CN104383551A - Traditional Chinese medicine soft capsule auxiliary material with universality and method for preparing traditional Chinese medicine soft capsules - Google Patents
Traditional Chinese medicine soft capsule auxiliary material with universality and method for preparing traditional Chinese medicine soft capsules Download PDFInfo
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- CN104383551A CN104383551A CN201410740304.1A CN201410740304A CN104383551A CN 104383551 A CN104383551 A CN 104383551A CN 201410740304 A CN201410740304 A CN 201410740304A CN 104383551 A CN104383551 A CN 104383551A
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Abstract
The invention relates to a traditional Chinese medicine soft capsule forming core technology with universality and a traditional Chinese medicine soft capsule forming core process with universality. The process consists of the following technologies: preparing the content and emulsifying, preparing a capsule wall material and melting, pressing and forming, and drying. The process comprises the following three aspects: 1, a mixed emulsifier used for the traditional Chinese medicine soft capsules and a preparation method thereof; 2, a capsule wall material formula used for the traditional Chinese medicine soft capsules and a preparation method thereof; and 3, technical parameters for pre-drying and final drying in the method for preparing the traditional Chinese medicine soft capsules. The application research proves that the application range of the traditional Chinese medicine soft capsules is widened; the specific gravity of the drug effect material is improved, and the amount of auxiliary materials is reduced; the drug stability is high, and phenomena of layering, leakage, deformation and transfer are avoided; the difference control level of the device is improved; and the disintegration time limit prolonging is effectively controlled.
Description
Technical field
The present invention relates to medical art, specifically prepare with thawing, the technology such as compressing and dry as supporting with the preparation of the content of Chinese medicinal soft capsule agent molding and emulsifying, capsule material, providing a kind of Chinese medicinal soft capsule agent forming technique and the technique with versatility.
Background technology
Chinese medicinal soft capsule means and extract, liquid medicine and appropriate amount of auxiliary materials is mixed, and is sealed in the soft capsule of soft capsule material with dropping preparation method or pressing, is a kind of novel form grown up on hard capsule basis.Recent two decades comes, along with the exploitation sizing of domestic whole-automatic pattern soft capsule pellet processing machine, new equipment such as rotating cage type sizing predryer, customizations glue machine etc., to facilitate the development of Chinese medicinal soft capsule.But the content preparation of restriction Chinese medicinal soft capsule agent molding and emulsifying, capsule material prepares does not have breakthrough achievement in research with thawing, four core technologies such as compressing and dry, and the quality technology problems such as such as medical substance content is low, supplementary product consumption is large, medicine stability poor (layering, oil impregnate, distortion, migration), content uniformity exceeds standard, disintegration extends can thoroughly not solve.
Summary of the invention
An object of the present invention is the deficiency of the technology of preparing for existing Chinese medicinal soft capsule agent content, blended emulsifier (adjuvant) that a kind of Chinese medicinal soft capsule agent is provided and preparation method thereof.
The present invention adopts following technical scheme to realize:
There is a Chinese medicinal soft capsule adjuvant for versatility, form emulsifying agent I: 88% ~ 72%(weight by following component) soybean oil, 4% ~ 12%(weight) soybean phospholipid, 4% ~ 8%(weight) oil with hydrogenated soybean, 4% ~ 8%(weight) Cera Flava.
Or, form emulsifying agent II: 92% ~ 80%(weight by following component) soybean oil, 4% ~ 12%(weight) soybean phospholipid, 4% ~ 8%(weight) oil with hydrogenated soybean.
The selection of oil phase: the vegetable oil that can be used as oil carrier in the preparation of Chinese medicinal soft capsule agent content has a lot, as soybean oil, Oleum Arachidis hypogaeae semen, Oleum sesami, Oleum Helianthi, Petiolus Trachycarpi wet goods.Through test of many times, after comprehensive analysis, the present invention has selected soybean oil as the oil phase of blended emulsifier.Soybean oil system legume soybean (
glycine soya Bentham) seed refine the fatty oil made, be usually used in pharmaceutic adjuvant, solvent and dispersant etc.Soybean oil because its nontoxic nonirritant, untoward reaction are few, advantage of lower cost and as the oil carrier of blended emulsifier of the present invention.
The selection of naturally occurring emulsifying agent: naturally occurring emulsifying agent comprises the soybean phospholipid of phospholipid, lecithin and cholesterol, the arabic gum of polysaccharide, protein-based gelatin, albumin and casein.These naturally occurring emulsifying agents reduce the indifferent of interfacial tension, but they easily form polymeric membrane and emulsion droplet is stablized.Soybean phospholipid system Hydrolysis kinetics and the mixture of phospholipids obtained from Semen sojae atricolor.Calculate with anhydride, phosphorous (P) should be less than 2.7%; Nitrogenous (N) should be 1.5% ~ 2.0%; Should 45.0% be less than containing phosphatidylcholine, more than 30.0%, more than 5.0%, should should be usually used in pharmaceutic adjuvant, emulsifying agent and solubilizing agent etc. containing phosphatidylinositols containing PHOSPHATIDYL ETHANOLAMINE.Soybean phospholipid can be dissolved in ether, chloroform, cyclohexane extraction, fatty oil, mineral oil, both has hydrophilic containing phosphate radical and choline base isopolarity group in molecule, has hydrophobicity again, have certain emulsifiability containing hydrocarbon chain.Soybean phospholipid to be stablized than other phospholipid and toxicity is little and select the emulsifying agent doing blended emulsifier of the present invention because of it.
The selection of lubricant: common hydrogenated vegetable oil has oil with hydrogenated soybean, hydrogenated palm oil, hydrogenated coconut oil, hydrogenated castor wet goods.Oil with hydrogenated soybean system legume soybean (
glycine soya Bentham) seed refine the oil obtained, form through refine, decolouring, hydrogenation and deodorization.Be usually used in pharmaceutic adjuvant, lubricant and release blocker etc.Oil with hydrogenated soybean is nontoxic, nonirritant, is used as lubricant, viscosity modifier in blended emulsifier of the present invention.
