CN101204447B - Anti-hepatitis-jaundice soft capsule and preparation method thereof - Google Patents

Abstract

The invention provides a 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 5 per cent -85 per cent 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

A kind of Yinzhi huang capsule 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

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 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 defective of clinical these dosage forms makes 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, seemingly address the above problem good method.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 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 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.

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 a large amount of uses 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.

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, 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, liquid Paraffin, suspending agent, surfactant; The yellow extract of mattress Cape jasmine wherein: vegetable oil: liquid Paraffin: suspending agent: the part by weight of surfactant is 1: 0.05～5: 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, hydrogenated palm oil, 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 hydrogenated palm oil.

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 mattress Cape jasmine and liquid Paraffin is 1: 0.05～5, preferred 1: 0.08～3, more preferably 1: 0.1～2.

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 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.

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, standby.

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 and liquid Paraffin, 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, standby.

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 and liquid Paraffin, 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, 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, standby.

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 and liquid Paraffin, 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 standby mattress Cape jasmine also can use earlier and behind the micropowder silica gel mix homogeneously.

It can be single-matrixes such as vegetable oil, Polyethylene Glycol that prior art is instructed the substrate of our soft capsule, 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 has 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 constituent in the soft capsule shell mutual dissolved ability is arranged, especially the seam crossing that approaches partially for soft capsule shell causes 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.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 there are 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 rationally screen suspending agent and overcome, and for example discuss " the soft capsule oil impregnate problem that improvement contains Chinese medicine extract " in the document; 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 simple a large amount of vegetable oil 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.

Through a large amount of creationary exploratory experiments, the inventor finds, adds an amount of liquid Paraffin in the soft capsule, can specifically, unexpectedly solve the existing problem of Yinzhi huang capsule.Therefore, the soft capsule that contains liquid Paraffin has constituted pith of the present invention, and just this composite interstitial substance of liquid Paraffin and vegetable oil has played the mutual promoting action that those skilled in the art can't imagine.The inventor is in a large amount of groping in the experiment of the present invention, analyzing the mechanism of selecting quantitative liquid wax obviously to improve the quality of Yinzhi huang capsule is: 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 contain at least 10% moisture in the soft capsule skin, 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; The adding of liquid Paraffin has changed the character of content, content and capsule shell intermediate formation layer protecting film, stop or delayed the transfer of flavones ingredient to capsule shell, 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 yellow extract of suitable mattress Cape jasmine and vegetable oil, and the suitable proportioning of yellow extract of mattress Cape jasmine and liquid Paraffin, makes up then, can obtain the remarkable enhanced soft capsule of stability.And can significantly reduce because a large amount of use counter productive that vegetable oil brought.

For choice of base, 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: 0.5～2; The part by weight of yellow extract of active component mattress Cape jasmine and liquid Paraffin is 1: 0.05～5, preferred 1: 0.08～3, more preferably 1: 0.1～2.

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 to adopt vegetable oil and liquid Paraffin mixture be the Yinzhi huang capsule (sample B) of composite interstitial substance.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

10 clocks

15 minutes

32 minutes

97 minutes

＞120 minutes

---

---

---

Sample B

8 clocks

12 minutes

16 minutes

35 minutes

69 minutes

---

---

---

The room temperature test

25 ℃, the RH60% climatic chamber

Sample A

10 clocks

11 minutes

19 minutes

38 minutes

74 minutes

＞120 minutes

---

---

Sample B

8 clocks

12 minutes

13 minutes

17 minutes

15 minutes

20 minutes

41 minutes

55 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.But pharmacodynamics test shows: the product of composite interstitial substance preparation is compared with the Yinzhi huang capsule that with the vegetable oil is substrate merely, 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 test of process is groped and is screened, the discovery that the inventor is surprised, and the adding of surfactant tween has obtained unexpected effect, has significantly improved the effect of drugs of Yinzhi huang capsule.

