CN1939399A - Blood stream-breaking dispersing tablets - Google Patents
Blood stream-breaking dispersing tablets Download PDFInfo
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- CN1939399A CN1939399A CN 200510019531 CN200510019531A CN1939399A CN 1939399 A CN1939399 A CN 1939399A CN 200510019531 CN200510019531 CN 200510019531 CN 200510019531 A CN200510019531 A CN 200510019531A CN 1939399 A CN1939399 A CN 1939399A
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Abstract
A dispersing tablet of Herba clinopodii for treating functional metrorrhagia, menorrhagia, postpartum hemorrhage, hysteromyoma hemorrhage, nosebleed, purpura simplex, primary thrombocytopenic purpura, etc is prepared from Herba clinopodii and proper additives.
Description
Technical field
The present invention relates to Chinese patent medicine dispersible tablet technical field, relate in particular to a kind of dispersible tablet of Herba Clinopodii.
Background technology
Dispersible tablet is a kind of novel pharmaceutical formulation that development in recent years is got up, and the Herba Clinopodii class has multiple dosage form, has the cooling blood for hemostasis effect.Be used for dysfunctional uterine hemorrhage, menorrhagia, postpartum hemorrhage, hysteromyoma hemorrhage, hematuria is had blood in stool, and spits blood spitting of blood, epistaxis, simple purpura, idiopathic thrombocytopenic purpura etc.The Herba Clinopodii of one of former dosage form is that coated tablet has been listed Chinese Pharmacopoeia in.The stripping of Herba Clinopodii coated tablet is slow, absorption difference, and bioavailability is not high.
Compare ordinary tablet, dispersible tablet requires temperature at the disintegrate medium in 20 ± 1 ℃, and disintegration, the granule after the disintegrate should all sieve by No. 2 less than 3 minutes.It is rapid that medicine has a stripping, absorb fast, the bioavailability height, advantages such as taking convenience can swallow, chew, contain and suck or with taking after the aqueous dispersion, the patient who especially is fit to the old man and the difficulty of swallowing takes.Compare with liquid preparation, it is good that dispersible tablet has a medicine stability, packs, transports, preserves advantage easily.
Can use for this reason that the modern pharmaceutical technology changes its dosage form into both can be oral, can be scattered in the dispersible tablet that forms fragrant and sweet good to eat solution in the water again rapidly.
In fact disintegrate finishes and can not represent medicine well to absorb, and medicine need have good dissolution that good bioavailability height just can be arranged.The dissolution index of dispersible tablet is to investigate the important indicator of dispersible tablet performance.
Comparatively speaking, CMS-Na, LS-HPC, PVPP, CCMC-Na are more outstanding to the contribution of disintegrate, and microcrystalline Cellulose is not obvious to the contribution of disintegrate, and microcrystalline Cellulose is more outstanding to the contribution of dispersibility, dissolution.When the good dispersibility of needs, dissolution, need add a large amount of materials such as microcrystalline Cellulose.For example " center combination design optimization method screening Radix Lamiophlomidis Rotatae dispersible tablet preparation technology "/Chinese Pharmaceutical Journal .2004, the adjuvant of the Radix Lamiophlomidis Rotatae dispersible tablet of 39 (10) .-760-763 record is: 12%PVPP is that disintegrating agent, 14% pregelatinized Starch are that sweller, 3% micropowder silica gel are that lubricant and fluidizer, 45% microcrystalline Cellulose MCC are filler.The dispersible tablet disintegration time for preparing under the optimal conditions is 20.6s, and the t80 of luteoloside stripping is 1.68min, and the suspendible coefficient behind the dispersible tablet suspendible is 0.0689.According to another second section the record on the 763rd page of right side of this article, microcrystalline Cellulose MCC fluctuates in 40%, 45%, 55% scope, and all the time to disintegrate does not make significant difference.Add its purpose of microcrystalline Cellulose significantly and be better to improve Radix Lamiophlomidis Rotatae effective ingredient dissolution.
The most effective traditional dispersible tablet disintegrating agent is carboxymethyl starch sodium (CMS-Na), low-substituted hydroxypropyl cellulose (LS-HPC), crospolyvinylpyrrolidone (PVPP), cross-linking sodium carboxymethyl cellulose (CCMC-Na), combination between them needs satisfied temperature in 20 ± 1 ℃, disintegration is less than 3 minutes, the granule after the disintegrate should be all by the requirement of No. 2 sieves.The disintegrate efficient of CMS-Na, LS-HPC, PVPP, CCMC-Na totally is higher than sodium carboxymethyl cellulose, microcrystalline Cellulose, pregelatinized Starch medicine.The disintegrate principle of CMS-Na, LS-HPC, PVPP, CCMC-Na mainly is a suction back volume swelling significantly, thereby dispersible tablet is collapsed out.
