CN101204445B - Soft capsule for hepatitis and preparation method thereof - Google Patents
Soft capsule for hepatitis and preparation method thereof Download PDFInfo
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- CN101204445B CN101204445B CN200710198876A CN200710198876A CN101204445B CN 101204445 B CN101204445 B CN 101204445B CN 200710198876 A CN200710198876 A CN 200710198876A CN 200710198876 A CN200710198876 A CN 200710198876A CN 101204445 B CN101204445 B CN 101204445B
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Abstract
The invention provides a new dosage form of Yinzhihuang: soft capsules, wherein, active ingredient of substance of the soft capsules comprises Artemisia capillaria extract, gardenia extract, honeysuckle extract and baicalin; non-active ingredient comprises matrix, liquid wax and suspending agent. The liquid wax takes up 5percent-85 percent of the weight of the matrix. The soft capsules can prominently enhance the beneficial effect of the Yinzhihuang preparation which is provided with more prominent stability and treatment advantage than products on sale.
Description
Technical field
The present invention relates to a kind of Yinzhi huang capsule preparation that contains Herba Artemisiae Scopariae extract, Fructus Gardeniae extract, Flos Lonicerae extract and baicalin, it can significantly strengthen the beneficial effect of said preparation.
Background technology
YINZHIHUANG ZHIJI is become to be grouped into for four kinds by Herba Artemisiae Scopariae extract, Fructus Gardeniae extract, Flos Lonicerae extract and baicalin.Modern pharmacology also proves: mattress Cape jasmine Huang has heat-clearing and toxic substances removing, dampness removing jaundice, and jaundice eliminating subcutaneous ulcer and the effect that reduces GPT (NSC 334200 aminotransferase) are arranged.Clinically be used to treat acute, chronic hepatitis and I type hepatitis gravis, and the Comprehensive Treatment of other hepatitis gravis.
The yellow dosage form of the mattress Cape jasmine of clinical practice at present is main with oral and injection mainly, and oral formulations mainly provides medicinal with the form of oral liquid, granule or tablet, for example Yinzhihuang oral liquid.But for many years production and clinical practice prove that existing Yinzhihuang oral liquid and granule exist certain defective, for example, carry inconvenience, and use amount is big, make that patient's drug compliance is poor; Phenomenons such as useful life's weak point, long-term storage are prone to take place that solution precipitation is separated out; And affected by environment in actual use big, often promptly inefficacy or character are defective before the deadline; And oral liquid heavy bitter taste; Need a large amount of correctives or sugar to regulate; Thereby causing easily to go mouldy on the one hand causes microorganism defective; Be not suitable for the use of diabetics on the other hand, the conspicuous defective of clinical these dosage forms makes those skilled in the art urgently hope to develop that new suitable patient uses, good stability, the yellow oral formulations of mattress Cape jasmine that drug effect is high.
Among numerous peroral dosage forms, soft capsule have bioavailability height, good airproof performance, content accurately, good looking appearance, cover characteristics such as bad smell, the fine way that seemingly addresses the above problem.But soft capsule prepn also need overcome a lot of problems, and some is the obstacle that those skilled in the art also can't cross over so far.
The inventor is prepared into soft capsule with mattress Cape jasmine Huang; Have bioavailability height, good airproof performance, content accurately, good looking appearance, cover bad smell; The patient is easy to take and makes its compliance good; Do not add simultaneously correctivess such as saccharide in the soft capsule, make taking for a long time that diabetics can be relieved.
Usually; The substrate of soft capsule is divided into vegetable oil and Polyethylene Glycol; Polyethylene Glycol often is used in the soft capsule prepn as water-soluble base, and for example just having described a kind of in the application number 200410100803.0 is the Yinzhi huang capsule of substrate with PEG400 or 600.Because Polyethylene Glycol is a water-soluble base; At soft capsule between the storage life; Polyethylene Glycol in the content can be partly dissolved the water soluble ingredient in the soft capsule shell; Especially for the relatively thinner place of soft capsule seam, in case the content leaks phenomenon will take place in dissolving, this also is that those skilled in the art face the insurmountable so far difficult problem of Polyethylene Glycol substrate.
It is the soft capsule of substrate that mattress Cape jasmine Huang is processed with the vegetable oil; In the document (application number 200410056837.4) report is arranged also; As soft capsule prepn; Though the yellow dosage form of mattress Cape jasmine has improved, and need overcome a lot of difficulties, for example the soft capsule of prior art in storage period disintegrate become and material migration, effective ingredient generation sedimentation and content composition seepage equistability problem take place in defective, the capsule.To those skilled in the art, these problems are difficult to expect.
Only its content all is herein incorporated at this with the mode of quoting the above-mentioned patent No..
As everyone knows, producing medicine from the pharmaceutical factory generally will experience to the process that consumer uses: production, warehouse-in, pharmaceutical factory storage, transportation, distributor's storage, pharmacy or hospital put on the shelf after picking up goods, consumer buys, consumer uses in expiration date of drug.The Yinzhi huang capsule that utilizes prior art so and obtained is except keeping the cryogenic desirable environment of preserving in storage; Other links all become the unfavorable factor that influences disintegrate; And the Yinzhi huang capsule product of above-mentioned prior art can't overcome above unfavorable factor; This just inevitably brings product disintegrate before the deadline defective; Influence pharmaceutical effectiveness and can't reach therapeutic purposes; Explain that the scheme of prior art instruction obtains the Yinzhi huang capsule product, its ubiquity effect duration is short, disintegrate is defective, must cryopreservation (still effect duration is short under the low temperature, disintegrate is defective), on production, transportation and sales section inevitable defective.
Even the problems referred to above all overcome; Occurred the problem that can't overcome in the clinical practice again, the mattress Cape jasmine is yellow to be the treatment medicine for curing hepatitis, and the excess use of vegetable oil can increase the weight of the burden of liver; Not only do not reach the effect of treatment, play the opposite disastrous effect that increases the weight of the state of an illness possibly.
Seeing that the problem that occurs in the complexity of yellow extract its own particularity matter of mattress Cape jasmine and physicochemical property and the clinical practice thereof; Up to now also the teach literature that is fit to of neither one we how to overcome the existing above-mentioned all problems of Yinzhi huang capsule preparation, also have no talent and the beneficial effect that comprises the yellow soft capsule of mattress Cape jasmine provided the prediction of science.
Therefore, this area presses for the Yinzhi huang capsule dosage form that exploitation makes new advances, and said preparation should be reduced to bottom line with its negative effect when effectively improving product stability.This pharmaceutical dosage form can improve patient's treatment compliance, and must be safe.
Summary of the invention
The invention provides a kind of containing with the soft capsule of the yellow extract of mattress Cape jasmine as active component; It in the solution of success in the ubiquitous common problem of present soft capsule prepn; For example As time goes on disintegrate prolongs; Can also significantly strengthen the yellow beneficial effect of mattress Cape jasmine, remarkable stability and treatment advantage arranged than present commercially available prod.
The object of the present invention is to provide a kind of Yinzhi huang capsule pharmaceutical preparation; Particularly contain the yellow soft capsule prepn of mattress Cape jasmine; It has overcome the defective of the yellow oral formulations of existing mattress Cape jasmine; And overcome defective, the interior problem that material migration, effective ingredient sedimentation and content composition seepage equistability difference take place of capsule of disintegrate that soft capsule usually occurs, and strengthened the yellow beneficial effect of mattress Cape jasmine.Simultaneously, adopt the external test medicine to suppress the ability and the method for measuring drug effect of antibacterial, use the soft capsule of method preparation of the present invention to compare with the soft capsule of art methods preparation, effect of drugs has had and has significantly improved.In addition, the invention provides a kind of selection, it provides a kind of new safety product as the substituting of prior art, and this dosage form will be the approval that the doctor recommends to use and obtain doctor and patient.
