CN105878208B - A kind of starch base plant medicinal hard capsule forming agent and its application - Google Patents
A kind of starch base plant medicinal hard capsule forming agent and its application Download PDFInfo
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- CN105878208B CN105878208B CN201610230404.9A CN201610230404A CN105878208B CN 105878208 B CN105878208 B CN 105878208B CN 201610230404 A CN201610230404 A CN 201610230404A CN 105878208 B CN105878208 B CN 105878208B
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- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
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- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
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- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
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- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
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- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
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Abstract
The present invention relates to the production of medicine and the packaging axiliary materials of health food, specifically a kind of starch base plant medicinal hard capsule forming agent and its application.Forming agent by mass percentage, 40%-80% film forming, viscosity modifier, 10%-30% elasticity regulator and 10-30% friability regulator.Forming agent of the present invention can be exclusively used in the auxiliary material that compatibility starch prepares production capsule, it can make to obtain good mouldability with the colloid of starch major ingredient using the forming agent, and the capsule of production has (50 detections of good friability, friability 2), elasticity (50 detect simultaneously have no leakage medicine), disintegration time (4 minutes) and shelf-life (heart bottle closure ambient temperature and moisture preservation, the shelf-life 1 year or more).
Description
Technical field
The present invention relates to the production of medicine and the packaging axiliary materials of health food, specifically a kind of starch base plant is medicinal
Hard capsule forming agent and its application.
Background technique
The edibility packaging material that drug and health food use ----hard capsule case is a kind of special auxiliary material, it is with preparation
Enter digestion together, is absorbed by human body, almost everyone can take in a certain amount of hard capsule preparation, institute every year
It is directly related to the quality and safety of drug finished product and health food with its quality and safety, also directly pacifies with people's health
It is complete closely bound up.The drug and health food of hard capsule preparation, raw material used in capsule shells are most both at home and abroad at present
It is the skin of pig or ox, animal protein colloid gelatin made of bone.The own characteristic that gelatin production raw material mixes determines that its is congenital
The problem of security risk, has found heavy metals exceeding standard capsule medicine enterprise from after CCTV on April 15 exposure toxic capsule event in 2012
The tens of families of industry cause the earthquake of the entire pharmaceuticals industry of common concern and China of the whole society.The exceeded safety problem of removing heavy metals
Outside, there is also many other problems in use for the hard capsule of animal sources: first, water content requires have certain range
(12.5%-17.5%) is such as lower than this range, then the friability of capsule increases, and is unfavorable for the filling of drug.For certain moisture absorptions
Property ingredient, the moisture of capsule are easily filled with object and suck, and the drug and health food filled easily splits in Storage period capsule, if containing
There is unstable ingredient after moisture absorption, also affects effective Storage period of product.Second, the composition of gelatin Yi Yuhan aldehyde radical carries out anti-
It answers, generates insoluble substance, extend capsule disintegration time, and capsule color is made to change.Third, gelatin capsule formulation are wanted
There is certain constant-temperature constant-humidity environment storage, temperature is excessively high, the easy softening transform of capsule, and the too low capsule of temperature is easy friability again.In addition,
According to the national customs of domestic and international Moslem, cannot be eaten by capsule raw material of animality glue.This makes to Islamic state
When family and area provide drug and food, gelatin hard-shell capsule preparation cannot be introduced into these countries and regions at all.It is especially close
The frequent appearance of several years rabid ox diseases more promotes people to take great pains to research and finds new hard capsule raw material.Worldwide production is medicinal
The country of capsule is concentrated mainly on China, the U.S., Canada and India, and wherein the U.S., Canadian automatization level are high, production
Capsule for medicine is entirely mechanism capsule, and primary raw material is gelatine, the hide glue by extracting in animal (ox, pig) osteoderm.In state
Under the green foods development main trend of border, medicine sector is accelerating to research and develop substitute --- the plant capsule of animal capsule at present.
The plant capsule listed at present on the market mainly has hypromellose cellulose capsule, seaweed plants capsule and Propiram
Three kinds of products of polyoses capsule, and using hydroxypropyl methylcellulose (HPMC) capsule as main product.External HPMC plant capsule produces skill
Art is mainly monopolized by Pfizer Inc., and the HPMC produced using cotton as raw material is as the main component, based on pulullan polysaccharide at
The capsule technique divided is by French Capsugel capsule company monopolizing.In the country, China, Huang Dao is combined by institute of oceanography, the Chinese Academy of Sciences
National inventing patent new high-tech product-seaweed polysaccharide plant with independent intellectual property rights of plant capsule Co., Ltd research and development
Hollow hard-shell capsule has been obtained for the " national drug standard of State Food and Drug Administration's approval in March, 2005
F20050001 " and " national drug standard F20050002 " two authentication codes, and sold in market.
