; Radix Aconiti Coreani is obtained Radix Aconiti Coreani extract with being selected from following solvent extraction: water, aquiferous ethanol, ethanol; By the fine powder of Radix Aconiti Coreani extract and other four Chinese medicine material and the acceptable adjuvant mixing of optional pharmacy, make powder or granule, incapsulate in shell, to obtain final product.
Wound curative capsule according to a first aspect of the present invention described in arbitrary embodiment, it prepares according to following method substantially: get Rhizoma Arisaematis, the Radix Angelicae Dahuricae, Radix Saposhnikoviae and Rhizoma Et Radix Notopterygii, be ground into fine powder respectively for subsequent use; Radix Aconiti Coreani such as, is extracted with 10 ~ 90% ethanol (such as 25 ~ 80% ethanol, 50 ~ 75% ethanol, such as containing 1 ~ 5mmol hydrochloric acid in this ethanol, such as, containing 1 ~ 3mmol hydrochloric acid, containing 1 ~ 2mmol hydrochloric acid) and obtains Radix Aconiti Coreani extract; By the fine powder of Radix Aconiti Coreani extract and other four Chinese medicine material and the acceptable adjuvant mixing of optional pharmacy, make powder or granule, incapsulate in shell, to obtain final product.
Wound curative capsule according to a first aspect of the present invention described in arbitrary embodiment, it prepares according to following method substantially: get Rhizoma Arisaematis, the Radix Angelicae Dahuricae, Radix Saposhnikoviae and Rhizoma Et Radix Notopterygii, be ground into fine powder respectively for subsequent use; The Extraction solvent of raw Radix Aconiti Coreani by 5 ~ 10 times amount is soaked 1 ~ 3 hour, then reflux, extract, 1 ~ 3 hour; The filtering residue Extraction solvent of 5 ~ 10 times amount reflux, extract, 1 ~ 3 hour again; Merge extracted twice gained extracting solution, concentrated, be dried to moisture below 5%, obtaining powder is Radix Aconiti Coreani extract; By the fine powder of Radix Aconiti Coreani extract and other four Chinese medicine material and the acceptable adjuvant mixing of optional pharmacy, make powder or granule, incapsulate in shell, to obtain final product.
Second aspect present invention provides a kind of method preparing wound curative capsule such as wound curative capsule described in any one of first aspect present invention, and the method comprises the following steps: get Rhizoma Arisaematis, the Radix Angelicae Dahuricae, Radix Saposhnikoviae and Rhizoma Et Radix Notopterygii, is ground into fine powder respectively for subsequent use; Radix Aconiti Coreani is obtained Radix Aconiti Coreani extract with being selected from following solvent extraction: water, aquiferous ethanol, ethanol; By the fine powder of Radix Aconiti Coreani extract and other four Chinese medicine material and the acceptable adjuvant mixing of optional pharmacy, make powder or granule, incapsulate in shell, to obtain final product.
Method according to a second aspect of the present invention described in arbitrary embodiment, the weight proportion of wherein said five kinds of medical materials is:
Radix Aconiti Coreani 176 weight portion,
Rhizoma Arisaematis 15 ~ 45 weight portion,
The Radix Angelicae Dahuricae 5 ~ 25 weight portion,
Radix Saposhnikoviae 5 ~ 25 weight portion,
Rhizoma Et Radix Notopterygii 5 ~ 25 weight portion.
Method according to a second aspect of the present invention described in arbitrary embodiment, the weight proportion of wherein said five kinds of medical materials is:
Radix Aconiti Coreani 176 weight portion,
Rhizoma Arisaematis 20 ~ 40 weight portion,
The Radix Angelicae Dahuricae 10 ~ 20 weight portion,
Radix Saposhnikoviae 10 ~ 20 weight portion,
Rhizoma Et Radix Notopterygii 10 ~ 20 weight portion.
Method according to a second aspect of the present invention described in arbitrary embodiment, the weight proportion of wherein said five kinds of medical materials is:
Radix Aconiti Coreani 176 weight portion,
Rhizoma Arisaematis 25 ~ 35 weight portion,
The Radix Angelicae Dahuricae 12 ~ 18 weight portion,
Radix Saposhnikoviae 12 ~ 18 weight portion,
Rhizoma Et Radix Notopterygii 12 ~ 18 weight portion.
Method according to a second aspect of the present invention described in arbitrary embodiment, the weight proportion of wherein said five kinds of medical materials is:
Radix Aconiti Coreani about 176 weight portion,
Rhizoma Arisaematis about 30 weight portion,
The Radix Angelicae Dahuricae about 15 weight portion,
Radix Saposhnikoviae about 15 weight portion,
Rhizoma Et Radix Notopterygii about 15 weight portion.
