CN108498480A - Prevented in Chinese medicinal soft capsule sol-process gelatin congeal power reduction process - Google Patents
Prevented in Chinese medicinal soft capsule sol-process gelatin congeal power reduction process Download PDFInfo
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- CN108498480A CN108498480A CN201810554644.3A CN201810554644A CN108498480A CN 108498480 A CN108498480 A CN 108498480A CN 201810554644 A CN201810554644 A CN 201810554644A CN 108498480 A CN108498480 A CN 108498480A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4833—Encapsulating processes; Filling of capsules
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4816—Wall or shell material
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4816—Wall or shell material
- A61K9/4825—Proteins, e.g. gelatin
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Abstract
Prevented in Chinese medicinal soft capsule sol-process gelatin congeal power reduction process：Prepare Black Rouge, Ferric Oxide Suspension：Black Rouge, red ferric oxide are added in purified water, stirs evenly, it is 1. spare to obtain solution；In purified water, glycerine, polyethylene glycol 400 inputization glue tank, agitating paddle is opened, opens steam valve, starts heating water bath；1. and sodium pyrosulfite when 60 85 DEG C of tank Nei Wenduda, input gelatinum pro capsulae, sorbierite, solution, stir evenly, continue steam off after heating；It is evacuated to bubble to extract out substantially, closes agitating paddle and vacuum valve；Put glue：Timed incubations in insulation barrel are placed after glue filtering waits for pill.The present invention by controlling gel content, water content, charging order, heating temperature, heating time, soaking time are congealed the reduction of power to reduce gelatin, sealing rate when Chinese medicinal soft capsule pill is set to significantly improve, phenomena such as no content exudation and rubber are adhered occurs, it can be achieved that stable and controllable for quality.
Description
Technical field
The present invention relates to Chinese medicinal soft capsule fields, and in particular to prevents gelatin from congealing in a kind of Chinese medicinal soft capsule sol-process
The process that power reduces.
Background technology
Soft capsule is also known as flexible glue pill, and shape has circle, ellipse, fish shape, tubular etc., be by oils or to gelatin object without
Water-insoluble liquid or suspension of dissolution etc. are closed in the preparation formed in capsule shells.Taking dose is small, is insoluble in
Water is not easy in alimentary canal to absorb and meet light, wet, thermally labile and oxidizable drug, it can be dissolved in oil appropriate and makes
At soft capsule, gastral absorption is not only increased, improves curative effect, and stability is good, dosage is accurate, solves and takes
In place of the deficiencies of person's difficulty entrance, poor taste.
Soft capsule shell be usually by pharmagel, plasticizer, water, colorant and（Or）Opacifier forms, and also contains sometimes
Aromatic and（Or）Preservative.Gelatin is one of main component of soft capsule shell, and the quality and dosage of quality are directly related to
The quality of soft capsule, therefore the first gate of the quality monitoring that hold gelatin.Secondly, colloidal sol is capsule skin in soft capsule production technology
Process for preparation, and ensure the basic of soft capsule quality.The general jelly power for requiring gelatin, viscosity are leading indicator, if viscosity is low
Then soft capsule shell is easy to saponification.It is one important indicator of gelatin, the i.e. ability of congealing of gelatin solution to freeze power, is the letter of gel strength
Claim, at the standard conditions the Van der Waals force etc. of the polar group contained in gelatin molecule, linear polymeric main body, molecule interchain
The gel rigidity that reason is formed, it is closely related with the structure of gelatin molecule, molecular weight.Gelatin can form thermal reversibility with water and coagulate
Glue, gelatin solution experienced by the process of colloidal sol to gel, ultimately form semisolid, hard during gradual cooling
Tough and high resilience can bear jelly very energetically.During Gelatin, temperature freezes power to it and is affected, according to solidifying
The diffusivity of glue, gelatin concentration is low, and the diffusion velocity of hydrone wherein is fast, may be uniformly dispersed in gelatin skeleton gap,
It is combined well with polar group, forms tough and tensile, flexible jelly, that is, frozen power and rise.But as temperature constantly increases, meeting
Some gelatin molecule structures are destroyed, so that it is lost physical and chemical performance causes jelly power linearly to decline substantially；Extending the steaming glue time can make
Glue freezes the power range of decrease and increases.Since hydrolysis time extends, long-chain molecule is destructurized, therefore molecule interchain is not easy shape
Chaining tangled structure, intermolecular van der Waals interaction also weaken, thus Gel Strength of Gelatin be further destroyed it is on a declining curve.