Polyvinylpolypyrrolidone is the cross-linked homopolymer of N-vinyl-2-Pyrrolidone, and polyvinylpolypyrrolidone also is the swollen efficient disintegrating agent of a kind of rapid rate, and polyvinylpolypyrrolidone records in American National formulary and European Pharmacopoeia.
The difference of Western medicine dispersible tablet and dispersible tablets of Chinese medicine is that the industrialization difficulty of dispersible tablets of Chinese medicine is higher, this is because the Chinese medicine dose is big, Western medicine principal agent dose is little, the Western medicine principal agent is generally at below 20% of gross weight of whole dispersible tablet, a lot of below 10%, for example embodiment 1 record of " CN03137976.1 nitrendipine dispersible tablet and preparation method thereof ": dispersible tablet is formed: 150 milligrams of 10 milligrams of nitrendipines and pharmaceutical adjuvants.Embodiment 1,2,3 records of " CN200410012867.5 adefovir ester dispersible tablet and preparation method ": dispersible tablet is formed: adefovir ester 4.2-8.7%, the pharmaceutical adjuvant of surplus.Other Western medicine dispersible tablet patent reports all have similar record.
And dispersible tablets of Chinese medicine is in order to guarantee curative effect, its Chinese medicine principal agent is generally at more than 20% of gross weight of whole dispersible tablet, embodiment 4 records of " 200410014092.5 1 kinds of Flos Trollii novel formulation-Flos Trollii dispersible tablets that are more suitable for child, old man of CN ": dispersible tablet is formed: 333 gram Flos Trollii extracts, 612.5 gram pharmaceutical adjuvants.The most preferred embodiment record of " CN 200410074528.X Yimaikang dispersion tablet and preparation method thereof ": dispersible tablet is formed: Herba Erigerontis extractum 160g, lactose 120g, microcrystalline Cellulose 150g, low-substituted hydroxypropyl cellulose 90g, polyvinylpolypyrrolidone 60g, steviosin, micropowder silica gel, magnesium stearate are a small amount of, and pharmaceutical adjuvant amounts to about 420g.Other dispersible tablets of Chinese medicine patent reports all have similar record.
The principal agent ratio is all up to about 30-50% in most dispersible tablets of Chinese medicine, rely on remaining pharmaceutical adjuvant to guarantee quick disintegrate in 3 minutes, and to keep suitable dissolution be very very difficult, add that Chinese medicine extract contains macromolecular substances such as pectin, polysaccharide mostly and be attached on the surface when the dispersible tablets of Chinese medicine disintegrate, medicine disintegrate and stripping are caused negative effect.
In sum, most dispersible tablets of Chinese medicine are because of (1) Chinese medicine principal agent ratio content height, the sticking of macromolecular substances such as (2) pectin, polysaccharide, cause that the dispersible tablets of Chinese medicine disintegration rate is difficult to reach the requirement that is controlled in 3 minutes, than the more difficult industrialization of Western medicine dispersible tablet.Western medicine dispersible tablet kind in the industrialization of having reported is more, but the dispersible tablets of Chinese medicine kind of industrialization is considerably less.
Transform the form that existing herbal species makes it to become dispersible tablet, disintegrate is finished in the adjuvant combination that efficiency of selection is higher according to qualifications faster, so that obtain the better medicament bioavailability certain meaning is arranged.
Summary of the invention
The purpose of this invention is to provide a kind of blood flow cutting off dispersing tablet, conveniently take to better meet needs of medical treatment.
The present invention has also added sucrose fatty acid ester, tween 80 is used to increase Chinese medicine medicine disintegration.
The present invention adds a spot of HLB=15-16 sucrose fatty acid ester and further improves disintegration.A spot of HLB=15-16 sucrose fatty acid ester can shorten tens of seconds disintegration time approximately, can alleviate simple dependence carboxymethyl starch sodium (CMS-Na), low-substituted hydroxypropyl cellulose (LS-HPC), crospolyvinylpyrrolidone (PVPP), cross-linking sodium carboxymethyl cellulose (CCMC-Na) and finish the pressure of disintegrate, make that the design room for maneuver of dispersible tablets of Chinese medicine is bigger, help design and obtain more rational dispersible tablet.
Technical scheme of the present invention has following:
Blood flow cutting off dispersing tablet, the composition of this dispersible tablet comprises Herba Clinopodii extract, adjuvant; Adjuvant comprises disintegrating agent, filler, binding agent, lubricant, correctives.
Blood flow cutting off dispersing tablet, each constituent weight proportion is: Herba Clinopodii extract 10-80 part, disintegrating agent 10-50 part, filler 0-30 part, binding agent 0-10 part, lubricant 0-8 part, correctives 0-5 part.
Blood flow cutting off dispersing tablet, each constituent weight proportion is: Herba Clinopodii extract 10-40 part, disintegrating agent 10-50 part, filler 0-30 part, binding agent 0-10 part, lubricant 0-8 part, correctives 0-5 part.