Tween is counted as wetting agent in the soft capsule field always, and using method is usually in soft capsule: earlier suspending agent and wetting agent 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 preparation method becomes and well known to a person skilled in the art technology general knowledge.

Find in the test, Zhi Bei Yinzhi huang capsule 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 immediately and contain the vegetable oil of suspending agent and the composite interstitial substance of liquid Paraffin, 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 and contain the vegetable oil of suspending agent and the composite interstitial substance of liquid Paraffin, 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 and contain the vegetable oil of suspending agent and the composite interstitial substance of liquid Paraffin, 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 and contain the vegetable oil of suspending agent and the composite interstitial substance of liquid Paraffin, 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 and contain the vegetable oil of suspending agent and the composite interstitial substance of liquid Paraffin, 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, standby.

2) get tween, add above-mentioned raw materials, fully mixed to few 20 minutes, as stock solution A.

3) get vegetable oil and liquid Paraffin, 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 after, if after having bubble to add defoamer, be pressed into soft capsule.

In content, add wetting agent, can make that solid active agent and oleaginous base in the soft capsule is easier to be mixed fully, 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 using method and setup time among the present invention, and the unique effect of being brought into play in soft capsule 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 and contain the vegetable oil of suspending agent and the composite interstitial substance of liquid Paraffin, stir.

Sample preparation methods 2: the yellow extract of mattress Cape jasmine is distributed to earlier in the tween solution, stirred 30 minutes, add and contain the vegetable oil of suspending agent and the composite interstitial substance of liquid Paraffin, 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 composite interstitial substance 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 preparation method 3 preparations, and the effect of drugs of acquisition is more unexpected, and external bacteriostatic activity improves 9% than sample 1 and 2

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, standby.

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 and liquid Paraffin, 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 substrate) 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 entire content; And if among the present invention the use amount of tween be lower than substrate weight 6% (for guarantee the experiment and clinical therapeutic efficacy, preferably 8～25%), 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, the purpose difference, 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 preparation method 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 the fine powder that can cross 80 mesh sieves at least, mix homogeneously as the yellow extract of mattress Cape jasmine, adds micropowder silica gel, mixes, and is standby.

2) get the homogeneous mixture solotion of tween and phospholipid, add above-mentioned raw materials, fully mixed to few 20 minutes, as stock solution A.

3) get vegetable oil and liquid Paraffin, 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.

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: 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 joined the vegetable oil that contains suspending agent and the composite interstitial substance of liquid Paraffin, after stirring, the compacting soft capsule.

Sample 4: the yellow extract of mattress Cape jasmine (4 kinds of compositions) is distributed to earlier in the tween solution, stirred 30 minutes, add and contain the vegetable oil of suspending agent and the composite interstitial substance of liquid Paraffin, stir, the compacting soft capsule.

Sample 5: 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, will contain the vegetable oil of suspending agent and the composite interstitial substance of liquid Paraffin again and add wherein, stir, suppress 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 5＞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) to adding the vegetable oil substrate that contains suspending agent, after stirring, is suppressed 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 and contain the vegetable oil of suspending agent and the composite interstitial substance of liquid Paraffin, 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.

The medicine that liquid Paraffin records as 2005 editions pharmacopeia, be described to a kind ofly can cause the diarrheal active component, and be applied in clinically in a large number widely as national medical care insurance kind, its usage and dosage must reach each 10～30 milliliters, just can bring into play the effect that becomes cathartic.Even the substrate among the present invention all is liquid Paraffin, the single use amount can not surpass 2ml at most, and low like this use amount can not cause diarrhoea.

