CN101199631B

CN101199631B - Soft capsule containing micropowder silicagel and preparing method

Info

Publication number: CN101199631B
Application number: CN2007101988827A
Authority: CN
Inventors: 沈志强; 姚俊华
Original assignee: Individual
Current assignee: JIANGSU WANGAO PHARMACEUTICAL CO Ltd
Priority date: 2007-12-19
Filing date: 2007-12-19
Publication date: 2011-11-30
Anticipated expiration: 2027-12-19
Also published as: CN101199631A

Abstract

The invention provides a soft capsule- a new dosage form of Yizhihuang. The active ingredients contained in the capsule include herbel artemisiae capillaris extracts, Gardenia extracts, honeysuckle extracts and baicalin; the inactive ingredients include stroma, silica gel micro powder and suspending agent. The soft capsule of the invention can remarkably improve the good effects of the Yizhihuangpreparation and has better stability and more curative advantages than current products in the market.

Description

A kind of soft capsule that contains micropowder silica gel and preparation method thereof

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

Mattress Cape jasmine Huang 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 the effect of jaundice eliminating subcutaneous ulcer and reduction GPT (NSC 334200 aminotransferase) is arranged.Clinically be used for the treatment of 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 mainly based on oral and injection, 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 easily 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 defectives in clinical these dosage forms ground make those skilled in the art urgently wish 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 preparation also needs to 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 the life-time service 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 preparation 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 can be partly dissolved the water soluble ingredient in the soft capsule shell in the content, 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 made with the vegetable oil, in the document (application number 200410056837.4) report is arranged also, as soft capsule preparation, though the dosage form of mattress Cape jasmine Huang has improved, but need overcome a lot of difficulties, for example disintegrate becomes and material migration, effective ingredient generation sedimentation and content composition seepage equistability problem takes place in defective, the capsule in soft capsule storage period of prior art.To those skilled in the art, these problems are difficult to expect.

Only its content all is herein incorporated at this in 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, illustrate that the scheme of prior art instruction obtains the Yinzhi huang capsule product, its ubiquity effect duration is short, disintegrate is defective, necessary cryopreservation (still lack under the low temperature by effect duration, disintegrate is defective), producing, inevitable defective on transportation and the sales section.

In view of 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 of the soft capsule that comprises mattress Cape jasmine Huang 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 preparation, for example As time goes on disintegrate prolongs, can also significantly strengthen the beneficial effect of mattress Cape jasmine Huang, remarkable stability and treatment advantage be arranged than present commercially available prod.

The object of the present invention is to provide a kind of Yinzhi huang capsule pharmaceutical preparation, the soft capsule preparation that particularly contains mattress Cape jasmine Huang, 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 beneficial effect of mattress Cape jasmine Huang.Simultaneously, adopt the external test medicine to suppress the ability of antibacterial and measure the method for drug effect, adopt 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, micropowder silica gel; The yellow extract of mattress Cape jasmine wherein: vegetable oil: suspending agent: the part by weight of micropowder silica gel is 1: 0.05～5: 0.03～1: 0.001～0.5

Above-mentioned substrate is vegetable oil, is selected to be 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; One or more mixture in preferred Cera Flava, Petiolus Trachycarpi oil, hydrogenated palm oil, hydrogenated coconut oil, glyceryl monostearate, the mixed fatty glycerides; More preferably one or more mixture in Cera Flava, hydrogenated coconut oil, the hydrogenated palm oil.

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: 0.5～3.

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 micropowder silica gel is 1: 0.001～0.5, preferred 1: 0.003～0.3, more preferably 1: 0.004～0.2.

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 is prepared, and is for example made by following method:

The preparation of Herba Artemisiae Scopariae extract: get Herba Artemisiae Scopariae, decoct with water, collecting decoction filters, and filtrate 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, filtrate concentrates, and drying promptly gets Herba Artemisiae Scopariae extract.

The preparation of Fructus Gardeniae extract: get Fructus Gardeniae, be ground into coarse powder, decoct with water, collecting decoction filters, after filtrate concentrates, add ethanol, filter after the cold preservation, filtrate recycling ethanol, add ethanol again, filter after the cold preservation, filtrate recycling ethanol, add cold preservation behind the water, filter, filtrate concentrates, drying promptly gets Fructus Gardeniae extract.

The preparation of baicalin: get Radix Scutellariae, be ground into coarse powder, decoct with water, collecting decoction, filter, the filtrate heating adds hydrochloric acid and regulates pH value, leaves standstill, filter, precipitate adds water and stirs into pasty state, and hydro-oxidation sodium is regulated pH value, filter, filtrate adds ethanol, heating, add hydrochloric acid and regulate pH value, astragaloside is separated out, filter, use washing with alcohol, drying gets astragaloside.

The preparation of Flos Lonicerae extract: extracting honeysuckle decocts with water collecting decoction, filter, filtrate 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, filtrate hydro-oxidation sodium solution is regulated pH value, reclaims ethanol, is condensed into thick paste, drying promptly gets Flos Lonicerae extract.

Favourable, with the yellow extract of mattress Cape jasmine mixes with micropowder silica gel complete after, pulverizing.

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, 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, standby.