The key of dispersible tablet is its disintegration rate in water, so the selection of the disintegrate system in the tablet is extremely important, the disintegrating agent that the present invention chooses is any one or a few in carboxymethyl starch sodium (CMS-Na), low-substituted hydroxypropyl cellulose (LS-HPC), crospolyvinylpyrrolidone (PVPP), cross-linking sodium carboxymethyl cellulose (CCMC-Na), sodium carboxymethyl cellulose, microcrystalline Cellulose, polyvinylpolypyrrolidone, micropowder silica gel, the pregelatinized Starch.
Filler is in order to increasing the weight and volume of dispersible tablet, to be beneficial to molding and divided dose, the filler that the present invention chooses be in lactose, the mannitol any one or a few.
Lubricant be for can feed in raw material smoothly and slice, make the pharmaceutic adjuvant of tablet smooth and beautiful appearance, the lubricant that the present invention chooses be in magnesium stearate, micropowder silica gel, calcium stearate, Pulvis Talci, Stepanol MG, the silicon dioxide any one or a few; Correctives be in aspartame, glycyrrhizin, citric acid, the vanillin any one or a few.
Binding agent is to be convenient to wet granulation and the adherent pharmaceutic adjuvant of tabletting, and the binding agent of dispersible tablet of the present invention comprises in polyvinylpyrrolidone (PVP), polyethylene glycol 6000, the Macrogol 4000 any one or a few.
Dispersible tablet of the present invention also comprises sucrose fatty acid ester, tween 80, and addition is sucrose fatty acid ester 0.5-2.5 part, tween 80 0-0.5 part of the HLB=15-16 of weight proportion.
Dispersible tablet of the present invention, the model of the sucrose fatty acid ester of interpolation are P-1570 or P-1670 or LWA-1570.
In order to guarantee the stable of principal agent, can also add an amount of antioxidant etc.
Blood flow cutting off dispersing tablet obtains by following concrete steps: get Herba Clinopodii, cutting, decoct with water secondary, each 1.5 hours, collecting decoction, filter, it is 1.15 (80 ℃) that filtrate is concentrated into relative density, adds the ethanol of 1.7 times of amounts, fully stir, left standstill 24 hours, get the supernatant concentrating under reduced pressure and become the thick paste shape, be dried to dry extract, obtain the fine powder of Herba Clinopodii extract after dry extract is pulverized, progressively increase method with the fine powder of Herba Clinopodii extract and the mixture mixing of filler, disintegrating agent, mistake 80 mesh sieves by equivalent; Material behind the mixing is put in the appropriate containers, adds binding agent, and water or ethanol dissolve in right amount, make soft material; Make wet granular, drying, granulate adds the adjuvant of remainder again, mixing, tabletting promptly gets blood flow cutting off dispersing tablet.
Disintegrating agent add, add in can adopting or in add and add combination.
Instructions of taking of the present invention is: each 1-4 sheet, every day 2-4 time.
The English of sucrose fatty acid ester is: Sucrose fatty acid esters.Sucrose fatty acid ester also claims fatty acid cane sugar ester, is called for short SE, can be subdivided into mono fatty acid ester, double acid ester and tri-fatty acid ester.Sucrose fatty acid ester is a kind of food additive commonly used, also can be used as the adjuvant of medicine, for example sees the report that sucrose fatty acid ester is used for the Western medicine conventional tablet once in a while.
But the report of rarely found sucrose fatty acid ester also in the dispersible tablets of Chinese medicine field, this be because: sucrose fatty acid ester is because of the raw material sources difference, the technology difference, the difference that monoester, two fat, three fat replace, its HLB is distributed in the broad range of 2-16.Sucrose fatty acid ester of a great variety.For example: sucrose monolaurate, sucrose palmitic acid ester, sucrose hard fatty acid ester S-1,3,5,7,9,11,13,15,16 series, external F-10,20 series, S570,1170 series of producing, kinds such as P-1670, P-1570, LWA-1570.
Wherein the HLB value of P-1670, P-1570, LWA-1570 is respectively 16,15,15.
Suitable sucrose fatty acid ester kind is used for the dispersible tablets of Chinese medicine field also needs to pass through technology screening.
At first using of present domestic sucrose fatty acid ester at most be emulsifying agent in the field of food, be used for bread, cake can prevent to wear out, should use HLB greater than 11 sucrose ester, consumption is 0.2%～0.5% of a Semen Tritici aestivi flour, also can improve foaming effect.Be used for margarine, shortening, ice cream, can improve emulsion stability, should use low HLB value sucrose ester, consumption is 2%～5% of margarine, an oil quantity; Ice cream, 0.1%～0.3%; 0.008%～1.72% of shortening, oil quantity.Be used for chocolate and can suppress crystallization, reduce viscosity, should use the HLB value is 3～9 sucrose ester, and consumption is 0.2%～1.0%.Be used for cookies and can improve shortening property, water-retaining property and anti ageing property, can also reduce cookies at storage, damaged in the transportation and can improve operability, should use the HLB value is 7 sucrose ester, and consumption is 0.1%～0.5%.Be used for the chewing gum base and can make colloid be easy to knead, can prevent that rockiness from varying with temperature, can improve fragrance protectiveness, should use the HLB value is 5～9 sucrose ester, and consumption is 0.5%～3%.Be used for chewing gum, toffee can reduce viscosity, prevents that oil from separating out or crystallization, prevents the tooth that sticks to one's teeth, should use the HLB value is 2～4 sucrose ester, consumption is 5%～10%.
