CN104740230A - Silky fowl soft capsule and preparation method thereof - Google Patents

Abstract

The invention relates to a silky fowl soft capsule and a preparation method thereof. The silky fowl soft capsule is prepared by: subjecting, by weight, 50-60 parts of a silky fowl extract, 100-110 parts of deerhorn glue, 50-60 parts of vinegar processed turtle shell, 30-50 parts of calcined oyster, 50-60 parts of Mantis Egg-case, 100-110 parts of ginseng, 20-30 parts of astragalus, 120-130 parts of Chinese angelica, 100-110 parts of Radix Paeoniae Alba, 100-110 parts of vinegar processed cyperus rotundus, 50-60 parts of radix asparagi, 20-30 parts of licorice, 200-220 parts of rehmannia glutinosa, 200-220 parts of Radix Rehmanniae Preparata, 50-60 parts of Ligusticum wallichii, 20-30 parts of Radix Stellariae, 100-110 parts of Salvia Miltiorrhiza, 100-110 parts of Chinese yam, 50-60 parts of fried Euryale ferox, and 30-50 parts of Cornu Cervi Degelatinatum to extraction and adding appropriate auxiliary materials.

Description

A kind of Wujibaifeng soft capsule and preparation method thereof

Technical field

The invention belongs to technical field of Chinese medicines, especially relate to a kind of Chinese medicinal soft capsule and preparation method thereof.

Background technology

WUJI BAIFENG WAN originates from Imperial Medical Service of the Ming Dynasty and compiles " Prescriptions for Universal Relief ", and Qing Dynasty imperial palace imperial physician is improved to WUJI BAIFENG WAN, and modern age is named mainly with WUJI BAIFENG WAN.WUJI BAIFENG WAN prescription composition changes greatly, and has multiple prescription, the Tongren Wujibaifeng Pills that the contained WUJI BAIFENG WAN of " Chinese Pharmacopoeia " 2010 editions, ministry standard are contained, 12 WUJI BAIFENG WAN, Wuji Baifen pian, WUJI BAIFENG capsule etc.WUJI BAIFENG WAN is made up of two Ten Herbs such as Gallus Domesticus, Radix Ginseng, the Radix Paeoniae Alba, Radix Salviae Miltiorrhizae, Radix Angelicae Sinensis, Rhizoma Cyperis, with blackbone Chicken benefiting QI and nourishing blood, and principal agent in the enriching yin and nourishing kidney side of being; Compatibility Radix Ginseng, the Radix Astragali, Rhizoma Dioscoreae, QI invigorating; Radix Angelicae Sinensis, Radix Rehmanniae Preparata, Rhizoma Chuanxiong, the Radix Paeoniae Alba, Radix Salviae Miltiorrhizae, nourshing blood and promoting blood circulation; Colla cornus cervi, temperature male wind-supplying kidney, beneficial intensive culture blood; Other first, nourishing YIN for suppressing the hyperactive YANG, the Radix Rehmanniae, Radix Asparagi, the moon of liver and kidney tonifying; Dissolving lump and resolving mass; Rhizoma Cyperi, depressed liver-energy dispersing and QI regulating, menstruction regulating and pain relieving; Ootheca Mantidis, Concha Ostreae (calcined), Cornu Cervi Degelatinatum, Semen Euryales, restrain astringent or styptic treatment for spontaneous sweating; Radix Stellariae, clearind deficient heat; Radix Glycyrrhizae, coordinating the actions of various ingredients in a prescription has effect of benefiting qi and nourishing blood, adjusting meridian and stopping leukorrhea, cures mainly the asthenic body that deficiency of both QI and blood causes, waist soreness, night sweat due to yin deficiency, irregular menstruation, uterus deficiency and coldness, menalgia, bleeding not during menses, the disease such as to lose blood puerperal.Research shows, WUJI BAIFENG WAN can reduce rat triglyceride and OxLDL ELISA, prevention arteriosclerosis has control sclerotin loose, and the effects such as the liver protecting, have potential medical value to Alzheimer.More than CP method 20 tastes, Radix Rehmanniae Preparata, Radix Rehmanniae, Rhizoma Chuanxiong, Cornu Cervi Degelatinatum, Radix Stellariae, Semen Euryales, Rhizoma Dioscoreae, Radix Salviae Miltiorrhizae eight taste are ground into coarse powder, 12 tastes such as all the other Gallus Domesticuss, give as one thinks fit cataclasm respectively, put in tank, separately add yellow wine 1500g, add a cover closed, stewing out of water is most to wine, takes out, mixes even with above-mentioned coarse powder, cold drying, be ground into fine powder again, sieve, mixing.Every 100g powder adds refined honey 30 ~ 40g and appropriate water, general ball, dry, makes water-honeyed pill; Or add refined honey 90 ~ 120g and make small honey pill or big honeyed pills, to obtain final product.In preparation method, impurity is many, affects the treatment.

Although the Chinese patent medicine being similar to WUJI BAIFENG WAN is in the market of a great variety, relate to the dosage forms such as tablet, granule, syrup, hard capsule, but have that such as dosage is large, patient take disintegration time in inconvenience, body long, absorb the defects such as poor and bioavailability is low.Meanwhile, in these non-tight type pharmaceutical preparatioies, active component is easily subject to the destruction of moisture in air, light and oxygen, and stability and curative effect are all not fully up to expectations.Soft capsule preparation is the dosage form extensively adopted in recent years, and can overcome above-mentioned deficiency preferably, application prospect is tempting, as long as carry out studying for concrete formula and solve the technical problems such as its mouldability, stability and drug loading, can obtain promising result.Compared with other preparation, soft capsule tool has the following advantages:

The acceptable liquid medium of capsule liquid pharmaceutical active composition dissolves, suspendible, emulsifying, be uniformly dispersed, the factors such as one side is not stressed impact, dispersion, stripping and absorption rapidly in the gastrointestinal tract, bioavailability is high, and on the other hand, every soft gelatin pharmaceutical active component content error is little, content uniformity is more easy to control, stable curative effect; Prepared by epithelium gelatin, good airproof performance, intensity and barrier property high, active constituents of medicine is isolated from the outside, on the one hand, keep away the impact of face moisture in air, oxygen, light, anti-oxidation moisture absorption, can stable for extended periods of time, on the other hand, mask bad smell, smell taste, mouthfeel is good, and patient is easy to accept; Epithelium color, transparency, glossiness all can unrestricted choice, and compared with other preparation, visual experience is better; Preparation method technique is advanced, steady quality, can be patient, clinician provides new dosage form selection; The technology that soft capsule is prepared into sugarless type formulations is comparatively ripe, can expand sufferer crowd and be particularly useful for vast diabetics and take.

So patent application of the present invention selects soft capsule as research and development dosage form, be beneficial to take, and the effect of quick acting can be reached, meet the needs of patient medication better.Still there is following problem in existing Chinese medicinal soft capsule technology of preparing: oxygen, aldehydes mass-energy and gelatin generation chemical reaction cause that the gelatin degree of cross linking increases, degeneration is hardening, thus cause disintegrate defective, and wherein, aldehyde material may be present in capsule liquid; Easily occur lamination in storage process, after layering, capsule liquid fully contacts with capsule material, can accelerate the aging of soft capsule, and these all need to pay much attention to.

Summary of the invention

In order to solve the problem, invention provides a kind of Wujibaifeng soft capsule, this pharmaceutical composition is through extracting targetedly, its extract is made to have good antiinflammatory and the lissive effect of analgesia, improve the content of effective ingredient in medicine simultaneously, it be quality controllable, bioavailability is high, taking dose is little, easy to carry rapid-action.

Present invention also offers the preparation method of above-mentioned Wujibaifeng soft capsule.