2) get vegetable oil, add suspending agent, the heating suspending agent makes its fusion, adds the above-mentioned fine powder that contains the yellow extract of mattress Cape jasmine of micropowder silica gel, stirs, and crosses colloid mill, if be pressed into soft capsule after having bubble to add defoamer.

The present invention also provides a kind of method for preparing above-mentioned 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, add micropowder silica gel, mix homogeneously is crushed to and can crosses 80 mesh sieve fine powders at least, mixes, and is as the yellow extract of mattress Cape jasmine, standby.

2) get vegetable oil, add suspending agent, heating makes the suspending agent fusion, stir, cool, after the adding wetting agent stirs to 30～50 degrees centigrade, add the above-mentioned fine powder that contains the yellow extract of mattress Cape jasmine of micropowder silica gel, stir once more, cross colloid mill, if be pressed into soft capsule after having bubble to add defoamer.

Technique scheme of the present invention obtains by following experiment:

The inventor finds in test, the extracting method of four kinds of extracts (Herba Artemisiae Scopariae extract, Fructus Gardeniae extract, Flos Lonicerae extract and baicalin) is different in the mattress Cape jasmine Huang, the special nature of mixed extract and the complexity of extraction composition have been caused, the color of every kind of extract, character and proportion are different, have in addition completely contradict; Wherein Herba Artemisiae Scopariae extract, Flos Lonicerae extract and baicalin are yellow or pale brown color, are difficult for the moisture absorption, even also can not form heavy-gravity block after the moisture absorption, three's proportion is little; And Fructus Gardeniae extract not only color be brownish black, and very easily the moisture absorption becomes heavy-gravity bulk, and its proportion is obviously heavy than other three kinds of extracts, and not only irregular colour is even to cause the solution allotted, and always be mingled with big blocky black Fructus Gardeniae extract therein, and the solution layering is serious.So adopt the method for general preparation suspension to operate, be difficult to obtain not stratified settled suspendible liquid uniformly.

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 there are problems such as leakage of oil, content layering, prior art instruction those skilled in the art overcomes an above-mentioned difficult problem by granularity and the reasonable screening suspending agent that reduces extract particles, for example discusses " the soft capsule oil impregnate problem that improvement contains Chinese medicine extract " in the document.The inventor attempts to adopt the limit approach of instructing in the document, being about to active component is the superfine powder that the yellow extract of mattress Cape jasmine is crushed to the granule minimum, just the particulate granularity more than 90% must not solve and improve the stratified stability problem of not sedimentation of suspension greater than 5um.But in crushing process, and in the extract storage put procedure, the Fructus Gardeniae extract moisture absorption is violent, and the extract that causes just becoming fine powder lumps again; Even maintenance by every possible means the fine powder state of Fructus Gardeniae extract before preparation, in case enter in the substrate of vegetable oil, moment also can lump, the complex that adds a large amount of suspending agents or add several suspending agents still is difficult to improvement; After solution crossed colloid mill and grind homogenizing repeatedly, still the problems referred to above can appear after placing a period of time.Obviously, under the prior art aspect, the Yinzhi huang capsule of preparation quality good stability is difficult, and the method for teach literature can't solve the stability problem of the Yinzhi huang capsule with special nature.

Through a large amount of creationary exploratory experiments, the discovery that the inventor is surprised, add an amount of micropowder silica gel in the extract of soft capsule, can specifically, unexpectedly solve the existing problem of Yinzhi huang capsule.Therefore, the soft capsule that contains micropowder silica gel has constituted pith of the present invention, and the stable effect of promotion that those skilled in the art can't imagine has been played in micropowder silica gel just.

Micropowder silica gel (aerosil) has another name called silicon dioxide, is white or the high-purity anhydrous powder of milky, light weight, odorless, tasteless.At pharmaceutical field, micropowder silica gel Chang Zuowei lubricant and fluidizer use, and can reduce between the granule and the friction between granule and the manufacturing equipment, increase particulate flowability, guarantee that the individual weight differential of solid preparation is up to specification.Along with the large-scale development of quick releasing formulation in recent years, micropowder silica gel also often is used as disintegrating agent (perhaps auxiliary disintegrating agent) and uses, thereby because the quick disintegrate of its generation increases the dissolution of medicine.In addition, micropowder silica gel can also be used as anti-antagonistic agent, defoamer, clarifier, filter aid.Up to now, also nobody uses micropowder silica gel to improve with the stability problem of vegetable oil as the Yinzhi huang capsule of substrate.

As everyone knows, the Chinese medicine extract complicated component very easily reacts with some pharmaceutic adjuvant, shows as drug effect decline or detects the inaccurate of composition.And micropowder silica gel is single inorganic compound, without any therapeutical effect, stable in properties is inertia, not only can not reduce drug effect with the active component reaction in the yellow extract of mattress Cape jasmine, thereby can obtain better clinical effectiveness owing to having improved stability of formulation on the contrary; The simple adjuvant of this on the other hand definite ingredients helps guaranteeing that product microbiological contamination can not take place or goes mouldy, guarantee final products microbial limit.