As seen as the food compound mostly use be HLB at the sucrose fatty acid ester 12 below, mainly acting on is emulsifying agent.
Sucrose fatty acid ester records as excipient substance is disclosed: " character: this product for white to the powder or the heavy-gravity liquid of sundown, odorless or special odor is arranged slightly.Heating is then decomposed more than 145 degrees centigrade, and 120 degrees centigrade with next stable.Effect and purposes: this product has effects such as emulsifying, dispersion, solubilising, plasticising, is used as emulsifying agent, dispersant, solubilizing agent, stabilizing agent, thickening agent, the emulsifiable paste matrix of for oral administration and topical agent in medicament.Make the storage library material etc. of the transdermal absorption formulation of medicines such as hormones, anti-inflammatory analgesic class, painstaking effort tubing.This product also is a food additive, is widely used in food industry, is used to make margarine, shortening, ice cream etc., can improve emulsibility, stability, foaming characteristic." it specifically is applied to " fish glycerol, Futrator suppository, ointment base, the suspensoid of sulfur amine thiazole, increase such as the binding agent in the solid orally ingestible of Western medicine such as macrocyclic lactone, disintegrating agent, lubricant dissolution, raising bioavailability.”
" 56.3 milligrams of sucrose fatty acid ester and 6.4 milligrams of mixing of human body calcitonin with HLB11 are prepared into oral mealy medicine, can promote that human body absorbs calcitonin, the treatment hypercalcemia.”
The production and supply of domestic for a long time sucrose fatty acid ester mainly are the sucrose fatty acid ester of low HLB, be mainly used in the emulsifying agent of food or pharmaceuticals industry, and the product rareness of the sucrose fatty acid ester of its high HLB, and quality is stable inadequately, residual free sugar, sour more can't satisfy the strict demand of medical auxiliary materials, causes practical application and scientific research research to lag behind, particularly in the dispersible tablets of Chinese medicine field, the application report of rarely found sucrose fatty acid ester also.
Although the prompting of " sucrose fatty acid ester is used for the binding agent, disintegrating agent, lubricant of the solid orally ingestible of Western medicine such as macrocyclic lactone etc. increases dissolution, improves bioavailability " is arranged, specifically use the kind of which kind of classification, also need to pass through technology screening.For example experiment shows that sucrose hard fatty acid ester S-170, sucrose hard fatty acid ester S-570 etc. not only can not shorten disintegration rate, also prolong disintegration rate on the contrary.The sucrose fatty acid ester of HLB11 can not effectively shorten disintegration rate.Have only the kind of HLB 15-16 can effectively shorten disintegration rate.
Can not obviously shorten disintegration rate as the independent use of additive Tween 80 commonly used, but the sucrose hard fatty acid ester coupling of itself and HLB15-16 is remarkably productive, concrete reason is still not detailed.
Sucrose fatty acid ester is to be hydrophilic group with 8 hydroxyl sucrose, is the non-ionic surface active agent of hydrophobic group with the fatty acid part of having replaced the sucrose hydroxyl, forms by sucrose and fatty acid ester exchange reaction.The monoester rate height of the sucrose fatty acid ester of HLB15-16, the greasiness rate is low, and hydroxyl is few by metathetical amount, and good hydrophilic is arranged, and can reduce the tension force on liquid-solid surface, helps medicine to discharge from tablet faster.It is different that its action principle and carboxymethyl starch sodium (CMS-Na), low-substituted hydroxypropyl cellulose (LS-HPC), crospolyvinylpyrrolidone (PVPP), cross-linking sodium carboxymethyl cellulose dependence water absorption and swellings such as (CCMC-Na) are finished the principle of disintegrate.
Therefore relying on the sucrose hard fatty acid ester of a spot of HLB 15-16 to assist a large amount of carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, crospolyvinylpyrrolidone, cross-linking sodium carboxymethyl cellulose to accelerate the disintegrate of dispersible tablets of Chinese medicine, is that those of ordinary skill is difficult for expecting.
