CN104491007A - Preparation method of fructus schisandrae chinensis soft capsule - Google Patents
Preparation method of fructus schisandrae chinensis soft capsule Download PDFInfo
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/79—Schisandraceae (Schisandra family)
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- A61K9/00—Medicinal preparations characterised by special physical form
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- A61K9/4816—Wall or shell material
- A61K9/4825—Proteins, e.g. gelatin
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Abstract
The invention relates to a preparation method of a fructus schisandrae chinensis soft capsule. The preparation method comprises the following steps: firstly preparing a kadsura longepedunculata alcohol extract, preparing glue liquid from water, glutin, ethylparaben, glycerin and pigments, preparing material liquid from soybean oil, bee wax and the kadsura longepedunculata alcohol extract, granulating the glue liquid and the material liquid, and shaping and drying granulated glue pills, so as to obtain the fructus schisandrae chinensis soft capsule. According to the preparation method of the fructus schisandrae chinensis soft capsule, fructus schisandrae chinensis is prepared into the soft capsule, so that the dose is reduced, and the absorption of drugs is accelerated; no saccharose is added; the problems that an existing concentrated pill or tablet is bitter in taste and poor in oral taking absorption effect, and users are limited are solved; the product quality is easy to control, stable and reliable, and the product does not easily age and harden and has good flexibility.
Description
Technical field
The invention belongs to Chinese drug preparation technique field, be specifically related to a kind of preparation method of shizandra berry soft capsule.
Background technology
Fructus Schisandrae Chinensis is the fruit of magnoliaceae schisandra, is commonly called as Fructus Zanthoxyli Plansipini, sliding weight of steelyard, medicine Fructus Schisandrae Chinensis, face rattan, five Fructus Armeniacae Mumes etc., ancient medical book Cheng Ta Chi Zhu, profound and, meeting and.Schisandra fruit implementation Chinese medicine has supplementing QI for promoting the production of body fluid, nourishing kidney of astringing the lung, antidiarrheal, arresting seminal emission, the effect of calming the nerves, chronic cough dyspnea due to deficiency, the few xerostomia in Tianjin, disease such as seminal emission chronic diarrhea, forgetful insomnia etc. can be controlled.Pharmacological evaluation proves excitement and the process of inhibition that can regulate central nervous system, promotes organism metabolism, regulates gastric juice and bile secretion, has reducing effect to hepatitis convalescent period transaminase rising person.Main composition is lignan component, comprising multiple schizandrin, deoxyschizandrin, schisandrin, schisantherin B, schisandrol third, Schisantherinol D, schizantherin are first-class, have multiple pharmacological effect to central nervous system, cardiovascular system, digestive system etc.Seed is fatty, and oils and fats can soap system or machine oil.Stem and leaf and seed all can extract aromatic oil.
Fructus Schisandrae Chinensis can reduce serum glutamic pyruvic transminase, and have the effect of protection liver function, for chronic hepatitis alanine aminotransferase rising person, and toxic and side effects is little.Fructus Schisandrae Chinensis preparation conventional is at present concentrated pill or tablet, Fructus Schisandrae Chinensis effective ingredient lignanoid is that grease-like is semi-solid, there is special odor, and there is greasy feature, add correctives and regulate mouthfeel, still can not cover its foreign odor, use adjuvant multi-flavor sucrose, be not suitable for diabetics and use.There is oral absorption difference, low, the easy moisture absorption of bioavailability, be inconvenient to carry in existing concentrated pill or tablet, and the diversity of pelleting or filling is aborning comparatively large, is easily subject to the shortcomings such as secondary pollution.In addition, patient is large each serving consumption for every day, and pill or tablet bitter in the mouth, patient takes difficulty.
Summary of the invention
The object of this invention is to provide a kind of preparation method of shizandra berry soft capsule, solve existing concentrated pill or tablet bitter in the mouth, oral absorption is poor, use crowd is limited problem.
