CN1623599A - Xiaoyao soft capsule and its preparation technology - Google Patents
Xiaoyao soft capsule and its preparation technology Download PDFInfo
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- CN1623599A CN1623599A CN 200410033507 CN200410033507A CN1623599A CN 1623599 A CN1623599 A CN 1623599A CN 200410033507 CN200410033507 CN 200410033507 CN 200410033507 A CN200410033507 A CN 200410033507A CN 1623599 A CN1623599 A CN 1623599A
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- carefree
- soft capsule
- glycerol
- gelatin
- extraction
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- 238000002360 preparation method Methods 0.000 title claims description 19
- 239000008539 xiaoyao Substances 0.000 title abstract 2
- 238000005516 engineering process Methods 0.000 title description 4
- 239000000080 wetting agent Substances 0.000 claims abstract description 17
- 239000002904 solvent Substances 0.000 claims abstract description 15
- 239000003814 drug Substances 0.000 claims abstract description 14
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims description 90
- 235000011187 glycerol Nutrition 0.000 claims description 30
- 239000000843 powder Substances 0.000 claims description 25
- 239000000341 volatile oil Substances 0.000 claims description 23
- 108010010803 Gelatin Proteins 0.000 claims description 20
- 239000008273 gelatin Substances 0.000 claims description 20
- 229920000159 gelatin Polymers 0.000 claims description 20
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- 239000000284 extract Substances 0.000 claims description 19
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- 239000000375 suspending agent Substances 0.000 claims description 14
- 239000006187 pill Substances 0.000 claims description 13
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- 229940079593 drug Drugs 0.000 claims description 10
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- UGMCXQCYOVCMTB-UHFFFAOYSA-K dihydroxy(stearato)aluminium Chemical compound CCCCCCCCCCCCCCCCCC(=O)O[Al](O)O UGMCXQCYOVCMTB-UHFFFAOYSA-K 0.000 claims description 2
- 238000005538 encapsulation Methods 0.000 claims description 2
- ZEMPKEQAKRGZGQ-XOQCFJPHSA-N glycerol triricinoleate Natural products CCCCCC[C@@H](O)CC=CCCCCCCCC(=O)OC[C@@H](COC(=O)CCCCCCCC=CC[C@@H](O)CCCCCC)OC(=O)CCCCCCCC=CC[C@H](O)CCCCCC ZEMPKEQAKRGZGQ-XOQCFJPHSA-N 0.000 claims description 2
- IJDNQMDRQITEOD-UHFFFAOYSA-N n-butane Chemical compound CCCC IJDNQMDRQITEOD-UHFFFAOYSA-N 0.000 claims description 2
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- MOZDKDIOPSPTBH-UHFFFAOYSA-N Benzyl parahydroxybenzoate Chemical compound C1=CC(O)=CC=C1C(=O)OCC1=CC=CC=C1 MOZDKDIOPSPTBH-UHFFFAOYSA-N 0.000 description 1
- QFOHBWFCKVYLES-UHFFFAOYSA-N Butylparaben Chemical compound CCCCOC(=O)C1=CC=C(O)C=C1 QFOHBWFCKVYLES-UHFFFAOYSA-N 0.000 description 1
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Abstract
A medicine 'Xiaoyao soft capsule' is composed of shell and liquor prepared from active component, solvent, wetting agent and/or suspending aid. Its advantages are high stability, high curative effect and high biologic utilization rate.
Description
Technical field
The present invention relates to contain the soft capsule and the preparation technology thereof of carefree concentrated pill effective dose.