The selection of suspending agent: in the preparation of Chinese medicinal soft capsule agent content, conventional suspending agent has Cera Flava, glyceryl monostearate, ethyl cellulose class etc.Cera Flava system Apidae insecticide apis cerana
apis ceranafabricius or apis mellifera Linnaeus
apis melliferathe cerotin system of Linnaeus secretion forms.Be usually used in pharmaceutic adjuvant, ointment base or release blocker etc.Cera Flava is used in Emulsion, can form water-in-oil emulsion.Because it is nontoxic, nonirritant and as the suspending agent of blended emulsifier of the present invention.
Remove Cera Flava in the formula of emulsifying agent II, if Cera Flava obtains wax-oil mixture as suspending agent in extraction of traditional Chinese medicine (adding wax liposuction technique), emulsifying agent II so can be selected as carrier auxiliary material.
The each component consumption of blended emulsifier of the present invention utilizes the HLB value of emulsifying agent to have the feature of additivity through applicant, by lot of experiments, each component optimizing blended emulsifier I is soybean oil (88% ~ 72%), soybean phospholipid (4% ~ 12%), oil with hydrogenated soybean (4% ~ 8%), Cera Flava (4% ~ 8%).The each component of blended emulsifier II is soybean oil (92% ~ 80%), soybean phospholipid (4% ~ 12%), oil with hydrogenated soybean (4% ~ 8%).
The preparation technology of above-mentioned blended emulsifier is as follows:
The preparation method of blended emulsifier I, takes the soybean oil of 1/4 amount in proportion, adds Cera Flava, soybean phospholipid, oil with hydrogenated soybean, is heated to 60 ~ 65 DEG C, make it to melt completely, after mix homogeneously, then add remaining soybean oil, mix homogeneously, cross colloid mill, make emulsion, to obtain final product.
The preparation method of blended emulsifier II, takes the soybean oil of 1/4 amount in proportion, adds soybean phospholipid, oil with hydrogenated soybean, is heated to 60 ~ 65 DEG C, after mix homogeneously, then adds remaining soybean oil, mix homogeneously, crosses colloid mill, makes emulsion, to obtain final product.
Another object of the present invention is to provide a kind of Chinese medicinal soft capsule agent capsule material formula and preparation method thereof, and then prepares a kind of Chinese medicinal soft capsule.
Chinese medicinal soft capsule comprises capsule material housing, wraps up the content be made up of medicine (major ingredient) and adjuvant in described capsule material housing.
Wherein, the capsule material formula of Chinese medicinal soft capsule agent is made up of gelatin (skin gelatin and bone gelatin), glycerol, sorbitol, PEG400 and purified water.
The selection of capsule material major ingredient: the main sizing material of Chinese medicinal soft capsule agent capsule material commonly uses gelatin, arabic gum.Gelatin is the skin of animal, collagen protein is hydrolyzed through appropriateness the goods that after (acid system, alkaline process, soda acid mixing method or enzyme process), purification obtains in bone, tendon and ligament, or is the mixture of above-mentioned different gelatin goods.The gelatin that Corii Sus domestica, Corii Bovis seu Bubali are made is skin gelatin, and skin gelatin freezes that power is low, and viscosity is high, and transparency is slightly poor, and color and luster is partially dark, and production cost is low, cheap.The gelatin that Os Bovis seu Bubali, Os Sus domestica are made is bone gelatin, and bone gelatin freezes that power is high, and viscosity is low, and transparency is good, lighter color, and price is expensive.The character of gelatin is all very important to the formability of softgel shell, dissolubility.The content of pure oils to gelatin to freeze power less demanding, can skin gelatin be selected, can production cost be reduced like this; Some Chinese medicine suspensoid or some esters need when making soft capsule as content gelatin freeze power and viscosity is all suitably higher, bone gelatin or height just should be selected to freeze the skin gelatin of power.The present invention selects skin gelatin and bone gelatin as the major ingredient of Chinese medicinal soft capsule agent capsule material.
The selection of plasticizer: add plasticizer in soft capsule shell, can increase the plasticity of colloidal materials, and conventional plasticizer comprises glycerol, sorbitol, propylene glycol etc., is used alone or as a mixture.Glycerol is 1,2,3 ,-glycerol, and viscosity is low, is easily uniformly dispersed; Sorbitol is a kind of D-Glucose alcohol, stable chemical nature.Both can interact with gelatin molecule, the gel network structure that final formation thermodynamics is reversible and stable.In soft capsule capsule material, glycerol adds the dissolution rate that a small amount of sorbitol can improve medicine.The present invention selects glycerol and sorbitol jointly as the plasticizer of Chinese medicinal soft capsule agent softgel shell.
The selection of additives: use a small amount of additives can improve the dissolution rate constant of soft capsule in capsule shells.PEG400 and PEG400 are the mixture of oxirane and water polycondensation.At room temperature, PEG400 is liquid.Be commonly used for pharmaceutic adjuvant, solvent and plasticizer.In the formula of capsule casing material, add the PEG400 of gelatin amount 5% as co-disintegrant, effectively can shorten disintegration time.
The formula of Chinese medicinal soft capsule agent capsule material of the present invention after lot of experiments, determines that the unit formulations of capsule material is 100 parts, gelatin (hide glue), 4 parts, gelatin (osseocolla) through applicant, glycerol 30 ~ 50 parts, sorbitol 10 ~ 20 parts, PEG400 5 parts, purified water 80 ~ 100 parts.The optimum formula that warp preferably finally obtains capsule material is 100 parts, gelatin (hide glue), 4 parts, gelatin (osseocolla), glycerol 30 parts, sorbitol 10 parts, PEG400 5 parts, purified water 100 parts.