Various sucrose hard fatty acid esters are to the influence of disintegration rate:
Do the disintegration time experiment by 2000 editions officinal requirements.The product of each model is respectively got 6, calculates average disintegration time.
| The model of sucrose hard fatty acid ester and HLB value addition 1% | Disintegrating agent addition 46% | Filler 6% | Chinese medicine (infantile heat-clearing and antitussive) addition 36% | Average disintegration time (second) | |
| / | / | 46％ | 6％ | 36％ | 163.7 |
| S-170 | HLB1 | 46％ | 6％ | 36％ | 173.5 |
| S-570 | HLB5 | 46％ | 6％ | 36％ | 175.1 |
| S-770 | HLB7 | 46％ | 6％ | 36％ | 160.7 |
| S-970 | HLB9 | 46％ | 6％ | 36％ | 190.4 |
| S-1170 | HLB11 | 46％ | 6％ | 36％ | 180.6 |
| B-370 | HLB3 | 46％ | 6％ | 36％ | 196.8 |
| P-1570 | HLB15 | 46％ | 6％ | 36％ | 145.4 |
| P-1670 | HLB16 | 46％ | 6％ | 36％ | 134.5 |
| LWA-1570 | HLB15 | 46％ | 6％ | 36％ | 134.9 |
Sucrose hard fatty acid ester in this table is provided by Mitsubishi-Kagaku Foods Corp..To in the same old way disintegration time is 163.7 seconds.
Chinese medicine in this table is selected from the fine powder of infantile heat-clearing and antitussive extract.
The enlightenment that obtains thus is, has only the sucrose hard fatty acid ester of HLB 15-16 can shorten the disintegration time of infantile heat-clearing and antitussive dispersible tablets of Chinese medicine.Because of the sucrose hard fatty acid ester of HLB below 15 do not have actively and significantly effect the disintegration time that shortens dispersible tablets of Chinese medicine, can reject the sucrose hard fatty acid ester of HLB below 15.
Although the herbal species of infantile heat-clearing and antitussive and Herba Clinopodii is variant, we think that the sucrose hard fatty acid ester of HLB 15-16 should have similarity to the influence of infantile heat-clearing and antitussive and Herba Clinopodii disintegration time.Below test has also proved this trend.
Get sucrose hard fatty acid ester and Tween 80 and investigate its influence the disintegration time of dispersible tablets of Chinese medicine.The product of each model is respectively got 6, calculates average disintegration time.
| Sucrose hard fatty acid ester and Tween 80 addition % | Disintegrating agent addition 43% | Filler 5% | Chinese medicine (Herba Clinopodii) addition 50% | Average disintegration time (second) | |
| / | / | 43％ | 5％ | 50％ | 144.1 |
| Tween 80 | 2％ | 43％ | 5％ | 50％ | 149.7 |
| P-1570 | 1％ | 43％ | 5％ | 50％ | 120.6 |
| P-1670 | 1.5％ | 43％ | 5％ | 50％ | 136.3 |
| LWA-1570 | 2％ | 43％ | 5％ | 50％ | 123.2 |
| P-1570 | 0.5％ | 43％ | 5％ | 50％ | 130.2 |
| P-1670 | 2.0％ | 43％ | 5％ | 50％ | 113.6 |
| LWA-1570 | 1.0％ | 43％ | 5％ | 50％ | 125.2 |
| LWA-1570 adds Tween 80 in addition | 1.5％ 1.5％ | 41％ | 5％ | 50％ | 102.1 |
| S-170 | 1.0％ | 43％ | 5％ | 50％ | 159.8 |
| S-570 | 1.0％ | 43％ | 5％ | 50％ | 145.1 |
| S-770 | 1.0％ | 43％ | 5％ | 50％ | 142.7 |
| S-970 | 1.0％ | 43％ | 5％ | 50％ | 148.2 |
| S-1170 | 1.0％ | 43％ | 5％ | 50％ | 141.9 |
| B-370 | 1.0％ | 43％ | 5％ | 50％ | 177.5 |
The present invention adds a spot of HLB=14-16 sucrose fatty acid ester can also improve dissolution.A spot of HLB=14-16 sucrose fatty acid ester can substitute more microcrystalline Cellulose, is used with other adjuvants, and it is better than microcrystalline Cellulose to the efficient that improves dissolution.Help reducing the consumption of microcrystalline Cellulose, vacate more interpolation space, make that the design room for maneuver of dispersible tablets of Chinese medicine is bigger, help design and obtain more rational dispersible tablet.
The specific embodiment:
Embodiment 1:
The Chinese medicine extract of blood flow cutting off dispersing tablet and auxiliary material percentage by weight: the fine powder 20% of Herba Clinopodii extract, polyvinylpolypyrrolidone 24%, carboxymethyl starch sodium 20%, microcrystalline Cellulose 10%, lactose 20%, polyvinylpyrrolidone 3%, magnesium stearate 3%.
Blood flow cutting off dispersing tablet obtains by following concrete steps: get Herba Clinopodii, cutting, decoct with water secondary, each 1.5 hours, collecting decoction, filter, it is 1.15 (80 ℃) that filtrate is concentrated into relative density, adds the ethanol of 1.7 times of amounts, fully stirs, left standstill 24 hours, get the supernatant concentrating under reduced pressure and become the thick paste shape, be dried to dry extract, pulverize the fine powder that obtains Herba Clinopodii extract.