The technical solution adopted in the present invention is: a kind of preparation method of shizandra berry soft capsule, comprises the following steps:
Step 1: prepare Fructus Schisandrae Sphenantherae leaching alcohol cream;
Step 2: change glue
By in 35 pouring into of weight portion purified water glue tanks, be warming up to 70 DEG C, add 35 weight portion gelatin, 80 DEG C are warmed up to after micelle all dissolves, add 0.035 weight portion ethyl hydroxybenzoate, 12.25 parts by weight of glycerin and 0.245 weight portion pigment, stir 15 ~ 20 minutes, then vacuum heat-preserving certain hour makes gelatin viscosity reach 27000 ~ 32000mpas, with the above screen filtration glue of 80 order, by filter after glue 50-65 DEG C of steady glue be no less than 2 hours stand-by;
Step 3: feed liquid is prepared
Take 3 parts by weight of soybean oil, be heated to 70 ~ 80 DEG C, then add 0.2 weight portion Cera Flava, the Fructus Schisandrae Sphenantherae ethanol extractum that 10 weight portion steps 1 obtain is added after Cera Flava all dissolves, use colloidal grinding 3 ~ 5 times after being stirred by mixed liquor again, cross 100 eye mesh screens, be cooled to room temperature stand-by;
Step 4: pelleting
The feed liquid that glue step 2 obtained and step 3 obtain is poured in the soft capsule maker of having debugged and is carried out pelleting, obtains soft gelatin capsule; Pelleting time control glue skin thickness: 0.8-1.0mm, head air temperature: 8 ~ 12 DEG C, operation room temperature: 18 ~ 23 DEG C, sprinkler body temperature: 37 DEG C ~ 50 DEG C, contents temperature: >=40 DEG C, operation room relative humidity: 45% ~ 65%, dishcloth case temperature: 55 DEG C ~ 65 DEG C;
Step 5: soft gelatin capsule is shaped
Soft gelatin capsule step 4 suppressed is 18 ~ 26 DEG C in temperature, shapes 4 hours in the environment of relative humidity 45% ~ 65%;
Step 6: dry
Soft gelatin capsule after step 5 being shaped is placed on rotating cage inner drying 8 ~ 12 hours, ambient temperature 25 DEG C ~ 35 DEG C, humidity less than 40%, makes the moisture of soft capsule shell reach 8% ~ 12% to ensure that soft capsule has good external form and feel.
Feature of the present invention is also,
Step 1 is specially:
Step 1.1: the Fructus Schisandrae Sphenantherae getting oven dry, crosses 40 ~ 50 mesh sieves for subsequent use after pulverizing;
Step 1.2: add 10 times of water gagings in the Fructus Schisandrae Sphenantherae after pulverizing and sieving to step 1.1, decocts 1 ~ 1.5 hour, and filter, medicinal liquid discards, and obtains medicinal residues;
Step 1.3: medicinal residues crushed after being dried step 1.2 obtained, crosses 40 ~ 50 mesh sieves, obtains medicinal residues coarse powder;
Step 1.4: add the alcohol reflux 2 times that 8 times amount volumetric concentrations are 70% in the medicinal residues coarse powder that step 1.3 obtains, each 1.5 ~ 2 hours, filter, merge the filtrate of extracting for 2 times, medicinal residues discard, when the filtrate of merging being concentrated into 50 DEG C, relative density is 1.34 ~ 1.36, obtains Fructus Schisandrae Sphenantherae ethanol extractum.
Temperature dry in step 1.3 is 80 ~ 85 DEG C.
Pressure concentrated in step 1.4 is-0.06 ~-0.075MPa, and thickening temperature is 55 ~ 60 DEG C.
In step 2, the vacuum of vacuum heat-preserving is-0.05 ~-0.07Mpa, and temperature is 75 ~ 80 DEG C, and temperature retention time is no more than 5 hours.
In step 2, pigment is one or more in white carbon black, food coloring, iron oxide red, cologne earth, iron sesquioxide.