Technical background
Ease pill comes from " formulary of peaceful benevolent dispensary ", is the representative prescription of regulating the liver and spleen.Be made up of medicines such as Radix Bupleuri, the Radix Paeoniae Alba, Radix Angelicae Sinensis, the Rhizoma Atractylodis Macrocephalae (stir-fry), Poria, Radix Glycyrrhizae Preparatas, wherein Radix Bupleuri is monarch drug, dispersing the stagnated live-QI to relieve the stagnation of QI.Radix Angelicae Sinensis, Radix Paeoniae Alba nourishing blood to suppress the hyperactive liver are ministerial drug, and the Rhizoma Atractylodis Macrocephalae, Poria, Radix Glycyrrhizae invigorating the spleen and benefiting QI are adjuvant drug, and Radix Glycyrrhizae and the Radix Paeoniae Alba be 5 relieving spasm to stop pain mutually.Herba Menthae, Rhizoma Zingiberis Recens reach thoroughly stagnated heat of liver channel, hot loose to reach strongly fragrantly be messenger drug, and Rhizoma Zingiberis Recens 5 is intended to QI and blood regulating mutually with the Radix Angelicae Sinensis Radix Paeoniae Alba, the effect of common long memorial liver spleen, nourishing blood for regulating menstruation.Be used for depression of liver-QI clinically, distending pain in the chest and hypochondrium is had a dizzy spell, loss of appetite, the good medicine of diseases such as menoxenia.Modern pharmacological research shows that this product has analgesia, calmness, analgesic, antitussive effect; Antibiotic, antivirus action is arranged; The hepatoprotective choleretic effect is arranged; Also influential to gonad function, and have the neuropharmacology activity.The central nervous system disorder that is used for the treatment of hepatopathy, gynaecopathia (climacteric syndrome, cyclomastopathy, chloasma etc.) and stagnation of liver-QI and causes etc.Because this side's curative effect is conclusive to be recorded by one one of China's pharmacopeia.
The kind of market sale has ease pill (water honey, concentrated), sheet, granule, hard capsule, mixture, oral liquid, electuary, and often onset is slow for these existing preparations, and bioavailability is not high, volatile ingredient is store content for a long time and is descended, carry, store inconvenience, take inconvenience and easily go mouldy and wait deficiency.
Chinese patent 02117226.9 " preparation technology of novel form of ease pill " discloses ease pill preparation of soft capsule method, and it is with pulverizing medicinal materials, decocting in water, concentrates, and gets the Oleum menthae mixing of thick paste and an amount of vegetable oil and extraction, makes soft capsule.Because when extracting the extractum that obtains and volatile oil and directly mixes with vegetable oil according to ease pill prescription, extractum is semi-liquid-like, complicated component is made solvent with vegetable oil and can not be formed uniform suspension, and the macroscopic property instability makes troubles to suppressing soft capsule,
Summary of the invention
For overcoming the shortcoming of prior art, the invention provides a kind of curative effect reliable, absorb better, taking convenience, stable in properties, be applicable to new formulation---carefree concentrated pill soft capsule and preparation method thereof of big production.
Carefree concentrated pill soft capsule provided by the present invention, medicinal liquid by softgel shell and Qi Nei encapsulation is formed, medicinal liquid contains active component and solvent, their weight ratio is 1: 0.5～1.5, wetting agent can also be contained or/and suspending agent, active component and wetting agent are or/and the weight ratio of suspending agent is 1: 0.005～0.3, wherein active component extracts for the prescription according to ten ease pill of recording of Drug Standard of Ministry of Public Health of the Peoples Republic of China Chinese traditional patent formulation preparation (concentrated pill), is made up of extract powder and volatile oil; Softgel shell mainly contains gelatin and glycerol, and the weight proportion of gelatin and glycerol is 10: 3～6, also is added with an amount of antiseptic or coloring agent in addition in the softgel shell.
Ten ease pill of recording of Drug Standard of Ministry of Public Health of the Peoples Republic of China Chinese traditional patent formulation preparation (concentrated pill) prescription:
The Radix Bupleuri 100g Radix Angelicae Sinensis 100g Radix Paeoniae Alba 100g Rhizoma Atractylodis Macrocephalae (stir-fry) 100g
Poria 100g Herba Menthae 20g Rhizoma Zingiberis Recens 100g Radix Glycyrrhizae (processed with honey) 80g
More than eight flavors, Radix Bupleuri, Radix Angelicae Sinensis 50g, Herba Menthae, Rhizoma Zingiberis Recens extract volatile oil, the medicinal residues and the Rhizoma Atractylodis Macrocephalae, Poria decoct with water secondary, each 2 hours, collecting decoction filtered, it is 1.35～1.40 thick paste that filtrate is condensed into relative density, and the Radix Paeoniae Alba and residue Radix Angelicae Sinensis powder are broken into fine powder.The about 20g of extracting liquorice is ground into fine powder, and above-mentioned cream and powder mixing drying under reduced pressure were pulverized 120 mesh sieves, promptly gets carefree extract powder.