The invention provides a kind of soft capsule that contains the yellow extract of mattress Cape jasmine, be made up of the content and the capsule material of soft capsule, the content of this soft capsule contains the yellow extract of mattress Cape jasmine, vegetable oil, suspending agent, surfactant; The yellow extract of mattress Cape jasmine wherein: vegetable oil: suspending agent: the part by weight of surfactant is 1: 0.05～5: 0.03～1: 0.01～1;
Above-mentioned vegetable oil is selected from and is one or more mixture in Oleum Sesami, Oleum Arachidis hypogaeae semen, Semen Maydis oil, olive oil, Oleum Helianthi, soybean oil, salad oil, Oleum Gossypii semen, Oleum Brassicae campestris, the soybean salad oil; One or more mixture in preferred soybean oil, Semen Maydis oil, Oleum Brassicae campestris, salad oil, the soybean salad oil.More preferably one or more mixture in Semen Maydis oil, soybean oil, salad oil, the soybean salad oil;
Suspending agent is the conventional suspending agent in this area, is selected from mainly that Cera Flava, Cera Flava, white beeswax, mixing are cured, one or more mixture in the Petiolus Trachycarpi oil, hydrogenated vegetable oil, tristerin, aluminum monostearate, glyceryl monostearate, fatty glyceride, mixed fatty glycerides, sucrose fatty acid ester, micropowder silica gel, silicon dioxide; One or more mixture in preferred Cera Flava, Petiolus Trachycarpi oil, HPO, hydrogenated coconut oil, micropowder silica gel, glyceryl monostearate, the mixed fatty glycerides; More preferably one or more mixture in Cera Flava, hydrogenated coconut oil, micropowder silica gel, the HPO.
Surfactant is a tween, preferred tween 80.
Active component in the content of the soft capsule of the invention described above is the yellow extract of mattress Cape jasmine, comprises Herba Artemisiae Scopariae extract, Fructus Gardeniae extract, baicalin and Flos Lonicerae extract, and weight ratio is 1.5: 0.8: 5: 1.
The content of the soft capsule of the invention described above contains 12～67% the yellow extract of mattress Cape jasmine at least.
The part by weight of yellow extract of active component mattress Cape jasmine and vegetable oil is 1: 0.05～5, preferred 1: 0.2～4, more preferably 1: 0.5～2.
The part by weight of yellow extract of active component mattress Cape jasmine and suspending agent is 1: 0.03～1, preferred 1: 0.05～0.8, more preferably 1: 0.07～0.5.
The part by weight of yellow extract of active component mattress Cape jasmine and surfactant is 1: 0.01～1, preferred 1: 0.02～0.8, more preferably 1: 0.03～0.5.
The yellow extract of described mattress Cape jasmine can record according to the Chinese medicine standard (the standard numbering: the step method in the Yinzhihuang oral liquid WS3-B-2931-98) under the preparation prepares, and is for example made by following method:
The preparation of Herba Artemisiae Scopariae extract: get Herba Artemisiae Scopariae, decocte with water, collecting decoction filters, and filtrating adds ethanol after concentrating; Filter after the cold preservation, filtrate recycling ethanol adds ethanol again, filters filtrate recycling ethanol after the cold preservation; Add cold preservation behind the water, filter, filtrating concentrates, and drying promptly gets Herba Artemisiae Scopariae extract.
The preparation of Fructus Gardeniae extract: get Fructus Gardeniae, be ground into coarse powder, decocte with water, collecting decoction filters; Filtrating adds ethanol after concentrating, and filters filtrate recycling ethanol after the cold preservation; Add ethanol again, filter after the cold preservation, filtrate recycling ethanol adds cold preservation behind the water; Filter, filtrating concentrates, and drying promptly gets Fructus Gardeniae extract.
The preparation of baicalin: get Radix Scutellariae, be ground into coarse powder, decocte with water, collecting decoction filters; The filtrating heating adds hydrochloric acid and regulates pH value, leaves standstill, and filters, and precipitate adds water and stirs into pasty state; Hydro-oxidation sodium is regulated pH value, filters, and filtrating adds ethanol, and heating adds hydrochloric acid and regulates pH value; Astragaloside is separated out, filter, use washing with alcohol, drying gets astragaloside.
The preparation of Flos Lonicerae extract: extracting honeysuckle, decocte with water, collecting decoction filters, and filtrating concentrates; Cooling, the hydro-oxidation calcium solution is regulated pH value, filters, and precipitate adds ethanol; Leave standstill, add sulphuric acid and regulate pH value, filter, filtrating hydro-oxidation sodium solution is regulated pH value; Reclaim ethanol, be condensed into thick paste, drying promptly gets Flos Lonicerae extract.
For the more effective clinical effectiveness that improves preparation that reaches, more advantageously active component is carried out pretreatment, comprising the yellow extract of described mattress Cape jasmine is pulverized in advance; Be the above fine powder of 80 orders; This fine powder is the above fine powders of 80 orders,, crosses the micropowder (perhaps being called fine powder) of 80 mesh sieves that is; More than preferred 100 orders, more preferably more than 120 orders, even micronization.
Favourable, the yellow extract of mattress Cape jasmine is mixed with surfactant fully, for example: tween.
The present invention also provides a kind of method for preparing above-mentioned Yinzhi huang capsule, comprising:
1) get Herba Artemisiae Scopariae extract, Fructus Gardeniae extract, Flos Lonicerae extract and four kinds of extracts of baicalin respectively, be crushed to and can cross 80 mesh sieve fine powders at least, mix homogeneously, as the yellow extract of mattress Cape jasmine, subsequent use.
2) get tween, add the yellow extract of above-mentioned mattress Cape jasmine, fully mixed to few 20 minutes, as stock solution A.
3) get vegetable oil, add suspending agent, its fusion of heating suspending agent stirs, and cools to 30～50 degree, stirs once more, as stock solution B.
4) with B) join A) in, after stirring, cross colloid mill after, if be pressed into soft capsule after having bubble to add defoamer.
The method of Yinzhi huang capsule wherein also comprises:
1) get Herba Artemisiae Scopariae extract, Fructus Gardeniae extract, Flos Lonicerae extract and four kinds of extracts of baicalin respectively, be crushed to and can cross 80 mesh sieve fine powders at least, mix homogeneously adds micropowder silica gel, mixes, and is as the yellow extract of mattress Cape jasmine, subsequent use.
2) get tween, add the yellow extract of above-mentioned mattress Cape jasmine, fully mixed to few 20 minutes, as stock solution A.
3) get vegetable oil, add suspending agent, its fusion of heating suspending agent stirs, and cools to 30～50 degree, stirs once more, as stock solution B.
4) with B) join A) in, after stirring, cross colloid mill after, if be pressed into soft capsule after having bubble to add defoamer.
More favourable, the yellow extract of mattress Cape jasmine is mixed fully with surfactant and wetting agent, for example: tween and phospholipid.