The invention has the beneficial effects as follows: the preparation method of shizandra berry soft capsule of the present invention, Fructus Schisandrae Chinensis is made soft capsule, decrease dose, accelerating drug absorption, without the need to adding sucrose, solving existing concentrated pill or tablet bitter in the mouth, oral absorption is poor, use crowd is limited problem, product quality is easy to control, steady quality is reliable, and not easily ageing hardening, pliability is good.
Detailed description of the invention
Below in conjunction with detailed description of the invention, the present invention is described in detail.
The preparation method of shizandra berry soft capsule of the present invention, comprises the following steps:
Step 1: prepare Fructus Schisandrae Sphenantherae leaching alcohol cream, concrete grammar is:
Step 1.1: the Fructus Schisandrae Sphenantherae getting oven dry, crosses 40 ~ 50 mesh sieves for subsequent use after pulverizing;
Step 1.2: the Fructus Schisandrae Sphenantherae after step 1.1 being pulverized and sieved is put in extraction pot, adds 10 times of water gagings, decocts 1 ~ 1.5 hour, and filter, medicinal liquid discards, and obtains medicinal residues;
Step 1.3: medicinal residues step 1.2 obtained crushed after being dried at the temperature of 80 ~ 85 DEG C, crosses 40 ~ 50 mesh sieves, obtains medicinal residues coarse powder;
Step 1.4: add the alcohol reflux 2 times that 8 times amount volumetric concentrations are 70% in the medicinal residues coarse powder that step 1.3 obtains, each 1.5 ~ 2 hours, filter, merge the filtrate of extracting for 2 times, medicinal residues discard, and when the filtrate of merging being concentrated into 50 DEG C, relative density is 1.34 ~ 1.36, and concentrated pressure is-0.06 ~-0.075MPa, thickening temperature is 55 ~ 60 DEG C, obtains Fructus Schisandrae Sphenantherae ethanol extractum.
Step 2: change glue
By in 35 pouring into of weight portion purified water glue tanks, open hot water circulating pump, give and change the heating of glue tank, be warming up to 70 DEG C, add 35 weight portion gelatin, continuous stirring, micelle is all dissolved, then 80 DEG C are warmed up to, add 0.035 weight portion ethyl hydroxybenzoate, 12.25 parts by weight of glycerin and 0.245 weight portion color element, stir 15 ~ 20 minutes, then under the vacuum of-0.05 ~-0.07Mpa, 75 ~ 80 DEG C of insulations are no more than 5 hours, glue rotary viscosity is made to reach 27000 ~ 32000mpas, with the above screen filtration glue of 80 order, glue after filtering is placed in the heat-preserving container of 50-65 DEG C, steady glue is no less than 2 hours, stand-by, wherein, pigment is one or more in white carbon black, food coloring, iron oxide red, cologne earth, iron sesquioxide,
Step 3: feed liquid is prepared
Take 3 parts by weight of soybean oil, be heated to 70 ~ 80 DEG C, then add 0.2 weight portion Cera Flava, Cera Flava is all dissolved, then the Fructus Schisandrae Sphenantherae ethanol extractum that 10 weight portion steps 1 obtain is added, mixed liquor is constantly stirred, makes abundant mixing, the medicinal liquid stirred is used colloidal grinding 3 ~ 5 times again, make all by 100 eye mesh screens, put in clean stainless steel cask, through being cooled to room temperature after the assay was approved, stand-by;
Step 4: pelleting
First by paraffin oil debugging soft capsule maker after start, pour glue that step 2 obtains again into and the feed liquid that step 3 obtains carries out pelleting smoothly, glue is used for making rubber, and feed liquid is used for doing the content of parcel in rubber, obtains soft gelatin capsule.Pelleting time control glue skin thickness: 0.8-1.0mm, head air temperature: 8 ~ 12 DEG C, operation room temperature: 18 ~ 23 DEG C, sprinkler body temperature: 37 DEG C ~ 50 DEG C, contents temperature: >=40 DEG C, operation room relative humidity: 45% ~ 65%, dishcloth case temperature: 55 DEG C ~ 65 DEG C;
Step 5: soft gelatin capsule is shaped
Soft gelatin capsule step 4 suppressed is 18 ~ 26 DEG C in temperature, shapes 4 hours in the environment of relative humidity 45% ~ 65%;
Step 6: dry
Soft gelatin capsule after step 5 being shaped is placed on rotating cage inner drying, 8 ~ 12 hours usual drying times, environmental requirement temperature 25 DEG C ~ 35 DEG C, humidity less than 40%, makes the moisture of soft capsule shell reach 8% ~ 12% to ensure that soft capsule has good external form and feel.