In the present invention, supercritical extraction technique is also adopted in the extraction of volatile oil, experimental procedure is as follows: a certain amount of Radix Bupleuri, Radix Angelicae Sinensis, Herba Menthae, Rhizoma Zingiberis Recens are dropped in the extraction kettle, to extraction kettle, extraction-container I, extraction-container II, basin heats respectively or cool off.When reaching selected temperature, open CO
2Gas cylinder pressurizes to system, when reaching selected pressure, closes gas cylinder, cycling extraction, and keep constant temperature and pressure.After reaching selected extraction time, from extraction-container I, extraction-container II discharge hole for discharge, the volatile oil of medicines such as Radix Bupleuri.Calculated yield also checks its one-tenth to be grouped into the gas chromatography mass spectrometry chromatograph, and the volatile oil of supercritical fluid extraction is formed and steam method basically identical, and just each component content is variant.
The used extractant of supercritical extraction can be carbon dioxide, ethane, ethylene, propane, propylene, butane, pentane, cyclohexane extraction, benzene or toluene among the present invention.
Supercritical extraction extracts the extracting pressure 20～35MPa of volatile oil, 30 ℃～70 ℃ of temperature among the present invention.Extraction time is with 3～4h, and it is 10～15MPa and 60～70 ℃ that the I level is resolved pressure and temperature; It is 50～70MPa and 30～50 ℃ that the II level is resolved pressure and temperature.CO
2Flow is every 1kg raw material 10～20kgh
-1
With the volatile oil of medical materials such as supercritical fluid extraction Radix Bupleuri, compare with traditional steam distillation, can improve yield greatly, shorten extraction time, simple to operate, extract advantages such as safe, energy-conservation.
Solvent of the present invention can be liquid polyethylene glycol, isopropyl alcohol, tween 80, glycerol, propylene glycol or vegetable oil, or the mixture of above two or more material.
Choice of Solvent in the medicinal liquid has very big influence for uniformity, the stability of content.Single solvent that we select among the present invention such as liquid polyethylene glycol, isopropyl alcohol, glycerol, propylene glycol, the mixture of mixed solvent such as Polyethylene Glycol and glycerol mixes the uniform suspension of formation with active component, it has good stability, loading amount, effective content are accurate, are easy to characteristics such as molding.With these is that solvent can not add wetting agent and suspending agent can meet the demands.
And our single solvent of selecting such as vegetable oil, tween 80 in the present invention, the mixture of mixed solvent such as vegetable oil and tween 80, mix formation suspension (A) with active component, but this suspension is inhomogeneous, easily layering, poor stability causes loading amount, effective content inaccurate, can't molding, bring certain difficulty for the preparation soft capsule.Therefore except that selecting this kind solvent for use, also must add suitable wetting agent and suspending agent.
Wetting agent can be glycerol, tween 80, ethyoxyl castor oil hydrogenated or lecithin, or the mixture of above two or more material.
Suspending agent can be Cera Flava, aluminum monostearate, cellulose, micropowder silica gel or solid polyethylene glycol, or the mixture of above two or more material.
The wetting agent that we select among the present invention, suspending agent, the solvent mixture of tween 80 (vegetable oil, tween 80 and mixed solvent such as the vegetable oil with), active component mix formation suspension (B), the result shows that the suspension that forms behind adding wetting agent and the suspending agent is even, stable, not stratified, meet and fill soft capsule, make soft capsule be easy to molding about the requirement accurately of loading amount, effective dose.Two kinds of every indexs of suspension of above-mentioned A, B relatively see the following form.
The every index comparison sheet of two kinds of suspensions of A, B
Content of the test uniformity stability yield rate content uniformity effective content
(％)
Do not meet formulation
A inhomogeneous unstable 20 is against regulation
Quality standard
The matter that meets formulation
B uniform and stable 98 is up to specification
The amount standard
Annotate: instability: placing 2 hours is layering.