However, at present there is higher cost in all plant capsules on the market compared with gelatine capsule, application
It is raw material to produce capsule that people, which has attempted, cost lower starch more extensive using source, however is changed simply by starch
Property be unable to reach at all molding film forming and long term guarantee quality production target requirement.Also there is relevant patent (application number in the country in the recent period
201310435939.6,201310091716.2) plant capsule using starch as principal component was once reported, but very due to starch
Be easy aging dehydration, cause its frangible, can not ensure its shelf-life, the oligomict forming agent of letter often it cannot be guaranteed that colloid compared with
Suitable viscosity and film forming, and often can ensure that the capsule just produced can have good elasticity and friability,
But after placing week age or more, due to the problem of aging of starch, it is extremely fragile that it will cause its.However it can make
The molding compatibility ingredient of starch has tens of kinds, and researcher is universal to sort out these ingredients for plasticizer, not tangible
In pairs in the detailed-oriented classification and understanding of starch forming agent, therefore this also just directly results in the tune that practitioner does not form system
Save the medicine compatibility method of starch performance indexes.However, the composition of compatibility glue and the subtle change of proportion will have a direct impact on capsule
Every production and quality index etc., select suitable compatibility glue, acted on played in colloid according to compatibility glue, and according to certain
Ratio carries out compatibility, becomes the key for ensureing starch capsule manufacture.The compositing formula of compatibility glue not only needs technical staff couple
It has enough knowledge in the characteristic and colloid of colloid and the compatibility of starch, and needing largely to grope experiment can
Obtain the forming agent for being suitable for starch.By largely groping to test for a long time, in conjunction with starch molecular structure feature, and difference
The mutual compatible implementations of forming agent, it is stable, low in cost, safe and reliable, convenient fast that this patent obtains a kind of performance
The preparation method of prompt starch base medicinal hard capsule forming agent.
Summary of the invention
It is medicinal hard that the purpose of the present invention is to provide a kind of starch base plants low in cost, that performance is stable, safe and reliable
Capsule shaping agent and its application.
To achieve the above object, the invention adopts a technical scheme as:
A kind of starch base plant medicinal hard capsule forming agent, forming agent by mass percentage, 40%-80% film forming,
Viscosity modifier, 10%-30% elasticity regulator and 10-30% friability regulator.
The film forming, viscosity modifier are carragheen, gellan gum, pulullan polysaccharide, konjac glucomannan, locust bean gum, hydroxypropyl first
One of cellulose, carboxymethyl cellulose are a variety of；
Wherein, film forming viscosity modifier accounts for the 40%-80% of forming agent weight, and specific ingredient is in parts by weight
Meter,
1 part of carragheen, 0-5 parts of gellan gum, 0-100 parts of pulullan polysaccharide, 0-5 parts of konjac glucomannan, 0-5 parts of locust bean gum, hydroxypropyl
0-50 parts of methylcellulose, 0-50 parts of carboxymethyl cellulose；
1 part of gellan gum, 0-50 parts of carragheen, 0-100 parts of pulullan polysaccharide, 0-5 parts of konjac glucomannan, 0-5 parts of locust bean gum, hydroxypropyl
0-50 parts of methylcellulose, 0-50 parts of carboxymethyl cellulose；
1 part of pulullan polysaccharide, 0-50 parts of carragheen, 0-5 parts of gellan gum, 0-5 parts of konjac glucomannan, 0-5 parts of locust bean gum, hydroxypropyl first
0-50 parts of cellulose, 0-50 parts of carboxymethyl cellulose；
1 part of konjac glucomannan, 0-50 parts of carragheen, 0-100 parts of pulullan polysaccharide, 0-5 parts of gellan gum, 0-5 parts of locust bean gum, hydroxypropyl
0-50 parts of methylcellulose, 0-50 parts of carboxymethyl cellulose；
1 part of locust bean gum, 0-50 parts of carragheen, 0-100 parts of pulullan polysaccharide, 0-5 parts of konjac glucomannan, 0-5 parts of gellan gum, hydroxypropyl
0-50 parts of methylcellulose, 0-50 parts of carboxymethyl cellulose；
1 part of hydroxypropyl methylcellulose, 0-50 parts of carragheen, 0-100 parts of pulullan polysaccharide, 0-5 parts of konjac glucomannan, locust bean gum 0-5
Part, 0-5 parts of gellan gum, 0-50 parts of carboxymethyl cellulose；
Or, 1 part of carboxymethyl cellulose, 0-50 parts of carragheen, 0-100 parts of pulullan polysaccharide, 0-5 parts of konjac glucomannan, locust bean gum
0-5 parts, 0-50 parts of hydroxypropyl methylcellulose, 0-5 parts of gellan gum；
Preferably one of carragheen, pulullan polysaccharide, hydroxypropyl methylcellulose, konjac glucomannan and gellan gum or a variety of.