Pure water addition too much can make rubber partially soft, and elasticity is bad, affects quality; Addition is very few, and rubber toughness strengthens, and elasticity is not good enough, and feel is harder.
Fructus Schisandrae Chinensis lignanoid is fat-soluble comparatively strong, if make tablet, effective ingredient stripping is slow, have impact on the timely performance of drug effect; If make hard capsule, as a large amount of adjuvants will be added during granulation, desirable granule cannot be obtained; Make soft capsule, add less adjuvant and just can obtain the good preparation of shape, not only stable in properties, and can dosage be reduced.
The gained formulation disintegrates time is short, and the disintegration time in water and in gastric juice all meets relevant regulations, be beneficial to be rapidly absorbed, quick acting, and can effectively prevent content layering, capsule oil leakage phenomenon; Capsule good springiness, conventional storage, after 2 years, still can keep favorable elasticity, effectively prevent softgel shell dehydration catabiosis, improves drug quality stability, safety and effect reliability.
Embodiment 1
To prepare 10,000 soft capsules, comprise the following steps:
Step 1: prepare Fructus Schisandrae Sphenantherae leaching alcohol cream, concrete grammar is:
Step 1.1: the Fructus Schisandrae Sphenantherae getting oven dry, crosses 40 mesh sieves for subsequent use after pulverizing;
Step 1.2: the Fructus Schisandrae Sphenantherae after step 1.1 being pulverized and sieved is put in extraction pot, adds 10 times of water gagings, decocts 1 hour, and filter, medicinal liquid discards, and obtains medicinal residues;
Step 1.3: medicinal residues step 1.2 obtained crushed after being dried at the temperature of 80 DEG C, crosses 40 mesh sieves, obtains medicinal residues coarse powder;
Step 1.4: add the alcohol reflux 2 times that 8 times amount volumetric concentrations are 70% in the medicinal residues coarse powder that step 1.3 obtains, each 1.5 hours, filter, merge the filtrate of extracting for 2 times, medicinal residues discard, and when the filtrate of merging being concentrated into 50 DEG C, relative density is 1.34, and concentrated pressure is-0.06MPa, thickening temperature is 60 DEG C, obtains Fructus Schisandrae Sphenantherae ethanol extractum.
Step 2: change glue
By in pouring into of 35kg purified water glue tank, open hot water circulating pump, give and change the heating of glue tank, be warming up to 70 DEG C, add 35kg gelatin, continuous stirring, makes micelle all dissolve, and is then warmed up to 80 DEG C, add 0.035kg ethyl hydroxybenzoate, 12.25kg glycerol and 0.245kg pigment, stir 15 minutes, then under the vacuum of-0.05Mpa, 80 DEG C of insulations are no more than 5 hours, make glue rotary viscosity reach 27000mpas, with the above screen filtration glue of 80 order, be placed in the heat-preserving container of 50 DEG C by the glue after filtering, steady glue is no less than 2 hours, stand-by; Wherein, pigment is food coloring;
Step 3: feed liquid is prepared
Take 3kg soybean oil, be heated to 70 DEG C, then add 0.2kg Cera Flava, Cera Flava is all dissolved, then the Fructus Schisandrae Sphenantherae ethanol extractum that 10kg step 1 obtains is added, mixed liquor is constantly stirred, makes abundant mixing, the medicinal liquid stirred is used colloidal grinding 3 times again, make all by 100 eye mesh screens, put in clean stainless steel cask, through being cooled to room temperature after the assay was approved, stand-by;
Step 4: pelleting
First by paraffin oil debugging soft capsule maker after start, pour glue that step 2 obtains again into and the feed liquid that step 3 obtains carries out pelleting smoothly, glue is used for making rubber, and feed liquid is used for doing the content of parcel in rubber, obtains soft gelatin capsule.Pelleting time control glue skin thickness: 0.8mm, head air temperature: 8 DEG C, operation room temperature: 18 DEG C, sprinkler body temperature: 37 DEG C DEG C, contents temperature: >=40 DEG C, operation room relative humidity: 45%, dishcloth case temperature: 55 DEG C;
Step 5: soft gelatin capsule is shaped
Soft gelatin capsule step 4 suppressed is 18 DEG C in temperature, shapes 4 hours in the environment of relative humidity 45%;
Step 6: dry
Soft gelatin capsule after step 5 being shaped is placed on rotating cage inner drying, 8 hours drying times, environmental requirement temperature 25 DEG C, humidity less than 40%, makes the moisture of soft capsule shell reach 8% to ensure that soft capsule has good external form and feel.