Stable: place one month also not stratified.
The proportioning of gelatin, glycerol is difficult to grasp in the prescription of softgel shell, and the amount of glycerol is too many, and softgel shell is softer, than being easier to extrusion; The amount of glycerol very little, softgel shell is harder, influences the quality stability and the disintegration time of soft capsule.We have carried out experimental study to the proportioning of the gelatin in the softgel shell, glycerol and have determined proportioning preferably.
Antiseptic is glycerol, propylene glycol, methyl parahydroxybenzoate, ethylparaben, propyl p-hydroxybenzoate, butyl p-hydroxybenzoate, benzyl p-hydroxybenzoate, P-hydroxybenzoic acid phenyl ester, or the mixture of above two or more material.
An amount of gelatin is added in the rustless steel glue pot, add suitable quantity of water again, airtight, 80 ℃ are incubated 4 hours, add glycerol, the antiseptic of test consumption more respectively, stir, vacuumize degassing was put into 60 ℃ of insulation placements of gelatin heat-preserving container in 2 hours and is spent the night, second day, add medicinal liquid, be pressed into the soft capsule sample, put drying at room temperature, reserved sample observing three months, softgel shell outward appearance, physical property and the disintegration of examination sample the results are shown in following table.Medicinal liquid is 2kg.
Examination table after the sample room temperature kept sample three months
Gelatin: glycerol 10: 2 10: 3 10: 4 10: 5 10: 6 10: 6
The softgel shell outward appearance is too hard suitable softer
Physical property is the crisp suitable easy moisture absorption easily
Disintegration (min) 26 ± 1.2 20 ± 1.0 18 ± 1.2 15 ± 1.1 14 ± 1.0 10 ± 1.2
Shorten along with amounts of glycerol increases disintegration time as can be known by above test, but in conjunction with softgel shell outward appearance, physical property and practical experience show gelatin and glycerol proportioning be 10: 3～6 o'clock the most suitable, the softgel shell prescription that is filtered out is applicable to the environment of warm moist.
The preparation process of carefree soft capsule is as follows:
Feed intake by the prescription proportioning, earlier with wetting agent, suspending agent under 70 ± 2 ℃ of conditions thermosol in partial solvent, again the thermosol thing is joined in the residual solvent that is preheated to 35～45 ℃ lentamente, the limit edged stirs, add carefree extract powder and volatile oil then, it is moistening fully fully to mix assurance, crosses the colloid mill pulverizing and (reaches 5～50um) back pelletings, drying, promptly.
Medicinal liquid of the present invention is crossed colloid mill and is formed micronised suspension.This product micronised suspension (I) and its suspension (II) carry out the pharmacology contrast test, and the result shows (I) improvement for liver injury model, all are better than (II) (P＜0.05～0.01) for the influence and the central inhibitory action of gonad function.Concrete test data is as follows:
One, to CCl
4Cause the protective effect of rats'liver damage
1.1 40 of rats are got in the influence of Serum ALT vigor, be divided into 4 groups at random, be respectively normal control group, model control group, carefree suspension group, carefree micronised suspension group.Normally, model group the capacity normal saline such as gives, and presses table 1 dosage for all the other 2 groups, all ig administrations, 6d continuously.Experiment the 1st, 4d model contrast and each administration treated animal back sc0.4ml/100g CCl4, cause hepatic injury.Each group of 7d is plucked eyeball and is got blood, and separation of serum is surveyed ALT content, the results are shown in Table 1.The result shows: carefree suspension, carefree micronised suspension all can obviously reduce CCl
4Liver damage rat ALT vigor is to CCI
4Liver damage all has protective effect, and the micronised suspension group is obvious than the effect of suspension group.
Table 1 couple CCl4 causes influence (n=10, the x ± s) of hepatic injury rat ALT vigor
Group dosage (g/kg) ALT (nmols-1/L)
Capacity such as normal control 656.87 ± 57.18
Capacity 2678.01 ± 456.34 such as model contrast
△ △
Carefree suspension group 9.0 1760.27 ± 319.04
*
Carefree micronised suspension 9.0 705.78 ± 665.32
* ##
Compare △ P＜0.05, △ △ P＜0.01 with the normal control group;
Compare with model control group,
*P＜0.05,
*P＜0.01;
Compare #P＜0.05, ##P＜0.01 (down together) with the suspension group.