Earlier above-mentioned material is crossed 100 mesh sieves respectively, progressively increase method with the fine powder of Herba Clinopodii extract and the mixture mixing of filler, disintegrating agent by equivalent, the material behind the mixing is put in the appropriate containers, the adding binding agent, and water or ethanol dissolve in right amount, make soft material; 20 mesh sieves are made wet granular, drying, and 20 mesh sieve granulate add the adjuvant of remainder again, mixing, tabletting promptly gets blood flow cutting off dispersing tablet.
Embodiment 2:
The fine powder 30% of the Herba Clinopodii extract of percentage by weight, sodium carboxymethyl cellulose 20%, microcrystalline Cellulose 12%, crospolyvinylpyrrolidone 16%, polyvinylpyrrolidone 5%, lactose 10%, polyvinylpyrrolidone 4%, micropowder silica gel 1%, Stepanol MG 2%.All the other are with embodiment 1.
Embodiment 3:
The fine powder 36% of the Herba Clinopodii extract of percentage by weight, carboxymethyl starch sodium 20%, cross-linking sodium carboxymethyl cellulose 15%, crospolyvinylpyrrolidone 6%, low-substituted hydroxypropyl cellulose 3%, mannitol 9%, polyvinylpyrrolidone 7%, calcium stearate 2%, magnesium stearate 1%, the sucrose fatty acid ester 1% of HLB=15-16.Sucrose fatty acid ester is P-1570 or P-1670 or LWA-1570, and all the other are with embodiment 1.
Embodiment 4:
The Chinese medicine extract of blood flow cutting off dispersing tablet and auxiliary material weight proportion: 10 parts of the fine powders of Herba Clinopodii extract, 10 parts of disintegrating agents, 5 parts of filleies.Disintegrating agent is a low-substituted hydroxypropyl cellulose, and filler is a lactose.All the other are with embodiment 1.
Embodiment 5:
The Chinese medicine extract of blood flow cutting off dispersing tablet and auxiliary material weight proportion: 80 parts of the fine powders of Herba Clinopodii extract, 50 parts of disintegrating agents, 30 parts of filleies, 10 parts of binding agents, 8 parts of lubricants, 5 parts of correctivess.
Disintegrating agent is 35 parts of low-substituted hydroxypropyl celluloses, 15 parts of cross-linking sodium carboxymethyl celluloses, filler is 10 parts of lactose, 20 parts in mannitol, binding agent is a polyethylene glycol 6000, lubricant is 2 parts of calcium stearates, 2 parts of Pulvis Talci, 4 parts of silicon dioxide, and correctives is 1 part of glycyrrhizin, 3 parts of citric acids, 1 part of vanillin.All the other are with embodiment 1.
Embodiment 6:
The Chinese medicine extract of blood flow cutting off dispersing tablet and auxiliary material weight proportion: 40 parts of the fine powders of Herba Clinopodii extract, 30 parts of disintegrating agents, 25 parts of filleies, 5 parts of binding agents, 3 parts of lubricants, 2 parts of correctivess.
Disintegrating agent is 25 parts of low-substituted hydroxypropyl celluloses, 5 parts of cross-linking sodium carboxymethyl celluloses, and filler is a mannitol, and binding agent is a Macrogol 4000, and lubricant is 2 parts of magnesium stearate, 1 part of Stepanol MG, and correctives is that A Siba is sweet.All the other are with embodiment 1.
Embodiment 7:
The Chinese medicine extract of blood flow cutting off dispersing tablet and auxiliary material weight ratio: Herba Clinopodii divides 80 parts of the fine powders of extract, 10 parts of low-substituted hydroxypropyl celluloses, 5 parts of crospolyvinylpyrrolidone, 3 parts of cross-linking sodium carboxymethyl celluloses, 20 parts of lactose, 1 part of aspartame, 1 part of magnesium stearate.All the other are with embodiment 1.
Embodiment 8:
One group of blood flow cutting off dispersing tablet:
(1) Chinese medicine extract of blood flow cutting off dispersing tablet and auxiliary material weight ratio: 50 parts of the fine powders of Herba Clinopodii extract, 36 parts of microcrystalline Cellulose, 5 parts of polyvinylpolypyrrolidone, 5 parts of low-substituted hydroxypropyl celluloses, 2 parts of micropowder silica gels, 2 parts of magnesium stearate.All the other are with embodiment 1.
If conversion is weight percentage: the fine powder 50% of Herba Clinopodii extract, microcrystalline Cellulose 36%, polyvinylpolypyrrolidone 5%, low-substituted hydroxypropyl cellulose 5%, micropowder silica gel 2%, magnesium stearate 2%.