Embodiment 2
To prepare 10,000 soft capsules, comprise the following steps:
Step 1: prepare Fructus Schisandrae Sphenantherae leaching alcohol cream, concrete grammar is:
Step 1.1: the Fructus Schisandrae Sphenantherae getting oven dry, crosses 50 mesh sieves for subsequent use after pulverizing;
Step 1.2: the Fructus Schisandrae Sphenantherae after step 1.1 being pulverized and sieved is put in extraction pot, adds 10 times of water gagings, decocts 1.5 hours, and filter, medicinal liquid discards, and obtains medicinal residues;
Step 1.3: medicinal residues step 1.2 obtained crushed after being dried at the temperature of 85 DEG C, crosses 50 mesh sieves, obtains medicinal residues coarse powder;
Step 1.4: add the alcohol reflux 2 times that 8 times amount volumetric concentrations are 70% in the medicinal residues coarse powder that step 1.3 obtains, each 2 hours, filter, merge the filtrate of extracting for 2 times, medicinal residues discard, and when the filtrate of merging being concentrated into 50 DEG C, relative density is 1.36, and concentrated pressure is-0.075MPa, thickening temperature is 55 DEG C, obtains Fructus Schisandrae Sphenantherae ethanol extractum.
Step 2: change glue
By in pouring into of 35kg purified water glue tank, open hot water circulating pump, give and change the heating of glue tank, be warming up to 70 DEG C, add 35kg gelatin, continuous stirring, makes micelle all dissolve, and is then warmed up to 80 DEG C, add 0.035kg ethyl hydroxybenzoate, 12.25kg glycerol and 0.245kg pigment, stir 20 minutes, then under the vacuum of-0.07Mpa, 75 DEG C of insulations are no more than 5 hours, make glue rotary viscosity reach 32000mpas, with the above screen filtration glue of 80 order, be placed in the heat-preserving container of 65 DEG C by the glue after filtering, steady glue is no less than 3 hours, stand-by; Wherein, pigment is iron sesquioxide;
Step 3: feed liquid is prepared
Take 3kg soybean oil, be heated to 80 DEG C, then add 0.2kg Cera Flava, Cera Flava is all dissolved, then the Fructus Schisandrae Sphenantherae ethanol extractum that 10kg step 1 obtains is added, mixed liquor is constantly stirred, makes abundant mixing, the medicinal liquid stirred is used colloidal grinding 5 times again, make all by 100 eye mesh screens, put in clean stainless steel cask, through being cooled to room temperature after the assay was approved, stand-by;
Step 4: pelleting
First by paraffin oil debugging soft capsule maker after start, pour glue that step 2 obtains again into and the feed liquid that step 3 obtains carries out pelleting smoothly, glue is used for making rubber, and feed liquid is used for doing the content of parcel in rubber, obtains soft gelatin capsule.Pelleting time control glue skin thickness: 1.0mm, head air temperature: 12 DEG C, operation room temperature: 23 DEG C, sprinkler body temperature: 50 DEG C, contents temperature: >=40 DEG C, operation room relative humidity: 65%, dishcloth case temperature: 65 DEG C;
Step 5: soft gelatin capsule is shaped
Soft gelatin capsule step 4 suppressed is 26 DEG C in temperature, shapes 4 hours in the environment of relative humidity 65%;
Step 6: dry
Soft gelatin capsule after step 5 being shaped is placed on rotating cage inner drying, 12 hours usual drying times, environmental requirement temperature 35 DEG C, humidity less than 40%, makes the moisture of soft capsule shell reach 12% to ensure that soft capsule has good external form and feel.