The present invention is achieved by the following technical solutions:

Wujibaifeng soft capsule, is made up of content and soft capsule skin, and described soft capsule suitcase is overlying on content outside, and described content is made up of the crude drug of following percentage by weight and pharmaceutic adjuvant:

Described soft capsule skin is made up of the raw material of following percentage by weight:

The mass ratio of described content and soft capsule skin is 1: 0.8 ~ 1.5;

Wherein the composition of content is preferred:

The composition of capsule skin is preferred:

Wherein said WUJI BAIFENG extract is obtained by following preparation method:

(1) weight portion medical material is got: Gallus Domesticus extract 50-60 part, Colla cornus cervi 100-110 part, Carapax Trionycis (processed with vinegar) 50-60 part, Concha Ostreae (calcined) 30-50 part, Ootheca Mantidis 50-60 part, Radix Ginseng 100-110 part, Radix Astragali 20-30 part, Radix Angelicae Sinensis 120-130 part, Radix Paeoniae Alba 100-110 part, Rhizoma Cyperi (processed with vinegar) 100-110 part, Radix Asparagi 50-60 part, Radix Glycyrrhizae 20-30 part, Radix Rehmanniae 200-220 part, Radix Rehmanniae Preparata 200-220 part, Rhizoma Chuanxiong 50-60 part, Radix Stellariae 20-30 part, Radix Salviae Miltiorrhizae 100-110 part, Rhizoma Dioscoreae 100-110 part, Semen Euryales fry 50-60 part, Cornu Cervi Degelatinatum 30-50 part, are ground into fine powder for subsequent use;

(2) get the Radix Astragali, the Radix Paeoniae Alba, Radix Asparagi, Radix Ginseng, Radix Stellariae, Radix Glycyrrhizae ethanol extraction, filtrate crosses macroporous resin, ethanol elution, and collect eluent, drying under reduced pressure, obtains extract 1;

(3) Ootheca Mantidis, Carapax Trionycis, Radix Rehmanniae, Rhizoma Chuanxiong, Radix Salviae Miltiorrhizae, Concha Ostreae, Radix Angelicae Sinensis, Rhizoma Cyperi, Radix Rehmanniae Preparata, Semen Euryales, Rhizoma Dioscoreae, Cornu Cervi Degelatinatum water extraction, extracting solution concentrating under reduced pressure is dry, obtains extract 2;

(4) by said extracted thing 1,2, Gallus Domesticus extract and Colla cornus cervi powder mix homogeneously, sieve and obtain compositions.Above-mentioned dispersant is selected from the one in soybean oil, Semen Maydis oil, Oleum Gossypii semen, Oleum Brassicae campestris, sunflower oil, cupu oil, Petiolus Trachycarpi oil, Oleum Arachidis hypogaeae semen, Oleum sesami, olive oil, Oleum Camelliae, perilla oil, linolenic acid, refined oil or Polyethylene Glycol;

Described suspending agent is selected from the one in Cera Flava, aluminum monostearate, methylcellulose, hexyl cellulose, Carmomer, lecithin, propylene glycol, agar, arabic gum or tween;

Described stabilizing agent I is selected from fumaric acid, glycine or citric acid;

Described stabilizing agent II is selected from fumaric acid, glycine or citric acid;

Described antioxidant I is selected from the one in cysteine, sodium pyrosulfite or sodium sulfite;

Described antioxidant II is selected from the one in cysteine, sodium pyrosulfite or sodium sulfite;

Described sizing material is the normal gelatin raw material preparing pharmaceutical soft capsule skin;

Described plasticizer is selected from the one in glycerol, sorbitol, xylitol or hydrogenated corn syrup;

Described opacifier is titanium dioxide or zinc oxide;

Described food coloring is the one in cocoa pigment, brown iron oxide or chocolate palm fibre;

Described antiseptic is the one in methyl parahydroxybenzoate, ethylparaben, para hydroxybenzene methyl propionate, butyl p-hydroxybenzoate, benzyl p-hydroxybenzoate, P-hydroxybenzoic acid phenyl ester, benzoic acid, sodium benzoate, sodium diacelate, sorbic acid or sorbic acid.

Adjuvant is preferred; Dispersant is Semen Maydis oil; Suspending agent is the combination of agar and Cera Flava; Stabilizing agent I is citric acid; Antioxidant I is sodium pyrosulfite; Sizing material is gelatin; Plasticizer is xylitol; Stabilizing agent II is citric acid; Antioxidant is II is sodium sulfite; Opacifier is zinc oxide; Food coloring is cocoa pigment; Antiseptic is para hydroxybenzene methyl propionate.

Described WUJI BAIFENG extract preparation process (1) is: the Gallus Domesticus of getting removing feather claw and intestine is cut into block, adds 2-5 times of water gaging, boils 0.5-4 hour, use 5-15: 1 hard paraffin defat while hot, the papain adding 40-500: 1 afterwards stirs, and adjust pH is to 4-8,40-65 DEG C, is hydrolyzed after 2-8 hour, boils 2-20 minute, centrifugal, supernatant is evaporated to thick paste, and relative density 60 DEG C surveys 1.02-1.32, at 50-100 DEG C, 0.02-0.12Mpa vacuum drying, gets dry extract, for subsequent use.

Described WUJI BAIFENG extract preparation process (1) Chinese crude drug weight portion is: Gallus Domesticus extract 40 parts, Colla cornus cervi 108 parts, Carapax Trionycis (processed with vinegar) 54 parts, Concha Ostreae (calcined) 40 parts, Ootheca Mantidis 40 parts, Radix Ginseng 108 parts, the Radix Astragali 27 parts, Radix Angelicae Sinensis 125 parts, the Radix Paeoniae Alba 108 parts, Rhizoma Cyperi (processed with vinegar) 108 parts, Radix Asparagi 54 parts, 27 parts, Radix Glycyrrhizae, Radix Rehmanniae 215 parts, Radix Rehmanniae Preparata 216 parts, Rhizoma Chuanxiong 54 parts, Radix Stellariae 20 parts, Radix Salviae Miltiorrhizae 108 parts, Rhizoma Dioscoreae 108 parts, Semen Euryales fry 54 parts, Cornu Cervi Degelatinatum 40 parts is for subsequent use.

Described WUJI BAIFENG extract preparation process (2) is the Radix Astragali, the Radix Paeoniae Alba, Radix Asparagi, Radix Ginseng, Radix Stellariae, the Radix Glycyrrhizae 60-100% ethanol extraction of 4-6 times of medical material amount preferably, extract 1-3 time, each 2-4 hour, filter, it is 1.02-1.20 that filtrate is concentrated into 60 DEG C of relative densities, add macroporous resin column or polyamide column, first wash with water, then use 50-95% ethanol elution, collect eluent, eluent is evaporated to thick paste, and 60 DEG C of relative densities are 1.02-1.20, dry extract 1.

Described WUJI BAIFENG extract preparation process (2) more preferably gets the Radix Astragali, the Radix Paeoniae Alba, Radix Asparagi, Radix Ginseng, Radix Stellariae, the Radix Glycyrrhizae 60-100% ethanol extraction of 4-6 times of medical material amount, extract 1-3 time, each 2-4 hour, filter, it is 1.02-1.20 that filtrate is concentrated into 60 DEG C of relative densities, add macroporous resin column or polyamide column, first wash with water, use 50% respectively, 70%, 80%, 90% ethanol elution, 50% eluent discards, collect 70%, 80%, 90% eluent, merge eluent, eluent is evaporated to thick paste, 60 DEG C of relative densities are 1.02-1.20, dry extract 1.

Described WUJI BAIFENG extract preparation process (3) is Ootheca Mantidis, Carapax Trionycis, Radix Rehmanniae, Rhizoma Chuanxiong, Radix Salviae Miltiorrhizae, Concha Ostreae, Radix Angelicae Sinensis, Rhizoma Cyperi, Radix Rehmanniae Preparata, Semen Euryales, Rhizoma Dioscoreae, Cornu Cervi Degelatinatum 4-6 times soak by water preferably, boiling water decocts 2-4 hour, filter, merge decoction liquor, decoction liquor stand at low temperature, with filter plates, it is 70-85% that filtrate is sink to determining alcohol with 60-95% ethanol alcohol again, decompression recycling ethanol, the extract 2 that drying is.