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, 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 and liquid Paraffin, 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 substrate 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, 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 the yellow granule of mattress Cape jasmine, (cover the serious bitterness of the yellow extract of mattress Cape jasmine 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 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

The yellow extract of mattress Cape jasmine promptly is an active component among the present invention in context, and 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, weight ratio 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 known composition 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: be ground into coarse powder, decoct with water three times, each 1 hour, collecting decoction, filter, filtrate is heated to 80 ℃, adds hydrochloric acid and regulates pH1～2, leaves 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: 0.11g

Liquid Paraffin: 0.11g

Tween 80: 0.05g

Cera Flava: 0.02g

Hydrogenated palm oil: 0.02g

Soybean phospholipid: 0.008g

Make 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 at least, 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 liquid Paraffin of recipe quantity, add Cera Flava and hydrogenated palm 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 3:

Herba Artemisiae Scopariae extract: 0.06g

Fructus Gardeniae extract: 0.032g

Baicalin: 0.2g

Flos Lonicerae extract: 0.04g

Semen Maydis oil: 0.23g

Liquid Paraffin: 0.08g

Tween 80: 0.04g

Cera Flava: 0.04g

Hydrogenated coconut oil: 0.01g

Soybean phospholipid: 0.02g

Make 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 at least, 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 and the liquid Paraffin 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: 0.135g

Liquid Paraffin: 0.175g

Tween 80: 0.02g

Cera Flava: 0.07g

Hydrogenated palm oil: 0.03g

Make 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 at least, 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 Semen Maydis oil and the liquid Paraffin of recipe quantity, add Cera Flava and hydrogenated palm oil, 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: 0.165g

Liquid Paraffin: 0.04g

Tween 80: 0.04g

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, be ground into the fine powder that to cross 100 mesh sieves at least, 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 soybean oil and the liquid Paraffin 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: 0.20g

Liquid Paraffin: 0.01g

Tween 80: 0.02g

Cera Flava: 0.017g

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, be ground into micropowder, its granularity more than 90% all less than 10um, 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 soybean oil and the liquid Paraffin 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

Salad oil: 0.08g

Liquid Paraffin: 0.19g

Tween 80: 0.03g

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 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 at least, add micropowder silica gel, behind the mix homogeneously, in 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 and the liquid Paraffin of recipe quantity, add Cera Flava and hydrogenated palm 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 8

Herba Artemisiae Scopariae extract: 0.03g

Fructus Gardeniae extract: 0.016g

Baicalin: 0.1g

Flos Lonicerae extract: 0.02g

Semen Maydis oil: 0.065g

Liquid Paraffin: 0.2g

Tween 80: 0.038g

Cera Flava: 0.05g

Hydrogenated palm oil: 0.05g

Soybean phospholipid: 0.03g

Make 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 at least, 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 and the liquid Paraffin of recipe quantity, add Cera Flava and hydrogenated palm 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: 0.195g

Liquid Paraffin: 0.035g

Tween 80: 0.065g

Glyceryl monostearate: 0.01g

Hydrogenated palm oil: 0.01g

Soybean phospholipid: 0.015g

Make 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 at least, 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 recipe quantity Oleum Brassicae campestris and liquid Paraffin, add glyceryl monostearate and hydrogenated palm oil, 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: 0.1g

Liquid Paraffin: 0.065g

Tween 80: 0.014g

Glyceryl monostearate: 0.05g

Make 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 200 mesh sieves at least, 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 and the liquid Paraffin 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: 0.278g

Liquid Paraffin: 0.03g

Tween 80: 0.058g

Hydrogenated palm oil: 0.013g

Lecithin: 0.01g

Make 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 and the liquid Paraffin of recipe quantity, add hydrogenated palm 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 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: 0.34g

Liquid Paraffin: 0.03g

Tween 80: 0.022g

Cera Flava: 0.02g

Hydrogenated coconut oil: 0.01g

Soybean phospholipid: 0.003g

Make 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 at least, adding micropowder silica gel mixes, 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 soybean oil, salad oil and the liquid Paraffin 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: 0.01g

Soybean salad oil: 0.14g

Liquid Paraffin: 0.03g

Tween 80: 0.024g

Cera Flava: 0.015g

Hydrogenated coconut oil: 0.015g

Make 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 250 mesh sieve fine powders at least, adding micropowder silica gel mixes, join in the recipe quantity tween 80, fully disperse to stir, jitter time must not be less than 20 minutes, as stock solution 1.