Chinese medicine preparation is mostly medicinal extract preparation, and hard capsule, which is made, need to be added excessive filler, and appearance is contacted with air
The easy moisture absorption will appear be adhered phenomenon during storage, and soft capsule, which is made, to be efficiently modified.But Chinese medical concrete preparation is glutinous
Property it is larger, to rubber congeal power requirement it is high, in the case where the higher aerosol time of collosol temperature is longer, the power of congealing of rubber
It is lower.Therefore gelatin how is reduced in Chinese medicinal soft capsule production process to congeal power decline, and Chinese medicinal soft capsule pill sealing rate is made to carry
Height, be conducive to soft capsule content exudation does not occur during storage, the problems such as capsule skin is tacky need it is urgently to be resolved hurrily.In order to
Soft capsule finished product stability can be further increased, it is ensured that product quality.
Invention content
The object of the present invention is to provide prevented in a kind of Chinese medicinal soft capsule sol-process gelatin congeal power reduction technique side
Method, it is ensured that phenomena such as content exudation does not occur in the flow process of market for product, and rubber is adhered meets imperial want
It asks.To achieve the goals above, inventor is by market survey, literature search, interior exchange of technology of going together, discovery gelatine type,
After realizing an equilibrium valve between water content, plasticising dosage, by controlling heating temperature, heating time, soaking time, it can subtract
Few gelatin congeals the reduction of power.It is measured through rotary viscosity, preparation process of the present invention prepares gained gelatin viscosity compared with traditional handicraft can
80% or so are improved, realizes rubber stable quality.
In order to complete above-mentioned task, the technical solution adopted by the present invention is, is prevented in a kind of Chinese medicinal soft capsule sol-process
Gelatin congeal power reduction process, which is characterized in that steps are as follows：
（1）Prepare Black Rouge, Ferric Oxide Suspension：Appropriate purified water is weighed to be placed in clean container, addition Black Rouge,
Red ferric oxide stirs evenly, and obtains solution 1., spare；
（2）By in purified water, glycerine, polyethylene glycol-400 inputization glue tank, agitating paddle is opened, opens steam valve, starts water
Bath heating；
（3）When tank Nei Wenduda 60-85 DEG C, input gelatinum pro capsulae, sorbierite, solution are 1. and sodium pyrosulfite, stirring are equal
It is even, so that temperature in tank is reduced because feeding intake, need to continue after being heated up to certain temperature, steam off；
（4）Vacuum valve is unscrewed, is vacuumized, until glue bubble is extracted out substantially in tank, agitating paddle is closed, closes vacuum valve；
（5）Put glue：It is placed in gelatin insulation barrel after glue filtering, send between colloid storage, be neatly placed in defined region, it is fixed
Shi Baowen waits for pill.
The gelatinum pro capsulae that present invention process uses, power of congealing are 180 or more.
Present invention process method and step（1）Described in Black Rouge, red ferric oxide and purified water glue formula in matter
Measuring ratio is：Black Rouge 0.15-0.22, red ferric oxide 0.10-0.17, purified water 0.5-1.5.
Recommendation ratio is：Black Rouge 0.18, red ferric oxide 0.14, purified water 1.
Step（2）Middle purified water, glycerine, the polyethylene glycol-400 mass ratio in glue formula is：Purified water 30-40, glycerine 10-
20, polyethylene glycol-400 3-5.
Recommendation ratio is：Purified water 35, glycerine 15, polyethylene glycol-400 4.
Present invention process step method（3）Described in tank temperature be reduced to 45-60 DEG C, continue heating and rise to 50-70
DEG C, steam off；Step（3）Described in gelatinum pro capsulae, sorbierite, solution 1., sodium pyrosulfite glue formula in quality
Than for：Gelatinum pro capsulae 35-46, sorbierite 3.5-5.5, solution 1. 0.75-1.89, sodium pyrosulfite 0.3-0.5.
Recommendation ratio is：Gelatinum pro capsulae 40, sorbierite 4.28, solution 1. 1.32, sodium pyrosulfite 0.4.