(2) Chinese medicine extract of blood flow cutting off dispersing tablet and auxiliary material weight ratio: 49 parts of the fine powders of Herba Clinopodii extract, 20 parts of microcrystalline Cellulose, 15 parts of polyvinylpolypyrrolidone, 15 parts of low-substituted hydroxypropyl celluloses, 0.5 part of micropowder silica gel, 0.5 part of magnesium stearate.All the other are with embodiment 1.
If conversion is weight percentage: the fine powder 49% of Herba Clinopodii extract, microcrystalline Cellulose 20%, polyvinylpolypyrrolidone 15%, low-substituted hydroxypropyl cellulose 15%, micropowder silica gel 0.5%, magnesium stearate 0.5%.
(3) Chinese medicine extract of blood flow cutting off dispersing tablet and auxiliary material weight ratio: 30 parts of the fine powders of Herba Clinopodii extract, 40 parts of microcrystalline Cellulose, 15 parts of polyvinylpolypyrrolidone, 9 parts of low-substituted hydroxypropyl celluloses, 3 parts of micropowder silica gels, 3 parts of magnesium stearate.All the other are with embodiment 1.
If conversion is weight percentage: the fine powder 30% of Herba Clinopodii extract, microcrystalline Cellulose 40%, polyvinylpolypyrrolidone 15%, low-substituted hydroxypropyl cellulose 9%, micropowder silica gel 3%, magnesium stearate 3%.
Earlier above-mentioned material is crossed 100 mesh sieves respectively, progressively increase method with the fine powder of Herba Clinopodii extract and the mixture mixing of disintegrating agent by equivalent, the material behind the mixing is put in the appropriate containers, and water or ethanol dissolve in right amount, make soft material; 20 mesh sieves are made wet granular, drying, and 20 mesh sieve granulate add the adjuvant of remainder again, mixing, tabletting promptly gets blood flow cutting off dispersing tablet.All the other are with embodiment 1.
(4) Chinese medicine extract of blood flow cutting off dispersing tablet and auxiliary material weight ratio: 50 parts of the fine powders of Herba Clinopodii extract, 28 parts of microcrystalline Cellulose, 12 parts of polyvinylpolypyrrolidone, 3 parts of low-substituted hydroxypropyl celluloses, 5 parts of lactose, 1 part of micropowder silica gel, 1 part of magnesium stearate.All the other are with embodiment 1.
Embodiment 9:
Blood flow cutting off dispersing tablet, the model of also adding sucrose fatty acid ester are 2.5 parts of P-1570.0.3 part of tween 80.All the other repeat above-mentioned all embodiment respectively.
Embodiment 10:
Blood flow cutting off dispersing tablet, the model of also adding sucrose fatty acid ester are 0.5 part of P-1570,0.5 part of tween 80.All the other repeat above-mentioned all embodiment respectively.
Embodiment 11:
Blood flow cutting off dispersing tablet, the model of also adding sucrose fatty acid ester are 2.5 parts of P-1670.0.3 part of tween 80.All the other repeat above-mentioned all embodiment respectively.
Embodiment 12:
Blood flow cutting off dispersing tablet, the model of also adding sucrose fatty acid ester are 0.5 part of P-1670,0.5 part of tween 80.All the other repeat above-mentioned all embodiment respectively.
Embodiment 13:
Blood flow cutting off dispersing tablet, the model of also adding sucrose fatty acid ester are 2.0 parts of P-1570.All the other repeat above-mentioned all embodiment respectively.
Embodiment 14:
Blood flow cutting off dispersing tablet, the model of also adding sucrose fatty acid ester are 0.5 part of P-1670.All the other repeat above-mentioned all embodiment respectively.
Embodiment 15:
Blood flow cutting off dispersing tablet, the model of also adding sucrose fatty acid ester are 1.5 parts of P-1570.All the other repeat above-mentioned all embodiment respectively.
Embodiment 16:
Blood flow cutting off dispersing tablet, the model of also adding sucrose fatty acid ester are 1.5 parts of P-1670.All the other repeat above-mentioned all embodiment respectively.
Embodiment 17:
Blood flow cutting off dispersing tablet, the model of also adding sucrose fatty acid ester are 1.2 parts of P-1570.All the other repeat above-mentioned all embodiment respectively.
Embodiment 18:
Blood flow cutting off dispersing tablet, the model of also adding sucrose fatty acid ester are 1.2 parts of P-1670.All the other repeat above-mentioned all embodiment respectively.
Claims (10)
1, a kind of blood flow cutting off dispersing tablet is characterized in that the composition of this dispersible tablet comprises Herba Clinopodii extract, adjuvant; Adjuvant comprises disintegrating agent, filler, binding agent, lubricant, correctives.