The yellow extract of mattress Cape jasmine contains a large amount of flavones ingredients, for the oleaginous base of soft capsule field routine, these compositions show as more hydrophilic (being that water solublity is better), and hydrophilic composition is very easily separated from oleaginous base on the one hand, and macro manifestations is content generation sedimentation layering; Contain at least 10% moisture in the soft capsule skin on the other hand, the existence of these moisture can guide Flavonoid substances slowly to be transferred to the soft capsule Intradermal, thus the disintegrate that prolongs soft capsule with cross linking of gelatin; And the adding of micropowder silica gel can significantly improve the above-mentioned almost insurmountable problem that present Yinzhi huang capsule exists.

The inventor is in a large amount of groping in the experiment of the present invention, analyzing the mechanism of selecting quantitative micropowder silica gel obviously to improve the quality of Yinzhi huang capsule is: micropowder silica gel is because its specific surface area is big, have very strong adsorption, this adsorption comprises to oils and fats with to the absorption of moisture.

To greasy absorption: though micropowder silica gel is insoluble in water, but its hydrophilic is fine, hydrophilic micropowder silica gel is wrapped up the flavonoid active component fully, complex behind the parcel is the lubricant component in the adsorbing base again, thereby make this composite parts that constitutes by micropowder silica gel and the yellow extract of mattress Cape jasmine, stable existence in the soft capsule content that with the vegetable oil is substrate has been avoided the sedimentation layering.

Absorption to moisture: because the intensive adsorptivity of micropowder silica gel; especially to the absorption of moisture; make and in time adsorbed by micropowder silica gel by the moisture that enters in the content in capsule skin or the external environment; thereby restrain or reduced in the content flavones ingredient to the transfer of capsule shell; avoided soft capsule content is caused adverse effect, thus the disintegrate of having protected the intrinsic property of gelatin self to prolong soft capsule.

As the improvement of dosage form, the present invention finds through overtesting, selects the suitable proportioning of yellow extract of mattress Cape jasmine and micropowder silica gel, makes up then, can obtain the remarkable enhanced soft capsule of stability.For the selection of micropowder silica gel, the present invention has done a large amount of screening experiment, simultaneously with prior art be that the soft capsule of substrate compares test with simple vegetable oil.The part by weight of yellow extract of final definite active component mattress Cape jasmine and vegetable oil is 1: 0.05～5, preferred 1: 0.2～4, more preferably 1: 0.5～3; The part by weight of yellow extract of active component mattress Cape jasmine and micropowder silica gel is 1: 0.001～0.5, preferred 1: 0.003～0.3, more preferably 1: 0.004～0.2.

But, be not to need only micropowder silica gel is joined the optimum efficiency that just can reach test in the yellow suspension of mattress Cape jasmine.Test is found, the difference adding method of micropowder silica gel, and the poor stability of the suspension that is obtained is apart from remarkable.

After method 1, extract are pulverized, add and contain in the vegetable oil of suspending agent and micropowder silica gel;

Method 2, mix evenly with extract after, add and contain in the vegetable oil of suspending agent;

Method 3, with pulverize after extract mixes evenly after, adding contains in the vegetable oil of suspending agent;

Method 4, mix evenly with extract, the common back of pulverizing adds and contains in the vegetable oil of suspending agent; Above-mentioned Yinzhi huang capsule stability of sample is investigated and be the results are shown in following table

Sample	The extract moisture absorption	The suspension state	Suspension stability	The compacting situation
					Method 1	Seriously	Irregular colour is even, and a large amount of black patches is arranged	Layering is serious	Leakage of oil, layering are serious
Method 2	Moderate	Irregular colour is even, and stain is arranged	Layering	Leakage of oil is serious
					Method 3	Moderate	Irregular colour is even, and stain is arranged	Layering	Leakage of oil, layering
Method 4	Well	Color even, no block	Not stratified	Good stability

Favourable, after four kinds of extracts of mattress Cape jasmine Huang and micropowder silica gel be pre-mixed, be ground into fine powder again, join again in the vegetable oil that contains suspending agent, suspendible and homogeneous are in good condition.

The preparation method of above-mentioned Yinzhi huang capsule, comprising:

In the preparation stability that solves Yinzhi huang capsule, another object of the present invention is: prepare the Yinzhi huang capsule that clinical efficacy significantly improves.

The inventor attempts to adopt with active component, it is the method solution raising curative effect of medication problem that the yellow extract of mattress Cape jasmine carries out superfine powder, perhaps in the process of superfine powder raw material, suitably add the conventional means and the method that can increase curative effect of medication according to solid preparation, for example, with extract and surfactant or water soluble adjuvant superfine powder, sorbefacient surfactant such as sodium lauryl sulphate, sorbefacient water soluble adjuvant such as lactose, the particle diameter of the microgranule that obtains behind the ultra micro more than 90% all less than 5um; Adopting vegetable oil and Polyethylene Glycol respectively is that substrate prepares soft capsule, adopts Yinzhihuang oral liquid medicine in contrast; Carry out extracorporeal bacteria inhibitor test, 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.