The grain of above-mentioned important soft capsule is heavily 300 ~ 1000m9, has antiinflammatory and lissive effect.

In order to confirm the above-mentioned beneficial effect of technical solution of the present invention, inventor has done the pharmacodynamic feature of corresponding pharmacodynamics test and contrast test many-side research medicine of the present invention.

Test example one,

1 test material

1.1 given the test agent

Contrast medicine: Wuji Baifen pian, Lerentang Pharmaceutical Factory, Zhongxin Pharmaceutical Group Co., Ltd., Tianj, prepares according to CN03130018.9 embodiment.

Medicine of the present invention: Wujibaifeng soft capsule, prepares according to embodiment one

1.2 laboratory animal

Male ICR mouse, female unpregnancy Wistar rat, Beijing Vital River Experimental Animals Technology Co., Ltd. provides, animal quality certification SCXK (capital) 2012-0001.

1.3 medicines and reagent

Aspirin effervescent tablets, lot number: 1208124, AstraZeneca pharmaceutical Co. Ltd.

Sodium carboxymethyl cellulose, lot number: 20120928, Chemical Reagent Co., Ltd., Sinopharm Group.

Dimethylbenzene, lot number: 20100110, Tianjin Kermel Chemical Reagent Co., Ltd..

Diethylstilbestrol injection, lot number: 080621, Tianjin KingYork Amino Acid Co., Ltd..

Oxytocin inj, lot number: 111205, Shanghai Hefeng Pharmaceutical Co., Ltd..

Verapamil hydrochloride injection, lot number: 121101, Shanghai Hefeng Pharmaceutical Co., Ltd..

Sodium chloride, lot number: 20130502, Chemical Reagent Co., Ltd., Sinopharm Group.

Potassium chloride, lot number: F20100728, Chemical Reagent Co., Ltd., Sinopharm Group.

Glucose, lot number: 20120525, Chemical Reagent Co., Ltd., Sinopharm Group.

Magnesium chloride, lot number: 20050401, Tianjin is large chemical reagent development centre forever.

Sodium bicarbonate, lot number: 20110413, Tianjin Kermel Chemical Reagent Co., Ltd..

Anhydrous calcium chloride, lot number: 20020105, Tianjin northization glass purchase and sale center.

Nutritional solution De-Jalon ' s sol: to configure 1L, weighs NaCl9g, KCl0.42g, NaHCO ₃0.5g, glucose 0.5g are dissolved in appropriate new boiling water, weigh CaCl ₂0.06g, MgCl ₂0.005g dissolves in appropriate new boiling water respectively, merges solution, is settled to 1L.

1.4 instrument and equipment

Electronic balance, prunus mume (sieb.) sieb.et zucc. Teller AE240.

Ear is swollen makes ear device, YLS-Q4, Jinan Yi Yan development in science and technology company limited.

HV-4 in vitro tissue organ constant temperature perfusion system, Chengdu TME Technology Co., Ltd..

HW-1000 thermostatic water-circulator bath, Chengdu TME Technology Co., Ltd..

BL-420S biological functional system, Chengdu TME Technology Co., Ltd..

JH-2 muscular tension sensor, Beijing Aviation engineering in medicine institute.

2 test methods and result

2.1 contrast medicines and medicine xylol of the present invention bring out the impact of mice ear

Mice is divided into 8 groups at random by body weight, that is: model control group, positive drug control group (aspirin 0.3g/kg), Wuji Baifen pian and the basic, normal, high dosage group of Wujibaifeng soft capsule (2.5,5,10g crude drug/kg), often organize 10, continuous gastric infusion 2 weeks, administration volume is 20ml/kg, and model control group and positive drug control group give equal-volume 0.5% sodium carboxymethyl cellulose, and positive drug control group is in causing inflammation gavage aspirin on the same day once.Within after the administration of each treated animal last 1 hour, cause inflammation, auris dextra two sides is only coated with 100% dimethylbenzene 20ul/, left ear is contrast, mice is put to death after causing scorching 45min, two ears are cut along auricle baseline, make ear device lay round auricle at same position respectively with 8mm diameter ear is swollen, use electronic balance weighing weight in wet base, and calculate swelling and suppression ratio.Test data adopts Excel to carry out t-inspection, and result of the test refers to table 1.

The left auricle weight mg of swelling mg=auris dextra sheet weight mg-

Table 1 Wuji Baifen pian and Wujibaifeng soft capsule xylol bring out the impact of mice ear

Compare with model control group, * P<0.05, * * P<0.01

As shown in Table 1, compare with model control group, Wuji Baifen pian and Wujibaifeng soft capsule each administration group mice auricle swelling degree obviously alleviate, except dosage group in Wujibaifeng soft capsule, all there is significant difference (P<0.05, P<0.01), suppression ratio is all higher than 30%, the mice ear that prompting Wuji Baifen pian and the equal xylol of Wujibaifeng soft capsule bring out has certain inhibitory action, high dose group, the inhibitory action of Wujibaifeng soft capsule of the present invention is better than matched group Wuji Baifen pian.

2.2 Wuji Baifen pians and Wujibaifeng soft capsule bring out the impact of Isolated Rat Uterus smooth muscle contraction spasm to oxytocin

Female unpregnancy Wistar rat, every day every subcutaneous injection diethylstilbestrol 2mg/kg, successive administration 3 days, impels animal to be in proestrus or rutting period, to improve the sensitivity of uterus to medicine.4th day, cervical dislocation put to death rat, cuts abdominal cavity open rapidly, peeled off uterus surrounding tissue gently, clip uterus, be placed in pre-cooling through gaseous mixture (95%O ₂and 5%CO ₂) clean in saturated nutritional solution.Clip is about 1cm uterus section, and two ends are threading respectively, and be little ring, nearly ovary end is hung on tonotransducer after being connected with the elongated hook of L shape, and nearly cervix uteri end is fixed on ventilation hook place, and place 30ml nutritional solution in bath, operating temperature keeps 37 DEG C, continuously logical 95%O ₂and 5%CO ₂mist.

Adjustment of tonicity sensor, slowly increase uterus tension force, load remains on about 0.5g tension stability, balance about 1 hour, within every 20 minutes, change one time of nutrition liquid, start test when uterus autorhythm shrinking law, trace one section of normal uterus curve movement in contrast.Oxytocin 0.01U/ml is added in bath, uterine muscle strips is caused to shrink, act on and add relative medicine after 30 minutes, adopt accumulation method for dosing medicine to make Wuji Baifen pian and Wujibaifeng soft capsule final concentration be respectively 1,2,4,8mg crude drug/ml (nutrient solution), dosing interval 30min.Vehicle controls group gives isopyknic nutritional solution, and positive drug group gives verapamil hydrochloride 10 ^-6mol/L, action time is 30min.Use the automatic acquisition of image data of BL-420S biological functional system software.Uterine contraction mean tension, peak-to-peak value are added up, and calculates suppression ratio.Test data uses Excel to carry out t-inspection, and result of the test refers to accompanying drawing 1-3 and table 2.

Table 2 Wuji Baifen pian and Wujibaifeng soft capsule bring out the impact of Isolated Rat Uterus smooth muscle contraction spasm to oxytocin

Compare with normal group, ^{Δ Δ}p<0.01; Compare with oxytocin group, * P<0.05**P<0.01; Compare with Vehicle controls group, ##P<0.01, #P<0.05

From Fig. 1-3 and table 2, the uterine smooth muscle of normal contraction adds oxytocin after-contraction to be strengthened, mean tension, peak-to-peak value all obviously increase, there is pole significant difference (P<0.01), illustrate that oxytocin can bring out Isolated Rat Uterus smooth muscle contraction spasm, modeling success; After modeling, add nutritional solution, specimen indices, all without significant change, illustrates that nutritional solution as the solvent of dissolved substance, can not affect this test; After modeling, method of cumulative scale adds the Wuji Baifen pian of variable concentrations, specimen decreases before shrinking comparatively dosing, mean tension, peak-to-peak value are all lower than oxytocin group, 4,8mg crude drug/ml group has significant difference (P<0.05, P<0.01), Testing index and suppression ratio all present obvious dose-effect relationship; After modeling, method of cumulative scale adds the Wujibaifeng soft capsule of variable concentrations, specimen decreases before shrinking comparatively dosing, mean tension, peak-to-peak value are all lower than oxytocin group, 4,8mg crude drug/ml has significant difference (P<0.05, P<0.01), Testing index and suppression ratio all present certain dose-effect relationship; Prompting Wuji Baifen pian and Wujibaifeng soft capsule all bring out Isolated Rat Uterus smooth muscle contraction spasm to oxytocin and have certain inhibitory action.Under same dose, Wujibaifeng soft capsule group suppression ratio is a little more than Wuji Baifen pian group.