Embodiment 3
To prepare 10,000 soft capsules, comprise the following steps:
Step 1: prepare Fructus Schisandrae Sphenantherae leaching alcohol cream, concrete grammar is:
Step 1.1: the Fructus Schisandrae Sphenantherae getting oven dry, crosses 45 mesh sieves for subsequent use after pulverizing;
Step 1.2: the Fructus Schisandrae Sphenantherae after step 1.1 being pulverized and sieved is put in extraction pot, adds 10 times of water gagings, decocts 1.2 hours, and filter, medicinal liquid discards, and obtains medicinal residues;
Step 1.3: medicinal residues step 1.2 obtained crushed after being dried at the temperature of 82 DEG C, crosses 45 mesh sieves, obtains medicinal residues coarse powder;
Step 1.4: add the alcohol reflux 2 times that 8 times amount volumetric concentrations are 70% in the medicinal residues coarse powder that step 1.3 obtains, each 1.7 hours, filter, merge the filtrate of extracting for 2 times, medicinal residues discard, and when the filtrate of merging being concentrated into 50 DEG C, relative density is 1.35, and concentrated pressure is-0.07MPa, thickening temperature is 58 DEG C, obtains Fructus Schisandrae Sphenantherae ethanol extractum.
Step 2: change glue
By in pouring into of 35kg purified water glue tank, open hot water circulating pump, give and change the heating of glue tank, be warming up to 70 DEG C, add 35kg gelatin, continuous stirring, makes micelle all dissolve, and is then warmed up to 80 DEG C, add 0.035kg ethyl hydroxybenzoate, 12.25kg glycerol and 0.245kg pigment, stir 18 minutes, then under the vacuum of-0.06Mpa, 78 DEG C of insulations are no more than 5 hours, make glue rotary viscosity reach 30000mpas, with the above screen filtration glue of 80 order, be placed in the heat-preserving container of 60 DEG C by the glue after filtering, steady glue is no less than 2 hours, stand-by; Wherein, pigment is that ferrum is red;
Step 3: feed liquid is prepared
Take 3kg soybean oil, be heated to 75 DEG C, then add 0.2kg Cera Flava, Cera Flava is all dissolved, then the Fructus Schisandrae Sphenantherae ethanol extractum that 10kg step 1 obtains is added, mixed liquor is constantly stirred, makes abundant mixing, the medicinal liquid stirred is used colloidal grinding 4 times again, make all by 100 eye mesh screens, put in clean stainless steel cask, through being cooled to room temperature after the assay was approved, stand-by;
Step 4: pelleting
First by paraffin oil debugging soft capsule maker after start, pour glue that step 2 obtains again into and the feed liquid that step 3 obtains carries out pelleting smoothly, glue is used for making rubber, and feed liquid is used for doing the content of parcel in rubber, obtains soft gelatin capsule.Pelleting time control glue skin thickness: 0.9mm, head air temperature: 10 DEG C, operation room temperature: 20 DEG C, sprinkler body temperature: 45 DEG C, contents temperature: >=40 DEG C, operation room relative humidity: 50%, dishcloth case temperature: 60 DEG C;
Step 5: soft gelatin capsule is shaped
Soft gelatin capsule step 4 suppressed is 22 DEG C in temperature, shapes 4 hours in the environment of relative humidity 50%;
Step 6: dry
Soft gelatin capsule after step 5 being shaped is placed on rotating cage inner drying, 10 hours usual drying times, environmental requirement temperature 30 DEG C, humidity less than 40%, makes the moisture of soft capsule shell reach 10% to ensure that soft capsule has good external form and feel.
