CN105456215A - Osteon myospalacem baileyi compound extract tablet with function of treating arthritis and preparing method - Google Patents
Osteon myospalacem baileyi compound extract tablet with function of treating arthritis and preparing method Download PDFInfo
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- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
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- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
- A61K35/32—Bones; Osteocytes; Osteoblasts; Tendons; Tenocytes; Teeth; Odontoblasts; Cartilage; Chondrocytes; Synovial membrane
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- A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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Abstract
The invention provides an osteon myospalacem baileyi compound extract tablet with the function of treating arthritis and a preparing method. The tablet is mainly prepared from osteon myospalacem baileyi compound extract, maltodextrin, a filling agent, a disintegrating agent, a lubricating agent and other raw materials, wherein the raw materials are each of specific dosage. The tablet has the advantages of being good in disintegrative performance, good in pharmacological effect, capable of effectively treating and inhibiting arthritis, good in stability, high in bioavailability and the like, the quantity of auxiliary materials is small, and the osteon myospalacem baileyi compound extract is dispersed uniformly. A specific material adding step is adopted in the preparing method of the tablet, so that the osteon myospalacem baileyi compound extract is dispersed uniformly, the pharmacological effect of the osteon myospalacem baileyi compound extract tablet with the function of treating arthritis is promoted further, and bioavailability is promoted; in addition, the defect that the disintegrating action is poor when the disintegrating agent is only added internally or externally, or the disintegrating agent is not in a fine powder shape after being disintegrated, and therefore bioavailability is low is overcome; the preparing technology is simple and easy to operate, and the preparing method is suitable for mass production.
Description
Technical field
The present invention relates to Chinese patent drug technique field, in particular to a kind of Bailey Myospalax Born composite extract tablet and the preparation method with treatment of arthritis effect.
Background technology
Joint is the significant points of support human body action, once wind and cold is wet invade joint tissue position, can cause that joint blood is obstructed to be obstructed, of a specified duration can produce rheumatism, rheumatoid arthritis.Particularly weak and puerperal women, when not noting protection, the intrusion that irresistible wind and cold is wet; Because its immunity is poor, wind and cold is wet invades joint tissue, damp and hot severe one, and local there will be red and swollen heating suppuration symptom; Rheumatism severe one, there will be arthroncus, activities adverse, apathetic symptom, severe patient can not be walked, and can pathological changes be there is in rheumatism, form migrans arthritis, the joint part of whole body may be invaded, as can not symptomatic treatment in time, joint tissue necrosis and quadriplegia can be caused, also can produce the consequences such as rheumatic heart disease.In prior art, general employing western medicine arthritis, but Western medicine can only take stopgap measures and can not effect a permanent cure, even it is also bad that Western medicine is expelled to intraarticular effect.
Bailey Myospalax Born is the full skeleton of drying of zokor section animal Myospalax baileyi (Myospalaxbaileyi), is the Chinese medicine one kind new medicine material that Ministry of Public Health was ratified in nineteen ninety.Bailey Myospalax Born slightly warm in nature, acrid in the mouth are salty, enter Liver and kidney warp, and major function is expelling wind and removing dampness cold expelling, relaxing muscles and tendons and activating QI and blood in the collateral, strengthening the tendons and bones and enhancing human body resistance.Its Bone Defect Repari effect is remarkable, pharmacological action and traditional rare Chinese medicine Os Tigris similar.Bailey Myospalax Born and other plurality of Chinese are mainly carried out compatibility use by Bailey Myospalax Born drug development before: a kind of Bailey Myospalax Born drug regimen announced as CN10102835A, be that Bailey Myospalax Born, Herba Saussureae Involueratae Flos Carthami three kinds of medical materials are carried out compatibility, form a kind of Bailey Myospalax Born prescription drug with blood circulation invigorating efficacies.And for example a kind of Bailey Myospalax Born drug regimen of CN1301544A announcement, is carry out water extraction after being mixed with Herba Saussureae Involueratae by Bailey Myospalax Born, obtains a kind of drug regimen with treatment of arthritis effect.A kind of Bailey Myospalax Born capsule announced in CN1089092C, is mixed with the medicine such as Herba Saussureae Involueratae, Radix Gentianae Macrophyllae by Bailey Myospalax Born, makes the capsule with the effect such as dispelling cold and dehumidification, reducing swelling and alleviating pain; But Bailey Myospalax Born medicine of the prior art can not play good treatment of arthritis effect.
In view of this, special proposition the present invention.
Summary of the invention
The first object of the present invention is to provide a kind of Bailey Myospalax Born composite extract tablet with treatment of arthritis effect, and the described Bailey Myospalax Born composite extract tablet with treatment of arthritis effect has that adjuvant amount is little, Bailey Myospalax Born composite extract is uniformly dispersed, disintegration of tablet is good, good drug efficacy, good stability, bioavailability advantages of higher.
The second object of the present invention is to provide a kind of described preparation method with the Bailey Myospalax Born composite extract tablet for the treatment of of arthritis effect, the method overcome and only will to add in disintegrating agent or outer added-time disintegration is weak or the shortcoming that do not become fine-powdered after disintegrate and cause bioavailability low, and preparation technology is simple, easy to operate, is suitable for large-scale production.