1.2 to the hepatic injury pathological tissue influence rat grouping and administration the same, 7d puts to death animal in experiment, taking out liver fixes with neutral formalin, the routine paraffin wax embedding, haematoxylin-Yihong dyeing, the pathological changes situation of 10 lobules of liver of each specimen of light microscopy checking is according to its extent of disease and degree analysis-by-synthesis.Microscopy is the result show, CCl
4Can cause tangible liver tissue injury, hepatocellular degeneration (as endochylema puffing, the change of balloon sample, steatosis etc.), hepatic necrosis, cell infiltration occur, carefree suspension, carefree micronised suspension all can resist CCl
4Liver damage, the hepatocellular degeneration of especially carefree micronised suspension group, necrosis obviously alleviate, and cell infiltration also is suppressed.
Two, to the influence of gonad function
2.1 40 of minor female mices are got in the influence of Mouse Uterus quality; body weight 8～10g; be divided into 4 groups at random: normal control, carefree suspension group, carefree micronised suspension group and diethylstilbestrol group, administering mode and dosage see Table 2, preceding 3 groups of administrations every day 1 time; the every other day administration of diethylstilbestrol group; in 11d mice is taken off cervical vertebra and put to death, separating uterus takes by weighing the wet quality in uterus with analytical balance rapidly; obtain body constitution amount-uterus quality percentage, the results are shown in Table 2.Carefree suspension, carefree micronised suspension group all can make the uterus quality of mice increase, and the effect of carefree micronised suspension group is more obvious, but all than a little less than the diethylstilbestrol, show the carefree estrogen-like effects that can have gentleness.
The influence of table 2 pair Mouse Uterus quality (n=10, x ± s)
Quality body constitution amount-uterus quality percentage wets in group dosage end-body quality uterus
(g/kg) (g) (mg) (％)
Capacity such as normal control 13.1 ± 2.23 55 ± 16.1 4.3
Carefree suspension group 9.0 13.5 ± 1.19 64 ± 23.2
△ △5.1
Carefree micronised suspension group 9.0 12.8 ± 2.12 84 ± 17.2
△ △ # ▲ ▲6.8
Diethylstilbestrol 0.001 14.2 ± 2.23 250 ± 85.0
△ △23.6
Compare with the diethylstilbestrol group, ▲ P＜0.05, ▲ ▲ P＜0.01 (down together)
2.2 40 of male rats are got in the influence of rat seminal vesicle quality, be divided into 4 groups at random, successive administration 10d respectively organizes rat in 11d and takes off cervical vertebra execution, take out seminal vesicle, remove its all fat, squeeze and remove seminal fluid, claim its wet quality with analytical balance, ask body constitution amount-seminal vesicle quality percentage, the results are shown in Table 3.Carefree suspension group does not have obvious influence to rat seminal vesicle quality, and carefree micronised suspension group can make the seminal vesicle quality alleviate, but than a little less than the diethylstilbestrol effect.
The influence of table 3 pair rat seminal vesicle quality (n=10, x ± s)
Group dosage seminal vesicle quality body constitution amount-seminal vesicle quality percentage
(g/kg) (mg) (％)
Capacity such as normal control 215.2 ± 30.35 10.5
Carefree suspension 9.0 210.3 ± 32.36
▲10.8
Carefree micronised suspension group 9.0 172.5 ± 22.31
△ ▲9.7
Diethylstilbestrol 0.002 168.4 ± 31.76
△8.8
Three, to central nervous system's influence
3.1 40 of body constitution amount (20 ± 2) g mices are got in the influence of spontaneous activity in mice, after water 12h is can't help in fasting, are divided into 4 groups as table 6 at random, 30min begins after the administration, continuously the mice activity time in the observed and recorded 10min, is activity to lift the forward foot in a step and to walk about, the volt of crawling is motionless for quiet, the results are shown in Table 4.Carefree suspension, carefree micronised suspension group all can obviously suppress spontaneous activity in mice.