Step（4）Described in vacuumize, vacuum degree control is in -0.07MPa-0.095MPa, about 35-70 minutes time.It takes out
Pot temperature maintains 55-70 DEG C when vacuum；
Step（4）In the judgment method of " glue bubble is extracted out substantially in tank " be：It uses in production process and is estimated from form.
Step（5）Described in filter type can be alternatively filter cloth with sieves, mesh number is 40-60 mesh, and the glue of gained exists
2-8 hours are kept the temperature under 45-60 DEG C of state, waits for pill.
The medicine such as other opacifiers, including yellow ferric oxide, titanium dioxide and field of health care food can also be used in glue
One or more mixtures in common material.Its dosage is the conventional amount used according to this field.
In glue can also use quality percentage be 0.3-0.5% other antioxidants, including sodium sulfite, sulfurous
Sour hydrogen sodium, sodium thiosulfate, ascorbic acid, methionine（Methionine）, thiocarbamide, Calcium Disodium Versenate, and/or citric acid
In one or more mixtures.
Traditional handicraft is respectively adopted in inventor and present invention process has carried out the trial-manufacture of sample of more batches of Chinese medicinal soft capsules, passes through
6 months long-term stable experiments are investigated, and after discovery improves traditional handicraft, water consumption, heating temperature are purified using changing
Degree, mode of heating and glue soaking time etc., it is intact to may be implemented capsule pill sealing rate, rubber stable quality.
Inventor has carried out technological improvement on the basis of conventional preparation techniques, using cryosol technique, and strictly controls
The factors pilot sample such as mode of heating, heating time, soaking time.The sample that through the invention prepared by technique and traditional handicraft into
After row critical data comparative study, it was demonstrated that present invention process method can make soft capsule rubber stable quality, when pill seal it is intact,
Not phenomena such as not generating content exudation.In addition, to the production process of Chinese medicinal soft capsule to bring other beneficial for the implementation of the present invention
Effect：（1）The present invention reduces about 2% purifying water consumption, improves gelatin compared with traditional processing technology in change glue formula
Concentration.The reduction of moisture makes the pumpdown time shorten, and so that glue and the time of contact of heatingization glue tank is shortened indirectly, reduces bright
The decline of power is frozen in gelling.In addition vacuum degree is got higher, and is also beneficial to gelatin swelling, and colloid bubble tails off, it is ensured that rubber quality is steady
Fixed, soft capsule good appearance.（2）Persistently overheating method is used in traditional handicraft, first throws purified water and glycerine, polyethylene glycol-400
In entering glue tank, agitating paddle is opened, steam valve is opened, begins to warm up.When 40 DEG C of tank Nei Wenduda, input capsule is with bright
Glue, sorbierite put into pigment suspension it is further heated up to 50 DEG C, are continuously heating to glue temperature and reach 60-70 DEG C, close and steam
Steam valve door keeps the temperature 45 minutes, finally vacuumizes and stir 45-60 minutes.Present invention process is using first by purified water and glycerine, poly-
In -400 inputization glue tank of ethylene glycol, agitating paddle is opened, steam valve is opened, begins to warm up.Wait for tank Nei Wenduda 60-85 DEG C
When, input gelatinum pro capsulae, sorbierite put into pigment suspension, antioxidant are added, stirs evenly, and temperature drop is caused due to feeding intake
It is low, heating need to be continued and rise to 50-70 DEG C, vacuumize while stirring 35-70 minutes after steam off.Compared with traditional handicraft, no
It needs to control heating rate, reduces operation link, while changing the glue time and saving 1 hour, Gel Strength of Gelatin degree improves, shape
At glue stable homogeneous, no agglomerate or particulate material.（3）The present invention uses heating water bath glue, and temperature control is secure, avoids
Appearanceization glue is uneven or due to the excessively high generation colloid part coking phenomenon of tank wall temperature.（4）Gained glue of the invention and tradition
Technique is compared, and be may filter that using 40-60 mesh, without agglomerate and particulate matter in glue, and is reduced filtration time.
Embodiment 1：Chinese medicinal soft capsule colloidal sol traditional handicraft.
1. preparing red ferric oxide, Black Rouge suspension：It weighs appropriate purified water to be placed in a clean container, be added red
Iron oxide, Black Rouge, stir evenly, and obtain solution 1., spare.The Black Rouge, red ferric oxide and purified water are in glue
Mass ratio is：Black Rouge 0.18, red ferric oxide 0.14, purified water 0.95.