In order to realize above-mentioned purpose of the present invention, spy by the following technical solutions:
There is the Bailey Myospalax Born composite extract tablet for the treatment of of arthritis effect, described in there is treatment of arthritis effect Bailey Myospalax Born composite extract tablet prepare primarily of the raw material of following mass fraction:
Bailey Myospalax Born composite extract 700 ~ 1100 parts, maltodextrin 30 ~ 70 parts, filler 2 ~ 18 parts, disintegrating agent 5 ~ 35 parts, lubricant 5 ~ 35 parts;
Described Bailey Myospalax Born composite extract comprise in Bailey Myospalax Born water extract, Bailey Myospalax Born n-butanol extract, Bailey Myospalax Born ethanol extraction, Bailey Myospalax Born methanolic extract, Bailey Myospalax Born ethyl acetate extract one or more;
Described filler comprises one or more the combination in starch, lactose, mannitol, xylitol, sorbitol; Described disintegrating agent comprise in carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, microcrystalline Cellulose, polyvidone, cross-linking sodium carboxymethyl cellulose one or more; Described lubricant comprise in magnesium stearate, hydrogenated vegetable oil, stearic acid, silicon dioxide, micropowder silica gel, PEG400, Stepanol MG one or more.
The Bailey Myospalax Born composite extract tablet that the present invention has treatment of arthritis effect adopts specific composition and consumption, and the Bailey Myospalax Born composite extract tablet that gained has treatment of arthritis effect has that adjuvant amount is little, Bailey Myospalax Born composite extract is uniformly dispersed, disintegration of tablet is good, good drug efficacy, effectively can treat and suppress arthritis, good stability, bioavailability advantages of higher.
Described Bailey Myospalax Born composite extract preferably includes the composition of following mass fraction:
Bailey Myospalax Born water extract 100 ~ 800 parts, Bailey Myospalax Born n-butanol extract 1 ~ 300 part, Bailey Myospalax Born ethanol extraction 1 ~ 300 part, Bailey Myospalax Born methanolic extract 1 ~ 300 part, Bailey Myospalax Born ethyl acetate extract 1 ~ 300 part.
Often only adopt Bailey Myospalax Born water extract in prior art, but the water extracting method of this cheapness can cause in Bailey Myospalax Born medical material the loss with highly active low pole compound, affects the drug effect of Bailey Myospalax Born.The Sailongbone extracts (as water extract, ethanol extraction, ethyl acetate extract etc.) that the present invention adopts Different Extraction Method to obtain the Bailey Myospalax Born chemical composition that comprises different, wherein the weak polar solvent extract such as ethyl acetate mainly comprises Bailey Myospalax Born low pole compound, mainly comprise the Bailey Myospalax Born compound of strong polarity and middle polarity compound in the intensive polar solvent such as water and ethanol extract, these different extracts have diverse pharmacologically active.The Sailongbone extracts that these Different Extraction Method obtain mixes by the present invention by a certain percentage, can obtain the Sailongbone extracts combination with better pharmacologically active.
Described filler comprises one or more the combination in starch, lactose, mannitol, xylitol, sorbitol; Described disintegrating agent comprise in carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, microcrystalline Cellulose, polyvidone, cross-linking sodium carboxymethyl cellulose one or more; Described lubricant comprises the one or many in magnesium stearate, hydrogenated vegetable oil, stearic acid, silicon dioxide, micropowder silica gel, PEG400, Stepanol MG; Preferably, described filler is starch, and described disintegrating agent is microcrystalline Cellulose, and described lubricant is silicon dioxide and magnesium stearate, and the mass fraction of described silicon dioxide and magnesium stearate is preferably: silicon dioxide 2 ~ 17 parts, magnesium stearate 3 ~ 18 parts.
Adopt the filler of special component and consumption, disintegrating agent, lubricant can improve Bailey Myospalax Born composite extract disintegration of tablet and the stability that the present invention has treatment of arthritis effect.
The described raw material with the Bailey Myospalax Born composite extract tablet for the treatment of of arthritis effect preferably also comprises Emulsifier LM-102, and the mass fraction of described Emulsifier LM-102 is 2 ~ 18 parts.
Further, described in there is the Bailey Myospalax Born composite extract tablet for the treatment of of arthritis effect raw material preferably also comprise carrageenan, the mass fraction of described carrageenan is 2 ~ 18 parts.
The described Bailey Myospalax Born composite extract tablet with treatment of arthritis effect preferably prepares primarily of the raw material of following mass fraction:
Bailey Myospalax Born composite extract 900 parts, maltodextrin 50 parts, starch 10 parts, microcrystalline Cellulose 20 parts, silica 10 part, magnesium stearate 10 parts.
The described Bailey Myospalax Born composite extract tablet with treatment of arthritis effect preferably prepares primarily of the raw material of following mass fraction:
Bailey Myospalax Born composite extract 800 parts, maltodextrin 40 parts, starch 6 parts, 4 parts, mannitol, carboxymethyl starch sodium 10 parts, PEG400 9 parts, Emulsifier LM-102 8 parts.
The described Bailey Myospalax Born composite extract tablet with treatment of arthritis effect preferably prepares primarily of the raw material of following mass fraction:
Bailey Myospalax Born composite extract 900 parts, maltodextrin 50 parts, starch 10 parts, microcrystalline Cellulose 20 parts, silica 10 part, magnesium stearate 10 parts, Emulsifier LM-102 10 parts, carrageenan 10 parts.
The specific composition of preferred employing and consumption, improve further the present invention and have the disintegrative of the Bailey Myospalax Born composite extract tablet for the treatment of of arthritis effect, drug effect, stability and bioavailability.