Wherein, the preparation technology of the glue of the capsule material of Chinese medicinal soft capsule agent is, take purified water in proportion, glycerol, sorbitol, PEG400 put in water-bath type glue tank, after being heated to 65 DEG C, add gelatin (skin gelatin, bone gelatin), stir and melt, be warming up to 68 ~ 70 DEG C, vacuum outgas, decompression boils to viscosity 2700 ~ 3000Pas, moisture 38 ~ 40%, obtains glue.
Another object of the present invention is the deficiency for Chinese medicinal soft capsule agent forming technique, prepare with thawing, the technology such as compressing and dry as supporting with the preparation of the content of Chinese medicinal soft capsule agent molding and emulsifying, capsule material, providing a kind of Chinese medicinal soft capsule agent forming technique and the technique with versatility.
First, adjuvant emulsifying agent I or emulsifying agent II is prepared according to said method, then, get emulsifying agent I or emulsifying agent II in adjuvant, heat to 45 ~ 50 DEG C, add the active drug chosen, comprise one or more in volatile oil, ethanol-soluble extractives, water solubility extract, effective site, effective ingredient, by active drug and adjuvant mix homogeneously, first cross colloid mill, microemulsion is made again, i.e. the content of soft capsule with high speed agitator or high pressure homogenizer; Afterwards, the glue of capsule material is prepared according to said method.Finally, as shown in Figure 1, Chinese medicinal soft capsule is obtained through following steps successively.
Pattern encapsulating machine is rolled in compressing employing, and roll mould and adopt suitable dies, sprinkler body adopts side spray, oval orifice, and capsule material thickness selects 0.70 ~ 0.80mm, pelleting temperature setting 40 ± 2 DEG C.
Sizing employing 4 ~ 6 saves sizing rotating cage drying machine, and shaping time is 2 ~ 3h, and after sizing, softgel shell moisture is 22 ~ 25%.
Predry adopts 8 ~ 10 joint fluid bed predry rotating cage drying machines, and wind pushing temperature is 25 ~ 28 DEG C, and relative humidity is 20 ~ 30%, and the predry time is 4 ~ 6h; After predry, softgel shell moisture is no more than 18%.
Dry employing flow-through type carriage-type drying machine eventually, wind pushing temperature is 15 ~ 20 DEG C, and relative humidity is 10 ~ 20%, and the dry time is 24 ~ 36h eventually, and dry rear softgel shell moisture is no more than 10% eventually.
Obtained Chinese medicinal soft capsule preparation.
By 10 the large production applications of Batch such as Saigae Tataricae GANMAO RUANJIAONANG, YIMAIKANH soft capsule, flavone soft capsule for heart disease, ' Yangweishu ' soft capsule, Herba Andrographis soft capsule, antiphlogistic gallbladder-benefiting soft capsule, Duyiwei soft capsule, GANMAO RUANJIAONANG, Agastachel patchoule summer heat dispelling soft capsule, cyperus-amomum stomach soft capsule to registration at present, connect soft capsule with Chinese medicine 6 kind new medicine mountain gold, healthy energy soft capsule preparation molding applied research of relieving summer heat shows, tool of the present invention has the following advantages:
1, expanded the Chinese medicinal soft capsule agent scope of application, adjuvant prepared by the present invention is applicable to the preparation emulsifying of dosage contents of folk prescription (ethanol-soluble extractives, water solubility extract, effective site, effective ingredient), compound recipe (volatile oil, ethanol-soluble extractives, water solubility extract, effective site, effective ingredient one or more).
2, improve the proportion of effective substance, reduce supplementary product consumption.Connect soft capsule for mountain gold, by preparation prescription gauge, major ingredient (Radix Scutellariae extract, extract fine powder, Oleum menthae, wax-oil mixture) 422.4g, accounts for 70.4% of total amount; Adjuvant (Emulsion of soybean oil) 177.6g, accounts for 29.6% of total amount.Healthy energy relieves summer heat soft capsule by preparation prescription gauge, and major ingredient (Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) etc. 8 taste extractum fine powder, wax-oil mixture, Flos Caryophylli volatile oil, patchouli oil, Folium perillae acutae oil) 400g, accounts for 66.7% of total amount; Adjuvant (Emulsion of soybean oil) 200g, accounts for 33.3% of total amount.
3, medicine stability is good, without layering, seepage, distortion, transport phenomena.By to 10 kinds such as Saigae Tataricae GANMAO RUANJIAONANG, the reserved sample observing of 127 batches of finished products, the character of whole kind, discriminating, limit test of microbe, each index components content have no significant change.Mountain gold connects soft capsule long-term stable experiment and shows, under normal temperature condition (temperature 10 ~ 30 DEG C, RH < 65%), in sample, character, discriminating, limit test of microbe, each index components content have no significant change.Healthy energy soft capsule long-term stable experiment of relieving summer heat shows, under normal temperature condition (temperature 10 ~ 30 DEG C, RH < 65%), in sample, character, discriminating, limit test of microbe, each index components content have no significant change.
4, improve content uniformity level of control, by 10 kinds such as Saigae Tataricae GANMAO RUANJIAONANG, more than 1200 data statistics of 127 batches of finished product content uniformity shows, product all meets statutory standards regulation.74 batches of wherein content uniformity ± 4%, account for 58.3%; 49 batches of content uniformity ± 8%, account for 38.6%; 4 batches of content uniformity ± 10%, account for 3.1%.
5, the prolongation of disintegration is effectively controlled.By to 10 kinds such as Saigae Tataricae GANMAO RUANJIAONANG, the reserved sample observing of 127 batches of finished products, the disintegration of whole kind can control before the deadline in 1 hour.Mountain gold connects soft capsule long-term stable experiment and shows, in 18 months, disintegration time extends to 38.3 minutes in 11.3 minutes by equal disintegration time.Healthy energy soft capsule long-term stable experiment of relieving summer heat shows, in 18 months, disintegration time extends to 42 minutes in 11.3 minutes by equal disintegration time.