The method of Yinzhi huang capsule, comprising:
1) get Herba Artemisiae Scopariae extract, Fructus Gardeniae extract, Flos Lonicerae extract and four kinds of extracts of baicalin respectively, be crushed to and can cross 80 mesh sieve fine powders at least, mix homogeneously, as the yellow extract of mattress Cape jasmine, subsequent use.
2) get the homogeneous mixture solotion of tween and phospholipid, add the yellow extract of above-mentioned mattress Cape jasmine, fully mixed to few 20 minutes, as stock solution A.
3) get vegetable oil, add suspending agent, heating makes the suspending agent fusion, stirs, and cools to 30～50 degree, stirs once more, as stock solution B.
4) with B) join A) in, after stirring, cross colloid mill, if be pressed into soft capsule after having bubble to add defoamer.
The yellow extract of above-mentioned subsequent use mattress Cape jasmine also can use earlier and behind the micropowder silica gel mix homogeneously.
The substrate of our soft capsule of prior art instruction can be single-matrixes such as vegetable oil, Polyethylene Glycol, adds the content that suspending agent and/or lubricant etc. are formed soft capsule in addition.
The soft capsule that with the Polyethylene Glycol is substrate is commonplace usually, and four kinds of extraction processes that extract all adopts water to carry in the yellow extract of mattress Cape jasmine wherein contain a large amount of water soluble ingredients; Test finds that the Yinzhi huang capsule that with the Polyethylene Glycol is the substrate preparation is after placing a period of time, and the water soluble ingredient in the extract can be transferred in the softgel shell along with the migration of moisture in the content, thereby causes the degeneration of softgel shell and cause disintegrate to postpone; Simultaneously because Polyethylene Glycol is a water-soluble base, with composition in the soft capsule shell mutual dissolved ability is arranged, the seam crossing that especially approaches partially for soft capsule shell causes content constantly to leak; Just to the yellow extract of mattress Cape jasmine involved in the present invention, nearly all be not the ubiquitous common problem of soft capsule of substrate with the Polyethylene Glycol to this problem.So it is substrate that the present invention adopts vegetable oil.
With regard to simple vegetable oil substrate; Also exist many difficulties that are difficult to overcome in the soft capsule field; Wherein the character of therapeutic component is most important to the quality influence of soft capsule finished product in the content; Mainly have problems such as leakage of oil, content layering, these can adopt the granularity of the minimizing extract particles of instructing in handbook or the document and reasonable screening suspending agent to overcome, and for example discuss in the document " the soft capsule oil impregnate problem that improvement contains Chinese medicine extract "; But for prolonged disintegration, this difficult problem but is an insurmountable up to now difficult problem.Though people such as Ma Xu just studied soft capsule prolonged disintegration phenomenon influence factor in 2003; But the phenomenon of prolonged disintegration is not obviously improved, and the existence of this phenomenon has caused this advantage dosage form of soft capsule can't increase the purpose that the medicine stripping reaches the raising drug effect.And the use of the vegetable oil of simple excess can increase the weight of the burden of liver, not only do not reach the effect of treatment, plays the opposite disastrous effect that increases the weight of the state of an illness possibly.
According to general knowledge well known in the art, disintegrate just means fast Absorption fast, thereby reaches the effect in addition of quick acting even raising drug effect.This also is the final target of pursuing of the inventor, and a kind of product is stable, the outstanding Yinzhi huang capsule clinical prods of reliable quality effect of drugs for extensive patients provides.But pharmacodynamics test shows: the Yinzhi huang capsule that with the vegetable oil is substrate is merely compared with existing YINZHIHUANG ZHIJI (for example oral liquid), and drug effect does not significantly improve; Point out us quick disintegrate and do not mean that thereby fast Absorption obtains good drug effect.The inventor attempts to adopt another kind of the selection; Soon the yellow extract dry powder of mattress Cape jasmine keeps smaller particle size to satisfy the requirement that fast Absorption improves drug effect in the body as far as possible in the soft capsule of the present invention; For example achieve the goal by superfine powder (90% above particle diameter is less than 5um); Regrettably, do not obtain satisfied effect equally.
The a large amount of creative exploratory experiment of process is groped and is screened; The discovery that the inventor is surprised; Add an amount of surfactant in the soft capsule, can specifically, unexpectedly solve the existing problem of Yinzhi huang capsule, significantly improved the effect of drugs of Yinzhi huang capsule.。Therefore, the soft capsule that contains tween has constituted pith of the present invention, and just this composite interstitial substance of tween and vegetable oil has played the mutual promoting action that those skilled in the art can't imagine.
Tween is counted as wetting agent in the soft capsule field always, and method for using is usually in soft capsule: earlier suspending agent and wetting agent tween are joined in the vegetable oil, be heated to fusing/thawing, treat that temperature reduces the back and adds active component, stir; Or earlier suspending agent is joined in the vegetable oil, after heat fused/thawing or the dispersion, treat that temperature reduces the back and adds wetting agent, and then active component is added wherein, stir.This method for preparing becomes and well known to a person skilled in the art technological general knowledge.
Find in the test, the Yinzhi huang capsule for preparing according to the method described above, curative effect of medication is compared effect of drugs with the Yinzhi huang capsule that adopts prior art for preparing and is not significantly improved.And adopt the yellow extract of mattress Cape jasmine is dispersed in earlier in the tween, the substrate that will contain suspending agent again adds wherein, stirs, and can obtain beyond thought effect.This effect is to adopt extracorporeal bacteria inhibitor test, and the method for investigation medicine resisting pathogenic microbes effect realizes, just adopts the agar dilution method to measure the external Mlc of different samples to pathogenic bacterium.
But, be not as long as the yellow extract of mattress Cape jasmine is dispersed in the optimum efficiency that just can reach in the tween in the anticipation, find also in the test that jitter time is close with the strong or weak relation that obtains external bacteriostasis.
After the two simple mixing, add the vegetable oil substrate that contains suspending agent immediately, external Mlc test shows that bacteriostasis is equal to the sample that does not add tween.
The yellow extract of mattress Cape jasmine is distributed in the tween, stirred 10 minutes, add the vegetable oil that contains suspending agent, external Mlc test shows that the sample bacteriostatic activity that this sample does not more add tween increases by 7%.
The yellow extract of mattress Cape jasmine is distributed in the tween, stirred 20 minutes, add the vegetable oil that contains suspending agent, external Mlc test shows that the sample bacteriostatic activity that this sample does not more add tween increases by 22%.
The yellow extract of mattress Cape jasmine is distributed in the tween, stirred 30 minutes, add the vegetable oil that contains suspending agent, external Mlc test shows that the sample bacteriostatic activity that this sample does not more add tween increases by 29%.
The yellow extract of mattress Cape jasmine is distributed in the tween, stirred 60 minutes, add the vegetable oil that contains suspending agent, external Mlc test shows that the sample bacteriostatic activity that sample does not more add tween increases by 33%.
Favourable, the yellow extract of mattress Cape jasmine to be mixed with surfactant fully, incorporation time must not be less than 20 minutes.
The method for preparing above-mentioned Yinzhi huang capsule, comprising:
1) get Herba Artemisiae Scopariae extract, Fructus Gardeniae extract, Flos Lonicerae extract and four kinds of extracts of baicalin respectively, be crushed to and can cross 80 mesh sieve fine powders at least, mix homogeneously, as the yellow extract of mattress Cape jasmine, subsequent use.
2) get tween, add above-mentioned raw materials, fully mixed to few 20 minutes, as stock solution A.