Result of the test is as follows:

	The superfine powder composition	Soft capsule matrix
			Prescription one	Do not have	Polyethylene Glycol
Prescription two	Do not have	Vegetable oil
			Prescription three	Four kinds of extracts in the mattress Cape jasmine Huang	Polyethylene Glycol
Prescription four	Four kinds of extracts in the mattress Cape jasmine Huang	Vegetable oil
			Prescription five	Four kinds of extract+SDS-Na in the mattress Cape jasmine Huang	Polyethylene Glycol
Prescription six	Four kinds of extract+SDS-Na in the mattress Cape jasmine Huang	Vegetable oil

Prescription seven	Four kinds of extract+lactose in the mattress Cape jasmine Huang	Polyethylene Glycol
			Prescription eight	Four kinds of extract+lactose in the mattress Cape jasmine Huang	Vegetable oil
Prescription nine	Four kinds of extract+lactose+SDS-Na in the mattress Cape jasmine Huang	Polyethylene Glycol
			Prescription ten	Four kinds of extract+lactose+SDS-Na in the mattress Cape jasmine Huang	Vegetable oil
Write out a prescription 11	Four kinds of extract+micropowder silica gels in the mattress Cape jasmine Huang	Polyethylene Glycol
			Write out a prescription 12	Four kinds of extract+micropowder silica gels in the mattress Cape jasmine Huang	Vegetable oil

Result of the test:

With the Polyethylene Glycol be substrate Yinzhi huang capsule respectively organize almost indifference of sample extracorporeal bacteria inhibitor test, but all than test drugs compared Yinzhihuang oral liquid slightly a little less than.

The strong and weak order of the sample extracorporeal bacteria inhibitor test effect of respectively organizing that with the vegetable oil is the Yinzhi huang capsule of substrate is followed successively by: prescription 12＞prescription 6＞prescription 10 〉=contrast＞prescription 2=writes out a prescription 4＞writes out a prescription 8.

The soft capsule that with the Polyethylene Glycol is substrate is commonplace usually, it is the soft capsule of substrate that prior art once instructed us to adopt Polyethylene Glycol, can play the effect that is similar to solid dispersion, thereby increase substantially the curative effect of medicine, but for yellow this special active component of mattress Cape jasmine, above-mentioned instruction obviously is false.Result of the test shows: with the Polyethylene Glycol is the Yinzhi huang capsule of substrate, even extract superfine powder and the external antibacterial situation variation of adding surfactant is also little, compares with existing preparation, and effect is not progressive; On this basis, the Yinzhi huang capsule with Polyethylene Glycol substrate is not suitable for improving drug effect in the body substantially.Simultaneously, the Polyethylene Glycol that water solublity is very strong makes the as easy as rolling off a log moisture absorption caking of four kinds of extracts in the mattress Cape jasmine Huang, and the sample stability of preparation is poor, even it is still undesirable to add the very strong micropowder silica gel effect of water absorption.

From the result of above-mentioned test more as can be seen, the particularity and the complexity of four kinds of extract self components in the mattress Cape jasmine Huang on the one hand, 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; The Yinzhi huang capsule that the preparation effect of drugs is good under the aspect of prior art is difficult on the other hand: simultaneously because Polyethylene Glycol is a water-soluble base, with the composition in the soft capsule shell mutual dissolved ability is arranged, especially for the thin partially seam crossing of soft capsule shell, cause content constantly to leak; Just at 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.

Above-mentioned test shows: adding suitable favourable composition in the vegetable oil, can play the effect that significantly improves drug effect, is not absolute factor and extract is carried out superfine powder.But because sodium lauryl sulphate itself is alkalescence, be unfavorable for that the acid-base value of content and the soft capsule skin that is neutral slant acidity are consistent, the water solublity that while sodium lauryl sulphate itself presents also is unfavorable for solving the difficult problem of the extract moisture absorption.And, just might solve this difficult problem to being that the prescription of the Yinzhi huang capsule of substrate is tested with the vegetable oil.So the inventor is to being that the Yinzhi huang capsule of substrate has been made further creative preparation and explored with the vegetable oil, what adopt to add micropowder silica gel is that the sample extracorporeal bacteria inhibitor test effect of the Yinzhi huang capsule of substrate significantly strengthens with the vegetable oil, and this effect is that those skilled in the art are unpredictable.

With regard to simple vegetable oil substrate, when having solved problems such as present ubiquitous leakage of oil, content layering, also be faced with many difficulties, for example: prolonged disintegration, this difficult problem are insurmountable up to now difficult problems.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.

Through a large amount of creative experimental studies, unexpected surprised discovery of inventor, add an amount of micropowder silica gel in the soft capsule, not only can solve Yinzhi huang capsule poor stability, significantly improve the problem of drug effect, significantly reduced the disintegration time of Yinzhi huang capsule simultaneously, the beat all effect of bringing.

The inventor adopts the method for regulation under 2005 editions two relevant appendix items of Chinese Pharmacopoeia to carry out slaking test, the Yinzhi huang capsule that it is substrate that test specimen is respectively simple employing vegetable oil (sample A), and the Yinzhi huang capsule (sample B) that adopts the vegetable oil substrate that adds micropowder silica gel.The result is as follows in the sample slaking test:

Experimental condition

The sampling and measuring time (unit: month)

Test specimen

0

1

2

3

6

12

18

24

Accelerated test

37 ℃, the RH70% climatic chamber

Sample A

9 minutes

12 minutes

27 minutes

89 minutes

＞120 minutes

---

Sample B

12 minutes

16 minutes

19 minutes

37 minutes

79 minutes

---

The room temperature test

25 ℃, the RH60% climatic chamber

Sample A

10 minutes

13 minutes

20 minutes

36 minutes

＞120 minutes

---

Sample B

11 minutes

10 minutes

15 minutes

12 minutes

14 minutes

18 minutes

33 minutes

46 minutes

According to the product that scheme obtained of prior art instruction, the disintegrate in 3 months of 37 ℃ of accelerated tests is just defective, and the effect duration of prompting product is very short, substantially in 1 year; And room temperature test disintegrate in 6 months is defective; And adopting the disintegration time of product accelerated test in the time of 3 months that the present invention obtained to shorten fully near 1 hour than sample A, 25 degree room temperatures keep sample and can keep in 2 years disintegrate qualified.