3 conclusions

Wuji Baifen pian and Wujibaifeng soft capsule all have inflammation-inhibiting and to the lissive pharmacological action in uterus, the solution spasm effect of Wujibaifeng soft capsule is slightly excellent.

Test two preparation process contrasts

1.1 given the test agent

Contrast medicine: Wuji Baifen pian, Lerentang Pharmaceutical Factory, Zhongxin Pharmaceutical Group Co., Ltd., Tianj, prepares according to CN03130018.9 embodiment.

Medicine of the present invention: Wujibaifeng soft capsule, prepares according to embodiment 1

1.2 disintegrates and hygroscopicity comparative result

	Wuji Baifen pian	Wujibaifeng soft capsule
			Dissolution time	15min	5min
Preparation stability	There is moisture absorption phenomenon in 12h	Place 3 days, still dry and comfortable

Beneficial effect of the present invention:

Wujibaifeng soft capsule involved in the present invention, determined curative effect, energy is inflammation-inhibiting well, and the effect of solution spasm is obvious.

Preparation aspect:

The acceptable liquid medium of this soft capsule pharmaceutical active composition dissolves, suspendible, emulsifying, be uniformly dispersed, the factors such as one side is not stressed impact, dispersion, stripping and absorption rapidly in the gastrointestinal tract, bioavailability is high, and on the other hand, every soft gelatin pharmaceutical active component content error is little, content uniformity is more easy to control, stable curative effect; Prepared by epithelium gelatin, good airproof performance, intensity and barrier property high.

Active constituents of medicine is isolated from the outside, and on the one hand, avoids the impact of moisture in air, oxygen, light, anti-oxidation moisture absorption, can stable for extended periods of time, and on the other hand, mask bad smell, smell taste, mouthfeel is good, and patient is easy to accept; Epithelium color, transparency, glossiness all can unrestricted choice, and compared with other preparation, visual experience is better;

This soft capsule is conducive to taking simultaneously, and can reach the effect of quick acting, meets the needs of patient medication better.

In preparation technology:

The present invention adopts gradient elution successively, and can be eluted by active component completely, yield is high, and extractive content is stablized, and product quality is controlled.In prior art, be all extract once with resin column, extraction ratio is not high, and the active component of plant does not extract completely completely, and residue is discarded, and is applied in suitability for industrialized production and needs medical material more, destroys plant natural environment.Adopt preparation method of the present invention, extraction ratio is high, avoids the waste on the energy.Different concentration ethanol extract powder of the present invention, namely prepares the extract of different content with Same Way, can be used alone according to the technological requirement of preparation also can merge use, reduces cost, is more conducive to suitability for industrialized production.Opposed polarity solvent of the present invention is to resin column repeatedly eluting, and contaminating impurity is few, and resin is easy to recover to reclaim, and recycling, reduces costs, be conducive to environmental protection.Avoid a large amount of as petroleum ether in the present invention, ethyl acetate, the use of the organic solvents such as normal hexane, reduces environmental pollution, decreases the infringement of chemical solvent to the body and mind of staff.Only be the use of the ethanol of water and variable concentrations in the present invention, drop to minimum by toxicity and hazardness, production cost is low simultaneously, is applicable to large-scale industrial production.Preparation method of the present invention, preparation process is simple, and operability is good, easily grasps, favorable reproducibility.

In order to simple and clear technical scheme of the present invention; pharmacodynamics and the contrast test data of embodiment 1 are only listed in description; the compositions of other embodiments and claim 1 protection domain can both realize experiment purpose of the present invention, has antiinflammatory and lissive effect.

Accompanying drawing explanation

Fig. 1 nutritional solution and verapamil hydrochloride bring out the impact of Isolated Rat Uterus smooth muscle contraction spasm to oxytocin

Fig. 2 Wuji Baifen pian (WB) brings out the impact of Isolated Rat Uterus smooth muscle contraction spasm on oxytocin

Fig. 3 Wujibaifeng soft capsule (WB-5) brings out the impact of Isolated Rat Uterus smooth muscle contraction spasm on oxytocin

Specific embodiment

Embodiment 1

A kind of Wujibaifeng soft capsule is obtained by following preparation method:

(1) preparation of medicinal liquid

Get weight portion WUJI BAIFENG extract 140 parts pulverizing, cross 100 mesh sieves, fine powder gradation slowly joins in 195 parts of Semen Maydis oil, mixing; Then 8.4 parts of agar and 0.39 part of Cera Flava, 4 parts of citric acids and 3.5 parts of sodium pyrosulfite are added, mixing; Adopt colloid mill ground and mixed 50min, obtain medicinal liquid, i.e. content, another device storage, stand for standby use;

(2) preparation of glue

Get 155 parts of gelatin, 42.5 parts of xylitol, 130 parts of water, put in glue pot, abundant swelling, at 65 DEG C, be incubated 40min; Add 2.5 parts of citric acids, 2.5 parts of sodium sulfite, 1.5 parts of zinc oxide, 0.9 part of cocoa pigment and 0.2 part of para hydroxybenzene methyl propionate, stir 45min, vacuum outgas 40min, obtains glue, i.e. soft capsule skin, and another device storage, is incubated for subsequent use at 50 DEG C;

(3) preparation of Chinese medicinal soft capsule

On soft capsule unit, with roller, step (2) gained glue is made offset plate, with syringe pump, step (1) gained medicinal liquid is injected offset plate, the soft capsule be pressed into be shaped at 10 ~ 25 DEG C dry 6h with rotating cage; Again by soft capsule dry 12 ~ 48h at 20 ~ 30 DEG C, wipe surface lubrication oil, packaging, obtains Wujibaifeng soft capsule.

Wherein the preparation method of WUJI BAIFENG extract is:

1) weight portion Chinese crude drug is got: Gallus Domesticus extract 40 parts, Colla cornus cervi 108 parts, Carapax Trionycis (processed with vinegar) 54 parts, Concha Ostreae (calcined) 40 parts, Ootheca Mantidis 40 parts, Radix Ginseng 108 parts, the Radix Astragali 27 parts, Radix Angelicae Sinensis 125 parts, the Radix Paeoniae Alba 108 parts, Rhizoma Cyperi (processed with vinegar) 108 parts, Radix Asparagi 54 parts, 27 parts, Radix Glycyrrhizae, Radix Rehmanniae 215 parts, Radix Rehmanniae Preparata 216 parts, Rhizoma Chuanxiong 54 parts, Radix Stellariae 20 parts, Radix Salviae Miltiorrhizae 108 parts, Rhizoma Dioscoreae 108 parts, Semen Euryales fry 54 parts, Cornu Cervi Degelatinatum 40 parts is for subsequent use;

2) Radix Astragali, the Radix Paeoniae Alba, Radix Asparagi, Radix Ginseng, Radix Stellariae, the Radix Glycyrrhizae 60-100% ethanol extraction of 4-6 times of medical material amount, extract 1-3 time, each 2-4 hour, filter, it is 1.02-1.20 that filtrate is concentrated into 60 DEG C of relative densities, add macroporous resin column or polyamide column, first wash with water, use 50%, 70%, 80%, 90% ethanol elution respectively, 50% eluent discards, and collects 70%, 80%, 90% eluent, merge eluent, eluent is evaporated to thick paste, and 60 DEG C of relative densities are 1.02-1.20, dry extract 1;

3) Ootheca Mantidis, Carapax Trionycis, Radix Rehmanniae, Rhizoma Chuanxiong, Radix Salviae Miltiorrhizae, Concha Ostreae, Radix Angelicae Sinensis, Rhizoma Cyperi, Radix Rehmanniae Preparata, Semen Euryales, Rhizoma Dioscoreae, Cornu Cervi Degelatinatum 4-6 times of soak by water, boiling water decocts 2-4 hour, filter, merge decoction liquor, decoction liquor stand at low temperature, with filter plates, it is 70-85% that filtrate is sink to determining alcohol with 60-95% ethanol alcohol again, decompression recycling ethanol, the extract 2 that drying is;

4) by said extracted thing 1,2, Gallus Domesticus extract and Colla cornus cervi powder mix homogeneously, sieve and obtain compositions.