Further preferably carragheen；Carragheen, pulullan polysaccharide, hydroxypropyl methylcellulose and konjac glucomannan；Or carragheen and
Gellan gum.
More preferably according to parts by weight, carragheen 0.5-2 parts, 0.1-2 parts of pulullan polysaccharide, hydroxypropyl methylcellulose 0.5-
2 parts and konjac glucomannan 0.005-0.5 parts；Or 1-2 parts and gellan gum 0.1-1 parts of carragheen.
Elasticity regulator is one of potassium chloride, potassium citrate, phosphate, lauryl sodium sulfate or a variety of；
Elasticity regulator accounts for the 10%-30% of forming agent weight, and specific ingredient is potassium chloride 1 according to parts by weight
Part, 0-5 parts of potassium citrate, 0-5 parts of phosphate, 0-5 parts of lauryl sodium sulfate；
1 part of potassium citrate, 0-5 parts of potassium chloride, 0-5 parts of phosphate, 0-5 parts of lauryl sodium sulfate.
1 part of sodium potassium phosphate, 0-5 parts of potassium citrate, 0-5 parts of potassium chloride, 0-5 parts of lauryl sodium sulfate.
Or, 1 part of lauryl sodium sulfate, 0-5 parts of potassium citrate, 0-5 parts of phosphate, 0-5 parts of potassium chloride.
It is preferred that are as follows: one of potassium chloride, sodium dihydrogen phosphate and potassium citrate are a variety of.
It is further preferred are as follows: potassium chloride；Potassium chloride and sodium dihydrogen phosphate；Or potassium chloride and potassium citrate.
More preferably according to parts by weight, potassium chloride 0.01-0.5 parts and sodium dihydrogen phosphate 0.01-0.5 parts；Or potassium chloride
0.01-0.5 parts and potassium citrate 0.01-0.5 parts.
Friability regulator is mannitol, glycerol, sorbierite, maltitol, polyethylene glycol, povidone, polyglycereol fat
One of acid esters, diacetyl tartaric acid monodiglyceride, citric acid fatty glyceride, lactic acid fatty glyceride are more
Kind.
Friability and shelf-life regulator account for the 10%-30% of forming agent weight, specific ingredient be according to parts by weight,
1 part of mannitol, 0-50 parts of sorbierite, 0-50 parts of maltitol, 0-5 parts of polyethylene glycol, 0-5 parts of povidone, gathers 0-50 parts of glycerol
0-5 parts of fatty acid glyceride, 0-5 parts of diacetyl tartaric acid monodiglyceride, 0-5 parts of citric acid fatty glyceride, lactic acid rouge
0-5 parts of fatty acid glyceride；
1 part of glycerol, 0-50 parts of mannitol, 0-50 parts of sorbierite, 0-50 parts of maltitol, 0-5 parts of polyethylene glycol, povidone
0-5 parts, 0-5 parts of polyglyceryl fatty acid ester, 0-5 parts of diacetyl tartaric acid monodiglyceride, citric acid fatty glyceride 0-5
Part, 0-5 parts of lactic acid fatty glyceride；
1 part of sorbierite, 0-50 parts of glycerol, 0-50 parts of mannitol, 0-50 parts of maltitol, 0-5 parts of polyethylene glycol, povidone
0-5 parts, 0-5 parts of polyglyceryl fatty acid ester, 0-5 parts of diacetyl tartaric acid monodiglyceride, citric acid fatty glyceride 0-5
Part, 0-5 parts of lactic acid fatty glyceride；
0.1 part of maltitol, 0-50 parts of glycerol, 0-50 parts of sorbierite, 0-50 parts of mannitol, 0-5 parts of polyethylene glycol, poly- dimension
0-5 parts of ketone, 0-5 parts of polyglyceryl fatty acid ester, 0-5 parts of diacetyl tartaric acid monodiglyceride, citric acid fatty glyceride 0-5
Part, 0-5 parts of lactic acid fatty glyceride；
0.1 part of polyethylene glycol, 0-50 parts of sorbierite, 0-50 parts of maltitol, 0-50 parts of mannitol, gathers 0-50 parts of glycerol
Tie up ketone 0-5 parts, 0-5 parts of polyglyceryl fatty acid ester, 0-5 parts of diacetyl tartaric acid monodiglyceride, citric acid fatty glyceride
0-5 parts, 0-5 parts of lactic acid fatty glyceride；
0.1 part of povidone, 0-50 parts of glycerol, 0-50 parts of sorbierite, 0-50 parts of maltitol, 0-5 parts of polyethylene glycol, sweet dew
0-50 parts of alcohol, 0-5 parts of polyglyceryl fatty acid ester, 0-5 parts of diacetyl tartaric acid monodiglyceride, citric acid fatty glyceride 0-
5 parts, 0-5 parts of lactic acid fatty glyceride.