2. by purified water and glycerine, polyethylene glycol-400 inputization glue tank, agitating paddle is opened, steam valve is opened, opens
Begin to heat.The purified water, glycerine, the polyethylene glycol-400 quality hundred in glue formula is：Purified water 37, is gathered glycerine 15.3
Ethylene glycol -400 3.8.
3. when 40 DEG C of tank Nei Wenduda, input gelatinum pro capsulae, sorbierite.50 DEG C are continuously heating to, solution is put into
①.Glue temperature is continuously heating to up to 60 DEG C, steam off valve keeps the temperature 45 minutes, and sodium pyrosulfite is added, continues to stir.
The gelatinum pro capsulae, sorbierite, solution 1., sodium pyrosulfite mass ratio in glue formula be：Gelatinum pro capsulae 38, sorb
Alcohol 4.25, solution 1. 1.27, sodium pyrosulfite 0.38.
4. unscrewing vacuum valve, vacuumize（Vacuum degree control is in -0.06MPa to -0.08MPa）, the pumpdown time about 60
Minute, until when glue bubble is extracted out substantially in tank, agitating paddle is closed, closes vacuum valve.
5. putting glue.With 100 mesh filter-cloth filterings in gelatin insulation barrel, send between colloid storage, be neatly placed in defined
Region, 55 DEG C keep the temperature 8 hours, for use.
Embodiment 2：Prevented in Chinese medicinal soft capsule sol-process gelatin congeal power reduction process.
1. preparing Black Rouge, Ferric Oxide Suspension：It weighs appropriate purified water to be placed in a clean container, be added black
Iron oxide, red ferric oxide, stir evenly, and obtain solution 1., spare.The Black Rouge, red ferric oxide and purified water are matched in glue
Mass ratio is in side：Black Rouge 0.18, red ferric oxide 0.14, purified water 0.95.
2. by purified water and glycerine, polyethylene glycol-400 inputization glue tank, agitating paddle is opened, steam valve is opened, opens
Begin to heat.Purified water, glycerine, the polyethylene glycol-400 mass ratio in glue formula is：Purified water 37, glycerine 15.3, poly- second two
Alcohol -400 3.8.
3. when 60 DEG C of tank Nei Wenduda, input gelatinum pro capsulae, sorbierite, input solution 1., sodium pyrosulfite.This
When tank in temperature can reduce, be continuously heating to glue temperature up to 60 DEG C, steam off valve keeps the temperature 45 minutes, continues to stir.Institute
State gelatinum pro capsulae, sorbierite, solution 1., sodium pyrosulfite mass ratio in glue formula be：Gelatinum pro capsulae 38, sorbierite
4.25, solution 1. 1.27, sodium pyrosulfite 0.38.
4. unscrewing vacuum valve, vacuumize（Vacuum degree control is in -0.06MPa to -0.08MPa）, the pumpdown time about 60
Minute, until when glue bubble is extracted out substantially in tank, agitating paddle is closed, closes vacuum valve
5. putting glue.With 80 mesh filter-cloth filterings in gelatin insulation barrel, send between colloid storage, is neatly placed in defined region,
55 DEG C keep the temperature 16 hours, for use.
Embodiment 3：Prevented in Chinese medicinal soft capsule sol-process gelatin congeal power reduction process.
1. preparing Black Rouge, Ferric Oxide Suspension：It weighs appropriate purified water to be placed in a clean container, be added black
Iron oxide, red ferric oxide, stir evenly, and obtain solution 1., spare.The Black Rouge, red ferric oxide and purified water are matched in glue
Mass ratio is in side：Black Rouge 0.15, red ferric oxide 0.17, purified water 0.5.
2. by purified water and glycerine, polyethylene glycol-400 inputization glue tank, agitating paddle is opened, steam valve is opened, opens
Begin to heat.Purified water, glycerine, the polyethylene glycol-400 mass ratio in glue formula is：Purified water 35.38, glycerine 20, poly- second two
Alcohol -400 3.