Above-mentioned a kind of preparation method with the Bailey Myospalax Born composite extract tablet for the treatment of of arthritis effect, comprises the steps:
A) take Bailey Myospalax Born composite extract and pulverize, sieving, being preferably 80 ~ 100 orders, for subsequent use;
B) take maltodextrin, grinding, grinding limit, limit add step a) gained Bailey Myospalax Born composite extract continue grinding, winner's abrasive material;
C) disintegrating agent of filler, 50% ~ 75% quality accounting is ground, obtain secondary abrasive material;
D) by described main abrasive material and secondary abrasive material mix homogeneously, granulate, obtain coarse granule;
E) described coarse granule is sieved, be preferably 100 ~ 120 orders, obtain fine grained;
F) mixed homogeneously with described fine grained by the disintegrating agent of lubricant and remainder, tabletting, has the Bailey Myospalax Born composite extract tablet for the treatment of of arthritis effect described in obtaining.
The preparation method that the present invention has the Bailey Myospalax Born composite extract tablet for the treatment of of arthritis effect adopts specific addition step, Bailey Myospalax Born composite extract is uniformly dispersed, and promote that gained has the drug effect of the Bailey Myospalax Born composite extract tablet for the treatment of of arthritis effect, promotes bioavailability further; In addition, overcome and only will to add in disintegrating agent or outer added-time disintegration is weak or the shortcoming that do not become fine-powdered after disintegrate and cause bioavailability low, and preparation technology is simple, easy to operate, is suitable for large-scale production.
Further, above-mentioned a kind of preparation method with the Bailey Myospalax Born composite extract tablet for the treatment of of arthritis effect, preferably includes following steps:
A) take Bailey Myospalax Born composite extract to pulverize, cross 80 ~ 100 mesh sieves, for subsequent use; ;
B) take maltodextrin and Emulsifier LM-102, grinding, grinding limit, limit add step a) gained Bailey Myospalax Born composite extract continue grinding, winner's abrasive material;
C) starch, the microcrystalline Cellulose of 50% ~ 75% quality accounting and the carrageenan of described mass parts are ground, obtain secondary abrasive material;
D) by described main abrasive material and secondary abrasive material mix homogeneously, granulate, obtain coarse granule;
E) described coarse granule is crossed 100 ~ 120 mesh sieves, obtain fine grained;
F) mixed homogeneously with described fine grained by the microcrystalline Cellulose of silicon dioxide, magnesium stearate and remainder, tabletting, has the Bailey Myospalax Born composite extract tablet for the treatment of of arthritis effect described in obtaining.
Compared with prior art, beneficial effect of the present invention is:
The Bailey Myospalax Born composite extract tablet that the present invention has treatment of arthritis effect adopts specific composition and consumption, and the Bailey Myospalax Born composite extract tablet that gained has treatment of arthritis effect has that adjuvant amount is little, Bailey Myospalax Born composite extract is uniformly dispersed, disintegration of tablet is good, good drug efficacy, effectively can treat and suppress arthritis, good stability, bioavailability advantages of higher.The preparation method that the present invention has the Bailey Myospalax Born composite extract tablet for the treatment of of arthritis effect adopts specific addition step, Bailey Myospalax Born composite extract is uniformly dispersed, and promote that gained has the drug effect of the Bailey Myospalax Born composite extract tablet for the treatment of of arthritis effect, promotes bioavailability further; In addition, overcome and only will to add in disintegrating agent or outer added-time disintegration is weak or the shortcoming that do not become fine-powdered after disintegrate and cause bioavailability low, and preparation technology is simple, easy to operate, is suitable for large-scale production.
Detailed description of the invention
Below in conjunction with embodiment, embodiment of the present invention are described in detail, but it will be understood to those of skill in the art that the following example only for illustration of the present invention, and should not be considered as limiting the scope of the invention.Unreceipted actual conditions person in embodiment, the condition of conveniently conditioned disjunction manufacturer suggestion is carried out.Agents useful for same or the unreceipted production firm person of instrument, be and can buy by commercially available the conventional products obtained.
Embodiment 1
A kind of preparation method with the Bailey Myospalax Born composite extract tablet for the treatment of of arthritis effect:
Raw material: in mass fraction, Bailey Myospalax Born composite extract 900 parts, maltodextrin 50 parts, starch 10 parts, microcrystalline Cellulose 20 parts, silica 10 part, magnesium stearate 10 parts, Emulsifier LM-102 10 parts, carrageenan 10 parts.
Method for making:
A) by mass fraction (Bailey Myospalax Born water extract 300 parts, Bailey Myospalax Born n-butanol extract 100 parts, Bailey Myospalax Born ethanol extraction 200 parts, Bailey Myospalax Born methanolic extract 150 parts, Bailey Myospalax Born ethyl acetate extract 150 parts) preparation Bailey Myospalax Born composite extract;
B) the Bailey Myospalax Born composite extract taking recipe quantity is pulverized, and crosses 100 mesh sieves, for subsequent use;
C) take maltodextrin and the Emulsifier LM-102 of recipe quantity, grinding, grinding limit, limit adds step Bailey Myospalax Born composite extract a) and continues grinding, winner's abrasive material;
D) starch of described mass parts, the microcrystalline Cellulose of 55% quality accounting and the carrageenan of described mass parts are ground, obtain secondary abrasive material;
E) by described main abrasive material and secondary abrasive material mix homogeneously, granulate, obtain coarse granule;
F) described coarse granule is crossed 100 eye mesh screens, obtain fine grained;
G) mixed homogeneously with described fine grained by the microcrystalline Cellulose of the silicon dioxide of described mass parts, magnesium stearate and remainder, tabletting, obtains the Bailey Myospalax Born composite extract tablet that the present invention has treatment of arthritis effect.
Embodiment 2
A kind of preparation method with the Bailey Myospalax Born composite extract tablet for the treatment of of arthritis effect:
Raw material: in mass fraction, Bailey Myospalax Born composite extract 800 parts, maltodextrin 40 parts, starch 6 parts, 4 parts, mannitol, carboxymethyl starch sodium 10 parts, PEG400 9 parts, Emulsifier LM-102 8 parts.