3) get vegetable oil, add suspending agent, heating makes its fusion of suspending agent, stirs, and cools to 30～50 degree, stirs once more, as stock solution B.
4) with B) join A) in, after stirring, cross colloid mill, if be necessary colloid mill grind several all over after, if after having bubble to add defoamer, be pressed into soft capsule.
In content, add wetting agent, the solid active agent in the soft capsule is mixed fully with oleaginous base more easily, play the effect of auxiliary suspending.The adding method that well known to a person skilled in the art the wetting agent of soft capsule comprises: suspending agent and wetting agent are mixed to join in the vegetable oil; Or earlier suspending agent is joined in the vegetable oil; After heat fused/thawing or the dispersion, treat that temperature reduces the back and adds wetting agent.Because the special role of surfactant and creative method for using and setup time among the present invention; And the unique effect of in soft capsule, being brought into play is different fully with prior art; Test is a prerequisite with test method of the present invention, has investigated the difference between the product that the difference adding method of wetting agent obtained.
Sample preparation methods 1: the yellow extract of mattress Cape jasmine is distributed to earlier in the tween solution, stirred 30 minutes, add the vegetable oil that contains suspending agent, stir.
Sample preparation methods 2: the yellow extract of mattress Cape jasmine is distributed to earlier in the tween solution, stirred 30 minutes, add the vegetable oil that contains suspending agent, after stirring, add wetting agent, stir.
Sample preparation methods 3: after the yellow extract of mattress Cape jasmine being dispersed in the mixed solution of tween and wetting agent earlier, stirred 30 minutes, the vegetable oil adding that will contain suspending agent wherein stirs.
The discovery that the inventor is surprised in test, sample 1 and 2 external bacteriostatic activity are approaching, and adopt the Yinzhi huang capsule sample of method for preparing 3 preparations, and the effect of drugs of acquisition is more unexpected, and external bacteriostatic activity is than sample 1 and 2 raisings 9%
In order to reach better effect, added wetting agent in the soft capsule of the present invention.Wetting agent is a phospholipid, arbitrary or its combination in preferred soybean phospholipid, lecithin, the egg yolk lecithin; More preferably soybean phospholipid.The yellow extract of wherein above-mentioned mattress Cape jasmine: the part by weight of wetting agent is 1: 0.01～0.5, preferred 1: 0.02～0.2, more preferably 1: 0.03～0.1;
Favourable, the yellow extract of mattress Cape jasmine to be mixed with surfactant fully, incorporation time must not be less than 20 minutes.
More favourable, the yellow extract of mattress Cape jasmine to be mixed fully with surfactant and wetting agent, incorporation time must not be less than 20 minutes, for example: tween and soybean phospholipid.
The method for preparing above-mentioned Yinzhi huang capsule wherein also can comprise:
1) get Herba Artemisiae Scopariae extract, Fructus Gardeniae extract, Flos Lonicerae extract and four kinds of extracts of baicalin respectively, be crushed to and can cross 80 mesh sieve fine powders at least, mix homogeneously, as the yellow extract of mattress Cape jasmine, subsequent use.
2) get the homogeneous mixture solotion of tween 80 and soybean phospholipid, add above-mentioned raw materials, fully mixed to few 20 minutes, as stock solution A.
3) get vegetable oil, add suspending agent, heating makes its fusion, stirs, and cools to 30～50 degree, stirs once more, as stock solution B.
4) with B) join A) in, after stirring, cross colloid mill, if be pressed into soft capsule after having bubble to add defoamer.
Also there is document to put down in writing the amount of the adding of relevant suspending agent; The additional proportion (accounting for the weight of vegetable oil) of general suspending agent is seldom greater than 5%; So what tween played as wetting agent in some document is the effect of auxiliary suspending; Use amount can not surpass the use amount of suspending agent, and proportion is very little in the whole contents thing; And if the use amount of tween is lower than 6% (in order to guarantee experiment and clinical therapeutic efficacy, preferably 8～25%) of vegetable oil weight among the present invention, then do not have peptizaiton; Big like this use amount; In fact can be tween as a kind of novel substrate, therefore, the present invention also can put tween in the composite interstitial substance under; That is the composite interstitial substance of vegetable oil and tween.In addition; Tween addition of the present invention especially adds method and is not the employing stability experiment that adopts in some document and judges addition, but adopts the experiment of external fungistatic effect to pass judgment on; Purpose is different, and the means of employing also are different with technical scheme.In addition, creationary tween and the wetting agent phospholipid of adding simultaneously of the inventor, its purpose also is different from suspending and the lubrication that prior art is instructed, but significantly improves the effect of medicine.
The inventor finds also that in test behind yellow extract of mattress Cape jasmine and micropowder silica gel mix homogeneously, again according to the Yinzhi huang capsule that method for preparing of the present invention obtained, the suspendible effect of content is better.The method for preparing above-mentioned Yinzhi huang capsule wherein can also comprise:
1) get Herba Artemisiae Scopariae extract, Fructus Gardeniae extract, Flos Lonicerae extract and four kinds of extracts of baicalin respectively, be crushed to and can cross 80 mesh sieve fine powders at least, mix homogeneously as the yellow extract of mattress Cape jasmine, adds micropowder silica gel, mixes, as stock solution A.
2) get the homogeneous mixture solotion of tween and phospholipid, add above-mentioned raw materials, fully mixed to few 20 minutes, as stock solution B.
3) get vegetable oil, add suspending agent, heating makes its fusion, stirs, and cools to 30～50 degree, stirs once more, and is subsequent use.
4) with B) join A) in, after stirring, cross colloid mill, if be pressed into soft capsule after having bubble to add defoamer.
The inventor has the effect that significantly protects the liver and increase immunity for more favourable explanation product of the present invention; Adopt the use carbon tetrachloride that is widely used at present to make the model of animal liver fibrosis (liver cirrhosis), come the further curative effect of medication of checking product of the present invention.
Protect the liver the test of pesticide effectiveness:
It is experimental animal that mice is adopted in test, and the carbon tetrachloride oil solution of employing 0.1% is made the model of mice dosage form hepatic injury; Experimental animal is divided into 6 groups at random, is respectively blank group (use normal saline), model group and test group (4 groups).
Trial drug:
Sample 1: commercially available Yinzhihuang oral liquid
Sample 2: the yellow extract of mattress Cape jasmine (4 kinds of compositions) is joined the vegetable oil substrate that contains suspending agent, after stirring, the compacting soft capsule.
Sample 3: the yellow extract of mattress Cape jasmine (4 kinds of compositions) is distributed to earlier in the tween solution, stirred 30 minutes, add the vegetable oil substrate that contains suspending agent, stir, the compacting soft capsule.
Sample 4: after the yellow extract of mattress Cape jasmine (4 kinds of compositions) being dispersed in the mixed solution of tween and wetting agent earlier, stirred 30 minutes, the vegetable oil substrate adding that will contain suspending agent wherein stirs, and suppresses soft capsule.
Result of the test: compare with model group with the blank group, each sample sets all has good protection effect to hepatocyte.Each strong and weak order of organizing protective effect is followed successively by: sample 4＞sample 3＞sample 1＞sample 2.