Method according to a second aspect of the present invention described in arbitrary embodiment, the weight proportion of wherein said five kinds of medical materials is:
Radix Aconiti Coreani about 176 weight portion,
Rhizoma Arisaematis about 29 weight portion,
The Radix Angelicae Dahuricae about 15 weight portion,
Radix Saposhnikoviae about 15 weight portion,
Rhizoma Et Radix Notopterygii about 15 weight portion.
Method according to a second aspect of the present invention described in arbitrary embodiment, the weight proportion of wherein said five kinds of medical materials is:
Radix Aconiti Coreani about 176 weight portion,
Rhizoma Arisaematis about 31 weight portion,
The Radix Angelicae Dahuricae about 17 weight portion,
Radix Saposhnikoviae about 13 weight portion,
Rhizoma Et Radix Notopterygii about 15 weight portion.
Method according to a second aspect of the present invention described in arbitrary embodiment, the weight proportion of wherein said five kinds of medical materials is:
Radix Aconiti Coreani about 176 weight portion,
Rhizoma Arisaematis about 29 weight portion,
The Radix Angelicae Dahuricae about 16 weight portion,
Radix Saposhnikoviae about 15 weight portion,
Rhizoma Et Radix Notopterygii about 14 weight portion.
Method according to a second aspect of the present invention described in arbitrary embodiment, wherein said Rhizoma Arisaematis is Rhizoma Arisaematis (processed).Rhizoma Arisaematis (processed) is known in the art, and it is such as recorded in Chinese Pharmacopoeia version in 2010 54 pages.
Method according to a second aspect of the present invention described in arbitrary 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 containing 1 ~ 5mmol hydrochloric acid, such as, contains 1 ~ 3mmol hydrochloric acid, containing 1 ~ 2mmol hydrochloric acid.In one embodiment, wherein said Radix Aconiti Coreani extract is substantially as prepared by under type: soaked 1 ~ 3 hour by the Extraction solvent of raw Radix Aconiti Coreani by 5 ~ 10 times amount, then reflux, extract, 1 ~ 3 hour; The filtering residue Extraction solvent of 5 ~ 10 times amount reflux, extract, 1 ~ 3 hour again; Merge extracted twice gained extracting solution, concentrated, be dried to moisture below 5%, obtain powder and be Radix Aconiti Coreani extract.As well known to those skilled in the art, when determining Extraction solvent, concrete extraction process can be treated the concrete condition of hindering capsule according to the experience of those skilled in the art or the present invention and be done suitable adjustment, and therefore above-mentioned concrete extraction process is only a preferred embodiment of the present invention.Have been surprisingly found that, use specific solvent to extract gained and not only there is higher alkaloid, and the quantity relative ratio relationship of wherein key organism alkali can keep more stable state well, and prior art can set forth the stability property relevant to extracting factor of quantity relative ratio relationship without any instruction or theory.
Wound curative capsule according to a first aspect of the present invention described in arbitrary embodiment, it prepares according to following method substantially: get Rhizoma Arisaematis, the Radix Angelicae Dahuricae, Radix Saposhnikoviae and Rhizoma Et Radix Notopterygii, be ground into fine powder respectively for subsequent use; By Radix Aconiti Coreani 10 ~ 90% ethanol (such as 25 ~ 80% ethanol, such as 50 ~ 75% ethanol, such as containing 1 ~ 5mmol hydrochloric acid in this ethanol, such as, containing 1 ~ 3mmol hydrochloric acid, containing 1 ~ 2mmol hydrochloric acid) extract and obtain Radix Aconiti Coreani extract: water, aquiferous ethanol, ethanol; By the fine powder of Radix Aconiti Coreani extract and other four Chinese medicine material and the acceptable adjuvant mixing of optional pharmacy, make powder or granule, incapsulate in shell, to obtain final product.
Wound curative capsule according to a first aspect of the present invention described in arbitrary embodiment, it prepares according to following method substantially: get Rhizoma Arisaematis, the Radix Angelicae Dahuricae, Radix Saposhnikoviae and Rhizoma Et Radix Notopterygii, be ground into fine powder respectively for subsequent use; The Extraction solvent of raw Radix Aconiti Coreani by 5 ~ 10 times amount is soaked 1 ~ 3 hour, then reflux, extract, 1 ~ 3 hour; The filtering residue Extraction solvent of 5 ~ 10 times amount reflux, extract, 1 ~ 3 hour again; Merge extracted twice gained extracting solution, concentrated, be dried to moisture below 5%, obtaining powder is Radix Aconiti Coreani extract; By the fine powder of Radix Aconiti Coreani extract and other four Chinese medicine material and the acceptable adjuvant mixing of optional pharmacy, make powder or granule, incapsulate in shell, to obtain final product.