The influence of table 4 pair spontaneous activity in mice (n=10, x ± s)
Group dosage (g/kg) activity time (s)
Capacity such as normal control 542.87 ± 57.18
Carefree suspension group 9.0 432 ± 69.04
△
Carefree micronised suspension group 9.0 378.78 ± 56.3
△ △
3.2 to 3.1 together of the synergism animal grouping of the length of one's sleep of threshold dose pentobarbital sodium, administrations, 30min after the administration, each Mus ip pentobarbital sodium 50mg/kg, the record mouse sleep time the results are shown in Table 5.Carefree micronised suspension group can be worked in coordination with the sedative-hypnotic effect of pentobarbital sodium, improves the sleeping rate of mice, obviously prolong the length of one's sleep, and carefree suspension group does not have obvious effect.
The synergism of table 5 pentobarbital sodium (n=10, x ± s)
Group dosage (g/kg) rate (%) length of one's sleep (min) of falling asleep
Capacity such as normal control 25 42.87 ± 7.18
Carefree suspension group 9.0 35 52.23 ± 10.04
△
Carefree micronised suspension group 9.0 70 86.78 ± 9.33
△ △
Soft capsule for general Chinese medicine extract, content instability, layering often appear and in various degree phenomenons such as oil impregnate in storage period, and the carefree soft capsule of the present invention adopts micronized suspension as content, its particle diameter is little, kinetic property is stable, can satisfy its standard aspect outward appearance, hardness, disintegration and physical and chemical stability, and evident in efficacy, the bioavailability height.
The multi-flavor medicine contains volatile oil among the carefree side, can save technical finesses such as absorption, curing after being made into soft capsule, and avoids volatile oil to ooze out from absorb adjuvant effectively, and to improve the volatile ingredient loss, shortcoming such as lessen the curative effect; After adding wetting agent, suspending agent and micronization in the medicinal liquid of carefree soft capsule, make that content is stable, not stratified, loading amount, effective content be accurate, easy-formation and evident in efficacy, bioavailability height.
The specific embodiment
Consider that from many aspects when the present invention selects vegetable oil to make solvent, need to add an amount of wetting agent and suspending agent, the preferred ratio of weight and number of active component, solvent, wetting agent and suspending agent is 1: 0.7～1.2: 0.01～0.2: 0.01～0.2 in the medicinal liquid.
Further specifically describe the present invention below by embodiment.
Embodiment 1: carefree preparation of soft capsule
Take by weighing in Radix Bupleuri 107g, Radix Angelicae Sinensis 53.5g, Herba Menthae 21.4g, the Rhizoma Zingiberis Recens 107g input flask according to prescription, the water extraction of 10 times of amounts of adding 5 hours is collected volatile oil, and distillate device is in addition collected standby.The medicinal residues and the Rhizoma Atractylodis Macrocephalae, Poria add 8,6 times of water gagings respectively and decoct secondary, and each 2 hours, collecting decoction filtered, and filtrate is condensed into thick paste (relative density 1.30～1.35,50 ℃), and the Radix Paeoniae Alba and residue Radix Angelicae Sinensis powder are broken into fine powder.The about 21.4g of extracting liquorice is ground into fine powder, and the residue Radix Glycyrrhizae is by " making extractum (relative density 1.30～1.35,50 ℃) under Chinese pharmacopoeia version Radix Glycyrrhizae extractum in 2000 item, above-mentioned cream and powder mixing drying under reduced pressure were pulverized 120 mesh sieves, promptly get carefree extract powder.
Component weight (gram)
Carefree extract powder 340.0
Carefree volatile oil 5.35
Soybean oil 238.0
Lecithin 3.4
Gelatin 70.0
Glycerol 42.0
Water 70.0
Feed intake by said ratio, earlier with wetting agent under 70 ± 2 ℃ of conditions thermosol in partial solvent, again the thermosol thing is joined in the residual solvent that is preheated to 35～45 ℃ lentamente, the limit edged stirs, add carefree extract powder and volatile oil then, it is moistening fully fully to mix assurance, crosses colloid mill and pulverizes 1000 of (reaching 50um) back pelletings, drying, promptly.