Method for making:
A) by mass fraction (Bailey Myospalax Born water extract 300 parts, Bailey Myospalax Born n-butanol extract 100 parts, Bailey Myospalax Born ethanol extraction 100 parts, Bailey Myospalax Born methanolic extract 150 parts, Bailey Myospalax Born ethyl acetate extract 150 parts) preparation Bailey Myospalax Born composite extract;
B) the Bailey Myospalax Born composite extract taking recipe quantity is pulverized, and crosses 80 mesh sieves, for subsequent use; ;
C) take maltodextrin and the Emulsifier LM-102 of recipe quantity, grinding, grinding limit, limit adds step Bailey Myospalax Born composite extract a) and continues grinding, winner's abrasive material;
D) carboxymethyl starch sodium of the starch of described mass parts and mannitol, 68% quality accounting is ground, obtain secondary abrasive material;
E) by described main abrasive material and secondary abrasive material mix homogeneously, granulate, obtain coarse granule;
F) described coarse granule is crossed 100 eye mesh screens, obtain fine grained;
G) PEG400 of described mass parts and the carboxymethyl starch sodium of remainder are mixed homogeneously with described fine grained, tabletting, obtains the Bailey Myospalax Born composite extract tablet that the present invention has treatment of arthritis effect.
Embodiment 3
A kind of preparation method with the Bailey Myospalax Born composite extract tablet for the treatment of of arthritis effect:
Raw material: in mass fraction, Bailey Myospalax Born composite extract 900 parts, maltodextrin 50 parts, starch 10 parts, microcrystalline Cellulose 20 parts, silica 10 part, magnesium stearate 10 parts.
Method for making:
A) by mass fraction (Bailey Myospalax Born water extract 500 parts, Bailey Myospalax Born n-butanol extract 50 parts, Bailey Myospalax Born ethanol extraction 50 parts, Bailey Myospalax Born methanolic extract 150 parts, Bailey Myospalax Born ethyl acetate extract 150 parts) preparation Bailey Myospalax Born composite extract;
B) the Bailey Myospalax Born composite extract taking recipe quantity is pulverized, and crosses 100 mesh sieves, for subsequent use;
C) take the maltodextrin of recipe quantity, grinding, grinding limit, limit adds step Bailey Myospalax Born composite extract a) and continues grinding, winner's abrasive material;
D) microcrystalline Cellulose of the starch of described mass parts, 65% quality accounting is ground, obtain secondary abrasive material;
E) by described main abrasive material and secondary abrasive material mix homogeneously, granulate, obtain coarse granule;
F) described coarse granule is crossed 120 eye mesh screens, obtain fine grained;
G) mixed homogeneously with described fine grained by the microcrystalline Cellulose of the silicon dioxide of described mass parts, magnesium stearate and remainder, tabletting, obtains the Bailey Myospalax Born composite extract tablet that the present invention has treatment of arthritis effect.
Embodiment 4
A kind of preparation method with the Bailey Myospalax Born composite extract tablet for the treatment of of arthritis effect:
Raw material: in mass fraction, Bailey Myospalax Born composite extract 700 parts, maltodextrin 30 parts, starch 2 parts, xylitol 2 parts, cross-linking sodium carboxymethyl cellulose 5 parts, micropowder silica gel 3 parts, Emulsifier LM-102 2 parts, carrageenan 2 parts.
Method for making:
A) by mass fraction (Bailey Myospalax Born water extract 300 parts, Bailey Myospalax Born n-butanol extract 100 parts, Bailey Myospalax Born ethanol extraction 100 parts, Bailey Myospalax Born methanolic extract 100 parts, Bailey Myospalax Born ethyl acetate extract 100 parts) preparation Bailey Myospalax Born composite extract;
B) the Bailey Myospalax Born composite extract taking recipe quantity is pulverized, and crosses 80 mesh sieves, for subsequent use;
C) take maltodextrin and the Emulsifier LM-102 of recipe quantity, grinding, grinding limit, limit adds step Bailey Myospalax Born composite extract a) and continues grinding, winner's abrasive material;
D) starch of described mass parts and xylitol, the cross-linking sodium carboxymethyl cellulose of 60% quality accounting and the carrageenan of described mass parts are ground, obtain secondary abrasive material;
E) by described main abrasive material and secondary abrasive material mix homogeneously, granulate, obtain coarse granule;
F) described coarse granule is crossed 100 eye mesh screens, obtain fine grained;
G) two micropowder silica gels of described mass parts and the cross-linking sodium carboxymethyl cellulose of remainder are mixed homogeneously with described fine grained, tabletting, obtains the Bailey Myospalax Born composite extract tablet that the present invention has treatment of arthritis effect.
Embodiment 5
A kind of preparation method with the Bailey Myospalax Born composite extract tablet for the treatment of of arthritis effect:
Raw material: in mass fraction, Bailey Myospalax Born composite extract 700 parts, maltodextrin 30 parts, starch 2 parts, sorbitol 1 part, low-substituted hydroxypropyl cellulose 5 parts, Stepanol MG 3 parts, Emulsifier LM-102 2 parts.