Get the soybean salad oil and the liquid Paraffin 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

Soybean salad oil: 0.21g

Liquid Paraffin: 0.033g

Tween 80: 0.021g

Cera Flava: 0.01g

Hydrogenated palm oil: 0.01g

Fabaceous lecithin: 0.005g

Make 1 (0.4g)

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 250 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 salad oil and the liquid Paraffin of recipe quantity, add Cera Flava and hydrogenated palm 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.

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 improve and variation can not depart from category of the present invention and spirit in this open embodiment.

Claims (8)

1. Yinzhi huang capsule, the content that it is characterized in that this soft capsule is by the yellow extract of mattress Cape jasmine, vegetable oil, liquid Paraffin, suspending agent and surfactant are formed, and the yellow extract of described mattress Cape jasmine: vegetable oil: liquid Paraffin: suspending agent: the part by weight of surfactant is 1: 0.05～5: 0.05～5: 0.03～1: 0.01～1; The percentage by weight that the yellow extract of wherein said mattress Cape jasmine accounts for content is 12～67%; The yellow extract of mattress Cape jasmine is made up of Herba Artemisiae Scopariae extract, Fructus Gardeniae extract, baicalin and Flos Lonicerae extract, and weight ratio is 1.5: 0.8: 5: 1;

The yellow extract of wherein said mattress Cape jasmine is made up of 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;

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.

2. Yinzhi huang capsule as claimed in claim 1, the wherein yellow extract of mattress Cape jasmine: vegetable oil: liquid Paraffin: suspending agent: the part by weight of surfactant is 1: 0.2～4: 0.08～3: 0.05～0.8: 0.02～0.8.

3. Yinzhi huang capsule as claimed in claim 1, wherein said vegetable oil are 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, the Oleum Brassicae campestris.

4. Yinzhi huang capsule as claimed in claim 1, wherein said suspending agent are 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, mixed fatty glycerides, sucrose fatty acid ester, micropowder silica gel.

5. Yinzhi huang capsule according to claim 1, wherein said surfactant is selected from tween.

6. Yinzhi huang capsule, the content that it is characterized in that this soft capsule is by the yellow extract of mattress Cape jasmine, vegetable oil, liquid Paraffin, suspending agent, surfactant and wetting agent are formed, and the yellow extract of described mattress Cape jasmine: vegetable oil: liquid Paraffin: suspending agent: surfactant: the part by weight of wetting agent is 1: 0.05～5: 0.05～5: 0.03～1: 0.01～1: 0.01～0.5; The percentage by weight that the yellow extract of wherein said mattress Cape jasmine accounts for content is 12～67%; The yellow extract of mattress Cape jasmine is made up of Herba Artemisiae Scopariae extract, Fructus Gardeniae extract, baicalin and Flos Lonicerae extract, and weight ratio is 1.5: 0.8: 5: 1;

The yellow extract of wherein said mattress Cape jasmine is made up of 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;

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.

7. the preparation method of Yinzhi huang capsule according to claim 1 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, standby;

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 and liquid Paraffin, 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.

8. as the preparation method of Yinzhi huang capsule as described in the claim 6, it is characterized by:

1) get the yellow extract of mattress Cape jasmine, be crushed to the fine powder that can cross 80 mesh sieves at least, add micropowder silica gel, mix, as the yellow extract of mattress Cape jasmine, standby;

2) get tween and wetting agent,, fully mixed to few 20 minutes, as stock solution A with above-mentioned standby fine powder;

3) get vegetable oil and liquid Paraffin, 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, after stirring, cross colloid mill and be pressed into soft capsule.