Arbitrary technical characteristic that arbitrary embodiment of either side of the present invention or this either side has is suitable for arbitrary embodiment of other arbitrary embodiment or other either side equally, as long as they can not be conflicting, certainly at where applicable each other, necessary words can be done suitably to modify to individual features.Be further described with feature to various aspects of the present invention below.
All documents that the present invention quotes from, their full content is incorporated to herein by reference, and if the implication expressed by these documents and the present invention inconsistent time, be as the criterion with statement of the present invention.In addition, the various term that the present invention uses and phrase have and well known to a person skilled in the art general sense, nonetheless, the present invention still wishes to be described in more detail at this these terms and phrase and to explain, the term mentioned and phrase, if any inconsistent with common art-recognized meanings, are as the criterion with the implication that the present invention states.
Existing wound curative capsule is on the basis of ancient prescription " Yuzhen San ", to medical material various in prescription, according to its property of medicine, the different screening meticulously of effect, carries out that rational formula makes.Thus overcome the shortcomings such as the numb tongue of original dosage form, bitter in the mouth, dosage is inaccurate.Wound curative capsule is through a large amount of clinical verification, and to soft tissue injury, damage, the 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, desirable pure Chinese medicinal preparation.Have dispelling wind-evil and transforming calculus, the treatment of reducing swelling and alleviating pain effect hinders that capsule is red and swollen for the wound caused by traumatic injury, hypochondrium pain with internal injury, its pharmacological action comprises: 1, regulate whole body or local blood illusory, to improve the metabolism status of diseased region; 2, regulate the function of blood coagulation and anticoagulation system, there is dual regulation; 3, suppress inflammatory reaction, reduce the generation of inflammatory cut-off and the induced pain factor, slow down pain; 4, pathological changes reparation and tissue regeneration is promoted.
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, enter the heart, spleen, kidney channel; There is recuperating depleted YANG and rescuing the patient from collapse, dispelling cold by warming the meridian, the function of pain relieving.
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 are bitter, pungent, warm, return liver, spleen channel: there is drying dampness to eliminate phlegm, expelling wind for relieving convulsion, 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 are pungent, warm, attach to the lung and stomach meridians; There is 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, and nature and flavor acrid, sweet, warm, return bladder, lung, spleen channel; There is 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., and nature and flavor are pungent, bitter, and temperature, returns bladder, Liver Channel; Have and induce sweat, cold expelling, wind-damp dispelling, the function of pain relieving, for exterior syndrome due to wind-cold, anemofrigid-damp arthralgia, the diseases such as arthralgia.
In a word, the present invention can be used for treating raw Radix Aconiti Coreani in the capsule of traumatic injury can temperature all over the body positive, dispelling cold and dampness with warming the interior cold expelling, thus cold-evil's invasion can be used for, cold-damp wins caused disease 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's star (main containing benzoic acid) are ministerial drug, can wind-damp dispelling, stopping numbness pain, relieving convulsion, the detumescence function of the Radix Angelicae Dahuricae more so, Rhizoma Arisaematis (processed) have eliminate the phlegm, dampness, removing toxic substances effect.Whole prescription the monarch and his subjects help mutually, and expectorant has the merit of blood stasis dispelling, and dispel-wind drug also has the effect of circulation of qi promoting; Its Radix Saposhnikoviae, Rhizoma Et Radix Notopterygii can make the sensible whole body of the property of medicine by priming again.Therefore for soft tissue injury, the aseptic inflammation of the various tissues such as rheumatism, rheumatoid disease, bone injury, scapulohumeral periarthritis, and all kinds of blood stasis is pain caused all effective in cure.
Detailed description of the invention
Further illustrate the present invention below by specific embodiment/experimental example, but should be understood to, these embodiments and experimental example are only used for the use specifically described more in detail, and should not be construed as limiting the present invention in any form.
The present invention carries out generality and/or concrete description to the material used in test and test method.Although for realizing many materials that the object of the invention uses and operational approach is well known in the art, the present invention still describes in detail as far as possible at this.It will be apparent to those skilled in the art that hereinafter, if not specified, material therefor of the present invention and operational approach are well known in the art.
When capsule prepared in literary composition under the invention; every batch of material raw Radix Aconiti Coreani crude drug amount comprised that feeds intake is 1.76kg; other medical material is determined with the proportionate relationship between them as the case may be; and add appropriate amount of auxiliary materials when preparing capsule; the dose comprised in institute's gained total particle or the always every 250mg of powder is 176mg by raw Radix Aconiti Coreani crude drug gauge; every capsules loading amount counts 250mg with total particle or total powder, and the dose namely comprised in every capsules is 176mg by raw Radix Aconiti Coreani crude drug gauge.In hereafter instantiation, when mentioning Radix Aconiti Coreani, the raw Radix Aconiti Coreani of system, is Rhizoma Arisaematis (processed) when mentioning Rhizoma Arisaematis.
preparation example 1: prepare wound curative capsule of the present invention
Formula: Radix Aconiti Coreani 176 weight portion, Rhizoma Arisaematis 30 weight portion, the Radix Angelicae Dahuricae 15 weight portion, Radix Saposhnikoviae 15 weight portion, Rhizoma Et Radix Notopterygii 15 weight portion.