Embodiment 2: carefree preparation of soft capsule
Taking by weighing Radix Bupleuri 214g, Radix Angelicae Sinensis 107g, Herba Menthae 42.8g, Rhizoma Zingiberis Recens 214g according to prescription drops in the extraction kettle when reaching 50 ℃ of selected temperature, open the CO2 gas cylinder system is pressurizeed, when reaching selected pressure 28MPa, close gas cylinder, cycling extraction, and keep constant temperature and pressure.After reaching selected extraction time 4h, from extraction-container I, extraction-container II discharge hole for discharge, the volatile oil of medicines such as Radix Bupleuri, collect volatile oil.The medicinal residues and the Rhizoma Atractylodis Macrocephalae, Poria add 8,6 times of water gagings respectively and decoct secondary, and each 2 hours, collecting decoction filtered, and filtrate is condensed into thick paste (relative density 1.30～1.35,50 ℃), and the Radix Paeoniae Alba and residue Radix Angelicae Sinensis powder are broken into fine powder.The about 21.4g of extracting liquorice is ground into fine powder, and the residue Radix Glycyrrhizae is by " making extractum (relative density 1.30～1.35,50 ℃) under Chinese pharmacopoeia version Radix Glycyrrhizae extractum in 2000 item, above-mentioned cream and powder mixing drying under reduced pressure were pulverized 120 mesh sieves, promptly get carefree extract powder.
Component weight (gram)
Carefree extract powder 680
Carefree volatile oil 10.7
Polyethylene Glycol 816
Gelatin 136.0
Glycerol 68.0
Water 136.0
Feed intake by said ratio, with 2000 of embodiment 1 method compacting soft capsules, drying, promptly.
Embodiment 3: carefree preparation of soft capsule
Extraction process is with embodiment 1
Component weight (gram)
Carefree extract powder 1020
Carefree volatile oil 16
Semen Maydis oil 1020
Micropowder silica gel 23.4
Lecithin 34.5
Gelatin 237.5
Glycerol 95.0
Water 237.5
Feed intake by said ratio, with 3000 of embodiment 1 method compacting soft capsules, drying, promptly.
Embodiment 4: carefree preparation of soft capsule
Extraction process is with embodiment 2
Component: weight (gram)
Carefree extract powder 680
Carefree volatile oil 10.7
Soybean oil 544
Lecithin 6.80
Cera Flava 10.2
Micropowder silica gel 13.6
Gelatin 148.0
Glycerol 44.0
Water 148.0
Feed intake by said ratio, with 2000 of embodiment 1 method compacting soft capsules, drying, promptly.
Embodiment 5 carefree preparation of soft capsule
Extraction process is with embodiment 1
Component: weight (gram)
Carefree extract powder 340
Carefree volatile oil 5.35
Polyethylene Glycol 340
Glycerol (wetting agent) 10.0
Gelatin 70.0
Glycerol 42.0
Water 70.0
Feed intake by said ratio, with 1000 of embodiment 1 method compacting soft capsules, drying, promptly.
Embodiment 6 carefree preparation of soft capsule
Extraction process is with embodiment 2
Component: weight (gram)
Carefree extract powder 680
Carefree volatile oil 10.7
Semen Maydis oil 476
Lecithin 47.6
Cera Flava 38.1
Gelatin 148.0
Glycerol 44.0
Water 148.0
Feed intake by said ratio, with 2000 of embodiment 1 method compacting soft capsules, drying, promptly.
Claims (10)
1, a kind of carefree soft capsule, it is characterized in that what it was made up of the medicinal liquid of softgel shell and Qi Nei encapsulation, medicinal liquid contains active component and solvent, their weight ratio is 1: 0.5～1.5, and wherein active component is the carefree concentrated pill prescription that records by 11 in Drug Standard of Ministry of Public Health of the Peoples Republic of China Chinese traditional patent formulation preparation:
The Radix Bupleuri 100g Radix Angelicae Sinensis 100g Radix Paeoniae Alba 100g Rhizoma Atractylodis Macrocephalae (stir-fry) 100g
Poria 100g Herba Menthae 20g Rhizoma Zingiberis Recens 100g Radix Glycyrrhizae (processed with honey) 80g
The extract powder and the volatile oil that extract.