Method for making:
A) by mass fraction (Bailey Myospalax Born water extract 200 parts, Bailey Myospalax Born n-butanol extract 200 parts, Bailey Myospalax Born ethanol extraction 50 parts, Bailey Myospalax Born methanolic extract 150 parts, Bailey Myospalax Born ethyl acetate extract 100 parts) preparation Bailey Myospalax Born composite extract;
B) the Bailey Myospalax Born composite extract taking recipe quantity is pulverized, and crosses 90 mesh sieves, for subsequent use;
C) take maltodextrin and the Emulsifier LM-102 of recipe quantity, grinding, grinding limit, limit adds step Bailey Myospalax Born composite extract a) and continues grinding, winner's abrasive material;
D) low-substituted hydroxypropyl cellulose of the starch of described mass parts and sorbitol, 55% quality accounting is ground, obtain secondary abrasive material;
E) by described main abrasive material and secondary abrasive material mix homogeneously, granulate, obtain coarse granule;
F) described coarse granule is crossed 110 eye mesh screens, obtain fine grained;
G) Stepanol MG of described mass parts and the low-substituted hydroxypropyl cellulose of remainder are mixed homogeneously with described fine grained, tabletting, obtains the Bailey Myospalax Born composite extract tablet that the present invention has treatment of arthritis effect.
Embodiment 6
A kind of preparation method with the Bailey Myospalax Born composite extract tablet for the treatment of of arthritis effect:
Raw material: in mass fraction, Bailey Myospalax Born composite extract 700 parts, maltodextrin 30 parts, starch 2 parts, lactose 1 part, polyvidone 5 parts, Stepanol MG 3 parts.
Method for making:
A) by mass fraction (Bailey Myospalax Born water extract 200 parts, Bailey Myospalax Born n-butanol extract 100 parts, Bailey Myospalax Born ethanol extraction 100 parts, Bailey Myospalax Born methanolic extract 150 parts, Bailey Myospalax Born ethyl acetate extract 150 parts) preparation Bailey Myospalax Born composite extract;
B) the Bailey Myospalax Born composite extract taking recipe quantity is pulverized, and crosses 100 mesh sieves, for subsequent use;
C) take the maltodextrin of recipe quantity, grinding, grinding limit, limit adds step Bailey Myospalax Born composite extract a) and continues grinding, winner's abrasive material;
D) polyvidone of the starch of described mass parts and lactose, 70% quality accounting is ground, obtain secondary abrasive material;
E) by described main abrasive material and secondary abrasive material mix homogeneously, granulate, obtain coarse granule;
F) described coarse granule is crossed 120 eye mesh screens, obtain fine grained;
G) Stepanol MG of described mass parts and the polyvidone of remainder are mixed homogeneously with described fine grained, tabletting, obtains the Bailey Myospalax Born composite extract tablet that the present invention has treatment of arthritis effect.
Embodiment 7
A kind of preparation method with the Bailey Myospalax Born composite extract tablet for the treatment of of arthritis effect:
Raw material: in mass fraction, Bailey Myospalax Born composite extract 1100 parts, maltodextrin 70 parts, starch 18 parts, microcrystalline Cellulose 35 parts, silica 17 parts, magnesium stearate 18 parts, Emulsifier LM-102 18 parts, carrageenan 18 parts.
Method for making:
A) by mass fraction (Bailey Myospalax Born water extract 500 parts, Bailey Myospalax Born n-butanol extract 100 parts, Bailey Myospalax Born ethanol extraction 200 parts, Bailey Myospalax Born methanolic extract 150 parts, Bailey Myospalax Born ethyl acetate extract 150 parts) preparation Bailey Myospalax Born composite extract;
B) the Bailey Myospalax Born composite extract taking recipe quantity is pulverized, and crosses 100 mesh sieves, for subsequent use;
C) take maltodextrin and the Emulsifier LM-102 of recipe quantity, grinding, grinding limit, limit adds step Bailey Myospalax Born composite extract a) and continues grinding, winner's abrasive material;
D) starch of described mass parts, the microcrystalline Cellulose of 50% quality accounting and the carrageenan of described mass parts are ground, obtain secondary abrasive material;
E) by described main abrasive material and secondary abrasive material mix homogeneously, granulate, obtain coarse granule;
F) described coarse granule is crossed 100 eye mesh screens, obtain fine grained;
G) mixed homogeneously with described fine grained by the microcrystalline Cellulose of the silicon dioxide of described mass parts, magnesium stearate and remainder, tabletting, obtains the Bailey Myospalax Born composite extract tablet that the present invention has treatment of arthritis effect.
Embodiment 8
A kind of preparation method with the Bailey Myospalax Born composite extract tablet for the treatment of of arthritis effect:
Raw material: in mass fraction, Bailey Myospalax Born composite extract 1100 parts, maltodextrin 68 parts, starch 16 parts, microcrystalline Cellulose 30 parts, hydrogenated vegetable oil 17 parts, Emulsifier LM-102 18 parts.
Method for making:
A) by mass fraction (Bailey Myospalax Born water extract 400 parts, Bailey Myospalax Born n-butanol extract 100 parts, Bailey Myospalax Born ethanol extraction 300 parts, Bailey Myospalax Born methanolic extract 150 parts, Bailey Myospalax Born ethyl acetate extract 150 parts) preparation Bailey Myospalax Born composite extract
B) the Bailey Myospalax Born composite extract taking recipe quantity is pulverized, and crosses 80 mesh sieves, for subsequent use;
C) take maltodextrin and the Emulsifier LM-102 of recipe quantity, grinding, grinding limit, limit adds step Bailey Myospalax Born composite extract a) and continues grinding, winner's abrasive material;
D) microcrystalline Cellulose of the starch of described mass parts, 55% ~ 68% quality accounting is ground, obtain secondary abrasive material;
E) by described main abrasive material and secondary abrasive material mix homogeneously, granulate, obtain coarse granule;
F) described coarse granule is crossed 100 eye mesh screens, obtain fine grained;
G) hydrogenated vegetable oil of described mass parts and the microcrystalline Cellulose of remainder are mixed homogeneously with described fine grained, tabletting, obtains the Bailey Myospalax Born composite extract tablet that the present invention has treatment of arthritis effect.