Increase the immunity test of pesticide effectiveness
It is experimental animal that mice is adopted in test; Experimental animal is divided into 3 groups at random, is respectively blank group (use normal saline), test group (2 groups).Test and give the experimental animal india ink latter stage;
Trial drug:
Sample 1: the yellow extract of mattress Cape jasmine (4 kinds of compositions) is joined the vegetable oil substrate that contains suspending agent, after stirring, the compacting soft capsule.
Sample 2: the yellow extract of mattress Cape jasmine (4 kinds of compositions) is distributed to earlier in the tween solution, stirred 30 minutes, add the vegetable oil substrate that contains suspending agent, stir, the compacting soft capsule.
Result of the test: compare with the blank assay group, 2 groups of test specimens all can improve the phagocytic function of the reticuloendothelial system of mice, and the raising effect of sample 2 is more obvious than sample 1.
Tween is as surfactant; Be used to pharmaceutical field for a long time; Tween haemolysis problem for public's worry; Clear and definite hemolytic test is the inspection item that is used for estimating the injection safety in the pharmacological testing rules, and haemolysis is to occur in the drug administration by injection process, and there is not the haemolysis problem in oral formulations.
Though above-mentioned argumentation is according to fully, in order further to eliminate the worry of the public for the safety of tween, the inventor has done the test of tween hemolytic and toxicity test simultaneously to verify security of products.
The test of tween hemolytic
The Sanguis Leporis seu oryctolagi normal saline suspension of employing 2% carries out hemolytic test; Test specimen adopts the maximum use amount of tween in the prescription, promptly accounts for vegetable oil weight 25% and prepares, and carry out test sample dilution and concrete operations according to the method in the test direction principle; The result shows that sample of the present invention does not have haemolysis and agglutination phenomenon takes place,
Toxicity test
Experimental animal is the mice of male and female half and half, is test specimen with above-mentioned sample 5, and mice daily dose dosage is equivalent to 500 times of human dosage, and 2 weeks were observed in the back of taking medicine, and all experimental animals are all normal, and no abnormal performance takes place with dead.Mtd test shows, the almost non-toxic side effect of product oral of the present invention, clinical practice safety.
Above-mentioned result of the test proves absolutely; Yinzhi huang capsule among the present invention; With the soft capsule that adopts prior art for preparing; Be in vivo or the external beyond thought drug effect and the quality of the pharmaceutical preparations of all having obtained, compare, reaching many advantages of soft capsule (cover the serious bitterness of the yellow extract of mattress Cape jasmine, loading amount accurately, appearance looks elegant and steady quality, be easy to take and carry or the like) in addition with the yellow granule of mattress Cape jasmine; Obtained satisfied clinical efficacy more, satisfied those skilled in the art and looked forward to all the time and can obtain than the eager hope in high-drug-effect ground through adopting advanced preparation means.
Its specification of Yinzhi huang capsule of the present invention generally can be divided into; Every contains yellow extract (containing Herba Artemisiae Scopariae extract, Fructus Gardeniae extract, Flos Lonicerae extract and four kinds of compositions of the baicalin) 0.1～0.4g of mattress Cape jasmine; Every soft capsule weight is at 0.25～0.9g/ grain, and clinical recommendation consumption is 2～10g/.
The present invention has following characteristic: good storing stability, and the deliquescence and the deterioration of preparation are suppressed, and active component preparation characteristics such as speed of stripping from preparation do not change, and overcome a series of defectives of existing product.More advantageously be; Preparation of the present invention has been covered the yellow disagreeable taste of mattress Cape jasmine fully, can also improve the taste of Chinese medicine preparation, and quantitatively accurately; Even also can be easily under anhydrous situation, have no the administration of uncomfortable ground, have significantly improved the compliance of patient to treatment.
To further make non restrictive description below to the present invention.
Active component
In context; The yellow extract of mattress Cape jasmine among the present invention promptly is an active component; This active component is the yellow extract of mattress Cape jasmine that meets the Chinese medicine ministry standard, comprises Herba Artemisiae Scopariae extract, Fructus Gardeniae extract, baicalin and Flos Lonicerae extract, and weight ratio is 1.5: 0.8: 5: 1.Said Herba Artemisiae Scopariae extract, Fructus Gardeniae extract, Flos Lonicerae extract and four kinds of extracts of baicalin can prepare voluntarily, also can sell through the merchant and buy.
Soft capsule content:
Said inclusions is meant the active component in the soft capsule (or claim soft gelatin capsule) and/or is carried on the active component in the excipient, and wherein content can following arbitrary state and exist.In view of the special requirement of inflammation treatment, the present invention especially preferably provides the content of suspension or emulsion-type to prepare soft capsule dosage form.This is because four kinds of extracts (Herba Artemisiae Scopariae extract, Fructus Gardeniae extract, Flos Lonicerae extract and the baicalin) active component that is carried in substrate and/or the excipient has dispersibility highly, has effectively improved its bioavailability.
Pharmaceutical composition provided by the invention, it contains the yellow extract of mattress Cape jasmine and the conventional medicine adjuvant of clinical treatment effective dose.
The preparation of soft capsule method
The present invention does not make specific limited to the method for preparing of Yinzhi huang capsule, can adopt this area conventional method, for example pressing or dropping preparation method (drop pill method).
Soft capsule rubber adopts known composition and compound method, except glue, plasticizer with the water, can add pigment, opacifier, antiseptic or acid-base modifier etc. simultaneously.
The specific embodiment
Embodiment 1: the preparation of four kinds of extracts in the yellow extract of mattress Cape jasmine
The preparation of Herba Artemisiae Scopariae extract: get Herba Artemisiae Scopariae, decocte with water three times, 1.5 hours for the first time, second, third time each 1 hour, collecting decoction; Filter, filtrating is concentrated into every ml and contains crude drug 2g, adds ethanol and makes pure content reach 70%, cold preservation 24 hours; Filter, filtrate recycling ethanol extremely every ml contains crude drug 5g, adds ethanol again and makes pure content reach 85%, cold preservation 24 hours; Filter, filtrate recycling ethanol extremely every ml contains crude drug 10g, adds the about 5 times of amounts of water, cold preservation 48 hours; Filter, filtrating is condensed into the thick paste shape, and vacuum drying promptly gets Herba Artemisiae Scopariae extract.
The preparation of Fructus Gardeniae extract: get Fructus Gardeniae, be ground into coarse powder, decocte with water three times, first and second time each 1 hour, 0.5 hour for the third time; Collecting decoction filters, and filtrating is concentrated into every ml and contains crude drug 1g, adds ethanol and makes pure content reach 70%, cold preservation 24 hours; Filter, filtrate recycling ethanol extremely every ml contains crude drug 3g, adds ethanol again and makes pure content reach 85%, cold preservation 24 hours; Filter, filtrate recycling ethanol extremely every ml contains crude drug 5g, adds the about 5 times of amounts of water, cold preservation 48 hours; Filter, filtrating is condensed into the thick paste shape, and vacuum drying promptly gets Fructus Gardeniae extract.
The preparation of baicalin: get Radix Scutellariae, be ground into coarse powder, decocte with water three times, each 1 hour, collecting decoction filtered; Filtrating is heated to 80 ℃, adds hydrochloric acid and regulates pH1～2, leaves standstill, and filters, and precipitate adds 2 times of water gagings and stirs into pasty state; Add 40% sodium hydroxide and regulate pH6.5～7, filter, filtrating adds equivalent ethanol, is heated to 80 ℃, adds hydrochloric acid and regulates pH1～2; Astragaloside is separated out, filter, use washing with alcohol, 80 ℃ of constant pressure and dries get astragaloside.