2, blood flow cutting off dispersing tablet as claimed in claim 1 is characterized in that Herba Clinopodii extract obtains by following concrete steps: get Herba Clinopodii, cutting, decoct with water secondary, each 1.5 hours, collecting decoction, filter, it is 1.15 (80 ℃) that filtrate is concentrated into relative density, adds the ethanol of 1.7 times of amounts, fully stirs, left standstill 24 hours, get the supernatant concentrating under reduced pressure and become the thick paste shape, be dried to dry extract, pulverize the fine powder that obtains Herba Clinopodii extract.
3, blood flow cutting off dispersing tablet as claimed in claim 1 is characterized in that each constituent weight proportion is: Herba Clinopodii extract 10-80 part, disintegrating agent 10-50 part, filler 0-30 part, binding agent 0-10 part, lubricant 0-8 part, correctives 0-5 part.
4, blood flow cutting off dispersing tablet as claimed in claim 1 is characterized in that each constituent weight proportion is: Herba Clinopodii extract 10-40 part, disintegrating agent 10-50 part, filler 0-30 part, binding agent 0-10 part, lubricant 0-8 part, correctives 0-5 part.
5, blood flow cutting off dispersing tablet as claimed in claim 3 is characterized in that disintegrating agent is any one or a few in carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, crospolyvinylpyrrolidone, cross-linking sodium carboxymethyl cellulose, sodium carboxymethyl cellulose, microcrystalline Cellulose, polyvinylpolypyrrolidone, micropowder silica gel, the pregelatinized Starch.
6, blood flow cutting off dispersing tablet as claimed in claim 3, it is characterized in that filler be in lactose, the mannitol any one or a few.Lubricant be in magnesium stearate, micropowder silica gel, calcium stearate, Pulvis Talci, Stepanol MG, the silicon dioxide any one or a few; Correctives is that A Siba is sweet, in the glycyrrhizin, citric acid, vanillin any one or a few.
7, blood flow cutting off dispersing tablet as claimed in claim 3 is characterized in that binding agent comprises in polyvinylpyrrolidone, polyethylene glycol 6000, the Macrogol 4000 any one or a few.
8, blood flow cutting off dispersing tablet as claimed in claim 3, it is characterized in that each constituent weight proportion is: fine powder 30-50 part of Herba Clinopodii extract, microcrystalline Cellulose 20-40 part, polyvinylpolypyrrolidone 5-15 part, low-substituted hydroxypropyl cellulose 5-15 part, micropowder silica gel 0.5-3 part, magnesium stearate 0.5-3 part.
9,, it is characterized in that also comprising helping and collapse agent sucrose fatty acid ester, tween 80 that addition is sucrose fatty acid ester 0.5-2.5 part, tween 80 0-0.5 part of the HLB=15-16 of weight proportion as claim 3 or 8 described blood flow cutting off dispersing tablet.
10, blood flow cutting off dispersing tablet as claimed in claim 9, the model that it is characterized in that sucrose fatty acid ester are P-1570 or P-1670 or LWA-1570.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510019531 CN1939399A (en) | 2005-09-30 | 2005-09-30 | Blood stream-breaking dispersing tablets |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510019531 CN1939399A (en) | 2005-09-30 | 2005-09-30 | Blood stream-breaking dispersing tablets |
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| Publication Number | Publication Date |
|---|---|
| CN1939399A true CN1939399A (en) | 2007-04-04 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 200510019531 Pending CN1939399A (en) | 2005-09-30 | 2005-09-30 | Blood stream-breaking dispersing tablets |
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| CN (1) | CN1939399A (en) |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102441029A (en) * | 2010-10-09 | 2012-05-09 | 安徽科创中药天然药物研究所有限责任公司 | Preparation method of hemostatics and clinopodium polycephalum preparation and quality control technology |
| CN103977071A (en) * | 2014-06-06 | 2014-08-13 | 余中华 | Clinopodium polycephalum tablet and preparation method thereof |
| CN104587219A (en) * | 2015-02-15 | 2015-05-06 | 山东省文登整骨医院 | Traditional Chinese medicine for treating functional uterine bleeding |
| CN105213472A (en) * | 2015-10-19 | 2016-01-06 | 翔宇药业股份有限公司 | A kind of blood stanching oral liquid comprising Herba Clinopodii |
-
2005
- 2005-09-30 CN CN 200510019531 patent/CN1939399A/en active Pending
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102441029A (en) * | 2010-10-09 | 2012-05-09 | 安徽科创中药天然药物研究所有限责任公司 | Preparation method of hemostatics and clinopodium polycephalum preparation and quality control technology |
| CN103977071A (en) * | 2014-06-06 | 2014-08-13 | 余中华 | Clinopodium polycephalum tablet and preparation method thereof |
| CN104587219A (en) * | 2015-02-15 | 2015-05-06 | 山东省文登整骨医院 | Traditional Chinese medicine for treating functional uterine bleeding |
| CN105213472A (en) * | 2015-10-19 | 2016-01-06 | 翔宇药业股份有限公司 | A kind of blood stanching oral liquid comprising Herba Clinopodii |
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Open date: 20070404 |