Method for making: get Rhizoma Arisaematis, the Radix Angelicae Dahuricae, Radix Saposhnikoviae and Rhizoma Et Radix Notopterygii, is ground into fine powder for subsequent use respectively; Radix Aconiti Coreani 8 times amount 50% ethanol (being wherein added with 2mmol hydrochloric acid) are soaked 2 hours, then reflux, extract, 2 hours; The filtering residue aforementioned Extraction solvent of 6 times amount reflux, extract, 2 hours again; Merge extracted twice gained extracting solution, concentrated, be dried to moisture below 5%, obtaining powder is Radix Aconiti Coreani extract; By the mixing of the fine powder of Radix Aconiti Coreani extract and other four Chinese medicine material, add medical material that appropriate dextrin makes to comprise in the total powder of every 250mg with Radix Aconiti Coreani crude drug gauge for 176mg, fully mix, make powder, load in hungry area softgel shell, to obtain final product.
preparation example 2: prepare wound curative capsule of the present invention
Formula: Radix Aconiti Coreani 176 weight portion, Rhizoma Arisaematis 29 weight portion, the Radix Angelicae Dahuricae 15 weight portion, Radix Saposhnikoviae 15 weight portion, Rhizoma Et Radix Notopterygii 15 weight portion.
Method for making: get Rhizoma Arisaematis, the Radix Angelicae Dahuricae, Radix Saposhnikoviae and Rhizoma Et Radix Notopterygii, is ground into fine powder for subsequent use respectively; Radix Aconiti Coreani 10 times amount 65% ethanol (being wherein added with 1.5mmol hydrochloric acid) are soaked 3 hours, then reflux, extract, 3 hours; The filtering residue aforementioned Extraction solvent of 5 times amount reflux, extract, 1 hour again; Merge extracted twice gained extracting solution, concentrated, be dried to moisture below 5%, obtaining powder is Radix Aconiti Coreani extract; By the mixing of the fine powder of Radix Aconiti Coreani extract and other four Chinese medicine material, add medical material that suitable amount of sucrose makes to comprise in the total powder of every 250mg with Radix Aconiti Coreani crude drug gauge for 176mg, fully mix, make powder, load in hungry area softgel shell, to obtain final product.
preparation example 3: prepare wound curative capsule of the present invention
Formula: Radix Aconiti Coreani 176 weight portion, Rhizoma Arisaematis 31 weight portion, the Radix Angelicae Dahuricae 17 weight portion, Radix Saposhnikoviae 13 weight portion, Rhizoma Et Radix Notopterygii 15 weight portion.
Method for making: get Rhizoma Arisaematis, the Radix Angelicae Dahuricae, Radix Saposhnikoviae and Rhizoma Et Radix Notopterygii, is ground into fine powder for subsequent use respectively; Radix Aconiti Coreani 5 times amount 75% ethanol (being wherein added with 1mmol hydrochloric acid) are soaked 1 hour, then reflux, extract, 1 hour; The filtering residue aforementioned Extraction solvent of 10 times amount reflux, extract, 3 hours again; Merge extracted twice gained extracting solution, concentrated, be dried to moisture below 5%, obtaining powder is Radix Aconiti Coreani extract; By the mixing of the fine powder of Radix Aconiti Coreani extract and other four Chinese medicine material, add medical material that appropriate dextrin makes to comprise in the total powder of every 250mg with Radix Aconiti Coreani crude drug gauge for 176mg, fully mix, make powder, load in hungry area softgel shell, to obtain final product.
preparation example 4: prepare wound curative capsule of the present invention
Formula: Radix Aconiti Coreani 176 weight portion, Rhizoma Arisaematis 29 weight portion, the Radix Angelicae Dahuricae 16 weight portion, Radix Saposhnikoviae 15 weight portion, Rhizoma Et Radix Notopterygii 14 weight portion.