The present invention is reasonable in design, shows through applied research, has expanded the Chinese medicinal soft capsule agent scope of application; Improve the proportion of effective substance, reduce supplementary product consumption; Medicine stability is good, without layering, seepage, distortion, transport phenomena; Improve content uniformity level of control; Effectively control the prolongation of disintegration.
Accompanying drawing explanation
Fig. 1 represents preparation technology's flow chart of Chinese medicinal soft capsule of the present invention.
Detailed description of the invention
embodiment 1
Saigae Tataricae GANMAO RUANJIAONANG preparations shaping technique
1, pharmaceutical formulation
Major ingredient: (Fructus Forsythiae, Herba Schizonepetae carry the water extracted immersing paste after volatile oil to dry extract, the water extracted immersing paste of Flos Lonicerae, Radix Platycodonis, Herba Lophatheri, Radix Glycyrrhizae, the alcohol-extracted extract of Fructus Arctii, Semen Sojae Preparatum) 220g, Cornu Saigae Tataricae powder 6.0g, Mentholum 1.5g, Oleum menthae 0.75ml, Fructus Forsythiae, Herba Schizonepetae volatile oil 3.0ml.
Adjuvant: emulsifying agent I 218.75g.
Specification: every dress 0.45g, makes 1000.
2, the preparation of emulsifying agent I
Formula: soybean oil 80%, soybean phospholipid 8%, oil with hydrogenated soybean 6%, Cera Flava 6%.
Preparation method: the soybean oil taking 1/4 amount in proportion, adds Cera Flava, soybean phospholipid, oil with hydrogenated soybean, is heated to 60 DEG C, makes it to melt completely, after mix homogeneously, then adds remaining soybean oil, mix homogeneously, crosses colloid mill, makes emulsion, to obtain final product.
3, content preparation
Get emulsifying agent I, heat to 45 DEG C, add dry extract, Cornu Saigae Tataricae powder, Mentholum, Oleum menthae, Fructus Forsythiae and Herba Schizonepetae volatile oil, mix homogeneously, first cross colloid mill, then make microemulsion with high pressure homogenizer.
4, the preparation of capsule material (glue)
Formula: 100 parts, gelatin (hide glue), 4 parts, gelatin (osseocolla), glycerol 30 parts, sorbitol 10 parts, PEG400 5 parts, purified water 100 parts.
Preparation method: take purified water in proportion, glycerol, sorbitol, PEG400 put in water-bath type glue tank, after being heated to 65 DEG C, add gelatin (skin gelatin, bone gelatin) and appropriate opacifier (titanium dioxide and amaranth), stir and melt, be warming up to 70 DEG C, vacuum outgas, decompression boils to viscosity 2700Pas, the glue of moisture 39%.
5, compressing
Equipment: roll pattern encapsulating machine,
Roll mould: No. 10 encryption olive-type moulds,
Sprinkler body: side spray, oval orifice,
Capsule material thickness (wetting): 0.70mm,
Pelleting temperature: 40 ± 2 DEG C.
6, shape
Equipment: 4 ~ 6 joint sizing rotating cage drying machines,
Shaping time: 2h,
Softgel shell moisture: 22%.
7, predry
Equipment: 8 ~ 10 joint fluid bed predry rotating cage drying machines,
Wind pushing temperature: 28 DEG C,
Relative humidity: 25%,
The predry time: 4h,
Softgel shell moisture: be no more than 18%.
8, dry eventually
Equipment: flow-through type carriage-type drying machine,
Wind pushing temperature: 15 DEG C,
Relative humidity: 15%,
Dry time: 36h eventually,
Softgel shell moisture: be no more than 10%.
Continuous stability investigation is carried out to the Saigae Tataricae GANMAO RUANJIAONANG preparation adopting said method to prepare.
Research shows: Saigae Tataricae GANMAO RUANJIAONANG is (temperature 10 DEG C ~ 30 DEG C under normal temperature condition, RH < 65%) test, in sample, character, discriminating, limit test of microbe, each index components content have no significant change, but disintegration time extends to 39 minutes in 12.6 minutes by equal disintegration time, assay all conforms with the regulations, show that sample is stable in lower 18 months of room temperature (temperature 10 DEG C ~ 30 DEG C, RH < 65%) condition.
embodiment 2
YIMAIKANH soft capsule preparation moulding process
1, pharmaceutical formulation
Major ingredient: dry extract (Herba Erigerontis alcohol-extracted extract) 160g.
Adjuvant: emulsifying agent I 290g.
Specification: every dress 0.45g, makes 1000.
2, the preparation of emulsifying agent I
Formula: soybean oil 82%, soybean phospholipid 6%, oil with hydrogenated soybean 6%, Cera Flava 6%.
Preparation method: the soybean oil taking 1/4 amount in proportion, adds Cera Flava, soybean phospholipid, oil with hydrogenated soybean, is heated to 62 DEG C, makes it to melt completely, after mix homogeneously, then adds remaining soybean oil, mix homogeneously, crosses colloid mill, makes emulsion, to obtain final product.
3, content preparation
Get emulsifying agent I, heat to 48 DEG C, add Herba Erigerontis dry extract, mix homogeneously, first cross colloid mill, then make microemulsion with high pressure homogenizer.
4, the preparation of capsule material (glue)
Formula: 100 parts, gelatin (hide glue), 4 parts, gelatin (osseocolla), glycerol 50 parts, sorbitol 20 parts, PEG400 5 parts, purified water 80 parts.
Preparation method: take purified water in proportion, glycerol, sorbitol, PEG400 put in water-bath type glue tank, after being heated to 65 DEG C, add gelatin (skin gelatin, bone gelatin) and appropriate opacifier (titanium dioxide and light blue, carmine), stir and melt, be warming up to 68 DEG C, vacuum outgas, decompression boils to viscosity 3000Pas, the glue of moisture 40%.