3. when 60 DEG C of tank Nei Wenduda, input gelatinum pro capsulae, sorbierite, solution 1., sodium pyrosulfite, continue to stir
It mixes.Temperature can reduce in tank at this time, be continuously heating to glue temperature up to 60 DEG C, steam off valve.The gelatinum pro capsulae, mountain
Pears alcohol, solution 1., sodium pyrosulfite mass ratio in glue formula be：Gelatinum pro capsulae 35, sorbierite 5.5, solution 1. 0.82,
Sodium pyrosulfite 0.3.
4. unscrewing vacuum valve, vacuumize（Vacuum degree control is in -0.07MPa -0.095MPa）, the pumpdown time about 60
Minute, until when glue bubble is extracted out substantially in tank, agitating paddle is closed, closes vacuum valve.
5. putting glue, with the filtering of 50 mesh sieves in gelatin insulation barrel, send between colloid storage, be neatly placed in regulation
Region, 55 DEG C keep the temperature 5 hours, for use.
Embodiment 4：Prevented in Chinese medicinal soft capsule sol-process gelatin congeal power reduction process.
1. preparing Black Rouge, Ferric Oxide Suspension：It weighs appropriate purified water to be placed in a clean container, be added black
Iron oxide, red ferric oxide, stir evenly, and obtain solution 1., spare.The Black Rouge, red ferric oxide and purified water are matched in glue
Mass ratio is in side：Black Rouge 0.22, red ferric oxide 0.1, purified water 1.5.
2. by purified water and glycerine, polyethylene glycol-400 inputization glue tank, agitating paddle is opened, steam valve is opened, opens
Begin to heat.Purified water, glycerine, the polyethylene glycol-400 mass ratio in glue formula is：Purified water 33.18, glycerine 10, poly- second two
Alcohol -400 5.
3. when 85 DEG C of tank Nei Wenduda, 1., sodium pyrosulfite, stirring is equal for input gelatinum pro capsulae, sorbierite, solution
Even, temperature is reduced to 56-58 DEG C in tank, continues heating and rises to 60 DEG C, steam off.The gelatinum pro capsulae, sorbierite, solution
1., sodium pyrosulfite mass ratio in glue formula be：Gelatinum pro capsulae 46, sorbierite 5.5, solution 1. 1.82, pyrosulfurous acid
Sodium 0.5.
4. unscrewing vacuum valve, vacuumize（Vacuum degree control is in -0.07MPa -0.095MPa）About 60 minutes time, until
When glue bubble is extracted out substantially in tank, agitating paddle is closed, closes vacuum valve.Pot temperature maintains 60-65 DEG C when vacuumizing.
5. putting glue.With 40 mesh filter-cloth filterings in gelatin insulation barrel, send between colloid storage, be neatly placed in defined
Region, 55 DEG C keep the temperature 8 hours, for use.
Embodiment 5：Prevented in Chinese medicinal soft capsule sol-process gelatin congeal power reduction process.
1. preparing Black Rouge, Ferric Oxide Suspension：It weighs appropriate purified water to be placed in a clean container, be added black
Iron oxide, red ferric oxide, stir evenly, and obtain solution 1., spare.The Black Rouge, red ferric oxide and purified water are matched in glue
Mass ratio is in side：Black Rouge 0.18, red ferric oxide 0.14, purified water 1.0.
2. will be formulated in remaining purified water and glycerine, polyethylene glycol-400 inputization glue tank, agitating paddle is opened, opens and steams
Steam valve door, begins to warm up.Purified water, glycerine, the polyethylene glycol-400 mass ratio in glue formula is：Purified water 35, glycerine 15,
Polyethylene glycol-400 4.
3. when 70 DEG C of tank Nei Wenduda, 1., sodium pyrosulfite, stirring is equal for input gelatinum pro capsulae, sorbierite, solution
Even, temperature is reduced to 56-58 DEG C in tank, continues heating and rises to 60 DEG C, steam off.The gelatinum pro capsulae, sorbierite, solution
1., sodium pyrosulfite mass ratio in glue formula be：Gelatinum pro capsulae 40, sorbierite 4.28, solution 1. 1.32, pyrosulfurous acid
Sodium 0.4.
4. unscrewing vacuum valve, vacuumize（Vacuum degree control is in -0.07MPa -0.095MPa）About 45 minutes time, until
When glue bubble is extracted out substantially in tank, agitating paddle is closed, closes vacuum valve.Pot temperature maintains 60-65 DEG C when vacuumizing.