Method for making: get Rhizoma Arisaematis, the Radix Angelicae Dahuricae, Radix Saposhnikoviae and Rhizoma Et Radix Notopterygii, is ground into fine powder for subsequent use respectively; Radix Aconiti Coreani 6 times amount 60% ethanol (being wherein added with 1.3mmol hydrochloric acid) are soaked 2 hours, then reflux, extract, 2 hours; The filtering residue aforementioned Extraction solvent of 8 times amount reflux, extract, 2 hours again; Merge extracted twice gained extracting solution, concentrated, be dried to moisture below 5%, obtaining powder is Radix Aconiti Coreani extract; By the mixing of the fine powder of Radix Aconiti Coreani extract and other four Chinese medicine material, add medical material that appropriate dextrin makes to comprise in the total powder of every 250mg with Radix Aconiti Coreani crude drug gauge for 176mg, fully mix, make powder, load in hungry area softgel shell, to obtain final product.
preparation example 5: prepare wound curative capsule of the present invention
Formula: Radix Aconiti Coreani 176 weight portion, Rhizoma Arisaematis 20 weight portion, the Radix Angelicae Dahuricae 20 weight portion, Radix Saposhnikoviae 10 weight portion, Rhizoma Et Radix Notopterygii 20 weight portion.
Method for making: get Rhizoma Arisaematis, the Radix Angelicae Dahuricae, Radix Saposhnikoviae and Rhizoma Et Radix Notopterygii, is ground into fine powder for subsequent use respectively; Radix Aconiti Coreani 6 times amount 60% ethanol (being wherein added with 1.5mmol hydrochloric acid) are soaked 2 hours, then reflux, extract, 2 hours; The filtering residue aforementioned Extraction solvent of 8 times amount reflux, extract, 2 hours again; Merge extracted twice gained extracting solution, concentrated, be dried to moisture below 5%, obtaining powder is Radix Aconiti Coreani extract; By the mixing of the fine powder of Radix Aconiti Coreani extract and other four Chinese medicine material, add medical material that appropriate dextrin makes to comprise in the total powder of every 250mg with Radix Aconiti Coreani crude drug gauge for 176mg, fully mix, make powder, load in hungry area softgel shell, to obtain final product.
preparation example 6: prepare wound curative capsule of the present invention
Formula: Radix Aconiti Coreani 176 weight portion, Rhizoma Arisaematis 40 weight portion, the Radix Angelicae Dahuricae 10 weight portion, Radix Saposhnikoviae 20 weight portion, Rhizoma Et Radix Notopterygii 10 weight portion.
Method for making: get Rhizoma Arisaematis, the Radix Angelicae Dahuricae, Radix Saposhnikoviae and Rhizoma Et Radix Notopterygii, is ground into fine powder for subsequent use respectively; Radix Aconiti Coreani 6 times amount 60% ethanol (being wherein added with 1.3mmol hydrochloric acid) are soaked 2 hours, then reflux, extract, 2 hours; The filtering residue aforementioned Extraction solvent of 8 times amount reflux, extract, 2 hours again; Merge extracted twice gained extracting solution, concentrated, be dried to moisture below 5%, obtaining powder is Radix Aconiti Coreani extract; By the mixing of the fine powder of Radix Aconiti Coreani extract and other four Chinese medicine material, add medical material that appropriate dextrin makes to comprise in the total powder of every 250mg with Radix Aconiti Coreani crude drug gauge for 176mg, fully mix, make powder, load in hungry area softgel shell, to obtain final product.
preparation example 7: prepare wound curative capsule of the present invention
Formula: Radix Aconiti Coreani 176 weight portion, Rhizoma Arisaematis 25 weight portion, the Radix Angelicae Dahuricae 18 weight portion, Radix Saposhnikoviae 12 weight portion, Rhizoma Et Radix Notopterygii 18 weight portion.
Method for making: get Rhizoma Arisaematis, the Radix Angelicae Dahuricae, Radix Saposhnikoviae and Rhizoma Et Radix Notopterygii, is ground into fine powder for subsequent use respectively; Radix Aconiti Coreani 6 times amount 60% ethanol (being wherein added with 1.5mmol hydrochloric acid) are soaked 2 hours, then reflux, extract, 2 hours; The filtering residue aforementioned Extraction solvent of 8 times amount reflux, extract, 2 hours again; Merge extracted twice gained extracting solution, concentrated, be dried to moisture below 5%, obtaining powder is Radix Aconiti Coreani extract; By the mixing of the fine powder of Radix Aconiti Coreani extract and other four Chinese medicine material, add medical material that appropriate dextrin makes to comprise in the total powder of every 250mg with Radix Aconiti Coreani crude drug gauge for 176mg, fully mix, make powder, load in hungry area softgel shell, to obtain final product.
preparation example 8: prepare wound curative capsule of the present invention
Formula: Radix Aconiti Coreani 176 weight portion, Rhizoma Arisaematis 35 weight portion, the Radix Angelicae Dahuricae 12 weight portion, Radix Saposhnikoviae 18 weight portion, Rhizoma Et Radix Notopterygii 12 weight portion.