0.1 part of polyglyceryl fatty acid ester, 0-50 parts of mannitol, 0-50 parts of glycerol, 0-50 parts of sorbierite, maltitol 0-50
Part, 0-5 parts of polyethylene glycol, 0-5 parts of povidone, 0-5 parts of diacetyl tartaric acid monodiglyceride, citric acid fatty glyceride 0-
5 parts, 0-5 parts of lactic acid fatty glyceride.
0.1 part of diacetyl tartaric acid monodiglyceride, 0-50 parts of mannitol, 0-50 parts of glycerol, 0-50 parts of sorbierite, malt
0-50 parts of sugar alcohol, 0-5 parts of polyethylene glycol, 0-5 parts of povidone, 0-5 parts of polyglyceryl fatty acid ester, citric acid fatty glyceride 0-
5 parts, 0-5 parts of lactic acid fatty glyceride.
0.1 part of citric acid fatty glyceride, 0-50 parts of mannitol, 0-50 parts of glycerol, 0-50 parts of sorbierite, maltitol
0-50 parts, 0-5 parts of polyethylene glycol, 0-5 parts of povidone, 0-5 parts of polyglyceryl fatty acid ester, diacetyl tartaric acid monodiglyceride 0-
5 parts, 0-5 parts of lactic acid fatty glyceride.
0.1 part of lactic acid fatty glyceride, 0-50 parts of mannitol, 0-50 parts of glycerol, 0-50 parts of sorbierite, maltitol 0-
50 parts, 0-5 parts of polyethylene glycol, 0-5 parts of povidone, 0-5 parts of polyglyceryl fatty acid ester, diacetyl tartaric acid monodiglyceride 0-5
Part, 0-5 parts of citric acid fatty glyceride.
It is preferred that are as follows: glycerol, lactic acid fatty glyceride, one of polyglyceryl fatty acid ester, maltitol and povidone
Or it is several.
Further preferably glycerine；Glycerol, lactic acid fatty glyceride and polyglyceryl fatty acid ester；Or glycerol, polyglycereol
Aliphatic ester, maltitol and povidone.
More preferably according to parts by weight, glycerol 0.01-1 parts, 0.01-1 parts of lactic acid fatty glyceride and polyglycerol ester
0.01-1 parts of fat acid esters；Or 0.01-1 parts of glycerol, 0.01-1 parts of polyglyceryl fatty acid ester, 0.01-1 parts of maltitol and povidone
0.01-1 parts.
A kind of application of starch base plant medicinal hard capsule forming agent, the forming agent and starch base are mixed to form preparation and form sediment
Powder base plant medicinal hard capsule composition.
Forming agent accounts for 10wt%-50wt%, starch fiduciary point 50wt%-90wt% in the composition.
The starch base is common starch or modified starch；Wherein, it is raw material through peroxide that modified starch, which is using common starch,
Change, acidolysis, enzymatic hydrolysis, high temperature high pressure process and obtain.
The common starch is one of tapioca, cornstarch, wheaten starch, potato starch, rice starch
Or it is a variety of.
A kind of starch base plant medicinal hard capsule: preparation starch base botanical medicine is mixed to form by above-mentioned forming agent and starch base
Gained is prepared with hard capsule composition.
The preparation of capsule:
It weighs forming agent and each raw material → hot water dissolving of starch base (80-90 DEG C of pure water) → constant temperature supports glue (38-60
DEG C) → it is stained with glue groove bin stock → automatic dipping glue (35-45 DEG C) → shaping and drying → demoulding cutting fastening → warehousing finished products.
Advantage for present invention:
Forming agent of the present invention can be exclusively used in the auxiliary material that compatibility starch prepares production capsule, can be made using the forming agent with starch
Good mouldability is obtained for the colloid of major ingredient, and the capsule produced has good friability (50 detections, friability are less than 2
Grain), elasticity (50 detect simultaneously have no leakage medicine), disintegration time (4 minutes) and shelf-life (heart bottle closure ambient temperature and moisture guarantor
It deposits, guarantees the quality 1 year or more).Forming agent of the present invention can ensure that capsule main material is in the case where starch (50% the above are starch),
Make gum forming capsule.Production cost is reduced simultaneously, since starch price is at a fairly low honest and clean (10000 yuan/ton or less), is adopted
It is controlled at 35000 yuan/ton with forming agent capsule manufacture cost of material of the present invention hereinafter, well below gelatine capsule raw material 60000
Yuan/ton cost and 80000 yuan/ton of seaweed plants capsule of cost.Furthermore it can prevent a huge sum of money completely using forming agent of the present invention
Belong to excessive problem, various features are significantly better than that existing gelatine capsule and plant capsule.Ensure capsule friability rate less than 95%,
Disintegration time was less than 10 minutes, and the shelf-life 1 year or more.