Above-mentioned test data suffices to show that and adopts the product that the present invention obtained, and has solved long-term puzzlement those skilled in the art's a difficult problem, has obtained beyond thought technological break-through.

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.

Test is found, adding wetting agent in content can make the solid active agent in the soft capsule be more prone to mix fully with oleaginous base, in order to reach better effect, soft capsule of the present invention also contains wetting agent, described wetting agent is selected from phospholipid, the part by weight of yellow extract of mattress Cape jasmine and wetting agent is 1: 0.01～0.5, preferred 1: 0.02～2, more preferably 1: 0.03～0.1.Because phospholipid to the high temperature instability, so we have more optimized preparation technology on the basis of above-mentioned test, promptly guarantees the uniformity of whole solution, has increased the stability of phospholipid in the solution again.

Optimize following technology:

1) get Herba Artemisiae Scopariae extract, Fructus Gardeniae extract, Flos Lonicerae extract and four kinds of extracts of baicalin respectively, add micropowder silica gel, mix homogeneously is crushed to the fine powder that can cross 80 mesh sieves at least, and is as the yellow extract of mattress Cape jasmine, standby.

2) get vegetable oil, add suspending agent, heating makes its fusion, cool to 30～50 degree, add wetting agent again, stir, add the above-mentioned yellow extract fine powder of mattress Cape jasmine that contains micropowder silica gel, colloid mill is crossed in the back that stirs once more, 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), further verify the curative effect of medication of 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 7 groups at random, is respectively blank group (use normal saline), model group and test group (5 groups).

Trial drug:

Sample 1: commercially available Yinzhihuang oral liquid

Sample 2: after the yellow extract of mattress Cape jasmine (4 kinds of compositions) pulverizing, join the vegetable oil substrate that contains suspending agent, after stirring, the compacting soft capsule.

Sample 3: after the yellow extract of mattress Cape jasmine (4 kinds of compositions) pulverizing, join the vegetable oil substrate that contains suspending agent and micropowder silica gel, after stirring, the compacting soft capsule.

Sample 4: after the yellow extract of mattress Cape jasmine (4 kinds of compositions) pulverizing,, add the vegetable oil substrate that contains suspending agent again, stir the compacting soft capsule with the micropowder silica gel mix homogeneously.

Sample 5: with yellow extract (4 kinds of compositions) of mattress Cape jasmine and micropowder silica gel mix homogeneously, after the pulverizing, add again and contain in the vegetable oil substrate of suspending agent, stir the compacting soft capsule.

Result of the test: compare 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 5＞sample 4＞sample 1＞sample 2=sample 3.

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) to adding the vegetable oil substrate that contains suspending agent, after stirring, is suppressed soft capsule.

Sample 2: with yellow extract (4 kinds of compositions) of mattress Cape jasmine and micropowder silica gel mix homogeneously, after the pulverizing, add again and contain in the vegetable oil substrate of 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.

At pharmaceutical field, micropowder silica gel is because its structure is clear and definite and be inertia and do not have any activity and therapeutical effect, and is widely used, and Chang Zuowei lubricant and fluidizer use, and also often are used as disintegrating agent (perhaps auxiliary disintegrating agent) in recent years to use; Though above-mentioned argumentation is according to abundant, but up to now, also nobody uses micropowder silica gel to improve with the stability problem of vegetable oil as the Yinzhi huang capsule of substrate, in order further to eliminate the worry of the public for the safety of micropowder silica gel, the inventor has done the toxicity test of Yinzhi huang capsule with the checking security of products.

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, no abnormal performance and dead the generation.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 with other peroral dosage forms with Yinzhihuang oral liquid, (cover the scorching clean serious bitterness of extract of basin having reached many advantages of soft capsule, loading amount is accurate, appearance looks elegant and steady quality, be easy to take and carry or the like) in addition, 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 by 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/ day.

The yellow extract of active component in the extract among the present invention---mattress Cape jasmine is the yellow extract of mattress Cape jasmine that meets the Chinese medicine ministry standard, and the yellow extract of described mattress Cape jasmine can prepare voluntarily, also can sell by the merchant and buy.

Select as another kind, the yellow extract dry powder of mattress Cape jasmine also can keep smaller particle size to satisfy the dissolution requirement as far as possible in the soft capsule of the present invention, for example reaches the purpose of quick stripping by superfine powder.

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 disagreeable taste of mattress Cape jasmine Huang fully, can also improve the taste of Chinese medicine preparation, and quantitatively accurately, even also can be easily under anhydrous situation,, have significantly improved the compliance of patient to treatment without any the administration of uncomfortable ground.