The preparation of Flos Lonicerae extract: extracting honeysuckle, the decocte with water secondary, each 1 hour, collecting decoction filtered; Filtrating is concentrated into every ml and contains crude drug 2g, is chilled to 45～60 ℃, adds 20～40% aqua calcises and regulates pH value to 12, filters, and precipitate adds 2 times of amount ethanol; Leave standstill, add 50% sulphuric acid and regulate pH value to 3.0～4.0, filter, filtrating adds 40% sodium hydroxide solution and regulates pH value to 6.5～7.0; Reclaim ethanol, be condensed into thick paste, vacuum drying promptly gets Flos Lonicerae extract.
Embodiment 2:
Herba Artemisiae Scopariae extract: 0.06g
Fructus Gardeniae extract: 0.032g
Baicalin: 0.2g
Flos Lonicerae extract: 0.04g
Soybean oil: 0.22g
Tween 80: 0.05g
Cera Flava: 0.02g
HPO: 0.02g
Soybean phospholipid: 0.008g
Process 1 (0.65g)
Preparation technology
Get the tween 80 and the soybean phospholipid of recipe quantity, be stirred well to mix homogeneously, as stock solution 1.
Get Herba Artemisiae Scopariae extract, Fructus Gardeniae extract, baicalin and Flos Lonicerae extract among the embodiment 1; Be ground into the fine powder that to cross 200 mesh sieves, join in the above-mentioned stock solution 1, fully disperse to stir; Jitter time must not be less than 20 minutes, as stock solution 2.
Get the soybean oil of recipe quantity, add Cera Flava and HPO, heating makes the suspending agent fusion, stirs, and cools to 50 degree; Solution is poured in the above-mentioned stock solution 2, is stirred once more, cross colloid mill, if bubble is arranged, add defoamer in right amount after, be pressed into soft capsule.
Embodiment 3:
Herba Artemisiae Scopariae extract: 0.06g
Fructus Gardeniae extract: 0.032g
Baicalin: 0.2g
Flos Lonicerae extract: 0.04g
Semen Maydis oil: 0.31g
Tween 80: 0.04g
Cera Flava: 0.04g
Hydrogenated coconut oil: 0.01g
Soybean phospholipid: 0.02g
Process 1 (0.75g)
Preparation technology
Get the tween 80 and the soybean phospholipid of recipe quantity, be stirred well to mix homogeneously, as stock solution 1.
Get Herba Artemisiae Scopariae extract, Fructus Gardeniae extract, baicalin and Flos Lonicerae extract among the embodiment 1; Be ground into the fine powder that to cross 180 mesh sieves, join in the above-mentioned stock solution 1, fully disperse to stir; Jitter time must not be less than 20 minutes, as stock solution 2.
Get the Semen Maydis oil of recipe quantity, add Cera Flava and hydrogenated coconut oil, heating makes the suspending agent fusion, stirs, and cools to 45 degree; Solution is poured in the above-mentioned stock solution 2, is stirred once more, cross colloid mill, if bubble is arranged, add defoamer in right amount after, be pressed into soft capsule.
Embodiment 4:
Herba Artemisiae Scopariae extract: 0.04g
Fructus Gardeniae extract: 0.02133g
Baicalin: 0.1333g
Flos Lonicerae extract: 0.0267g
Semen Maydis oil: 0.305g
Tween 80: 0.025g
Cera Flava: 0.07g
HPO: 0.03g
Process 1 (0.65g)
Preparation technology
Get Herba Artemisiae Scopariae extract, Fructus Gardeniae extract, baicalin and Flos Lonicerae extract among the embodiment 1; Be ground into the fine powder that to cross 120 mesh sieves, join in the tween 80 of recipe quantity, fully disperse to stir; Jitter time must not be less than 20 minutes, as stock solution 1.
Get the Semen Maydis oil of recipe quantity, add Cera Flava and HPO, heating makes the suspending agent fusion, stirs, and cools to 45 degree; Solution is poured in the above-mentioned stock solution 1, is stirred once more, cross colloid mill, if bubble is arranged, add defoamer in right amount after, be pressed into soft capsule.
Embodiment 5
Herba Artemisiae Scopariae extract: 0.03g
Fructus Gardeniae extract: 0.016g
Baicalin: 0.1g
Flos Lonicerae extract: 0.02g
Soybean oil: 0.205g
Tween 80: 0.04
Cera Flava: 0.02g
Hydrogenated rapeseed oil: 0.02g
Process 1 (0.45g)
Preparation technology
Get Herba Artemisiae Scopariae extract, Fructus Gardeniae extract, baicalin and Flos Lonicerae extract among the embodiment 1; Be ground into the fine powder that to cross 100 mesh sieves, join in the tween 80 of recipe quantity, fully disperse to stir; Jitter time must not be less than 20 minutes, as stock solution 1.
Get the soybean oil of recipe quantity, add Cera Flava and hydrogenated rapeseed oil, heating makes the suspending agent fusion, stirs, and cools to 40 degree; Solution is poured in the above-mentioned stock solution 1, is stirred once more, cross colloid mill, if bubble is arranged, add defoamer in right amount after, be pressed into soft capsule.
Embodiment 6
Herba Artemisiae Scopariae extract: 0.024g
Fructus Gardeniae extract: 0.0128g
Baicalin: 0.08g
Flos Lonicerae extract: 0.016g
Soybean oil: 0.21g
Tween 80: 0.02g
Cera Flava: 0.017g
Hydrogenated coconut oil: 0.02g
Process 1 (0.4g)
Preparation technology
Get Herba Artemisiae Scopariae extract, Fructus Gardeniae extract, baicalin and Flos Lonicerae extract among the embodiment 1, be ground into micropowder, its granularity more than 90% all less than 10um; Join in the tween 80 of recipe quantity; Fully disperse to stir, jitter time must not be less than 20 minutes, as stock solution 1.
Get the soybean oil of recipe quantity, add Cera Flava and hydrogenated coconut oil, heating makes the suspending agent fusion, stirs, and cools to 50 degree; Solution is poured in the above-mentioned stock solution 1, is stirred once more, cross colloid mill, if bubble is arranged, add defoamer in right amount after, be pressed into soft capsule.
Embodiment 7
Herba Artemisiae Scopariae extract: 0.024g
Fructus Gardeniae extract: 0.0128g
Baicalin: 0.08g
Flos Lonicerae extract: 0.016g
Soybean salad oil: 0.26g
Tween 80: 0.04g
Micropowder silica gel: 0.0065
Cera Flava: 0.0535g
HPO: 0.04g
Soybean phospholipid: 0.017g
Process 1 (0.55g)
Preparation technology
Get the tween 80 and the soybean phospholipid of recipe quantity, be stirred well to mix homogeneously, as stock solution 1.
Get Herba Artemisiae Scopariae extract, Fructus Gardeniae extract, baicalin and Flos Lonicerae extract among the embodiment 1, add micropowder silica gel, behind the mix homogeneously; Be ground into micropowder; Its granularity all less than 10um, joins in the above-mentioned stock solution 1 more than 90%, fully disperses to stir; Jitter time must not be less than 20 minutes, as stock solution 2.
Get the soybean salad oil of recipe quantity, add Cera Flava and HPO, heating makes the suspending agent fusion, stirs, and cools to 40 degree; Solution is poured in the above-mentioned stock solution 1, is stirred once more, cross colloid mill, if bubble is arranged, add defoamer in right amount after, be pressed into soft capsule.