The soft capsule peel that the inventive method prepares is soft, there is no crackle, according to official method, saponification number is carried out to soft capsule prepared by the embodiment of the present invention 3, iodine number, peroxide value, microbial limit detect, all meet relevant criterion requirement, constant product quality.In the soft capsule obtain embodiment 3 and commercially available 3, the softgel shell elasticity of soft capsule, disintegration time compare, and the results are shown in Table 1:
The different soft capsule of table 1 is apart from disintegration time contrast during 6 months dates of manufacture
As can be seen from Table 1, soft capsule prepared by method of the present invention, compared with existing soft capsule, apart from disintegration time during 6 months dates of manufacture much smaller than existing commercially available soft capsule, has good superiority, soft capsule of the present invention is produced latter 15 days, and disintegration time is within 5 minutes.Capsule is soft, good springiness, and conventional storage, after 2 years, still can keep favorable elasticity, effectively prevent softgel shell dehydration catabiosis, improves drug quality stability, safety and effect reliability.
Claims (6)
1. the preparation method of shizandra berry soft capsule, is characterized in that, comprises the following steps:
Step 1: prepare Fructus Schisandrae Sphenantherae leaching alcohol cream;
Step 2: change glue
By in 35 pouring into of weight portion purified water glue tanks, be warming up to 70 DEG C, add 35 weight portion gelatin, 80 DEG C are warmed up to after micelle all dissolves, add 0.035 weight portion ethyl hydroxybenzoate, 12.25 parts by weight of glycerin and 0.245 weight portion pigment, stir 15 ~ 20 minutes, then vacuum heat-preserving certain hour makes gelatin viscosity reach 27000 ~ 32000mpas, with the above screen filtration glue of 80 order, by filter after glue 50-65 DEG C of steady glue be no less than 2 hours stand-by;
Step 3: feed liquid is prepared
Take 3 parts by weight of soybean oil, be heated to 70 ~ 80 DEG C, then add 0.2 weight portion Cera Flava, the Fructus Schisandrae Sphenantherae ethanol extractum of 10 weight portion steps 1 is added after Cera Flava all dissolves, use colloidal grinding 3 ~ 5 times after being stirred by mixed liquor again, cross 100 eye mesh screens, be cooled to room temperature stand-by;
Step 4: pelleting
The feed liquid that glue step 2 obtained and step 3 obtain is poured in the soft capsule maker of having debugged and is carried out pelleting, obtains soft gelatin capsule; Pelleting time control glue skin thickness: 0.8-1.0mm, head air temperature: 8 ~ 12 DEG C, operation room temperature: 18 ~ 23 DEG C, sprinkler body temperature: 37 DEG C ~ 50 DEG C, contents temperature: >=40 DEG C, operation room relative humidity: 45% ~ 65%, dishcloth case temperature: 55 DEG C ~ 65 DEG C;
Step 5: soft gelatin capsule is shaped
Soft gelatin capsule step 4 suppressed is 18 ~ 26 DEG C in temperature, shapes 4 hours in the environment of relative humidity 45% ~ 65%;
Step 6: dry
Soft gelatin capsule after step 5 being shaped is placed on rotating cage inner drying 8 ~ 12 hours, ambient temperature 25 DEG C ~ 35 DEG C, humidity less than 40%, makes the moisture of soft capsule shell reach 8% ~ 12% to ensure that soft capsule has good external form and feel.
2. the preparation method of shizandra berry soft capsule as claimed in claim 1, it is characterized in that, described step 1 is specially:
Step 1.1: the Fructus Schisandrae Sphenantherae getting oven dry, crosses 40 ~ 50 mesh sieves for subsequent use after pulverizing;
Step 1.2: add 10 times of water gagings in the Fructus Schisandrae Sphenantherae after pulverizing and sieving to step 1.1, decocts 1 ~ 1.5 hour, and filter, medicinal liquid discards, and obtains medicinal residues;
Step 1.3: medicinal residues crushed after being dried step 1.2 obtained, crosses 40 ~ 50 mesh sieves, obtains medicinal residues coarse powder;
Step 1.4: add the alcohol reflux 2 times that 8 times amount volumetric concentrations are 70% in the medicinal residues coarse powder that step 1.3 obtains, each 1.5 ~ 2 hours, filter, merge the filtrate of extracting for 2 times, medicinal residues discard, when the filtrate of merging being concentrated into 50 DEG C, relative density is 1.34 ~ 1.36, obtains Fructus Schisandrae Sphenantherae ethanol extractum.