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.Described Herba Artemisiae Scopariae extract, Fructus Gardeniae extract, Flos Lonicerae extract and four kinds of extracts of baicalin can prepare voluntarily, also can sell by the merchant and buy.

Soft capsule content:

Described inclusions is meant the active component in the soft capsule (or claim soft gelatin capsule) and/or is carried on 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 preparation method of Yinzhi huang capsule, can adopt this area conventional method, for example pressing or dropping preparation method (drop pill method).

Soft capsule rubber adopts disclosed composition of handbook and compound method, except glue, plasticizer and 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, decoct with water three times, 1.5 hours for the first time, second, third time each 1 hour, collecting decoction filters, and filtrate is concentrated into every ml and contains crude drug 2g, adding ethanol makes pure content reach 70%, cold preservation 24 hours filters, and filtrate recycling ethanol extremely every ml contains crude drug 5g, adding ethanol again makes pure content reach 85%, cold preservation 24 hours filters, and filtrate recycling ethanol extremely every ml contains crude drug 10g, add the about 5 times of amounts of water, cold preservation 48 hours filters, and filtrate is condensed into the thick paste shape, vacuum drying promptly gets Herba Artemisiae Scopariae extract.

The preparation of Fructus Gardeniae extract: get Fructus Gardeniae, be ground into coarse powder, decoct with water three times, first and second time each 1 hour, 0.5 hour for the third time, collecting decoction, filter, filtrate 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, filtrate 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, decoct with water three times, each 1 hour, collecting decoction filters, and filtrate is heated to 80 ℃, adds hydrochloric acid and regulates pH1～2, leave standstill, filter, precipitate adds 2 times of water gagings and stirs into pasty state, adds 40% sodium hydroxide and regulates pH6.5～7, filter, filtrate adds equivalent ethanol, is heated to 80 ℃, add hydrochloric acid and regulate 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 decocts with water secondary, each 1 hour, collecting decoction filters, and filtrate is concentrated into every ml and contains crude drug 2g, be chilled to 45～60 ℃, add 20～40% aqua calcises and regulate pH value to 12, filter, precipitate adds 2 times of amount ethanol, leaves standstill, and adds 50% sulphuric acid and regulates pH value to 3.0～4.0, filter, filtrate adds 40% sodium hydroxide solution and regulates pH value to 6.5～7.0, reclaims 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: 0.245g

Micropowder silica gel: 0.05g

Cera Flava: 0.005g

Hydrogenated palm oil: 0.01g

Soybean phospholipid: 0.008g

Make 1 (0.65g)

Preparation technology

Get Herba Artemisiae Scopariae extract, Fructus Gardeniae extract, baicalin and Flos Lonicerae extract among the embodiment 1, add the recipe quantity micropowder silica gel, behind the mix homogeneously, be crushed to the fine powder that can cross 200 mesh sieves at least, standby.

Get the soybean oil of recipe quantity, add Cera Flava and hydrogenated palm oil, heating makes the suspending agent fusion, stirs, and cools to 35 degree, adds soybean phospholipid, stirs; Add the fine powder of the yellow extract of the above-mentioned mattress Cape jasmine that is mixed with micropowder silica gel, stir 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: 0.35g

Micropowder silica gel: 0.01g

Cera Flava: 0.02g

Hydrogenated coconut oil: 0.02g

Soybean phospholipid: 0.02g

Make 1 (0.75g)

Preparation technology

Get Herba Artemisiae Scopariae extract, Fructus Gardeniae extract, baicalin and Flos Lonicerae extract among the embodiment 1, add the recipe quantity micropowder silica gel, behind the mix homogeneously, be crushed to the fine powder that can cross 180 mesh sieves at least, standby.

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 50 degree, adds soybean phospholipid, stirs; Add the fine powder of the yellow extract of the above-mentioned mattress Cape jasmine that is mixed with micropowder silica gel, stir 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: 0.325g

Micropowder silica gel: 0.005g

Cera Flava: 0.05g

Hydrogenated palm oil: 0.05g

Make 1 (0.65g)

Preparation technology

Get Herba Artemisiae Scopariae extract, Fructus Gardeniae extract, baicalin and Flos Lonicerae extract among the embodiment 1, add the recipe quantity micropowder silica gel, behind the mix homogeneously, be crushed to the fine powder that can cross 120 mesh sieves at least, standby.

Get the Semen Maydis oil of recipe quantity, add Cera Flava and hydrogenated palm oil, heating makes the suspending agent fusion, adds the above-mentioned fine powder that is mixed with the yellow extract of mattress Cape jasmine of micropowder silica gel, stir, the mistake 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: 0.23g

Micropowder silica gel: 0.015g

Cera Flava: 0.02g

Hydrogenated rapeseed oil: 0.02g

Make 1 (0.45g)

Preparation technology

Get Herba Artemisiae Scopariae extract, Fructus Gardeniae extract, baicalin and Flos Lonicerae extract among the embodiment 1, add the recipe quantity micropowder silica gel, behind the mix homogeneously, be crushed to the fine powder that can cross 100 mesh sieves at least, standby.