Embodiment 9
A kind of preparation method with the Bailey Myospalax Born composite extract tablet for the treatment of of arthritis effect:
Raw material: in mass fraction, Bailey Myospalax Born composite extract 1000 parts, maltodextrin 65 parts, starch 16 parts, microcrystalline Cellulose 32 parts, stearic acid 15 parts.
Method for making:
A) by mass fraction (Bailey Myospalax Born water extract 400 parts, Bailey Myospalax Born n-butanol extract 100 parts, Bailey Myospalax Born ethanol extraction 200 parts, Bailey Myospalax Born methanolic extract 100 parts, Bailey Myospalax Born ethyl acetate extract 200 parts) preparation Bailey Myospalax Born composite extract
B) the Bailey Myospalax Born composite extract taking recipe quantity is pulverized, and crosses 100 mesh sieves, for subsequent use;
C) take the maltodextrin of recipe quantity, grinding, grinding limit, limit adds step Bailey Myospalax Born composite extract a) and continues grinding, winner's abrasive material;
D) microcrystalline Cellulose of the starch of described mass parts, 55% ~ 68% quality accounting is ground, obtain secondary abrasive material;
E) by described main abrasive material and secondary abrasive material mix homogeneously, granulate, obtain coarse granule;
F) described coarse granule is crossed 100 eye mesh screens, obtain fine grained;
G) stearic acid of described mass parts and the microcrystalline Cellulose of remainder are mixed homogeneously with described fine grained, tabletting, obtains the Bailey Myospalax Born composite extract tablet that the present invention has treatment of arthritis effect.
Embodiment 10
A kind of preparation method with the Bailey Myospalax Born composite extract tablet for the treatment of of arthritis effect:
Raw material: in mass fraction, Bailey Myospalax Born composite extract 900 parts, starch 10 parts, microcrystalline Cellulose 20 parts, silica 10 part, magnesium stearate 10 parts.
Method for making:
A) by mass fraction (Bailey Myospalax Born water extract 300 parts, Bailey Myospalax Born n-butanol extract 50 parts, Bailey Myospalax Born ethanol extraction 150 parts, Bailey Myospalax Born methanolic extract 250 parts, Bailey Myospalax Born ethyl acetate extract 150 parts) preparation Bailey Myospalax Born composite extract
B) the Bailey Myospalax Born composite extract taking recipe quantity is pulverized, and crosses 100 mesh sieves, for subsequent use;
C) take the maltodextrin of recipe quantity, grinding, grinding limit, limit adds step Bailey Myospalax Born composite extract a) and continues grinding, winner's abrasive material;
D) microcrystalline Cellulose of the starch of described mass parts, 65% quality accounting is ground, obtain secondary abrasive material;
E) by described main abrasive material and secondary abrasive material mix homogeneously, granulate, obtain coarse granule;
F) described coarse granule is crossed 120 eye mesh screens, obtain fine grained;
G) mixed homogeneously with described fine grained by the microcrystalline Cellulose of the silicon dioxide of described mass parts, magnesium stearate and remainder, tabletting, obtains the Bailey Myospalax Born composite extract tablet with treatment of arthritis effect of the present invention.
Bailey Myospalax Born tablet resisting rheumatoid disease arthritis pharmacological evaluation:
Experimental technique:
A) testing sample preparation:
First the Bailey Myospalax Born tablet in the various embodiments described above is crushed to 200 order powder, is then separated into emulsion with distilled water, prepare with 1g tablet/mL, it is for subsequent use that positive control drug dexamethasone is mixed with aqueous solution with 1mg/mL concentration.
B) preparation of adjuvant:
Lyophilized bacillus calmette-guerin vaccine preparation (nonimmune inoculation is used), 60mg/ props up purchased from Lanzhou Inst. of Biological Products, Ministry of Public Health, lot number 940204.Get the deactivation 1 hour in 70 DEG C of water of bacillus calmette-guerin vaccine preparation, holiday grinds well in autoclaved liquid paraffin in advance, be made into containing bacillus calmette-guerin vaccine 10mg/mL Fei Shi (Freund ' s) Freund's complete adjuvant, put refrigerator for subsequent use.
Pharmacological evaluation 1:
Bailey Myospalax Born tablet is to the preventive effect of rat assist agent arthritis pathological changes:
Experimental technique: get Wistar rat 90, body weight is 190 ± 12g, and male and female dual-purpose is divided into 9 groups at random.Rat left hind ankle joint and sufficient sole of the foot girth is measured in advance before test, gastric infusion 1 time, dosage is 1mL/100g body weight (matched group replaces with distilled water), after administration 1 hour, inflammation is caused to every left back sufficient sole of the foot intradermal injection Freund ' s Freund's complete adjuvant 0.1mL of Mus, measure left hind ankle joint and sufficient sole of the foot girth after Yu Zhiyan after 2,4,7,16,24 hours respectively, thus scorching before and after with ankle joint and sufficient sole of the foot girth and difference as swelling, the data obtained carries out variance analysis process.Experimental result: in table 1.
Table 1 Bailey Myospalax Born tablet is to the prevention result (± S) of rat assist agent arthritis pathological changes
Note: *, * * represents p<0.05, p<0.01 compared with matched group respectively.
Statistical table 1 processes rear data and shows that the Bailey Myospalax Born tablet emulsion in each embodiment all has significant preventive effect to the development of rat assist agent arthritis pathological changes.