Embodiment 2

Wujibaifeng soft capsule prescription

Content is made up of the crude drug of following percentage by weight and pharmaceutic adjuvant:

Soft capsule skin is made up of the raw material of following percentage by weight:

The mass ratio of content and soft capsule skin is 1: 1.5

Wherein WUJI BAIFENG extract is obtained by following preparation method:

(1) weight portion medical material is got: Gallus Domesticus extract 60 parts, Colla cornus cervi 110 parts, Carapax Trionycis (processed with vinegar) 60 parts, Concha Ostreae (calcined) 50 parts, Ootheca Mantidis 60 parts, Radix Ginseng 110 parts, the Radix Astragali 30 parts, Radix Angelicae Sinensis 130 parts, the Radix Paeoniae Alba 110 parts, Rhizoma Cyperi (processed with vinegar) 110 parts, Radix Asparagi 60 parts, 30 parts, Radix Glycyrrhizae, Radix Rehmanniae 220 parts, Radix Rehmanniae Preparata 220 parts, Rhizoma Chuanxiong 60 parts, Radix Stellariae 30 parts, Radix Salviae Miltiorrhizae 110 parts, Rhizoma Dioscoreae 110 parts, Semen Euryales fry 60 parts, Cornu Cervi Degelatinatum 50 parts, are ground into fine powder for subsequent use;

(2) Radix Astragali, the Radix Paeoniae Alba, Radix Asparagi, Radix Ginseng, Radix Stellariae, Radix Glycyrrhizae 80% ethanol extraction of 5 times of medical material amounts, extract 2 times, each 3 hours, filter, it is 1.02-1.20 that filtrate is concentrated into 60 DEG C of relative densities, add macroporous resin column or polyamide column, first wash with water, use 50%, 70%, 80%, 90% ethanol elution respectively, 50% eluent discards, and collects 70%, 80%, 90% eluent, merge eluent, eluent is evaporated to thick paste, and 60 DEG C of relative densities are 1.02-1.20, dry extract 1;

(3) Ootheca Mantidis, Carapax Trionycis, Radix Rehmanniae, Rhizoma Chuanxiong, Radix Salviae Miltiorrhizae, Concha Ostreae, Radix Angelicae Sinensis, Rhizoma Cyperi, Radix Rehmanniae Preparata, Semen Euryales, Rhizoma Dioscoreae, Cornu Cervi Degelatinatum water extraction, extracting solution concentrating under reduced pressure is dry, obtains extract 2;

(4) by said extracted thing 1,2, Gallus Domesticus extract and Colla cornus cervi powder mix homogeneously, sieve and obtain compositions.

Embodiment 3

Wujibaifeng soft capsule prescription is:

Content is made up of the crude drug of following percentage by weight and pharmaceutic adjuvant:

Soft capsule skin is made up of the raw material of following percentage by weight:

The mass ratio of content and soft capsule skin is 1: 1.2

Wherein WUJI BAIFENG extract is obtained by following preparation method:

(1) weight portion medical material is got: Gallus Domesticus extract 50 parts, Colla cornus cervi 100 parts, Carapax Trionycis (processed with vinegar) 50 parts, Concha Ostreae (calcined) 30 parts, Ootheca Mantidis 50 parts, Radix Ginseng 100 parts, the Radix Astragali 20 parts, Radix Angelicae Sinensis 120 parts, the Radix Paeoniae Alba 100 parts, Rhizoma Cyperi (processed with vinegar) 100 parts, Radix Asparagi 50 parts, 20 parts, Radix Glycyrrhizae, Radix Rehmanniae 200 parts, Radix Rehmanniae Preparata 200 parts, Rhizoma Chuanxiong 50 parts, Radix Stellariae 20 parts, Radix Salviae Miltiorrhizae 100 parts, Rhizoma Dioscoreae 100 parts, Semen Euryales fry 50 parts, Cornu Cervi Degelatinatum 30 parts, are ground into fine powder for subsequent use;

(2) get the Radix Astragali, the Radix Paeoniae Alba, Radix Asparagi, Radix Ginseng, Radix Stellariae, Radix Glycyrrhizae ethanol extraction, filtrate crosses macroporous resin, ethanol elution, and collect eluent, drying under reduced pressure, obtains extract 1;

(3) Ootheca Mantidis, Carapax Trionycis, Radix Rehmanniae, Rhizoma Chuanxiong, Radix Salviae Miltiorrhizae, Concha Ostreae, Radix Angelicae Sinensis, Rhizoma Cyperi, Radix Rehmanniae Preparata, Semen Euryales, Rhizoma Dioscoreae, Cornu Cervi Degelatinatum water extraction, extracting solution concentrating under reduced pressure is dry, obtains extract 2;

(4) by said extracted thing 1,2, Gallus Domesticus extract and Colla cornus cervi powder mix homogeneously, sieve and obtain compositions.

Embodiment 4

Wujibaifeng soft capsule content is made up of the crude drug of following percentage by weight and pharmaceutic adjuvant:

Soft capsule skin is made up of the raw material of following percentage by weight:

The mass ratio of content and soft capsule skin is 1: 0.8

Wherein WUJI BAIFENG extract is obtained by following preparation method:

(1) weight portion medical material is got: Gallus Domesticus extract 40 parts, Colla cornus cervi 108 parts, Carapax Trionycis (processed with vinegar) 54 parts, Concha Ostreae (calcined) 40 parts, Ootheca Mantidis 40 parts, Radix Ginseng 108 parts, the Radix Astragali 27 parts, Radix Angelicae Sinensis 125 parts, the Radix Paeoniae Alba 108 parts, Rhizoma Cyperi (processed with vinegar) 108 parts, Radix Asparagi 54 parts, 27 parts, Radix Glycyrrhizae, Radix Rehmanniae 215 parts, Radix Rehmanniae Preparata 216 parts, Rhizoma Chuanxiong 54 parts, Radix Stellariae 20 parts, Radix Salviae Miltiorrhizae 108 parts, Rhizoma Dioscoreae 108 parts, Semen Euryales fry 54 parts, Cornu Cervi Degelatinatum 40 parts is for subsequent use;

(2) Radix Astragali, the Radix Paeoniae Alba, Radix Asparagi, Radix Ginseng, Radix Stellariae, Radix Glycyrrhizae 100% ethanol extraction of 6 times of medical material amounts, extract 1 time, each 2 hours, filter, it is 1.20 that filtrate is concentrated into 60 DEG C of relative densities, add macroporous resin column or polyamide column, first wash with water, then use 95% ethanol elution, collect eluent, eluent is evaporated to thick paste, and 60 DEG C of relative densities are 1.20, dry extract 1;

(3) Ootheca Mantidis, Carapax Trionycis, Radix Rehmanniae, Rhizoma Chuanxiong, Radix Salviae Miltiorrhizae, Concha Ostreae, Radix Angelicae Sinensis, Rhizoma Cyperi, Radix Rehmanniae Preparata, Semen Euryales, Rhizoma Dioscoreae, Cornu Cervi Degelatinatum 6 times of soak by water, boiling water decocts 2 hours, filter, merge decoction liquor, decoction liquor stand at low temperature, with filter plates, it is 85% that filtrate is sink to determining alcohol with 95% ethanol alcohol again, decompression recycling ethanol, the extract 2 that drying is;

(4) by said extracted thing 1,2, Gallus Domesticus extract and Colla cornus cervi powder mix homogeneously, sieve and obtain compositions.