Get the soybean oil of recipe quantity, add Cera Flava and hydrogenated rapeseed oil, heating makes the suspending agent fusion, stirs, add the above-mentioned fine powder that is mixed with the yellow extract of mattress Cape jasmine of micropowder silica gel, stir 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: 0.24g

Micropowder silica gel: 0.01g

Cera Flava: 0.007g

Hydrogenated coconut oil: 0.01g

Make 1 (0.4g)

Preparation technology

Get Herba Artemisiae Scopariae extract, Fructus Gardeniae extract, baicalin and Flos Lonicerae extract among the embodiment 1, add the recipe quantity micropowder silica gel, behind the mix homogeneously, be ground into micropowder, its granularity more than 90% all less than 10um, standby.

Get the soybean oil of recipe quantity, add Cera Flava and hydrogenated coconut oil, heating makes the suspending agent fusion, adds the above-mentioned fine powder that is mixed with the yellow extract of mattress Cape jasmine of micropowder silica gel, stir, the mistake 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: 0.3g

Micropowder silica gel: 0.0065

Cera Flava: 0.0535g

Hydrogenated palm oil: 0.04g

Soybean phospholipid: 0.017g

Make 1 (0.55g)

Preparation technology

Get the soybean salad oil of recipe quantity, add Cera Flava and hydrogenated palm oil, heating makes the suspending agent fusion, stirs, and cools to 50 degree, adds soybean phospholipid, stirs; Add the fine powder of the yellow extract of the above-mentioned mattress Cape jasmine that is mixed with micropowder silica gel, stir 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

Semen Maydis oil: 0.3g

Micropowder silica gel: 0.005g

Cera Flava: 0.05g

Hydrogenated coconut oil: 0.05g

Soybean phospholipid: 0.03g

Make 1 (0.6g)

Preparation technology

Get Herba Artemisiae Scopariae extract, Fructus Gardeniae extract, baicalin and Flos Lonicerae extract among the embodiment 1, add the recipe quantity micropowder silica gel, behind the mix homogeneously, be crushed to the fine powder that can cross 150 mesh sieves at least, standby.

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, adds soybean phospholipid, stirs; Add the fine powder of the yellow extract of the above-mentioned mattress Cape jasmine that is mixed with micropowder silica gel, stir 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: 0.288g

Micropowder silica gel: 0.005g

Glyceryl monostearate: 0.01g

Hydrogenated palm oil: 0.01g

Soybean phospholipid: 0.015g

Make 1 (0.55g)

Preparation technology

Get Herba Artemisiae Scopariae extract, Fructus Gardeniae extract, baicalin and Flos Lonicerae extract among the embodiment 1, add the recipe quantity micropowder silica gel, behind the mix homogeneously, be crushed to the fine powder that can cross 80 mesh sieves at least, standby.

Get the Oleum Brassicae campestris of recipe quantity, add glyceryl monostearate and hydrogenated palm oil, heating makes the suspending agent fusion, stirs, and cools to 50 degree, adds soybean phospholipid, stirs; Add the fine powder of the yellow extract of the above-mentioned mattress Cape jasmine that is mixed with micropowder silica gel, stir 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: 0.18g

Micropowder silica gel: 0.001g

Glyceryl monostearate: 0.048g

Make 1 (0.45g)

Preparation technology

Get Herba Artemisiae Scopariae extract, Fructus Gardeniae extract, baicalin and Flos Lonicerae extract among the embodiment 1, add the recipe quantity micropowder silica gel, behind the mix homogeneously, be crushed to the fine powder that can cross 220 mesh sieves at least, standby.

Get the salad oil of recipe quantity, add glyceryl monostearate, heating makes the suspending agent fusion, adds the above-mentioned fine powder that is mixed with the yellow extract of mattress Cape jasmine of micropowder silica gel, stir, the mistake 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: 0.316g

Micropowder silica gel: 0.05g

Hydrogenated palm oil: 0.013g

Lecithin: 0.01g

Make 1 (0.5g)

Preparation technology

Get Herba Artemisiae Scopariae extract, Fructus Gardeniae extract, baicalin and Flos Lonicerae extract among the embodiment 1, add micropowder silica gel, mixed evenly after, be ground into micropowder, its granularity more than 90% all less than 5um, standby.

Get the Semen Maydis oil of recipe quantity, add hydrogenated palm oil, heating makes the suspending agent fusion, stirs, and cools to 45 degree, adds lecithin, stirs; Add the fine powder of the yellow extract of the above-mentioned mattress Cape jasmine that is mixed with micropowder silica gel, stir 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

Soybean oil and salad oil: 0.32g

Micropowder silica gel: 0.05g

Cera Flava: 0.005g

Hydrogenated coconut oil: 0.005g

Soybean phospholipid: 0.005g

Make 1 (0.55g)

Preparation technology

Get Herba Artemisiae Scopariae extract, Fructus Gardeniae extract, baicalin and Flos Lonicerae extract among the embodiment 1, add the recipe quantity micropowder silica gel, behind the mix homogeneously, be crushed to the fine powder that can cross 250 mesh sieves at least, standby.

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 40 degree, adds soybean phospholipid, stirs; Add the fine powder of the yellow extract of the above-mentioned mattress Cape jasmine that is mixed with micropowder silica gel, stir 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

Soybean salad oil: 0.4g

Micropowder silica gel: 0.007g

Cera Flava: 0.01g

Hydrogenated coconut oil: 0.017g

Make 1 (0.6g)

Preparation technology

Get the soybean salad oil of recipe quantity, add Cera Flava and hydrogenated coconut oil, heating makes the suspending agent fusion, add the above-mentioned fine powder that is mixed with the yellow extract of mattress Cape jasmine of micropowder silica gel, stir, cross colloid mill, if bubble is arranged, add defoamer in right amount after, be pressed into soft capsule.