Specific embodiment
Embodiment below can be with a person of ordinary skill in the art will more fully understand the present invention, but not with any side
The formula limitation present invention.
Forming agent of the present invention can be exclusively used in the auxiliary material that compatibility starch prepares production capsule, can be made using the forming agent with starch
Obtain good mouldability for the colloid of major ingredient, and the capsule produced have good friability (50 detections, friability 2),
Elasticity (50 are detected and had no leakage medicine), disintegration time (4 minutes) and shelf-life, (heart bottle closure ambient temperature and moisture saved, and protects
The matter phase 1 year or more).
Embodiment 1
The medicinal transparent capsule forming agent of starch base plant edible fiber be 1.5 kilograms of carragheen, 0.01 kilogram of potassium chloride, phosphorus
0.05 kilogram of acid dihydride sodium, 0.2 kilogram of mannitol, 0.2 kilogram of sorbierite, 1 kilogram of hydroxypropyl methylcellulose, povidone 0.01kg.
The preparation of the medicinal nontransparent capsule of starch base plant edible fiber: by above-mentioned forming agent and 20 kilograms of viscosity 200cp
Modified starch stir and evenly mix, add 160 kilograms of water, be heated to 80 DEG C of dissolutions, be then naturally cooling to that 60 DEG C of constant temperature are quiet to put glue in a suitable place to breed,
It will be then put into glue groove, glue is dipped in automatically through capsule mould, drying, demoulding cutting fastening, can be made into capsule.
Using the formula, capsule colloid during dipping in glue does not form a film, and the thickness for seriously affecting capsule is uniform.In addition, glue
The toughness of capsule finished product is insufficient, takes 50 to carry out friability experiment according to method as defined in Chinese Pharmacopoeia, 40 friability, take 50 according to
Method as defined in Chinese Pharmacopoeia carries out elasticity experiment, 20 leakage medicines.Disintegration time limited using intelligent disintegration tester test capsule is
Within 10 minutes.
Embodiment 2
The medicinal transparent capsule forming agent of starch base plant edible fiber is 2 kilograms of pulullan polysaccharide, sodium dihydrogen phosphate 0.05
Kilogram, 0.2 kilogram of mannitol, 0.2 kilogram of sorbierite, 1 kilogram of hydroxypropyl methylcellulose, povidone 0.01kg, konjac glucomannan 5g.
The preparation of the medicinal nontransparent capsule of starch base plant edible fiber: above-mentioned forming agent and 20 kilograms of viscosity are existed
The modified starch of 200cp stirs and evenly mixs, and adds 160 kilograms of water, dissolves by heating, and is naturally cooling to that 60 DEG C of constant temperature of glue are quiet to put glue in a suitable place to breed,
Glue is then put into glue groove, fastened through capsule mould automatic dipping glue, drying, demoulding cutting, can be made into capsule.
Using the formula, capsule colloid during dipping in glue does not form a film, and the thickness for seriously affecting capsule is uniform.In addition, glue
The toughness of capsule finished product is insufficient, takes 50 to carry out friability experiment according to method as defined in Chinese Pharmacopoeia, 36 friability, take 50 according to
Method as defined in Chinese Pharmacopoeia carries out elasticity experiment, 28 leakage medicines.Disintegration time limited using intelligent disintegration tester test capsule is
Within 10 minutes.
Embodiment 3
The medicinal transparent capsule forming agent of starch base plant edible fiber is 1.5 kilograms of carragheen, 0.01 kilogram of potassium chloride, general
0.1 kilogram of Shandong orchid polysaccharide, 0.05 kilogram of sodium dihydrogen phosphate, 0.2 kilogram of mannitol, 0.2 kilogram of sorbierite, hydroxypropyl methylcellulose 1
Kilogram, povidone 0.01kg.
The preparation of the medicinal nontransparent capsule of starch base plant edible fiber:
Above-mentioned forming agent and 20 kilograms of modified starches (viscosity is in 200cp) are stirred and evenly mixed, add 160 kilograms of water, is heated molten
Solution, is naturally cooling to that 60 DEG C of constant temperature of glue are quiet to put glue in a suitable place to breed, and glue is then put into glue groove, through capsule mould automatic dipping glue, drying,
Demoulding cutting fastens, can be made into capsule.