Pharmacological testing 2:
Bailey Myospalax Born tablet is to the inhibitory action to rat assist agent arthritis pathological changes:
Experimental technique: make experimental animal model of CFA induced adjuvant arthritis in rats according to method in pharmacological evaluation 1, rat adjuvant carries out seperator gastric infusion, dosage 1mL/100g on the 7th day, 1 day 1 time, continuous 7 days after causing inflammation, and blank group gives distilled water and replaces.Cause scorching starting from for 8th day to observe for 8,11,14,16 and 19 days, the contralateral hind limb foot sole of the foot and 2 forelimb interphalangeal joints with or without swelling, and do numeration record, calculate each group of limb and to swell rate:
Number of animals × 3 (3 limbs) in the limb rate of swelling=swollen limb number (except left hind)/group
Chi-square criterion is carried out to the percentage rate of gained, to swell other significance of rate variance respectively to organize limb, observe rat ear erythema and situation and rat body weight situation of change appear in afterbody tuberosity simultaneously.Experimental result: in table 2.
The suppression result (contralateral hind limb+forelimb) that table 2 Bailey Myospalax Born tablet swells to rat assist agent arthritis Secondary cases limb
Note: *, * * represents p<0.05, p<0.01 compared with matched group respectively.
Table 2 result shows, within the 14th day, starts to occur obvious Secondary cases limb swelling symptom after causing inflammation, and within the 19th day, peak after causing inflammation, each Bailey Myospalax Born tablet all shows obvious inhibitory action to rat assist agent arthritis Secondary cases limb swelling symptom.And each group rat has no obvious ear erythema and caudal knot joint, before and after administration, rat body weight growth pattern compares there was no significant difference with matched group.
The Bailey Myospalax Born composite extract tablet that the present invention has treatment of arthritis effect adopts specific composition and consumption, and the Bailey Myospalax Born composite extract tablet that gained has treatment of arthritis effect has that adjuvant amount is little, Bailey Myospalax Born composite extract is uniformly dispersed, disintegration of tablet is good, good drug efficacy, effectively can treat and suppress arthritis, good stability, bioavailability advantages of higher.The preparation method that the present invention has the Bailey Myospalax Born composite extract tablet for the treatment of of arthritis effect adopts specific addition step, Bailey Myospalax Born composite extract is uniformly dispersed, and promote that gained has the drug effect of the Bailey Myospalax Born composite extract tablet for the treatment of of arthritis effect, promotes bioavailability further; In addition, overcome and only will to add in disintegrating agent or outer added-time disintegration is weak or the shortcoming that do not become fine-powdered after disintegrate and cause bioavailability low, and preparation technology is simple, easy to operate, is suitable for large-scale production.
Although illustrate and describe the present invention with specific embodiment, however it will be appreciated that can to make when not deviating from the spirit and scope of the present invention many other change and amendment.Therefore, this means to comprise all such changes and modifications belonged in the scope of the invention in the following claims.
Claims (10)
1. there is the Bailey Myospalax Born composite extract tablet for the treatment of of arthritis effect, it is characterized in that, described in there is treatment of arthritis effect Bailey Myospalax Born composite extract tablet prepare primarily of the raw material of following mass fraction:
Bailey Myospalax Born composite extract 700 ~ 1100 parts, maltodextrin 30 ~ 70 parts, filler 2 ~ 18 parts, disintegrating agent 5 ~ 35 parts, lubricant 5 ~ 35 parts;
Described Bailey Myospalax Born composite extract comprise in Bailey Myospalax Born water extract, Bailey Myospalax Born n-butanol extract, Bailey Myospalax Born ethanol extraction, Bailey Myospalax Born methanolic extract, Bailey Myospalax Born ethyl acetate extract one or more.
2. a kind of Bailey Myospalax Born composite extract tablet with treatment of arthritis effect according to claim 1, it is characterized in that, described Bailey Myospalax Born composite extract comprises the composition of following mass fraction:
Bailey Myospalax Born water extract 100 ~ 800 parts, Bailey Myospalax Born n-butanol extract 1 ~ 300 part, Bailey Myospalax Born ethanol extraction 1 ~ 300 part, Bailey Myospalax Born methanolic extract 1 ~ 300 part, Bailey Myospalax Born ethyl acetate extract 1 ~ 300 part.
3. a kind of Bailey Myospalax Born composite extract tablet with treatment of arthritis effect according to claim 1, it is characterized in that, described filler comprises one or more the combination in starch, lactose, mannitol, xylitol, sorbitol; Described disintegrating agent comprise in carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, microcrystalline Cellulose, polyvidone, cross-linking sodium carboxymethyl cellulose one or more; Described lubricant comprises the one or many in magnesium stearate, hydrogenated vegetable oil, stearic acid, silicon dioxide, micropowder silica gel, PEG400, Stepanol MG; Preferably, described filler is starch, and described disintegrating agent is microcrystalline Cellulose, and described lubricant is silicon dioxide and magnesium stearate, and the mass fraction of described silicon dioxide and magnesium stearate is preferably: silicon dioxide 2 ~ 17 parts, magnesium stearate 3 ~ 18 parts.
4. a kind of Bailey Myospalax Born composite extract tablet with treatment of arthritis effect according to claim 1, it is characterized in that, the described raw material with the Bailey Myospalax Born composite extract tablet for the treatment of of arthritis effect also comprises Emulsifier LM-102, and the mass fraction of described Emulsifier LM-102 is 2 ~ 18 parts.
5. a kind of Bailey Myospalax Born composite extract tablet with treatment of arthritis effect according to claim 1, it is characterized in that, the described raw material with the Bailey Myospalax Born composite extract tablet for the treatment of of arthritis effect also comprises carrageenan, and the mass fraction of described carrageenan is 2 ~ 18 parts.