Embodiment 14

Herba Artemisiae Scopariae extract: 0.03

Fructus Gardeniae extract: 0.016g

Baicalin: 0.1g

Flos Lonicerae extract: 0.02g

Soybean salad oil: 0.16g

Micropowder silica gel: 0.045g

Cera Flava: 0.01g

Hydrogenated coconut oil: 0.02g

Make 1 (0.4g)

Preparation technology

Get Herba Artemisiae Scopariae extract, Fructus Gardeniae extract, baicalin and Flos Lonicerae extract among the embodiment 1, add the recipe quantity micropowder silica gel, behind the mix homogeneously, be ground into micropowder, its granularity more than 90% all less than 5um, standby.

Embodiment 15

Herba Artemisiae Scopariae extract: 0.02g

Fructus Gardeniae extract: 0.01067g

Baicalin: 0.0667g

Flos Lonicerae extract: 0.0133g

Salad oil: 0.21g

Micropowder silica gel: 0.005g

Cera Flava: 0.01g

Hydrogenated palm oil: 0.01g

Fabaceous lecithin: 0.005g

Make 1 (0.35g)

Preparation technology

Get Herba Artemisiae Scopariae extract, Fructus Gardeniae extract, baicalin and Flos Lonicerae extract among the embodiment 1, add the recipe quantity micropowder silica gel, behind the mix homogeneously, be crushed to the fine powder that can cross 280 mesh sieves at least, standby.

Get the salad oil of recipe quantity, add Cera Flava and hydrogenated palm oil, heating makes the suspending agent fusion, stirs, and cools to 50 degree, adds fabaceous lecithin, stirs; Add the fine powder of the yellow extract of the above-mentioned mattress Cape jasmine that is mixed with micropowder silica gel, stir 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

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, micropowder silica gel and suspending agent, the yellow extract of described mattress Cape jasmine: vegetable oil: micropowder silica gel: the suspending agent part by weight is 1: 0.05～5: 0.001～0.5: 0.03～1.

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: micropowder silica gel: the suspending agent part by weight is 1: 0.2～4: 0.003～0.3: 0.05～0.8.

4. as 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, decoct with water, collecting decoction filters, and filtrate 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, filtrate concentrates, and drying promptly gets Herba Artemisiae Scopariae extract;

The preparation of Fructus Gardeniae extract: get Fructus Gardeniae, be ground into coarse powder, decoct with water, collecting decoction filters, after filtrate concentrates, add ethanol, filter after the cold preservation, filtrate recycling ethanol, add ethanol again, filter after the cold preservation, filtrate recycling ethanol, add cold preservation behind the water, filter, filtrate concentrates, drying promptly gets Fructus Gardeniae extract;

The preparation of baicalin: get Radix Scutellariae, be ground into coarse powder, decoct with water, collecting decoction, filter, the filtrate heating adds hydrochloric acid and regulates pH value, leaves standstill, filter, precipitate adds water and stirs into pasty state, and hydro-oxidation sodium is regulated pH value, filter, filtrate adds ethanol, heating, add hydrochloric acid and regulate pH value, astragaloside is separated out, filter, use washing with alcohol, drying gets astragaloside;

5. as each described Yinzhi huang capsule of claim 1～3, wherein said vegetable oil 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.

6. as 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.

7. as each described Yinzhi huang capsule of claim 1～3, this soft capsule also contains wetting agent, and described wetting agent is a phospholipid, and wherein, the part by weight of yellow extract of mattress Cape jasmine and wetting agent is 1: 0.01～0.5.

8. as the preparation method of claim 1～3 Yinzhi huang capsule as described in each, it is characterized by:

1) get Herba Artemisiae Scopariae extract, Fructus Gardeniae extract, Flos Lonicerae extract and four kinds of extracts of baicalin respectively, add micropowder silica gel, mix, be crushed to the fine powder that can cross 80 mesh sieves at least, standby as the yellow extract of mattress Cape jasmine,

2) get vegetable oil, add suspending agent, its fusion of heating suspending agent adds the above-mentioned fine powder that contains the yellow extract of mattress Cape jasmine of micropowder silica gel, stirs, and crosses colloid mill, if be pressed into soft capsule after having bubble to add defoamer.

9. the preparation method of the described Yinzhi huang capsule of claim 8 is characterized by:

1) get Herba Artemisiae Scopariae extract, Fructus Gardeniae extract, Flos Lonicerae extract and four kinds of extracts of baicalin respectively, add micropowder silica gel, mix homogeneously is crushed to and can crosses 80 mesh sieve fine powders at least, mixes, and is standby as the yellow extract of mattress Cape jasmine,

2) get vegetable oil, add suspending agent, heating makes the suspending agent fusion, stirs, and cools to 30～50 degrees centigrade, add wetting agent, after stirring, add the above-mentioned fine powder that contains the yellow extract of mattress Cape jasmine of micropowder silica gel, stir once more, cross colloid mill, if be pressed into soft capsule after having bubble to add defoamer.