Using the formula, capsule film forming during dipping in glue is good.In addition, the toughness of capsule finished product is insufficient, 50 are taken
Friability experiment is carried out according to method as defined in Chinese Pharmacopoeia, 39 friability take 50 to carry out according to method as defined in Chinese Pharmacopoeia
Elasticity experiment, 20 leakage medicines.Disintegration time limited using intelligent disintegration tester test capsule is within 10 minutes.
Embodiment 4
The medicinal transparent capsule forming agent of starch base plant edible fiber is 1.5 kilograms of carragheen, 0.01 kilogram of potassium chloride, general
0.1 kilogram of Shandong orchid polysaccharide, 0.05 kilogram of sodium dihydrogen phosphate, 0.2 kilogram of mannitol, 0.2 kilogram of glycerol, 0.2 kilogram of sorbierite, hydroxyl
Third 1 kilogram of methylcellulose.
Preparation: above-mentioned forming agent is stirred and evenly mixed with 20 kilograms of viscosity in the modified starch of 200cp, adds 160 kilograms of water, adds
Heat of solution, is naturally cooling to that 60 DEG C of constant temperature of glue are quiet to put glue in a suitable place to breed, and glue is then put into glue groove, through capsule mould automatic dipping glue,
Drying, demoulding cutting fasten, can be made into capsule.
Using the formula, capsule film forming during dipping in glue is improved.In addition, the toughness of capsule finished product is insufficient, 50 are taken
Friability experiment is carried out according to method as defined in Chinese Pharmacopoeia, 20 friability take 50 to carry out according to method as defined in Chinese Pharmacopoeia
Elasticity experiment, 15 leakage medicines.Disintegration time limited using intelligent disintegration tester test capsule is within 10 minutes.
Embodiment 5
Forming agent is 2 kilograms of carragheen, 0.3 kilogram of potassium chloride, 1 kilogram of glycerol.
Transparent capsule preparation: weighing viscosity at 20 kilograms of 200cp modified starch, 2 kilograms of carragheen, 0.3 kilogram of potassium chloride,
1 kilogram of glycerol.Above-mentioned ingredient is mixed, adds 160 kilograms of water, is dissolved by heating, is naturally cooling to that 60 DEG C of constant temperature of glue are quiet to put glue in a suitable place to breed,
Glue is then put into glue groove, fastened through capsule mould automatic dipping glue, drying, demoulding cutting, can be made into capsule.
It is obtained in micelle using above-mentioned forming agent, capsule film forming during dipping in glue is good.Take 50 in
Method as defined in state's pharmacopeia carries out friability experiment, and 2 friability take 50 to carry out elasticity reality according to method as defined in Chinese Pharmacopoeia
It tests, 8 leakage medicines.Disintegration time limited using intelligent disintegration tester test capsule is within 10 minutes.Heart bottle closure ambient temperature and moisture is protected
It deposits, the shelf-life 6 months.
Embodiment 6
Forming agent is 2 kilograms of carragheen, 0.1 kilogram of pulullan polysaccharide, 0.1 kilogram of potassium chloride, 0.2 kilogram of mannitol, sweet
0.5 kilogram of oil, 0.3 kilogram of sorbierite, polyethylene glycol 5g, 1 kilogram of hydroxypropyl methylcellulose, konjac glucomannan 5g, locust bean gum 5g, polyglycereol
Aliphatic ester 5g, diacetyl tartaric acid monodiglyceride 5g.
Transparent capsule preparation: weighing viscosity at 20 kilograms of modified starch of 200cp, 2 kilograms of carragheen, pulullan polysaccharide
0.1 kilogram, 0.1 kilogram of potassium chloride, 0.2 kilogram of mannitol, 0.5 kilogram of glycerol, 0.3 kilogram of sorbierite, polyethylene glycol 5g, hydroxypropyl
1 kilogram of methylcellulose, konjac glucomannan 5g, locust bean gum 5g, polyglyceryl fatty acid ester 5g, diacetyl tartaric acid monodiglyceride 5g will be upper
Ingredient mixing is stated, adds 160 kilograms of water, is dissolved by heating, is naturally cooling to that 60 DEG C of constant temperature of glue are quiet to put glue in a suitable place to breed, is then put into glue
Glue groove fastens through capsule mould automatic dipping glue, drying, demoulding cutting, can be made into capsule.
It is obtained in micelle using above-mentioned forming agent, capsule film forming during dipping in glue is good.Take 50 in
Method as defined in state's pharmacopeia carries out friability experiment, and 2 friability take 50 to carry out elasticity reality according to method as defined in Chinese Pharmacopoeia
It tests, 2 leakage medicines.Disintegration time limited using intelligent disintegration tester test capsule is within 5 minutes.Heart bottle closure ambient temperature and moisture is protected
It deposits, the shelf-life ten months.