Embodiment 5

Wujibaifeng soft capsule prescription is:

Content is made up of the crude drug of following percentage by weight and pharmaceutic adjuvant:

Soft capsule skin is made up of the raw material of following percentage by weight:

The mass ratio of content and soft capsule skin is 1: 1.4

Wherein WUJI BAIFENG extract is obtained by following preparation method:

(1) weight portion medical material is got: Gallus Domesticus extract 40 parts, Colla cornus cervi 108 parts, Carapax Trionycis (processed with vinegar) 54 parts, Concha Ostreae (calcined) 40 parts, Ootheca Mantidis 40 parts, Radix Ginseng 108 parts, the Radix Astragali 27 parts, Radix Angelicae Sinensis 125 parts, the Radix Paeoniae Alba 108 parts, Rhizoma Cyperi (processed with vinegar) 108 parts, Radix Asparagi 54 parts, 27 parts, Radix Glycyrrhizae, Radix Rehmanniae 215 parts, Radix Rehmanniae Preparata 216 parts, Rhizoma Chuanxiong 54 parts, Radix Stellariae 20 parts, Radix Salviae Miltiorrhizae 108 parts, Rhizoma Dioscoreae 108 parts, Semen Euryales fry 54 parts, Cornu Cervi Degelatinatum 40 parts is for subsequent use;

(2) Radix Astragali, the Radix Paeoniae Alba, Radix Asparagi, Radix Ginseng, Radix Stellariae, Radix Glycyrrhizae 60% ethanol extraction of 4 times of medical material amounts, extract 3 times, each 4 hours, filter, it is 1.20 that filtrate is concentrated into 60 DEG C of relative densities, add macroporous resin column or polyamide column, first wash with water, then use 50% ethanol elution, collect eluent, eluent is evaporated to thick paste, and 60 DEG C of relative densities are 1.020, dry extract 11;

(3) Ootheca Mantidis, Carapax Trionycis, Radix Rehmanniae, Rhizoma Chuanxiong, Radix Salviae Miltiorrhizae, Concha Ostreae, Radix Angelicae Sinensis, Rhizoma Cyperi, Radix Rehmanniae Preparata, Semen Euryales, Rhizoma Dioscoreae, Cornu Cervi Degelatinatum 4-6 times of soak by water, boiling water decocts 2 hours, filter, merge decoction liquor, decoction liquor stand at low temperature, with filter plates, it is 70% that filtrate is sink to determining alcohol with 60% ethanol alcohol again, decompression recycling ethanol, the extract 2 that drying is;

(4) by said extracted thing 1,2, Gallus Domesticus extract and Colla cornus cervi powder mix homogeneously, sieve and obtain compositions.

Embodiment 6

Wujibaifeng soft capsule prescription

Content is made up of the crude drug of following percentage by weight and pharmaceutic adjuvant:

Soft capsule skin is made up of the raw material of following percentage by weight:

The mass ratio of content and soft capsule skin is 1: 1.5

Wherein WUJI BAIFENG extract is obtained by following preparation method:

(1) weight portion medical material is got: Gallus Domesticus extract 60 parts, Colla cornus cervi 110 parts, Carapax Trionycis (processed with vinegar) 60 parts, Concha Ostreae (calcined) 50 parts, Ootheca Mantidis 60 parts, Radix Ginseng 110 parts, the Radix Astragali 30 parts, Radix Angelicae Sinensis 130 parts, the Radix Paeoniae Alba 110 parts, Rhizoma Cyperi (processed with vinegar) 110 parts, Radix Asparagi 60 parts, 30 parts, Radix Glycyrrhizae, Radix Rehmanniae 220 parts, Radix Rehmanniae Preparata 220 parts, Rhizoma Chuanxiong 60 parts, Radix Stellariae 30 parts, Radix Salviae Miltiorrhizae 110 parts, Rhizoma Dioscoreae 110 parts, Semen Euryales fry 60 parts, Cornu Cervi Degelatinatum 50 parts, are ground into fine powder for subsequent use;

(2) Radix Astragali, the Radix Paeoniae Alba, Radix Asparagi, Radix Ginseng, Radix Stellariae, Radix Glycyrrhizae 80% ethanol extraction of 5 times of medical material amounts, extract 2 times, each 3 hours, filter, it is 1.02-1.20 that filtrate is concentrated into 60 DEG C of relative densities, add macroporous resin column or polyamide column, first wash with water, use 50%, 70%, 80%, 90% ethanol elution respectively, 50% eluent discards, and collects 70%, 80%, 90% eluent, merge eluent, eluent is evaporated to thick paste, and 60 DEG C of relative densities are 1.02-1.20, dry extract 1;

(3) Ootheca Mantidis, Carapax Trionycis, Radix Rehmanniae, Rhizoma Chuanxiong, Radix Salviae Miltiorrhizae, Concha Ostreae, Radix Angelicae Sinensis, Rhizoma Cyperi, Radix Rehmanniae Preparata, Semen Euryales, Rhizoma Dioscoreae, Cornu Cervi Degelatinatum water extraction, extracting solution concentrating under reduced pressure is dry, obtains extract 2;

(4) by said extracted thing 1,2, Gallus Domesticus extract and Colla cornus cervi powder mix homogeneously, sieve and obtain compositions.

Embodiment 7

Wujibaifeng soft capsule prescription is:

Content is made up of the crude drug of following percentage by weight and pharmaceutic adjuvant:

Soft capsule skin is made up of the raw material of following percentage by weight:

The mass ratio of content and soft capsule skin is 1: 1.4

Wherein WUJI BAIFENG extract is obtained by following preparation method:

(1) weight portion medical material is got: Gallus Domesticus extract 40 parts, Colla cornus cervi 108 parts, Carapax Trionycis (processed with vinegar) 54 parts, Concha Ostreae (calcined) 40 parts, Ootheca Mantidis 40 parts, Radix Ginseng 108 parts, the Radix Astragali 27 parts, Radix Angelicae Sinensis 125 parts, the Radix Paeoniae Alba 108 parts, Rhizoma Cyperi (processed with vinegar) 108 parts, Radix Asparagi 54 parts, 27 parts, Radix Glycyrrhizae, Radix Rehmanniae 215 parts, Radix Rehmanniae Preparata 216 parts, Rhizoma Chuanxiong 54 parts, Radix Stellariae 20 parts, Radix Salviae Miltiorrhizae 108 parts, Rhizoma Dioscoreae 108 parts, Semen Euryales fry 54 parts, Cornu Cervi Degelatinatum 40 parts is for subsequent use;

(2) Radix Astragali, the Radix Paeoniae Alba, Radix Asparagi, Radix Ginseng, Radix Stellariae, Radix Glycyrrhizae 80% ethanol extraction of 5 times of medical material amounts, extract 2 times, each 3 hours, filter, it is 1.02-1.20 that filtrate is concentrated into 60 DEG C of relative densities, add macroporous resin column or polyamide column, first wash with water, use 50%, 70%, 80%, 90% ethanol elution respectively, 50% eluent discards, and collects 70%, 80%, 90% eluent, merge eluent, eluent is evaporated to thick paste, and 60 DEG C of relative densities are 1.02-1.20, dry extract 1;

(3) Ootheca Mantidis, Carapax Trionycis, Radix Rehmanniae, Rhizoma Chuanxiong, Radix Salviae Miltiorrhizae, Concha Ostreae, Radix Angelicae Sinensis, Rhizoma Cyperi, Radix Rehmanniae Preparata, Semen Euryales, Rhizoma Dioscoreae, Cornu Cervi Degelatinatum 4-6 times of soak by water, boiling water decocts 2 hours, filter, merge decoction liquor, decoction liquor stand at low temperature, with filter plates, it is 70% that filtrate is sink to determining alcohol with 60% ethanol alcohol again, decompression recycling ethanol, the extract 2 that drying is;

(4) by said extracted thing 1,2, Gallus Domesticus extract and Colla cornus cervi powder mix homogeneously, sieve and obtain compositions.