Method for making: get Rhizoma Arisaematis, the Radix Angelicae Dahuricae, Radix Saposhnikoviae and Rhizoma Et Radix Notopterygii, is ground into fine powder for subsequent use respectively; Radix Aconiti Coreani 6 times amount 60% ethanol (being wherein added with 1.3mmol hydrochloric acid) are soaked 2 hours, then reflux, extract, 2 hours; The filtering residue aforementioned Extraction solvent of 8 times amount reflux, extract, 2 hours again; Merge extracted twice gained extracting solution, concentrated, be dried to moisture below 5%, obtaining powder is Radix Aconiti Coreani extract; By the mixing of the fine powder of Radix Aconiti Coreani extract and other four Chinese medicine material, add medical material that appropriate dextrin makes to comprise in the total powder of every 250mg with Radix Aconiti Coreani crude drug gauge for 176mg, fully mix, make powder, load in hungry area softgel shell, to obtain final product.
reference examples 1: prepare wound curative capsule
Reference preparation example 2 above, unlike wherein using water for Extraction solvent, obtained capsule.
reference examples 2: prepare wound curative capsule
Reference preparation example 2 above, unlike wherein using water (being wherein added with 1.5mmol hydrochloric acid) to be Extraction solvent, obtained capsule.
reference examples 3: prepare wound curative capsule
Reference preparation example 2 above, unlike wherein using 15% ethanol (being wherein added with 1.5mmol hydrochloric acid) to be Extraction solvent, obtained capsule.
reference examples 4: prepare wound curative capsule
Reference preparation example 2 above, unlike wherein using 40% ethanol (being wherein added with 1.5mmol hydrochloric acid) to be Extraction solvent, obtained capsule.
reference examples 5: prepare wound curative capsule
Reference preparation example 2 above, unlike wherein using 85% ethanol (being wherein added with 1.5mmol hydrochloric acid) to be Extraction solvent, obtained capsule.
reference examples 6: prepare wound curative capsule
Reference preparation example 2 above, unlike wherein using 95% ethanol (being wherein added with 1.5mmol hydrochloric acid) to be Extraction solvent, obtained capsule.
reference examples 7: prepare wound curative capsule
Reference preparation example 2 above, unlike wherein using 65% ethanol (not adding hydrochloric acid) to be Extraction solvent, obtained capsule.
reference examples 8: prepare wound curative capsule
Reference preparation example 2 above, unlike wherein using 65% ethanol (being wherein added with 0.5mmol hydrochloric acid) to be Extraction solvent, obtained capsule.
reference examples 9: prepare wound curative capsule
According to the method preparation that CN101785818A (Chinese Patent Application No. 201010138372.2, Zhu Yangxin) description [0029] section is recorded, obtain 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 is wherein 176mg.
test example 1: measure total alkaloid content and Guan-fubase B content in each capsule
Capsule (prepare 3 Lot samples for often kind, measure their respective results, with meansigma methods or the Range Representation result residing for them) is hindered in treatment for above-mentioned each preparation example and reference examples, measures total alkaloid content and Guan-fubase B content in each capsule.
According to CN101785818A (Chinese Patent Application No. 201010138372.2; the method that Zhu Yangxin) description [0007] section is recorded measures Radix Aconiti Coreani total alkaloid content; and provide result (prior art is recorded and is generally total alkaloids 1.20 ~ 2.00mg/ grain) with total alkaloids (represent with Guan-fubase A (C24H31NO6), unit is mg/ grain) contained in every capsules contents particles or powder.
According to CN101785818A (Chinese Patent Application No. 201010138372.2; Zhu Yangxin) description [0099] ~ [0104] section HPLC method measures Guan-fubase B content in capsule, and provides result (prior art is recorded and is generally Guan-fubase B >0.15mg/ grain) with Guan-fubase B (unit is mg/ grain) contained in every capsules contents particles or powder.
Result: preparation example 1 ~ 8 capsule total alkaloid content is all within the scope of 1.40 ~ 1.80mg/ grain; Guan-fubase B is all within the scope of 0.25 ~ 0.35mg/ grain; And total alkaloids/Guan-fubase B ratio (ratio of the total alkaloid content recorded in every capsules and Guan-fubase B content, this value can be described as in the present invention " total heptan compares ") all in 3.5 ~ 7.5 scopes, particularly in 4.0 ~ 7.0 scopes (8 preparation example capsules are all within the scope of this).Such as preparation example 1 capsule total alkaloid content is 1.66mg/ grain, and Guan-fubase B content is 0.31mg/ grain, and total heptan, ratio was 5.35.