5, compressing
Equipment: roll pattern encapsulating machine,
Roll mould: No. 10 encryption olive-type moulds,
Sprinkler body: side spray, oval orifice,
Capsule material thickness (wetting): 0.70mm,
Pelleting temperature: 40 ± 2 DEG C.
6, shape
Equipment: 4 ~ 6 joint sizing rotating cage drying machines,
Shaping time: 3h,
Softgel shell moisture: 25%.
7, predry
Equipment: 8 ~ 10 joint fluid bed predry rotating cage drying machines,
Wind pushing temperature: 25 DEG C,
Relative humidity: 30%,
The predry time: 5h,
Softgel shell moisture: be no more than 18%.
8, dry eventually
Equipment: flow-through type carriage-type drying machine,
Wind pushing temperature: 17 DEG C,
Relative humidity: 20%,
Dry time: 24h eventually,
Softgel shell moisture: be no more than 10%.
Continuous stability investigation is carried out to the YIMAIKANH soft capsule preparation adopting said method to prepare.
Research shows: YIMAIKANH soft capsule is (temperature 10 DEG C ~ 30 DEG C under normal temperature condition, RH < 65%) test, in sample, character, discriminating, limit test of microbe, each index components content have no significant change, but disintegration time extends to 39.6 minutes in 13.3 minutes by equal disintegration time, assay all conforms with the regulations, show that sample is stable in lower 18 months of room temperature (temperature 10 DEG C ~ 30 DEG C, RH < 65%) condition.
embodiment 3
Flavone soft capsule for heart disease preparations shaping technique
1, pharmaceutical formulation
Major ingredient: Folium Crataegi extract 35g.
Adjuvant: emulsifying agent I 145g.
Specification: every dress 0.18g, makes 1000.
2, the preparation of emulsifying agent I
Formula: soybean oil 88%, soybean phospholipid 4%, oil with hydrogenated soybean 4%, Cera Flava 4%.
Preparation method: the soybean oil taking 1/4 amount in proportion, adds Cera Flava, soybean phospholipid, oil with hydrogenated soybean, is heated to 65 DEG C, makes it to melt completely, after mix homogeneously, then adds remaining soybean oil, mix homogeneously, crosses colloid mill, makes emulsion, to obtain final product.
3, content preparation
Get emulsifying agent I, heat to 46 DEG C, add Folium Crataegi extract, mix homogeneously, first cross colloid mill, then make microemulsion with high pressure homogenizer.
4, the preparation of capsule material (glue)
Formula: 100 parts, gelatin (hide glue), 4 parts, gelatin (osseocolla), glycerol 40 parts, sorbitol 15 parts, PEG400 5 parts, purified water 85 parts.
Preparation method: take purified water in proportion, glycerol, sorbitol, PEG400 put in water-bath type glue tank, after being heated to 65 DEG C, add gelatin (skin gelatin, bone gelatin) and appropriate opacifier (caramel color and amaranth), stir and melt, be warming up to 69 DEG C, vacuum outgas, decompression boils to viscosity 2800Pas, the glue of moisture 38%.
5, compressing
Equipment: roll pattern encapsulating machine,
Roll mould: No. 8 encryption spherical modules,
Sprinkler body: side spray, oval orifice,
Capsule material thickness (wetting): 0.80mm,
Pelleting temperature: 40 ± 2 DEG C.
6, shape
Equipment: 4 ~ 6 joint sizing rotating cage drying machines,
Shaping time: 2.5h,
Softgel shell moisture: 25%.
7, predry
Equipment: 8 ~ 10 joint fluid bed predry rotating cage drying machines,
Wind pushing temperature: 27 DEG C,
Relative humidity: 28%,
The predry time: 4.5h,
Softgel shell moisture: be no more than 18%.
8, dry eventually
Equipment: flow-through type carriage-type drying machine,
Wind pushing temperature: 15 DEG C,
Relative humidity: 10%,
Dry time: 28h eventually,
Softgel shell moisture: be no more than 10%.
Continuous stability investigation is carried out to the flavone soft capsule for heart disease preparation adopting said method to prepare.
Research shows: flavone soft capsule for heart disease is (temperature 10 DEG C ~ 30 DEG C under normal temperature condition, RH < 65%) test, in sample, character, discriminating, limit test of microbe, each index components content have no significant change, but disintegration time extends to 38 minutes in 14.3 minutes by equal disintegration time, assay all conforms with the regulations, show that sample is stable in lower 18 months of room temperature (temperature 10 DEG C ~ 30 DEG C, RH < 65%) condition.
embodiment 4
' Yangweishu ' soft capsule preparations shaping technique
1, pharmaceutical formulation
Major ingredient: dry extract (Radix Codonopsis etc. 11 taste the water extracted immersing paste) 235g.
Adjuvant: emulsifying agent I 265g.
Specification: every dress 0.5g, makes 1000.
2, the preparation of emulsifying agent I
Formula: soybean oil 72%, soybean phospholipid 12%, oil with hydrogenated soybean 8%, Cera Flava 8%.
Preparation method: the soybean oil taking 1/4 amount in proportion, adds Cera Flava, soybean phospholipid, oil with hydrogenated soybean, is heated to 63 DEG C, makes it to melt completely, after mix homogeneously, then adds remaining soybean oil, mix homogeneously, crosses colloid mill, makes emulsion, to obtain final product.
3, content preparation
Get emulsifying agent I, heat to 50 DEG C, add the 11 taste dry extracts such as Radix Codonopsis, mix homogeneously, first cross colloid mill, then make microemulsion with high pressure homogenizer.
4, the preparation of capsule material (glue)
Formula: 100 parts, gelatin (hide glue), 4 parts, gelatin (osseocolla), glycerol 35 parts, sorbitol 12 parts, PEG400 5 parts, purified water 95 parts.