3. the preparation method of shizandra berry soft capsule as claimed in claim 2, is characterized in that, temperature dry in described step 1.3 is 80 ~ 85 DEG C.
4. the preparation method of shizandra berry soft capsule as claimed in claim 2, is characterized in that, pressure concentrated in described step 1.4 is-0.06 ~-0.075MPa, and thickening temperature is 55 ~ 60 DEG C.
5. the preparation method of shizandra berry soft capsule as claimed in claim 1, it is characterized in that, in described step 2, the vacuum of vacuum heat-preserving is-0.05 ~-0.07Mpa, and temperature is 75 ~ 80 DEG C, and temperature retention time is no more than 5 hours.
6. the preparation method of shizandra berry soft capsule as claimed in claim 1, it is characterized in that, in described step 2, pigment is one or more in white carbon black, food coloring, iron oxide red, cologne earth, iron sesquioxide.
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| CN201410803418.6A CN104491007A (en) | 2014-12-19 | 2014-12-19 | Preparation method of fructus schisandrae chinensis soft capsule |
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| CN201410803418.6A CN104491007A (en) | 2014-12-19 | 2014-12-19 | Preparation method of fructus schisandrae chinensis soft capsule |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105435030A (en) * | 2015-12-16 | 2016-03-30 | 江西津正药业有限公司 | Preparation process of cough relieving loquat soft capsules |
| CN110496169A (en) * | 2019-09-30 | 2019-11-26 | 陕西盘龙药业集团股份有限公司 | A kind of preparation method assisting protect liver soft capsule |
| CN112717117A (en) * | 2021-03-01 | 2021-04-30 | 锦州福寿堂医药科技有限公司 | Preparation method of bufelone asthma-relieving soft capsule |
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| CN1522726A (en) * | 2003-02-21 | 2004-08-25 | 刘建生 | Novel schisandra fruit soft capsule formulation and its preparation method |
| US20090280200A1 (en) * | 2008-05-08 | 2009-11-12 | Industrial Technology Research Institute | Herbal extracts which induce immune cells to produce interferon and activate toll-like receptors |
| CN103494789A (en) * | 2013-09-17 | 2014-01-08 | 黑龙江八一农垦大学 | Preparation method of sea-buckthorn polysaccharide soft capsule |
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| CN1522726A (en) * | 2003-02-21 | 2004-08-25 | 刘建生 | Novel schisandra fruit soft capsule formulation and its preparation method |
| US20090280200A1 (en) * | 2008-05-08 | 2009-11-12 | Industrial Technology Research Institute | Herbal extracts which induce immune cells to produce interferon and activate toll-like receptors |
| CN103494789A (en) * | 2013-09-17 | 2014-01-08 | 黑龙江八一农垦大学 | Preparation method of sea-buckthorn polysaccharide soft capsule |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105435030A (en) * | 2015-12-16 | 2016-03-30 | 江西津正药业有限公司 | Preparation process of cough relieving loquat soft capsules |
| CN110496169A (en) * | 2019-09-30 | 2019-11-26 | 陕西盘龙药业集团股份有限公司 | A kind of preparation method assisting protect liver soft capsule |
| CN110496169B (en) * | 2019-09-30 | 2021-11-12 | 陕西盘龙药业集团股份有限公司 | Preparation method of liver protection assisting soft capsule |
| CN112717117A (en) * | 2021-03-01 | 2021-04-30 | 锦州福寿堂医药科技有限公司 | Preparation method of bufelone asthma-relieving soft capsule |
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