6. a kind of Bailey Myospalax Born composite extract tablet with treatment of arthritis effect according to claim 1, is characterized in that, described in there is treatment of arthritis effect Bailey Myospalax Born composite extract tablet prepare primarily of the raw material of following mass fraction:
Bailey Myospalax Born composite extract 900 parts, maltodextrin 50 parts, starch 10 parts, microcrystalline Cellulose 20 parts, silica 10 part, magnesium stearate 10 parts.
7. a kind of Bailey Myospalax Born composite extract tablet with treatment of arthritis effect according to claim 4, is characterized in that, described in there is treatment of arthritis effect Bailey Myospalax Born composite extract tablet prepare primarily of the raw material of following mass fraction:
Bailey Myospalax Born composite extract 800 parts, maltodextrin 40 parts, starch 6 parts, 4 parts, mannitol, carboxymethyl starch sodium 10 parts, PEG400 9 parts, Emulsifier LM-102 8 parts.
8. a kind of Bailey Myospalax Born composite extract tablet with treatment of arthritis effect according to claim 5, is characterized in that, described in there is treatment of arthritis effect Bailey Myospalax Born composite extract tablet prepare primarily of the raw material of following mass fraction:
Bailey Myospalax Born composite extract 900 parts, maltodextrin 50 parts, starch 10 parts, microcrystalline Cellulose 20 parts, silica 10 part, magnesium stearate 10 parts, Emulsifier LM-102 10 parts, carrageenan 10 parts.
9. a kind of preparation method with the Bailey Myospalax Born composite extract tablet for the treatment of of arthritis effect as described in as arbitrary in claim 1-8, is characterized in that, comprise the steps:
A) take Bailey Myospalax Born composite extract and pulverize, sieving for subsequent use;
B) take maltodextrin, grinding, grinding limit, limit add step a) gained Bailey Myospalax Born composite extract continue grinding, winner's abrasive material;
C) disintegrating agent of filler, 50% ~ 75% quality accounting is ground, obtain secondary abrasive material;
D) by described main abrasive material and secondary abrasive material mix homogeneously, granulate, obtain coarse granule;
E) described coarse granule is sieved, obtain fine grained;
F) mixed homogeneously with described fine grained by the disintegrating agent of lubricant and remainder, tabletting, has the Bailey Myospalax Born composite extract tablet for the treatment of of arthritis effect described in obtaining.
10. a kind of preparation method with the Bailey Myospalax Born composite extract tablet for the treatment of of arthritis effect according to claim 9, is characterized in that, comprise the steps:
A) take Bailey Myospalax Born composite extract to pulverize, sieve for subsequent use; ;
B) take maltodextrin and Emulsifier LM-102, grinding, grinding limit, limit add step a) gained Bailey Myospalax Born composite extract continue grinding, winner's abrasive material;
C) starch, the microcrystalline Cellulose of 50% ~ 75% quality accounting and the carrageenan of described mass parts are ground, obtain secondary abrasive material;
D) by described main abrasive material and secondary abrasive material mix homogeneously, granulate, obtain coarse granule;
E) described coarse granule is sieved, obtain fine grained;
F) mixed homogeneously with described fine grained by the microcrystalline Cellulose of silicon dioxide, magnesium stearate and remainder, tabletting, has the Bailey Myospalax Born composite extract tablet for the treatment of of arthritis effect described in obtaining.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113637769A (en) * | 2021-08-17 | 2021-11-12 | 青海大学 | Kit and method for identifying northeast zokor |
| CN115191448A (en) * | 2022-08-12 | 2022-10-18 | 宝鸡市烟草公司麟游分公司 | Microbial plant extract complexing agent for preventing and treating tobacco mosaic virus and application thereof |
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| CN1203793A (en) * | 1997-06-30 | 1999-01-06 | 中国科学院西北高原生物研究所 | Artificial tiger-bone and its producing process and use |
| CN1350852A (en) * | 2000-10-30 | 2002-05-29 | 兰州三极生物资源技术公司 | Medicine for treating rheumatic or rheumatoid arthritis, osteoarthropathy and gout |
| CN103610053A (en) * | 2013-11-27 | 2014-03-05 | 河西学院 | High-purity grape seed extract tablet and preparation method thereof |
| CN105055449A (en) * | 2015-07-27 | 2015-11-18 | 中国科学院西北高原生物研究所 | Sailong bone extract with activities of resisting inflammation and easing pain as well as preparation method and Chinese herbal preparation |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1203793A (en) * | 1997-06-30 | 1999-01-06 | 中国科学院西北高原生物研究所 | Artificial tiger-bone and its producing process and use |
| CN1350852A (en) * | 2000-10-30 | 2002-05-29 | 兰州三极生物资源技术公司 | Medicine for treating rheumatic or rheumatoid arthritis, osteoarthropathy and gout |
| CN103610053A (en) * | 2013-11-27 | 2014-03-05 | 河西学院 | High-purity grape seed extract tablet and preparation method thereof |
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| CN113637769A (en) * | 2021-08-17 | 2021-11-12 | 青海大学 | Kit and method for identifying northeast zokor |
| CN113637769B (en) * | 2021-08-17 | 2024-01-26 | 青海大学 | Kit and method for identifying northeast zokor |
| CN115191448A (en) * | 2022-08-12 | 2022-10-18 | 宝鸡市烟草公司麟游分公司 | Microbial plant extract complexing agent for preventing and treating tobacco mosaic virus and application thereof |
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Application publication date: 20160406 |