5. putting glue：With 50 mesh filter-cloth filterings in gelatin insulation barrel, send between colloid storage, be neatly placed in defined
Region, 55 DEG C keep the temperature 5 hours, for use.
1 embodiment effect observation of table：
Embodiment 6, it is substantially the same manner as Example 1, but step（1）Described in Black Rouge, red ferric oxide and purified water exist
Mass ratio is in glue formula：Black Rouge 0.18, red ferric oxide 0.14, purified water 1；Step（2）Described in purified water, sweet
Oil, polyethylene glycol-400 mass ratio in glue formula are：Purified water 35, glycerine 15, polyethylene glycol-400 4；Step（3）In
The input gelatinum pro capsulae, sorbierite, solution 1. and sodium pyrosulfite mass ratio in glue formula is：Gelatinum pro capsulae
40, sorbierite 4.28, solution 1. 1.32, sodium pyrosulfite 0.4.
Embodiment 7, it is substantially the same manner as Example 1, but step（1）Described in Black Rouge, red ferric oxide and purified water exist
Mass ratio is in glue formula：Black Rouge 0.15, red ferric oxide 0.17, purified water 0.5；
Step（2）Described in purified water, glycerine, the polyethylene glycol-400 mass ratio in glue formula be：Purified water 30, glycerine
20, polyethylene glycol-400 3；
Step（3）Described in input gelatinum pro capsulae, sorbierite, solution 1., sodium pyrosulfite, the above components are in glue formula
Middle mass ratio is：Gelatinum pro capsulae 35, sorbierite 5.5, solution 1. 0.75, sodium pyrosulfite 0.5.
Embodiment 8, it is substantially the same manner as Example 1, but step（1）Described in Black Rouge, red ferric oxide and purified water exist
Mass ratio is in glue formula：Black Rouge 0.22, red ferric oxide 0.10, purified water 1.5；
Step（2）Described in purified water, glycerine, the polyethylene glycol-400 mass ratio in glue formula be：Purified water 40, glycerine
10, polyethylene glycol-400 5；
Step（3）Described in input gelatinum pro capsulae, sorbierite, solution 1., sodium pyrosulfite, the above components are in glue formula
Middle mass ratio is：Gelatinum pro capsulae 46, sorbierite 3.5, solution 1. 1.89, sodium pyrosulfite 0.3.
Embodiment 9, it is substantially the same manner as Example 1, but step（1）Described in Black Rouge, red ferric oxide and purified water exist
Mass ratio is in glue formula：Black Rouge 0.15, red ferric oxide 0.10, purified water 0.5；
Step（2）Described in purified water, glycerine, the polyethylene glycol-400 mass ratio in glue formula be：Purified water 30, glycerine
10, polyethylene glycol-400 3；
Step（3）Described in input gelatinum pro capsulae, sorbierite, solution 1., sodium pyrosulfite, the above components are in glue formula
Middle mass ratio is：Gelatinum pro capsulae 35, sorbierite 3.5, solution 1. 0.75, sodium pyrosulfite 0.3.
Embodiment 10, it is substantially the same manner as Example 1, but step（1）Described in Black Rouge, red ferric oxide and purified water exist
Mass ratio is in glue formula：Black Rouge 0.22, red ferric oxide 0.17, purified water 1.5；
Step（2）Described in purified water, glycerine, the polyethylene glycol-400 mass ratio in glue formula be：Purified water 40, glycerine
20, polyethylene glycol-400 5；
Step（3）Described in input gelatinum pro capsulae, sorbierite, solution 1., sodium pyrosulfite, the above components are in glue formula
Middle mass ratio is：Gelatinum pro capsulae 46, sorbierite 5.5, solution 1. 1.89, sodium pyrosulfite 0.5.