Each reference examples Specimen Determination result is as follows:
| Test sample: Extraction 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 (without 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 |
Result from table, when using water or containing acid extraction, and working concentration lower than/equal the ethanol extraction of 40% time, although total heptan ratio with capsule of the present invention and prior art capsule quite, but total alkaloids and Guan-fubase B are all obviously on the low side.But when determining alcohol is greater than/equals 85%, although total alkaloid content is suitable with prior art capsule with capsule of the present invention, Guan-fubase B content is on the low side, and total heptan compares much larger than capsule of the present invention and prior art capsule.In addition, when using not containing sour or that acid content is lower ethanol water extraction, although Guan-fubase B content is suitable with capsule of the present invention and prior art capsule in product, total alkaloid content is on the low side, and total heptan is than on the low side.
test example 2: the stability measuring each capsule
Each capsule of preparation example of the present invention and reference examples is packed, May is placed under 45 ° of C, measure the ratio in total heptan in 0 month (when high-temperature treatment starts) in each sample and May (at the end of high-temperature treatment) 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%.
Result shows, and each capsule of preparation example 1 ~ 8 of the present invention total heptan all in 15 ~ 35% scopes, shows that Guan-fubase B content is in a slight decrease for total alkaloid content than percent change, and such as preparation example 1 total heptan is 22% than percent change.Surprisingly, reference examples 9 and reference examples 10, reference examples 1 ~ 4, each capsule of reference examples 7 ~ 8 total heptan than percent change all in 95 ~ 150% scopes, show that Guan-fubase B content has obvious reduction for total alkaloid content, such as reference examples 1 total heptan is 132% than percent change.The ethanol water that the display of these results uses the present invention to comprise appropriate amount of acid extracts the stability that the wound curative capsule that obtains of Radix Aconiti Coreani has good chemical composition relation, and the wound curative capsule of prior art and use water or the lower ethanol water of acid content to extract wound curative capsule that Radix Aconiti Coreani obtains show the stability of unsafty chemical composition relation.
test example 3: the biologic activity measuring wound curative capsule
Reagent: preparation example 1,2 capsule and reference examples 9,10 capsule, dosage all uses each capsule particle or powder 1.5g with every kg the weight of animals.Negative control group and positive controls are pressed literature method respectively and are arranged.
With reference to CN1883630A (Chinese Patent Application No. 200610051843.X, mouse auricle swelling test (test one) Zhu Yangxin) in Instructions Page 2 test 1, test the impact that each reagent xylol causes mice auricle swelling, percent basis is suppressed with swelling, that is, swelling suppresses percent=[the negative contrast groups swelling of (negative contrast groups swelling-administration group swelling) ÷] × 100%.Result shows, the swelling of preparation example 1,2 capsule and reference examples 9,10 capsule suppresses percent all in 47 ~ 56% scopes, and with negative contrast groups, more all there were significant differences, p<0.01, and the swelling of such as preparation example 1 capsule of the present invention suppresses percent to be 53%.
With reference to CN1883630A (Chinese Patent Application No. 200610051843.X, method Zhu Yangxin) in description page 4 test 2, test the impact of each reagent on mice autonomic activities, computational activity number of times reduces percent, and namely movable number of times reduces percent=[(negative contrast groups activity number of times-administration group activity number of times) ÷ negative contrast groups activity number of times] × 100%.Result shows, the movable number of times of preparation example 1,2 capsule and reference examples 9,10 capsule reduces percent all in 22 ~ 27% scopes, and with negative contrast groups, more all there were significant differences, p<0.01, it is 24% that the movable number of times of such as preparation example 2 capsule of the present invention reduces percent.
With reference to the method in CN1883630A (Chinese Patent Application No. 200610051843.X, Zhu Yangxin) description page 4 test 3, test the impact that each reagent Dichlorodiphenyl Acetate causes mouse writhing number of times, calculate analgesia percentage rate.Result shows, the analgesia percentage rate of preparation example 1,2 capsule and reference examples 9,10 capsule is all in 36 ~ 41% scopes, and with negative contrast groups, more all there were significant differences, p<0.01, and such as the analgesia percentage rate of preparation example 2 capsule of the present invention is 38%.
Above three biological test results display, capsule of the present invention is the same with existing product all has 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 the degeneration of joint such as hyperosteogeny, cervical spondylotic radiculopathy causes; Lumbago and skelalgia, sciatica, arthralgia, cervical vertebra pain.