Embodiment 8

The preparation method of any one of embodiment 2-7 Wujibaifeng soft capsule is:

(1) preparation of medicinal liquid

Get WUJI BAIFENG extract to pulverize, cross 60 mesh sieves, fine powder gradation slowly joins in dispersant, mixing; Then suspending agent, stabilizing agent I and antioxidant I is added, mixing; Adopt colloid mill ground and mixed 5min, obtain medicinal liquid, i.e. content, another device storage, stand for standby use;

(2) preparation of glue

Get sizing material, plasticizer, water, put in glue pot, abundant swelling, at 50 DEG C, be incubated 20min; Add stabilizing agent II, antioxidant II, opacifier, food coloring and antiseptic, stir 5min, vacuum outgas 20min, obtains glue, i.e. soft capsule skin, and another device storage, is incubated for subsequent use at 40 DEG C;

(3) preparation of Chinese medicinal soft capsule

On soft capsule unit, with roller, step (2) gained glue is made offset plate, with syringe pump, step (1) gained medicinal liquid is injected offset plate, the soft capsule be pressed into be shaped at 10 DEG C dry 1h with rotating cage; Again by soft capsule dry 12h at 20 DEG C, wipe surface lubrication oil, packaging, obtains Wujibaifeng soft capsule.

Embodiment 9

The preparation method of any one of embodiment 2-7 Wujibaifeng soft capsule is:

(1) preparation of medicinal liquid

Get WUJI BAIFENG extract to pulverize, cross 90 mesh sieves, fine powder gradation slowly joins in dispersant, mixing; Then suspending agent, stabilizing agent I and antioxidant I is added, mixing; Adopt colloid mill ground and mixed 45min, obtain medicinal liquid, i.e. content, another device storage, stand for standby use;

(2) preparation of glue

Get sizing material, plasticizer, water, put in glue pot, abundant swelling, at 60 DEG C, be incubated 50min; Add stabilizing agent II, antioxidant II, opacifier, food coloring and antiseptic, stir 40min, vacuum outgas 40min, obtains glue, i.e. soft capsule skin, and another device storage, is incubated for subsequent use at 50 DEG C;

(3) preparation of Chinese medicinal soft capsule

On soft capsule unit, with roller, step (2) gained glue is made offset plate, with syringe pump, step (1) gained medicinal liquid is injected offset plate, the soft capsule be pressed into be shaped at 15 DEG C dry 4h with rotating cage; Again by soft capsule dry 30h at 25 DEG C, wipe surface lubrication oil, packaging, obtains Wujibaifeng soft capsule.

Embodiment 10

The preparation method of any one of embodiment 2-7 Wujibaifeng soft capsule is:

(1) preparation of medicinal liquid

Get WUJI BAIFENG extract to pulverize, cross 60 mesh sieves, fine powder gradation slowly joins in dispersant, mixing; Then suspending agent, stabilizing agent I and antioxidant I is added, mixing; Adopt colloid mill ground and mixed 5min, obtain medicinal liquid, i.e. content, another device storage, stand for standby use;

(2) preparation of glue

Get sizing material, plasticizer, water, put in glue pot, abundant swelling, at 50 DEG C, be incubated 20min; Add stabilizing agent II, antioxidant II, opacifier, food coloring and antiseptic, stir 5min, vacuum outgas 20min, obtains glue, i.e. soft capsule skin, and another device storage, is incubated for subsequent use at 40 DEG C;

(3) preparation of Chinese medicinal soft capsule

On soft capsule unit, with roller, step (2) gained glue is made offset plate, with syringe pump, step (1) gained medicinal liquid is injected offset plate, the soft capsule be pressed into be shaped at 10 DEG C dry 1h with rotating cage; Again by soft capsule dry 12h at 20 DEG C, wipe surface lubrication oil, packaging, obtains Wujibaifeng soft capsule.

Claims (10)

1. a Wujibaifeng soft capsule, is made up of content and soft capsule skin, and described soft capsule suitcase is overlying on content outside, it is characterized in that:

Described content is made up of the crude drug of following percentage by weight and pharmaceutic adjuvant:

Described soft capsule skin is made up of the raw material of following percentage by weight:

The mass ratio of described content and soft capsule skin is 1: 0.8 ~ 1.5;

Described WUJI BAIFENG extract is obtained by following preparation method:

(1) weight portion medical material is got: Gallus Domesticus extract 50-60 part, Colla cornus cervi 100-110 part, Carapax Trionycis (processed with vinegar) 50-60 part, Concha Ostreae (calcined) 30-50 part, Ootheca Mantidis 50-60 part, Radix Ginseng 100-110 part, Radix Astragali 20-30 part, Radix Angelicae Sinensis 120-130 part, Radix Paeoniae Alba 100-110 part, Rhizoma Cyperi (processed with vinegar) 100-110 part, Radix Asparagi 50-60 part, Radix Glycyrrhizae 20-30 part, Radix Rehmanniae 200-220 part, Radix Rehmanniae Preparata 200-220 part, Rhizoma Chuanxiong 50-60 part, Radix Stellariae 20-30 part, Radix Salviae Miltiorrhizae 100-110 part, Rhizoma Dioscoreae 100-110 part, Semen Euryales fry 50-60 part, Cornu Cervi Degelatinatum 30-50 part, are ground into fine powder for subsequent use;

(2) get the Radix Astragali, the Radix Paeoniae Alba, Radix Asparagi, Radix Ginseng, Radix Stellariae, Radix Glycyrrhizae ethanol extraction, filtrate crosses macroporous resin, ethanol elution, and collect eluent, drying under reduced pressure, obtains extract 1;

(3) Ootheca Mantidis, Carapax Trionycis, Radix Rehmanniae, Rhizoma Chuanxiong, Radix Salviae Miltiorrhizae, Concha Ostreae, Radix Angelicae Sinensis, Rhizoma Cyperi, Radix Rehmanniae Preparata, Semen Euryales, Rhizoma Dioscoreae, Cornu Cervi Degelatinatum water extraction, extracting solution concentrating under reduced pressure is dry, obtains extract 2;

(4) by said extracted thing 1,2, Gallus Domesticus extract and Colla cornus cervi powder mix homogeneously, sieve and obtain compositions.

2. soft capsule as claimed in claim 1, is characterized in that:

Described dispersant is selected from the one in soybean oil, Semen Maydis oil, Oleum Gossypii semen, Oleum Brassicae campestris, sunflower oil, cupu oil, Petiolus Trachycarpi oil, Oleum Arachidis hypogaeae semen, Oleum sesami, olive oil, Oleum Camelliae, perilla oil, linolenic acid, refined oil or Polyethylene Glycol;

Described suspending agent is selected from the one in Cera Flava, aluminum monostearate, methylcellulose, hexyl cellulose, Carmomer, lecithin, propylene glycol, agar, arabic gum or tween;

Described stabilizing agent I is selected from fumaric acid, glycine or citric acid;

Described stabilizing agent II is selected from fumaric acid, glycine or citric acid;

Described antioxidant I is selected from the one in cysteine, sodium pyrosulfite or sodium sulfite;

Described antioxidant II is selected from the one in cysteine, sodium pyrosulfite or sodium sulfite;

Described sizing material is the normal gelatin raw material preparing pharmaceutical soft capsule skin;

Described plasticizer is selected from the one in glycerol, sorbitol, xylitol or hydrogenated corn syrup;

Described opacifier is titanium dioxide or zinc oxide;

Described food coloring is the one in cocoa pigment, brown iron oxide or chocolate palm fibre;

Described antiseptic is the one in methyl parahydroxybenzoate, ethylparaben, para hydroxybenzene methyl propionate, butyl p-hydroxybenzoate, benzyl p-hydroxybenzoate, P-hydroxybenzoic acid phenyl ester, benzoic acid, sodium benzoate, sodium diacelate, sorbic acid or sorbic acid.