Embodiment 7
Forming agent be 2 kilograms of carragheen, 0.1 kilogram of pulullan polysaccharide, 50 grams of dibastic sodium phosphate, 0.1 kilogram of potassium chloride, sweet dew
0.2 kilogram of alcohol, 0.5 kilogram of glycerol, 0.3 kilogram of sorbierite, 0.1 kilogram of carboxymethyl cellulose, 8 grams of lauryl sodium sulfate, evil spirit
5 grams of taro glue, citric acid fatty glyceride 5g.Transparent capsule preparation weighs 20 kilograms of modified starch of viscosity in 200cp, card
2 kilograms of glue of drawing, 0.1 kilogram of pulullan polysaccharide, 50 grams of dibastic sodium phosphate, 0.1 kilogram of potassium chloride, 0.2 kilogram of mannitol, glycerol 0.5
Kilogram, 0.3 kilogram of sorbierite, 0.1 kilogram of carboxymethyl cellulose, 8 grams of lauryl sodium sulfate, 5 grams of konjac glucomannan, citric acid fat
Acid glyceride 5g.
Preparation: above-mentioned ingredient is mixed, and adds 160 kilograms of water, is dissolved by heating, and is naturally cooling to that 60 DEG C of constant temperature of glue are quiet to put in a suitable place to breed
Glue is then put into glue groove by glue, is fastened through capsule mould automatic dipping glue, drying, demoulding cutting, be can be made into capsule.
It is obtained in micelle using above-mentioned forming agent, capsule film forming during dipping in glue is good.Take 50 in
Method as defined in state's pharmacopeia carries out friability experiment, and 2 friability take 50 to carry out elasticity reality according to method as defined in Chinese Pharmacopoeia
It tests, 0 leakage medicine.Disintegration time limited using intelligent disintegration tester test capsule is within 5 minutes.Heart bottle closure ambient temperature and moisture is protected
It deposits, the shelf-life ten months.
Embodiment 8
Forming agent is carragheen 1kg, pulullan polysaccharide 100g, hydroxypropyl methylcellulose 0.5kg, konjac glucomannan 5g, potassium chloride
100g, potassium citrate 20g, glycerol 0.5kg, lactic acid fatty glyceride 10g, polyglyceryl fatty acid ester 10g.
Transparent capsule preparation: 20 kilograms of modified starch of viscosity in 200cp, carragheen 1kg, pulullan polysaccharide are weighed
100g, hydroxypropyl methylcellulose 0.5kg, konjac glucomannan 5g, potassium chloride 100g, potassium citrate 20g, glycerol 0.5kg, lactic acid fatty acid are sweet
Grease 10g, polyglyceryl fatty acid ester 10g.Above-mentioned ingredient is mixed, adds 160 kilograms of water, dissolves by heating, is naturally cooling to glue
60 DEG C of constant temperature are quiet to put glue in a suitable place to breed, and glue is then put into glue groove, fastened through capsule mould automatic dipping glue, drying, demoulding cutting,
Capsule is made.
It is obtained in micelle using above-mentioned forming agent, capsule film forming during dipping in glue is good.Take 50 in
Method as defined in state's pharmacopeia carries out friability experiment, and 2 friability take 50 to carry out elasticity reality according to method as defined in Chinese Pharmacopoeia
It tests, 0 leakage medicine.Disintegration time limited using intelligent disintegration tester test capsule is within 5 minutes.Heart bottle closure ambient temperature and moisture is protected
It deposits, the shelf-life 1 year.
Embodiment 9
Forming agent is carragheen 1.5kg, gellan gum 150g, potassium chloride 150g, and potassium citrate 30g, glycerol 0.75kg gather sweet
Oil and fat acid esters 15g, maltitol 15g, povidone 15g.
Transparent capsule preparation: weighing 20 kilograms of modified starch of viscosity in 200cp, carragheen 1.5kg, gellan gum 150g,
Potassium chloride 150g, potassium citrate 30g, glycerol 0.75kg, polyglyceryl fatty acid ester 15g, maltitol 15g, povidone 15g.It will
Above-mentioned ingredient mixes, and adds 160 kilograms of water, dissolves by heating, and is naturally cooling to that 60 DEG C of constant temperature of glue are quiet to put glue in a suitable place to breed, then puts glue
Enter glue groove, is fastened through capsule mould automatic dipping glue, drying, demoulding cutting, can be made into capsule.