Preparation method: take purified water in proportion, glycerol, sorbitol, PEG400 put in water-bath type glue tank, after being heated to 65 DEG C, add gelatin (skin gelatin, bone gelatin) and appropriate opacifier (titanium dioxide and light blue, carmine), stir and melt, be warming up to 68 DEG C, vacuum outgas, decompression boils to viscosity 3000Pas, the glue of moisture 38%.
5, compressing
Equipment: roll pattern encapsulating machine,
Roll mould: No. 14 encryption olive-type moulds,
Sprinkler body: side spray, oval orifice,
Capsule material thickness (wetting): 0.80mm,
Pelleting temperature: 40 ± 2 DEG C.
6, shape
Equipment: 4 ~ 6 joint sizing rotating cage drying machines,
Shaping time: 3h,
Softgel shell moisture: 24%.
7, predry
Equipment: 8 ~ 10 joint fluid bed predry rotating cage drying machines,
Wind pushing temperature: 26 DEG C,
Relative humidity: 27%,
The predry time: 5.5h,
Softgel shell moisture: be no more than 18%.
8, dry eventually
Equipment: flow-through type carriage-type drying machine,
Wind pushing temperature: 20 DEG C,
Relative humidity: 18%,
Dry time: 32h eventually,
Softgel shell moisture: be no more than 10%.Continuous stability investigation is carried out to the ' Yangweishu ' soft capsule preparation adopting said method to prepare.
Research shows: ' Yangweishu ' soft capsule is (temperature 10 DEG C ~ 30 DEG C under normal temperature condition, RH < 65%) test, in sample, character, discriminating, limit test of microbe, each index components content have no significant change, but disintegration time extends to 45 minutes in 12.6 minutes by equal disintegration time, assay all conforms with the regulations, show that sample is stable in lower 18 months of room temperature (temperature 10 DEG C ~ 30 DEG C, RH < 65%) condition.
embodiment 5
It is as follows that mountain gold connects soft capsule preparation preparation technology:
1, pharmaceutical formulation:
Major ingredient: extractum fine powder (Flos Lonicerae etc. 8 taste alcohol-extracted extract, medicinal residues the water extracted immersing paste) 340g, Radix Scutellariae extract 20g, wax-oil mixture 60g, Oleum menthae 2.4ml; Wherein, wax-oil mixture means the mixture of Cera Flava and oily matter.
Adjuvant: emulsifying agent II 177.6g.
Specification: every dress 0.6g, makes 1000.
2, the preparation of emulsifying agent II:
Formula: soybean oil 88%, soybean phospholipid 6%, oil with hydrogenated soybean 6%.
Preparation method: the soybean oil taking 1/4 amount in proportion, adds soybean phospholipid, oil with hydrogenated soybean, is heated to 60 DEG C, after mix homogeneously, then adds remaining soybean oil, mix homogeneously, through colloid mill, makes emulsion, to obtain final product.
3, the preparation of content
Get emulsifying agent II, heat to 50 DEG C, add 8 taste extractum fine powder such as Radix Scutellariae extract, Flos Lonicerae, wax-oil mixture, Oleum menthae, mix homogeneously, first cross colloid mill, then make microemulsion with high speed agitator.
4, the preparation of capsule material (glue)
Formula: 100 parts, gelatin (hide glue), 4 parts, gelatin (osseocolla), glycerol 45 parts, sorbitol 18 parts, PEG400 5 parts, purified water 90 parts.
Preparation method: take purified water in proportion, glycerol, sorbitol, PEG400 put in water-bath type glue tank, after being heated to 65 DEG C, add gelatin (skin gelatin, bone gelatin) and appropriate opacifier (caramel color), stir and melt, be warming up to 70 DEG C, vacuum outgas, decompression boils to viscosity 2900Pas, the glue of moisture 40%.
5, compressing
Equipment: roll pattern encapsulating machine,
Roll mould: No. 14 encryption olive-type moulds,
Sprinkler body: side spray, oval orifice,
Capsule material thickness (wetting): 0.80mm,
Pelleting temperature: 40 ± 2 DEG C.
6, shape
Equipment: 4 ~ 6 joint sizing rotating cage drying machines,
Shaping time: 2h,
Softgel shell moisture: 22%.
7, predry
Equipment: 8 ~ 10 joint fluid bed predry rotating cage drying machines,
Wind pushing temperature: 28 DEG C,
Relative humidity: 26%,
The predry time: 6h,
Softgel shell moisture: be no more than 18%.
8, dry eventually
Equipment: flow-through type carriage-type drying machine,
Wind pushing temperature: 18 DEG C,
Relative humidity: 12%,
Dry time: 36h eventually,
Softgel shell moisture: be no more than 10%.
Soft capsule preparation is connected to the mountain gold adopting said method to prepare and carries out study on the stability.
Accelerated stability test: mountain gold connects soft capsule temperature 30 DEG C ± 2 DEG C, accelerated stability test is carried out under RH 65% ± 5% condition, in sample, character, discriminating, limit test of microbe, each index components content have no significant change, but Mean disintegration time extended to 30 minutes by 11.3 minutes, assay all conforms with the regulations, show that sample is at 30 DEG C ± 2 DEG C, RH 65% ± 5% condition is stablized in lower 6 months.
Long-term stable experiment: this product is (temperature 10 DEG C ~ 30 DEG C under normal temperature condition, RH < 65%) test, in sample, character, discriminating, limit test of microbe, each index components content have no significant change, but disintegration time extends to 38.3 minutes in 11.3 minutes by equal disintegration time, assay all conforms with the regulations, show that sample is stable in lower 18 months of room temperature (temperature 10 DEG C ~ 30 DEG C, RH < 65%) condition.
embodiment 6
Healthy energy is relieved summer heat soft capsule preparation moulding process
1, pharmaceutical formulation
Major ingredient: extractum fine powder (Flos Caryophylli carries the water extracted immersing paste after volatile oil, Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens), Radix Glycyrrhizae Preparata the water extracted immersing paste, Cortex Magnoliae Officinalis(processed with ginger) etc. 5 taste alcohol-extracted extract, medicinal residues the water extracted immersing paste) 340g, wax-oil mixture 48g, Flos Caryophylli volatile oil 7.5ml, patchouli oil 3.0ml, Folium perillae acutae oil 1.5ml.Wherein, wax-oil mixture means the mixture of Cera Flava and oily matter.