3. soft capsule as claimed in claim 1, is characterized in that: described dispersant is Semen Maydis oil; Described suspending agent is the combination of agar and Cera Flava; Described stabilizing agent I is citric acid; Described antioxidant I is sodium pyrosulfite; Described sizing material is gelatin; Described plasticizer is xylitol; Described stabilizing agent II is citric acid; Described antioxidant is II is sodium sulfite; Described opacifier is zinc oxide; Described food coloring is cocoa pigment; Described antiseptic is para hydroxybenzene methyl propionate.

4. soft capsule as claimed in claim 1, it is characterized in that, described WUJI BAIFENG extract preparation process (1) is cut into block for the Gallus Domesticus of getting removing feather claw and intestine, add 2-5 times of water gaging, boil 0.5-4 hour, use 5-15: 1 hard paraffin defat while hot, the papain adding 40-500: 1 afterwards stirs, adjust pH, to 4-8,40-65 DEG C, is hydrolyzed after 2-8 hour, boil 2-20 minute, centrifugal, supernatant is evaporated to thick paste, and relative density 60 DEG C surveys 1.02-1.32, at 50-100 DEG C, 0.02-0.12Mpa vacuum drying, gets dry extract, for subsequent use.

5. soft capsule as claimed in claim 1, it is characterized in that, described WUJI BAIFENG extract preparation process (1) Chinese crude drug weight portion is: Gallus Domesticus extract 40 parts, Colla cornus cervi 108 parts, Carapax Trionycis (processed with vinegar) 54 parts, Concha Ostreae (calcined) 40 parts, Ootheca Mantidis 40 parts, Radix Ginseng 108 parts, the Radix Astragali 27 parts, Radix Angelicae Sinensis 125 parts, the Radix Paeoniae Alba 108 parts, Rhizoma Cyperi (processed with vinegar) 108 parts, Radix Asparagi 54 parts, 27 parts, Radix Glycyrrhizae, Radix Rehmanniae 215 parts, Radix Rehmanniae Preparata 216 parts, Rhizoma Chuanxiong 54 parts, Radix Stellariae 20 parts, Radix Salviae Miltiorrhizae 108 parts, Rhizoma Dioscoreae 108 parts, Semen Euryales fry 54 parts, Cornu Cervi Degelatinatum 40 parts is for subsequent use.

6. soft capsule as claimed in claim 1, it is characterized in that, the Radix Astragali in described WUJI BAIFENG extract preparation process (2), the Radix Paeoniae Alba, Radix Asparagi, Radix Ginseng, Radix Stellariae, the Radix Glycyrrhizae 60-100% ethanol extraction of 4-6 times of medical material amount, extract 1-3 time, each 2-4 hour, filter, it is 1.02-1.20 that filtrate is concentrated into 60 DEG C of relative densities, add macroporous resin column or polyamide column, first wash with water, then use 50-95% ethanol elution, collect eluent, eluent is evaporated to thick paste, and 60 DEG C of relative densities are 1.02-1.20, dry extract 1.

7. soft capsule as claimed in claim 1, it is characterized in that, the Radix Astragali in described WUJI BAIFENG extract preparation process (2), the Radix Paeoniae Alba, Radix Asparagi, Radix Ginseng, Radix Stellariae, the Radix Glycyrrhizae 60-100% ethanol extraction of 4-6 times of medical material amount, extract 1-3 time, each 2-4 hour, filter, it is 1.02-1.20 that filtrate is concentrated into 60 DEG C of relative densities, add macroporous resin column or polyamide column, first wash with water, use 50% respectively, 70%, 80%, 90% ethanol elution, 50% eluent discards, collect 70%, 80%, 90% eluent, merge eluent, eluent is evaporated to thick paste, 60 DEG C of relative densities are 1.02-1.20, dry extract 1.

8. soft capsule as claimed in claim 1, it is characterized in that: the Ootheca Mantidis in described WUJI BAIFENG extract preparation process (3), Carapax Trionycis, Radix Rehmanniae, Rhizoma Chuanxiong, Radix Salviae Miltiorrhizae, Concha Ostreae, Radix Angelicae Sinensis, Rhizoma Cyperi, Radix Rehmanniae Preparata, Semen Euryales, Rhizoma Dioscoreae, Cornu Cervi Degelatinatum 4-6 times soak by water, boiling water decocts 2-4 hour, filter, merge decoction liquor, decoction liquor stand at low temperature, with filter plates, it is 70-85% that filtrate is sink to determining alcohol with 60-95% ethanol alcohol again, decompression recycling ethanol, the extract 2 that drying is.

9. the preparation method of the Chinese medicinal soft capsule as described in any one of claim 1 ~ 6, is characterized in that, comprises the steps:

(1) preparation of medicinal liquid

Get WUJI BAIFENG extract to pulverize, cross 60 ~ 120 mesh sieves, fine powder gradation slowly joins in dispersant, mixing; Then suspending agent, stabilizing agent I and antioxidant I is added, mixing; Adopt colloid mill ground and mixed 5 ~ 60min, obtain medicinal liquid, i.e. content, another device storage, stand for standby use;

(2) preparation of glue

Get sizing material, plasticizer, water, put in glue pot, abundant swelling, at 50 ~ 80 DEG C, be incubated 20 ~ 60min; Add stabilizing agent II, antioxidant II, opacifier, food coloring and antiseptic, stir 5 ~ 60min, vacuum outgas 20 ~ 60min, obtains glue, i.e. soft capsule skin, and another device storage, is incubated for subsequent use at 40 ~ 60 DEG C;

(3) preparation of Chinese medicinal soft capsule

On soft capsule unit, with roller, step (2) gained glue is made offset plate, with syringe pump, step (1) gained medicinal liquid is injected offset plate, the soft capsule be pressed into shape at 10 ~ 25 DEG C drying 1 ~ 6h with rotating cage; Again by soft capsule dry 12 ~ 48h at 20 ~ 30 DEG C, wipe surface lubrication oil, packaging, obtains Wujibaifeng soft capsule.

10. preparation method as claimed in claim 9, is characterized in that step is as follows:

(1) preparation of medicinal liquid

Get weight portion WUJI BAIFENG extract 140 parts pulverizing, cross 100 mesh sieves, fine powder gradation slowly joins in 195 parts of Semen Maydis oil, mixing; Then 8.4 parts of agar and 0.39 part of Cera Flava, 4 parts of citric acids and 3.5 parts of sodium pyrosulfite are added, mixing; Adopt colloid mill ground and mixed 50min, obtain medicinal liquid, i.e. content, another device storage, stand for standby use;

(2) preparation of glue

Get 155 parts of gelatin, 42.5 parts of xylitol, 130 parts of water, put in glue pot, abundant swelling, at 65 DEG C, be incubated 40min; Add 2.5 parts of citric acids, 2.5 parts of sodium sulfite, 1.5 parts of zinc oxide, 0.9 part of cocoa pigment and 0.2 part of para hydroxybenzene methyl propionate, stir 45min, vacuum outgas 40min, obtains glue, i.e. soft capsule skin, and another device storage, is incubated for subsequent use at 50 DEG C;

(3) preparation of Chinese medicinal soft capsule

On soft capsule unit, with roller, step (2) gained glue is made offset plate, with syringe pump, step (1) gained medicinal liquid is injected offset plate, the soft capsule be pressed into be shaped at 10 ~ 25 DEG C dry 6h with rotating cage; Again by soft capsule dry 12 ~ 48h at 20 ~ 30 DEG C, wipe surface lubrication oil, packaging, obtains Wujibaifeng soft capsule.