Embodiment 8
Herba Artemisiae Scopariae extract: 0.03g
Fructus Gardeniae extract: 0.016g
Baicalin: 0.1g
Flos Lonicerae extract: 0.02g
Micropowder silica gel: 0.005g
Semen Maydis oil: 0.28g
Tween 80: 0.02g
Cera Flava: 0.05g
Hydrogenated coconut oil: 0.05g
Soybean phospholipid: 0.03g
Process 1 (0.6g)
Preparation technology
Get the tween 80 and the soybean phospholipid of recipe quantity, be stirred well to mix homogeneously, as stock solution 1.
Get Herba Artemisiae Scopariae extract, Fructus Gardeniae extract, baicalin and Flos Lonicerae extract among the embodiment 1; Be ground into the fine powder that to cross 150 mesh sieves, add micropowder silica gel, behind the mix homogeneously; Join in the above-mentioned stock solution 1; Fully disperse to stir, jitter time must not be less than 20 minutes, as stock solution 2.
Get the Semen Maydis oil of recipe quantity, add Cera Flava and hydrogenated coconut oil, heating makes the suspending agent fusion, stirs, and cools to 45 degree; Solution is poured in the above-mentioned stock solution 2, is stirred once more, cross colloid mill, if bubble is arranged, add defoamer in right amount after, be pressed into soft capsule.
Embodiment 9
Herba Artemisiae Scopariae extract: 0.04g
Fructus Gardeniae extract: 0.02133g
Baicalin: 0.1333g
Flos Lonicerae extract: 0.0267g
Oleum Brassicae campestris: 0.225g
Tween 80: 0.065g
Glyceryl monostearate: 0.01g
HPO: 0.01g
Soybean phospholipid: 0.015g
Process 1 (0.55g)
Preparation technology
Get the tween 80 and the soybean phospholipid of recipe quantity, be stirred well to mix homogeneously, as stock solution 1.
Get Herba Artemisiae Scopariae extract, Fructus Gardeniae extract, baicalin and Flos Lonicerae extract among the embodiment 1; Be ground into the fine powder that to cross 80 mesh sieves, join in the above-mentioned stock solution 1, fully disperse to stir; Jitter time must not be less than 20 minutes, as stock solution 2.
Get the Oleum Brassicae campestris of recipe quantity, add glyceryl monostearate and HPO, heating makes the suspending agent fusion, stirs, and cools to 35 degree; Solution is poured in the above-mentioned stock solution 2, is stirred once more, cross colloid mill, if bubble is arranged, add defoamer in right amount after, be pressed into soft capsule.
Embodiment 10
Herba Artemisiae Scopariae extract: 0.04g
Fructus Gardeniae extract: 0.02133g
Baicalin: 0.1333g
Flos Lonicerae extract: 0.0267g
Salad oil: 0.17g
Tween 80: 0.01g
Glyceryl monostearate: 0.05g
Process 1 (0.45g)
Preparation technology
Get Herba Artemisiae Scopariae extract, Fructus Gardeniae extract, baicalin and Flos Lonicerae extract among the embodiment 1; Be ground into the fine powder that to cross 80 mesh sieves, join the tween 80 of recipe quantity, fully disperse to stir; Jitter time must not be less than 20 minutes, as stock solution 1.
Get the salad oil of recipe quantity, add glyceryl monostearate oil, heating makes the suspending agent fusion, stirs, and cools to 35 degree; Solution is poured in the above-mentioned stock solution 1, is stirred once more, cross colloid mill, if bubble is arranged, add defoamer in right amount after, be pressed into soft capsule.
Embodiment 11
Herba Artemisiae Scopariae extract: 0.02g
Fructus Gardeniae extract: 0.01067g
Baicalin: 0.0667g
Flos Lonicerae extract: 0.0133g
Semen Maydis oil: 0.308g
Tween 80: 0.058g
HPO: 0.013g
Lecithin: 0.01g
Process 1 (0.5g)
Preparation technology
Get the tween 80 and the lecithin of recipe quantity, be stirred well to mix homogeneously, as stock solution 1.
Get Herba Artemisiae Scopariae extract, Fructus Gardeniae extract, baicalin and Flos Lonicerae extract among the embodiment 1, be ground into micropowder, its granularity more than 90% all less than 5um; Join in the above-mentioned stock solution 1; Fully disperse to stir, jitter time must not be less than 20 minutes, as stock solution 2.
Get the Semen Maydis oil of recipe quantity, add HPO, heating makes the suspending agent fusion, stirs, and cools to 45 degree; Solution is poured in the above-mentioned stock solution 2, is stirred once more, cross colloid mill, if bubble is arranged, add defoamer in right amount after, be pressed into soft capsule.
Embodiment 12
Herba Artemisiae Scopariae extract: 0.03
Fructus Gardeniae extract: 0.016g
Baicalin: 0.1g
Flos Lonicerae extract: 0.02g
Micropowder silica gel: 0.01g
Soybean oil and salad oil: 0.36g
Tween 80: 0.03g
Cera Flava: 0.02g
Hydrogenated coconut oil: 0.01g
Soybean phospholipid: 0.005g
Process 1 (0.6g)
Preparation technology
Get the tween 80 and the soybean phospholipid of recipe quantity, be stirred well to mix homogeneously, as stock solution 1.
Get Herba Artemisiae Scopariae extract, Fructus Gardeniae extract, baicalin and Flos Lonicerae extract among the embodiment 1; Be ground into and cross 280 mesh sieve fine powders, add micropowder silica gel, mix; Join in the above-mentioned stock solution 1; Fully disperse to stir, jitter time must not be less than 20 minutes, as stock solution 2.
Get the soybean oil and the salad oil of recipe quantity, add Cera Flava and hydrogenated coconut oil, heating makes the suspending agent fusion, stirs, and cools to 50 degree; Solution is poured in the above-mentioned stock solution 2, is stirred once more, cross colloid mill, if bubble is arranged, add defoamer in right amount after, be pressed into soft capsule.
Embodiment 13
Herba Artemisiae Scopariae extract: 0.03
Fructus Gardeniae extract: 0.016g
Baicalin: 0.1g
Flos Lonicerae extract: 0.02g
Micropowder silica gel: 0.005g
Soybean salad oil: 0.15g
Tween 80: 0.04g
Cera Flava: 0.01g
Hydrogenated coconut oil: 0.02g
Process 1 (0.4g)
Preparation technology
Get Herba Artemisiae Scopariae extract, Fructus Gardeniae extract, baicalin and Flos Lonicerae extract among the embodiment 1; Be ground into and cross 280 mesh sieve fine powders, add micropowder silica gel, mix; Join in the tween 80 of recipe quantity; Fully disperse to stir, jitter time must not be less than 20 minutes, as stock solution 1.
Get the soybean salad oil of recipe quantity, add Cera Flava and hydrogenated coconut oil, heating makes the suspending agent fusion, stirs, and cools to 50 degree; Solution is poured in the above-mentioned stock solution 1, is stirred once more, cross colloid mill, if bubble is arranged, add defoamer in right amount after, be pressed into soft capsule.