Adjuvant: emulsifying agent II 200g.
Specification: every dress 0.6g, makes 1000.
2, the preparation of emulsifying agent II
Formula: soybean oil 92%, soybean phospholipid 4%, oil with hydrogenated soybean 4%.
Preparation method: the soybean oil taking 1/4 amount in proportion, adds soybean phospholipid, oil with hydrogenated soybean, is heated to 65 DEG C, after mix homogeneously, then adds remaining soybean oil, mix homogeneously, through colloid mill, makes emulsion, to obtain final product.
3, content preparation
Get emulsifying agent II, heat to 47 DEG C, add 8 taste extractum fine powder such as Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens), Radix Glycyrrhizae Preparata, Flos Caryophylli volatile oil, patchouli oil, Folium perillae acutae oil, wax-oil mixture, mix homogeneously, first cross colloid mill, then make microemulsion with high pressure homogenizer.
4, the preparation of capsule material (glue)
Formula: 100 parts, gelatin (hide glue), 4 parts, gelatin (osseocolla), glycerol 50 parts, sorbitol 16 parts, PEG400 5 parts, purified water 90 parts.
Preparation method: take purified water in proportion, glycerol, sorbitol, PEG400 put in water-bath type glue tank, after being heated to 65 DEG C, add gelatin (skin gelatin, bone gelatin) and appropriate opacifier (caramel color), stir and melt, be warming up to 68 DEG C, vacuum outgas, decompression boils to viscosity 3000Pas, the glue of moisture 38%.
5, compressing
Equipment: roll pattern encapsulating machine,
Roll mould: No. 14 encryption olive-type moulds,
Sprinkler body: side spray, oval orifice,
Capsule material thickness (wetting): 0.75mm,
Pelleting temperature: 40 ± 2 DEG C.
6, shape
Equipment: 4 ~ 6 joint sizing rotating cage drying machines,
Shaping time: 3h,
Softgel shell moisture: 23%.
7, predry
Equipment: 8 ~ 10 joint fluid bed predry rotating cage drying machines,
Wind pushing temperature: 25 DEG C,
Relative humidity: 30%,
The predry time: 4h,
Softgel shell moisture: be no more than 18%.
8, dry eventually
Equipment: flow-through type carriage-type drying machine,
Wind pushing temperature: 15 DEG C,
Relative humidity: 20%,
Dry time: 30h eventually,
Softgel shell moisture: be no more than 10%.
Study on the stability is carried out to adopting the healthy energy prepared of said method soft capsule preparation of relieving summer heat.
Accelerated stability test: healthy energy relieves summer heat soft capsule temperature 30 DEG C ± 2 DEG C, accelerated test is carried out under RH 65% ± 5% condition, in sample, character, discriminating, limit test of microbe, each index components content have no significant change, but Mean disintegration time extended to 29 minutes by 11.7 minutes, assay all conforms with the regulations, show that sample is at 30 DEG C ± 2 DEG C, RH 65% ± 5% condition is stablized in lower 6 months.
Long-term stable experiment: healthy energy is relieved summer heat soft capsule (temperature 10 DEG C ~ 30 DEG C under normal temperature condition, RH < 65%) test, in sample, character, discriminating, limit test of microbe, each index components content have no significant change, but disintegration time extends to 42 minutes in 11.3 minutes by equal disintegration time, assay all conforms with the regulations, show that sample is stable in lower 18 months of room temperature (temperature 10 DEG C ~ 30 DEG C, RH < 65%) condition.
Claims (7)
1. there is a Chinese medicinal soft capsule adjuvant for versatility, it is characterized in that: form emulsifying agent I: 88% ~ 72%(weight by following component) soybean oil, 4% ~ 12%(weight) soybean phospholipid, 4% ~ 8%(weight) oil with hydrogenated soybean, 4% ~ 8%(weight) Cera Flava;
Or, form emulsifying agent II: 92% ~ 80%(weight by following component) soybean oil, 4% ~ 12%(weight) soybean phospholipid, 4% ~ 8%(weight) oil with hydrogenated soybean.
2. a preparation method with the Chinese medicinal soft capsule adjuvant of versatility according to claim 1, it is characterized in that: the preparation method of emulsifying agent I is as follows: the soybean oil taking 1/4 amount in proportion, add Cera Flava, soybean phospholipid, oil with hydrogenated soybean, be heated to 60 ~ 65 DEG C, make it to melt completely, after mix homogeneously, add remaining soybean oil again, mix homogeneously, crosses colloid mill, makes emulsion;
Or the preparation method of emulsifying agent II is as follows: the soybean oil taking 1/4 amount in proportion, add soybean phospholipid, oil with hydrogenated soybean, be heated to 60 ~ 65 DEG C, after mix homogeneously, then add remaining soybean oil, mix homogeneously, cross colloid mill, make emulsion.
3. a Chinese medicinal soft capsule, comprises capsule material housing, and wrap up the content be made up of medicine and adjuvant in described capsule material housing, described medicine comprises one or more in volatile oil, ethanol-soluble extractives, water solubility extract, effective site, effective ingredient; It is characterized in that: described capsule material housing comprises following components by weight percent: skin gelatin 100 parts, bone gelatin 4 parts, glycerol 30 ~ 50 parts, sorbitol 10 ~ 20 parts, PEG400 5 parts, purified water 80 ~ 100 parts;
Described adjuvant forms emulsifying agent I: 88% ~ 72%(weight by following component) soybean oil, 4% ~ 12%(weight) soybean phospholipid, 4% ~ 8%(weight) oil with hydrogenated soybean, 4% ~ 8%(weight) Cera Flava; Or, form emulsifying agent II: 92% ~ 80%(weight by following component) soybean oil, 4% ~ 12%(weight) soybean phospholipid, 4% ~ 8%(weight) oil with hydrogenated soybean.