It is obtained in micelle using above-mentioned forming agent, capsule film forming during dipping in glue is good.Take 50 in
Method as defined in state's pharmacopeia carries out friability experiment, and 2 friability take 50 to carry out elasticity reality according to method as defined in Chinese Pharmacopoeia
It tests, 0 leakage medicine.Disintegration time limited using intelligent disintegration tester test capsule is within 5 minutes.Heart bottle closure ambient temperature and moisture is protected
It deposits, the shelf-life 18 months.
Claims (6)
1. a kind of starch base plant medicinal hard capsule forming agent, it is characterised in that:
The composition of forming agent are as follows: carragheen 1kg, pulullan polysaccharide 100g, hydroxypropyl methylcellulose 0.5kg, konjac glucomannan 5g, potassium chloride
100g, potassium citrate 20g, glycerol 0.5kg, lactic acid fatty glyceride 10g, polyglyceryl fatty acid ester 10g；
Or carragheen 1.5kg, gellan gum 150g, potassium chloride 150g, potassium citrate 30g, glycerol 0.75kg, polyglyceryl fatty acid ester
15g, maltitol 15g, povidone 15g.
2. a kind of application of starch base plant medicinal hard capsule forming agent described in claim 1, it is characterised in that: the molding
Agent and starch base are mixed to form preparation starch base plant medicinal hard capsule composition.
3. the application of starch base plant medicinal hard capsule forming agent as described in claim 2, it is characterised in that: the composition
Middle forming agent accounts for 10wt%-50 wt %, 50 wt %-90 wt % of starch fiduciary point.
4. pressing the application of starch base plant medicinal hard capsule forming agent described in claim 2 or 3, it is characterised in that: the shallow lake
Powder base is common starch or modified starch；Wherein, modified starch is by raw material of common starch through peroxidating, acidolysis, enzymatic hydrolysis, height
Warm HIGH PRESSURE TREATMENT and obtain.
5. the application of starch base plant medicinal hard capsule forming agent according to claim 4 is it is characterized by: the common shallow lake
Powder is one of tapioca, cornstarch, wheaten starch, potato starch, rice starch or a variety of.
6. a kind of starch base plant medicinal hard capsule, it is characterised in that: the forming agent as described in claim 1 is mixed with starch base
Form preparation starch base plant medicinal hard capsule composition preparation gained.
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| KR101990814B1 (en) * | 2017-11-07 | 2019-06-19 | 주식회사 서흥 | Process for manufacturing pullulan hard capsules having improved film properties |
| CN109288809B (en) * | 2018-11-04 | 2021-06-01 | 李国桐 | Composite raw material for preparing medicinal plant capsule |
| CN112603905A (en) * | 2020-12-30 | 2021-04-06 | 湖北人福药用辅料股份有限公司 | Preparation process of pullulan plant capsules |
| CN112569204A (en) * | 2020-12-30 | 2021-03-30 | 湖北人福药用辅料股份有限公司 | Pullulan polysaccharide and starch plant enteric-coated capsule and preparation method thereof |
| CN113018275B (en) * | 2021-03-11 | 2023-02-14 | 安徽黄山胶囊股份有限公司 | Povidone empty capsule and production process thereof |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20040105835A1 (en) * | 1998-09-30 | 2004-06-03 | Scott Robert A. | Modified starch film compositions |
| CN104055748A (en) * | 2013-03-21 | 2014-09-24 | 中国科学院化学研究所 | Composition for preparing modified starch matrix-containing hard capsule |
| CN104784150A (en) * | 2015-04-17 | 2015-07-22 | 湖南尔康制药股份有限公司 | Starch-base plant empty capsules and preparation technology thereof |
| CN103880736B (en) * | 2014-04-04 | 2017-05-17 | 深圳微芯生物科技有限责任公司 | E-configuration benzamide compounds, and pharmaceutical preparation application thereof |
-
2016
- 2016-04-14 CN CN201610230404.9A patent/CN105878208B/en active Active
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20040105835A1 (en) * | 1998-09-30 | 2004-06-03 | Scott Robert A. | Modified starch film compositions |
| CN104055748A (en) * | 2013-03-21 | 2014-09-24 | 中国科学院化学研究所 | Composition for preparing modified starch matrix-containing hard capsule |
| CN103880736B (en) * | 2014-04-04 | 2017-05-17 | 深圳微芯生物科技有限责任公司 | E-configuration benzamide compounds, and pharmaceutical preparation application thereof |
| CN104784150A (en) * | 2015-04-17 | 2015-07-22 | 湖南尔康制药股份有限公司 | Starch-base plant empty capsules and preparation technology thereof |
Non-Patent Citations (1)
| Title |
|---|
| 一种新型植物空心胶囊的研制;吴国庆;《明胶科学与技术》;20131231;第33卷(第4期);第194-198页 * |
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