Claims (10)
1. a wound curative capsule, it is made up of the medical material of following weight proportion: Radix Aconiti Coreani 176 weight portion, Rhizoma Arisaematis 20 ~ 40 weight portion, the Radix Angelicae Dahuricae 10 ~ 20 weight portion, Radix Saposhnikoviae 10 ~ 20 weight portion, Rhizoma Et Radix Notopterygii 10 ~ 20 weight portion; This wound curative capsule prepares according to following method: get Rhizoma Arisaematis, the Radix Angelicae Dahuricae, Radix Saposhnikoviae and Rhizoma Et Radix Notopterygii, is ground into fine powder respectively for subsequent use; 50 ~ 75% ethanol containing 1 ~ 2mmol hydrochloric acid giving birth to Radix Aconiti Coreani 5 ~ 10 times amount soak 1 ~ 3 hour as Extraction solvent, then reflux, extract, 1 ~ 3 hour; The filtering residue said extracted solvent of 5 ~ 10 times amount reflux, extract, 1 ~ 3 hour again; Merge extracted twice gained extracting solution, concentrated, be dried to moisture below 5%, obtain powder and be Radix Aconiti Coreani extract; By the fine powder of Radix Aconiti Coreani extract and other four Chinese medicine material and the acceptable adjuvant mixing of optional pharmacy, make powder or granule, incapsulate in shell, to obtain final product.
2. wound curative capsule according to claim 1, the acceptable adjuvant of wherein said pharmacy is selected from: diluent, filler, binding agent, lubricant, flavoring agent.
3. wound curative capsule according to claim 1, it is made up of the medical material of following weight proportion: Radix Aconiti Coreani 176 weight portion, Rhizoma Arisaematis 25 ~ 35 weight portion, the Radix Angelicae Dahuricae 12 ~ 18 weight portion, Radix Saposhnikoviae 12 ~ 18 weight portion, Rhizoma Et Radix Notopterygii 12 ~ 18 weight portion.
4. wound curative capsule according to claim 1, it is made up of the medical material of following weight proportion: Radix Aconiti Coreani 176 weight portion, Rhizoma Arisaematis 30 weight portion, the Radix Angelicae Dahuricae 15 weight portion, Radix Saposhnikoviae 15 weight portion, Rhizoma Et Radix Notopterygii 15 weight portion.
5. wound curative capsule according to claim 1, it is made up of the medical material of following weight proportion: Radix Aconiti Coreani 176 weight portion, Rhizoma Arisaematis 29 weight portion, the Radix Angelicae Dahuricae 15 weight portion, Radix Saposhnikoviae 15 weight portion, Rhizoma Et Radix Notopterygii 15 weight portion.
6. wound curative capsule according to claim 1, it is made up of the medical material of following weight proportion: Radix Aconiti Coreani 176 weight portion, Rhizoma Arisaematis 31 weight portion, the Radix Angelicae Dahuricae 17 weight portion, Radix Saposhnikoviae 13 weight portion, Rhizoma Et Radix Notopterygii 15 weight portion.
7. wound curative capsule according to claim 1, it is made up of the medical material of following weight proportion: Radix Aconiti Coreani 176 weight portion, Rhizoma Arisaematis 29 weight portion, the Radix Angelicae Dahuricae 16 weight portion, Radix Saposhnikoviae 15 weight portion, Rhizoma Et Radix Notopterygii 14 weight portion.
8. wound curative capsule according to claim 1, wherein said Rhizoma Arisaematis is Rhizoma Arisaematis (processed).
9. wound curative capsule according to claim 2, described diluent or filler are selected from: sucrose, glucose, lactose, corn starch, modified starch, amylum pregelatinisatum, dextrin, microcrystalline Cellulose; Described binding agent is selected from: the aqueous solution that starch slurry, PVP or HPMC are mixed with or suspension; Described lubricant is selected from: magnesium stearate, Pulvis Talci, silicon dioxide, micropowder silica gel; Described flavoring agent is selected from: aspartame, stevioside.
10. prepare the method for the wound curative capsule of claim 1, the method comprises the following steps: get Rhizoma Arisaematis, the Radix Angelicae Dahuricae, Radix Saposhnikoviae and Rhizoma Et Radix Notopterygii, is ground into fine powder respectively for subsequent use; 50 ~ 75% ethanol containing 1 ~ 2mmol hydrochloric acid giving birth to Radix Aconiti Coreani 5 ~ 10 times amount soak 1 ~ 3 hour as Extraction solvent, then reflux, extract, 1 ~ 3 hour; The filtering residue said extracted solvent of 5 ~ 10 times amount reflux, extract, 1 ~ 3 hour again; Merge extracted twice gained extracting solution, concentrated, be dried to moisture below 5%, obtain powder and be Radix Aconiti Coreani extract; By the fine powder of Radix Aconiti Coreani extract and other four Chinese medicine material and the acceptable adjuvant mixing of optional pharmacy, make powder or granule, incapsulate in shell, to obtain final product.
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| Title |
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| 盐酸关附甲素注射液的生产工艺改进研究;张志文;《中国优秀硕士学位论文全文数据库》;20071231;第22－23，43页 * |
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