4. Chinese medicinal soft capsule according to claim 3, is characterized in that: described capsule material housing comprises following components by weight percent: skin gelatin 100 parts, bone gelatin 4 parts, glycerol 30 parts, sorbitol 10 parts, PEG400 5 parts, purified water 100 parts.
5. the Chinese medicinal soft capsule according to claim 3 or 4, it is characterized in that: the preparation method of capsule material housing glue is as follows: take purified water in proportion, glycerol, sorbitol, PEG400 put in water-bath type glue tank, after being heated to 65 DEG C, add gelatin (skin gelatin, bone gelatin), stir and melt, be warming up to 68 ~ 70 DEG C, vacuum outgas, decompression boils to viscosity 2700 ~ 3000Pas, the glue of moisture 38 ~ 40%.
6. a preparation method for Chinese medicinal soft capsule, is characterized in that: comprise the steps:
(1), the preparation of adjuvant, adjuvant comprises emulsifying agent I or emulsifying agent II;
Described emulsifying agent I is made up of following component: 88% ~ 72%(weight) soybean oil, 4% ~ 12%(weight) soybean phospholipid, 4% ~ 8%(weight) oil with hydrogenated soybean, 4% ~ 8%(weight) Cera Flava; Preparation method is as follows: the soybean oil taking 1/4 amount in proportion, adds Cera Flava, soybean phospholipid, oil with hydrogenated soybean, is heated to 60 ~ 65 DEG C, makes it to melt completely, after mix homogeneously, then adds remaining soybean oil, mix homogeneously, crosses colloid mill, makes emulsion;
Described emulsifying agent II is made up of following component: 92% ~ 80%(weight) soybean oil, 4% ~ 12%(weight) soybean phospholipid, 4% ~ 8%(weight) oil with hydrogenated soybean; Preparation method is as follows: the soybean oil taking 1/4 amount in proportion, adds soybean phospholipid, oil with hydrogenated soybean, is heated to 60 ~ 65 DEG C, after mix homogeneously, then adds remaining soybean oil, mix homogeneously, crosses colloid mill, makes emulsion;
(2), the preparation of content
Get emulsifying agent I or emulsifying agent II in adjuvant, heat to 45 ~ 50 DEG C, add the active drug chosen, mix homogeneously, first cross colloid mill, then make microemulsion with high speed agitator or high pressure homogenizer;
(3), the preparation of capsule material glue
Capsule material comprises following components by weight percent: skin gelatin 100 parts, bone gelatin 4 parts, glycerol 30 ~ 50 parts, sorbitol 10 ~ 20 parts, PEG400 5 parts, purified water 80 ~ 100 parts;
Preparation method: take purified water in proportion, glycerol, sorbitol, PEG400 put in water-bath type glue tank, after being heated to 65 DEG C, add skin gelatin, bone gelatin and opacifier, stir and melt, be warming up to 68 ~ 70 DEG C, vacuum outgas, decompression boils to viscosity 2700 ~ 3000Pas, moisture 38 ~ 40%, obtains glue;
(4), compressing
Equipment: roll pattern encapsulating machine,
Roll mould: suitable dies,
Sprinkler body: side spray, oval orifice,
Capsule material thickness: 0.70 ~ 0.80mm,
Pelleting temperature: 40 ± 2 DEG C;
(5), shape
Equipment: 4 ~ 6 joint sizing rotating cage drying machines,
Shaping time: 2 ~ 3h,
Softgel shell moisture: 22 ~ 25%;
(6), predry
Equipment: 8 ~ 10 joint fluid bed predry rotating cage drying machines,
Wind pushing temperature: 25 ~ 28 DEG C,
Relative humidity: 20 ~ 30%,
The predry time: 4 ~ 6h,
Softgel shell moisture: be no more than 18%;
(7), dry eventually
Equipment: flow-through type carriage-type drying machine,
Wind pushing temperature: 15 ~ 20 DEG C,
Relative humidity: 10 ~ 20%,
Dry time: 24 ~ 36h eventually,
Softgel shell moisture: be no more than 10%;
Obtained Chinese medicinal soft capsule preparation.
7. the preparation method of Chinese medicinal soft capsule according to claim 6, is characterized in that: in step (3), and described capsule material comprises following components by weight percent: skin gelatin 100 parts, bone gelatin 4 parts, glycerol 30 parts, sorbitol 10 parts, PEG400 5 parts, purified water 100 parts.
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| CN104873393A (en) * | 2015-05-11 | 2015-09-02 | 潍坊澳力克制药机械有限公司 | Soft capsule drying device |
| CN107213134A (en) * | 2017-05-10 | 2017-09-29 | 安徽黄山胶囊股份有限公司 | A kind of anti-fragility gelatin hollow capsule and preparation method thereof |
| CN108245494A (en) * | 2018-02-13 | 2018-07-06 | 江苏康缘阳光药业有限公司 | Make the process that soft capsule content is not stratified |
| CN114983962A (en) * | 2021-03-02 | 2022-09-02 | 仙乐健康科技股份有限公司 | Soft capsule shell composition, soft capsule and preparation method and application thereof |
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| CN107213134B (en) * | 2017-05-10 | 2020-03-24 | 安徽黄山胶囊股份有限公司 | Anti-brittleness gelatin hollow capsule and preparation method thereof |
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| CN114983962B (en) * | 2021-03-02 | 2024-03-15 | 仙乐健康科技股份有限公司 | Soft capsule shell composition, soft capsule, preparation method and application thereof |
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Application publication date: 20150304 |