Claims (8)
1. prevented in a kind of Chinese medicinal soft capsule sol-process gelatin congeal power reduction process, which is characterized in that step is such as
Under：
（1）Prepare Black Rouge, Ferric Oxide Suspension：Appropriate purified water is weighed to be placed in clean container, addition Black Rouge,
Red ferric oxide stirs evenly, and obtains solution 1., spare；
（2）By in purified water, glycerine, polyethylene glycol-400 inputization glue tank, agitating paddle is opened, opens steam valve, starts water
Bath heating；
（3）When tank Nei Wenduda 60-85 DEG C, input gelatinum pro capsulae, sorbierite, solution are 1. and sodium pyrosulfite, stirring are equal
It is even, so that temperature in tank is reduced because feeding intake, need to continue after being heated up to certain temperature, steam off；
（4）Vacuum valve is unscrewed, is vacuumized, until glue bubble is extracted out substantially in tank, agitating paddle is closed, closes vacuum valve；
（5）Put glue：It is placed in gelatin insulation barrel after glue filtering, send between colloid storage, be placed in defined region, timing is protected
Temperature waits for pill.
2. prevented in Chinese medicinal soft capsule sol-process according to claim 1 gelatin congeal power reduction process,
It is characterized in that, the gelatinum pro capsulae, power of congealing is 180 or more.
3. prevented in Chinese medicinal soft capsule sol-process according to claim 1 gelatin congeal power reduction process,
It is characterized in that,
Step（1）Described in Black Rouge, red ferric oxide and the purified water mass ratio in glue formula be：Black Rouge 0.15-
0.22, red ferric oxide 0.10-0.17, purified water 0.5-1.5；
Step（2）Described in purified water, glycerine, the polyethylene glycol-400 mass ratio in glue formula be：It is purified water 30-40, sweet
Oily 10-20, polyethylene glycol-400 3-5；
Step（3）Described in input gelatinum pro capsulae, sorbierite, solution 1., sodium pyrosulfite, the above components are in glue formula
Middle mass ratio is：Gelatinum pro capsulae 35-46, sorbierite 3.5-5.5, solution 1. 0.75-1.89, sodium pyrosulfite 0.3-0.5.
4. prevented in Chinese medicinal soft capsule sol-process according to claim 3 gelatin congeal power reduction process,
It is characterized in that, step（1）The Black Rouge, red ferric oxide and the purified water mass ratio in glue formula is：Black Rouge
0.18, red ferric oxide 0.14, purified water 1；Step（2）Described in purified water, glycerine, polyethylene glycol-400 glue formula in matter
Measuring ratio is：Purified water 35, glycerine 15, polyethylene glycol-400 4；Step（3）Described in input gelatinum pro capsulae, sorbierite, it is molten
Liquid is 1. and sodium pyrosulfite mass ratio in glue formula is：Gelatinum pro capsulae 40, sorbierite 4.28, solution 1. 1.32, Jiao Ya
Sodium sulphate 0.4.
5. prevented in Chinese medicinal soft capsule sol-process according to claim 1 gelatin congeal power reduction process,
It is characterized in that, step（3）Described in tank temperature be to be reduced to 45-60 DEG C, be further continued for heating and rise to 50-70 DEG C, steam off.
6. prevented in Chinese medicinal soft capsule sol-process according to claim 1 gelatin congeal power reduction process,
It is characterized in that, step（4）Described in vacuumize, vacuum degree control is in -0.07MPa-0.095MPa, about 35-70 minutes time；It takes out
Pot temperature maintains 55-70 DEG C when vacuum.
7. prevented in Chinese medicinal soft capsule sol-process according to claim 1 gelatin congeal power reduction process,
It is characterized in that, step（5）Described in gel filtration, using sieves or use filter cloth, mesh number be 40-60 mesh, after filtering gained
Glue keeps the temperature 2-8 hours under 45-60 DEG C of state, waits for pill.
8. prevented in the Chinese medicinal soft capsule sol-process according to one of claims 1-7 gelatin congeal power reduction technique
Method, which is characterized in that also added with the antioxidant that weight percent is 0.3-0.5% in glue, which includes sulfurous
Sour sodium, sodium hydrogensulfite, sodium thiosulfate, ascorbic acid, methionine, thiocarbamide, Calcium Disodium Versenate, phosphoric acid and/or
One or more mixtures in citric acid.
Priority Applications (1)
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| CN112741844A (en) * | 2020-12-29 | 2021-05-04 | 扬州诺瑞药业有限公司 | Preparation method of soft-shelled turtle capsule |
| CN114344273A (en) * | 2021-12-08 | 2022-04-15 | 余述南 | A soft capsule for treating tuberculosis and multi-drug resistant tuberculosis |
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| CN108498480B (en) | 2020-11-13 |
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