Embodiment 14
Herba Artemisiae Scopariae extract: 0.02g
Fructus Gardeniae extract: 0.01067g
Baicalin: 0.0667g
Flos Lonicerae extract: 0.0133g
Salad oil: 0.2g
Tween 80: 0.02g
Cera Flava: 0.01g
HPO: 0.01g
Process 1 (0.35g)
Preparation technology
Get the tween 80 and the fabaceous lecithin of recipe quantity, be stirred well to mix homogeneously, as stock solution 1.
Get Herba Artemisiae Scopariae extract, Fructus Gardeniae extract, baicalin and Flos Lonicerae extract among the embodiment 1; Be ground into the fine powder that to cross 280 mesh sieves, join in the above-mentioned stock solution 1, fully disperse to stir; Jitter time must not be less than 20 minutes, as stock solution 2.
Get the salad oil of recipe quantity, add Cera Flava and HPO, heating makes the suspending agent fusion, stirs, and cools to 50 degree; Solution is poured in the above-mentioned stock solution 2, is stirred once more, cross colloid mill, if bubble is arranged, add defoamer in right amount after, be pressed into soft capsule.
More than described the preferred embodiment for the present invention, so it is not in order to limit the present invention.Those skilled in the art can not depart from the improvement and the variation of category of the present invention and spirit to embodiment disclosed herein.
Claims (9)
1. Yinzhi huang capsule; The content that it is characterized in that this soft capsule contains the yellow extract of mattress Cape jasmine; Vegetable oil, suspending agent and surfactant, the yellow extract of described mattress Cape jasmine: vegetable oil: suspending agent: the part by weight of surfactant is 1: 0.05～5: 0.03～1: 0.01～1, and said surfactant is a tween; With also contain wetting agent phospholipid in the content, wherein the part by weight of yellow extract of mattress Cape jasmine and wetting agent is 1: 0.01～0.5.
2. Yinzhi huang capsule as claimed in claim 1, the percentage by weight that the yellow extract of wherein said mattress Cape jasmine accounts for content is 12～67%; Comprise Herba Artemisiae Scopariae extract, Fructus Gardeniae extract, baicalin and Flos Lonicerae extract, weight ratio is 1.5: 0.8: 5: 1.
3. Yinzhi huang capsule as claimed in claim 1, the wherein yellow extract of mattress Cape jasmine: vegetable oil: suspending agent: the part by weight of surfactant is 1: 0.2～4: 0.05～0.8: 0.02～0.8.
4. like each described Yinzhi huang capsule of claim 1～3, the yellow extract of wherein said mattress Cape jasmine contains four kinds of extracts, is made by following method:
The preparation of Herba Artemisiae Scopariae extract: get Herba Artemisiae Scopariae, decocte with water, collecting decoction filters, and filtrating adds ethanol after concentrating; Filter after the cold preservation, filtrate recycling ethanol adds ethanol again, filters filtrate recycling ethanol after the cold preservation; Add cold preservation behind the water, filter, filtrating concentrates, and drying promptly gets Herba Artemisiae Scopariae extract.
The preparation of Fructus Gardeniae extract: get Fructus Gardeniae, be ground into coarse powder, decocte with water, collecting decoction filters; Filtrating adds ethanol after concentrating, and filters filtrate recycling ethanol after the cold preservation; Add ethanol again, filter after the cold preservation, filtrate recycling ethanol adds cold preservation behind the water; Filter, filtrating concentrates, and drying promptly gets Fructus Gardeniae extract.
The preparation of baicalin: get Radix Scutellariae, be ground into coarse powder, decocte with water, collecting decoction filters; The filtrating heating adds hydrochloric acid and regulates pH value, leaves standstill, and filters, and precipitate adds water and stirs into pasty state; Hydro-oxidation sodium is regulated pH value, filters, and filtrating adds ethanol, and heating adds hydrochloric acid and regulates pH value; Astragaloside is separated out, filter, use washing with alcohol, drying gets astragaloside.
The preparation of Flos Lonicerae extract: extracting honeysuckle, decocte with water, collecting decoction filters, and filtrating concentrates; Cooling, the hydro-oxidation calcium solution is regulated pH value, filters, and precipitate adds ethanol; Leave standstill, add sulphuric acid and regulate pH value, filter, filtrating hydro-oxidation sodium solution is regulated pH value; Reclaim ethanol, be condensed into thick paste, drying promptly gets Flos Lonicerae extract.
5. like each described Yinzhi huang capsule of claim 1～3, one or more mixture in wherein said vegetable oil Oleum Sesami, Oleum Arachidis hypogaeae semen, Semen Maydis oil, olive oil, Oleum Helianthi, soybean oil, salad oil, Oleum Gossypii semen, Oleum Brassicae campestris, the soybean salad oil.
6. like each described Yinzhi huang capsule of claim 1～3, wherein said suspending agent is selected from that Cera Flava, Cera Flava, white beeswax, mixing are cured, one or more mixture in the Petiolus Trachycarpi oil, hydrogenated vegetable oil, tristerin, aluminum monostearate, glyceryl monostearate, fatty glyceride, mixed fatty glycerides, sucrose fatty acid ester, micropowder silica gel, silicon dioxide.
7. like each said Yinzhi huang capsule of claim 1～3, wherein content also contains micropowder silica gel.
8. like the method for preparing of each said Yinzhi huang capsule of claim 1～3, it is characterized by:
1) get Herba Artemisiae Scopariae extract, Fructus Gardeniae extract, Flos Lonicerae extract and four kinds of extracts of baicalin respectively, be crushed to and can cross 80 mesh sieve fine powders at least, mix homogeneously, as the yellow extract of mattress Cape jasmine, subsequent use.
2) get the homogeneous mixture solotion of tween and phospholipid, add the yellow extract of above-mentioned mattress Cape jasmine, fully mixed to few 20 minutes, as stock solution A.
3) get vegetable oil, add suspending agent, its fusion of heating suspending agent stirs, and cools to 30～50 degree, stirs once more, as stock solution B.
4) with B) join A) in, after stirring, cross colloid mill after, if be pressed into soft capsule after having bubble to add defoamer.
9. like the method for preparing of the said Yinzhi huang capsule of claim 1～7, it is characterized by:
1) get the yellow extract of mattress Cape jasmine, add micropowder silica gel, mix, be crushed to the fine powder that can cross 80 mesh sieves at least, as the yellow extract of mattress Cape jasmine, subsequent use.
2) get tween and wetting agent, the fine powder of the yellow extract of above-mentioned mattress Cape jasmine is fully disperseed wherein, the dispersed with stirring time must not be less than 20 minutes, as stock solution A.
3) get vegetable oil, add suspending agent, heating makes the suspending agent fusion, stirs, and cools to 30～50 degree, stirs, as stock solution B.
4) with B) join A) in, stir the back and crossed colloid mill, be pressed into soft capsule.
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| CN1650992A (en) * | 2003-12-12 | 2005-08-10 | 山东绿叶天然药物研究开发有限公司 | Yinzhi huang capsule, its preparation method and use |
| CN1739650A (en) * | 2004-08-24 | 2006-03-01 | 芜湖绿叶制药有限公司 | Cappillary artemisia-cape jasmine-rhubarb soft capsule and its prepn process |
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| CN1650992A (en) * | 2003-12-12 | 2005-08-10 | 山东绿叶天然药物研究开发有限公司 | Yinzhi huang capsule, its preparation method and use |
| CN1739650A (en) * | 2004-08-24 | 2006-03-01 | 芜湖绿叶制药有限公司 | Cappillary artemisia-cape jasmine-rhubarb soft capsule and its prepn process |
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