2, according to the described carefree soft capsule of claim 1, it is characterized in that it also contains wetting agent or/and suspending agent, active component and wetting agent are or/and the weight ratio of suspending agent is 1: 0.005～0.3.
3, according to claim 1 or 2 described carefree soft capsules, it is characterized in that solvent is liquid polyethylene glycol, isopropyl alcohol, tween 80, glycerol, propylene glycol or vegetable oil, or the mixture of above two or more material.
4, according to the described carefree soft capsule of claim 2, it is characterized in that wetting agent is glycerol, tween 80, ethyoxyl castor oil hydrogenated or lecithin, or the mixture of above two or more material.
5, according to the described carefree soft capsule of claim 2, it is characterized in that suspending agent is Cera Flava, aluminum monostearate, cellulose, micropowder silica gel or solid polyethylene glycol, or the mixture of above two or more material.
6, according to claim 1 or 2 described carefree soft capsules, what it is characterized in that the extraction of volatile oil is adopted is supercritical extraction technique, and extractant adopts carbon dioxide, ethane, ethylene, propane, propylene, butane, pentane, cyclohexane extraction, benzene or toluene.
7, according to claim 1,2,4 or 5 described carefree soft capsules, it is characterized in that softgel shell mainly contains gelatin and glycerol, the weight proportion of gelatin and glycerol content is 10: 3～6.
8, according to the described carefree soft capsule of claim 3, it is characterized in that softgel shell mainly contains gelatin and glycerol, the weight proportion of gelatin and glycerol content is 10: 3～6.
9, according to the described carefree soft capsule of claim 6, it is characterized in that softgel shell mainly contains gelatin and glycerol, the weight proportion of gelatin and glycerol content is 10: 3～6.
10, a kind of carefree preparation of soft capsule method is characterized in that it is a medicinal liquid through after mixing, and crosses colloid mill and pulverizes the back pelleting and prepare carefree soft capsule.
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN102166341A (en) * | 2011-03-30 | 2011-08-31 | 山西大学 | Preparation method of ease powder antidepressant extractive |
| CN105853986A (en) * | 2016-06-06 | 2016-08-17 | 李晓维 | Traditional Chinese medicine composition for treating hyperplasia of mammary glands |
| CN111012891A (en) * | 2019-12-26 | 2020-04-17 | 深圳市中医院 | Traditional Chinese medicine formula for delaying atherosclerosis and preparation method thereof |
| CN114699499A (en) * | 2022-04-13 | 2022-07-05 | 浙江三溪堂中药有限公司 | Method for preparing liver-protecting spleen-harmonizing pills |
Family Cites Families (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1064258C (en) * | 1998-03-17 | 2001-04-11 | 昆明制药股份有限公司 | Pseudo-ginseng extract soft capsule and preparation technology thereof |
| CN1451417A (en) * | 2002-04-18 | 2003-10-29 | 北京天泰源医药技术开发有限公司 | Process for preparing novel form of ease pill |
| CN100512803C (en) * | 2003-01-13 | 2009-07-15 | 内蒙古吉兰泰盐化集团呼和浩特制药厂 | Natural carotene soft capsule and its production method |
| CN1212142C (en) * | 2003-03-05 | 2005-07-27 | 南京中山制药厂 | Prepn of medicine for treating male's sterility |
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102166341A (en) * | 2011-03-30 | 2011-08-31 | 山西大学 | Preparation method of ease powder antidepressant extractive |
| CN102166341B (en) * | 2011-03-30 | 2012-07-18 | 山西大学 | Preparation method of Xiaoyao powder antidepressant extract |
| CN105853986A (en) * | 2016-06-06 | 2016-08-17 | 李晓维 | Traditional Chinese medicine composition for treating hyperplasia of mammary glands |
| CN111012891A (en) * | 2019-12-26 | 2020-04-17 | 深圳市中医院 | Traditional Chinese medicine formula for delaying atherosclerosis and preparation method thereof |
| CN114699499A (en) * | 2022-04-13 | 2022-07-05 | 浙江三溪堂中药有限公司 | Method for preparing liver-protecting spleen-harmonizing pills |
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