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CN101185760A - Capsule material formula of soft capsule - Google Patents

Capsule material formula of soft capsule Download PDF

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Publication number
CN101185760A
CN101185760A CNA2006101282208A CN200610128220A CN101185760A CN 101185760 A CN101185760 A CN 101185760A CN A2006101282208 A CNA2006101282208 A CN A2006101282208A CN 200610128220 A CN200610128220 A CN 200610128220A CN 101185760 A CN101185760 A CN 101185760A
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China
Prior art keywords
sorbitol
gelatin
soft capsule
kilograms
water
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Pending
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CNA2006101282208A
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Chinese (zh)
Inventor
郭燕峰
郭明勋
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Individual
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Individual
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Priority to CNA2006101282208A priority Critical patent/CN101185760A/en
Publication of CN101185760A publication Critical patent/CN101185760A/en
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Abstract

The invention discloses a soft-gelatin capsule shell material formula, including gelatin and water, which is characterized in that the invention further contains sorbitol, and the weight percentages of all the components are: 19 to 45 percent gelatin, 40 to 50 percent water, 5 to 40 percent sorbitol and 0 to 0.5 percent preservative. As a good plasticizer, the sorbitol has the moisture retention performance and the effect which are more stable than those of glycerol. The invention adopts the sorbitol to replace the glycerol to compose a new formula of soft-gelatin capsule shell material, so the soft-gelatin capsule shell body can maintain certain water and the invention can effectively prevent the dryness and aging of the capsule shell body, improve the moisture retention performance of the capsule shell body and improve the quality of the capsule shell body.

Description

A kind of capsule material formula of soft capsule
Technical field
The present invention relates to the new prescription of capsule material glue in a kind of soft capsule material manufacturing process.
Background technology
The conventional formulation of soft capsule material comprises gelatin, glycerol, pure water and micro-antiseptic, and the capsule material quality of making is general, and moisture retention is general, and is easily dry, aging.
Summary of the invention
Technical problem to be solved by this invention is to overcome the deficiency that traditional capsule material formula exists, and provides a kind of soft capsule material newly to fill a prescription.
For achieving the above object, the present invention adopts following technical scheme: a kind of capsule material formula of soft capsule, comprise gelatin, water and sorbitol, and the percentage by weight of described each component is: gelatin 19~45%, water 40~50%, sorbitol 5~40%, antiseptic 0~0.5%.
In order to improve gelatin viscosity, also can add chitosan or alginate jelly in the prescription, the weight percent content of described chitosan or alginate jelly is 0.2~2%.
Employed water is pure water, and described antiseptic is methyl parahydroxybenzoate and/or propyl p-hydroxybenzoate, and described alginate jelly is carrageenin or sodium alginate or Furcellaran.
The physico-chemical property of sorbitol:
Sorbitol has another name called Sorbitol, glucitol, molecular formula C 6H 14O 6, relative molecular mass 182.17.It is present in many fruits of occurring in nature, and as Fructus Mali pumilae, pears, Fructus Pruni pseudocerasi, Fructus Pruni salicinae etc., it also is present in the crystalline lens and seminal vesicle of body blood, nerve, eye, is the normal product of organism metabolism.It is widely used at pharmaceutic adjuvant and food additive field.
The main specifications of sorbitol product has three kinds of 50% liquid, 70% liquid and solids, and the content of sorbitol is meant the effective content of sorbitol described in the component of the present invention.The fluid product outward appearance is the water white transparency viscous solution, and nothing is smelt, distinguishes the flavor of sweet; The solid product outward appearance is white, needle-shaped crystals or crystalline powder.Sorbitol tool cool sweet taste in the mouth flavor, sugariness is about 60% of sucrose, can produce the 1.67KJ/g energy in human body.Its relative density is 1.48, and the anhydride fusing point is between 110~112 ℃, and the fusing point when containing water of crystallization is between 93~97.7 ℃, and boiling point is 295 ℃.The optical rotation of 10% aqueous solution (α) D 20Be-1.98 °, refractive index (n D 20) be 1.3477, the PH of aqueous solution is 6~7.
Sorbitol has the polyhydric alcohol characteristic of 6 hydroxyls, and (1g/0.45ml) soluble in water, glycerol, propylene glycol etc. are slightly soluble in methanol, ethanol, acetic acid, phenol and acetamide.Dissolubility in the time of 25 ℃ is a 235g/100ml water, heat of solution-117.0J/g.Being difficult for crystallization in aqueous solution separates out.Sorbitol has very big hygroscopicity, but wettability power is slightly less than glycerol.Chemical property is stable under normal conditions, does not burn, and does not corrode, and is non-volatile, with acid, alkali effect, is not subject to air oxidation, also is difficult for and solubility amino-compound generation Maillard reaction.Especially Heat stability is good is strong to the resistance of microorganism.
Sorbitol also has good froth breaking effect, among the GB2760-1996 it is expanded as the food defoamer of permission use.Degeneration when sorbitol also can be used for preventing frozen protein.
Sorbitol also has following physiological function: sorbitol is oxidized to fructose by sorbito dehy drogenase in mammal and human body, enters the metabolism of fructose-1-phosphate ester approach then, and the intravital insulin of its metabolism and machine is irrelevant, can not cause blood glucose fluctuation.Simultaneously sorbitol also is not the appropriate effect substrate of oral microorganism and unlikely gingiva dental caries become, and has diuresis.
Sorbitol can reduce intracranial pressure, prevents edema, can be used as medicine and directly uses, and can be used for the normal edema oliguria of cardiorenal function symptom.
Sorbitol can promote that gallbladder is strong and shrink and expand the diastole of about flesh and function of gallbladder promoting, stimulating pancreas secretion pancreatic lipase etc., promote insulin to discharge, the hepatic bile secretory volume is increased, can quicken the wriggling and the absorption of small intestinal, gas after the mediation enteric cavity, thereby can improve disease patients' such as chronic liver and gall, gastrointestinal symptom greatly.
Sorbitol is a kind of important medicine intermediate, is synthetic V CPrimary raw material.Sorbitol is usually used in preparing aminoacids complex transfusion, as injection diluent and vitamin iron salt oral agents.Sorbitol can be used for producing Cernevit-12, choleretic and caccagogue etc. as the tablet excipient, also can be used for preventing scattering and disappearing of volatile acid in the medicament.
Sorbitol can also with other material and usefulness, play stable vitamin B 12, the effect of medicines such as procaine benzylpenicillin and aspirin.In addition, sorbitol also can be used for the production of medicines such as Kai Sailu.
The chitosan English name is chitosan, also is referred to as chitose, chitosan, chitosan, soluble chitin etc.Chemistry (1,4)-2-acetyl group by name-2-deoxidation-beta glucan.
Alginate jelly is a based food glue that extracts from natural seaweed, comprises carrageenin, sodium alginate, Furcellaran etc.Alginate jelly has significant advantage at aspects such as thickening property, stability, conformality, gelling, film property.Sodium alginate another name sodium alginate, Algin etc.
Carrageenin claims Cornu Cervi algin, CAR again, the trade name carrageenan, and relative molecular mass is more than 1,000,000.Character: be white or off-white powder, odorless, tasteless, water absorption and swelling gradually in cold water, dissolving forms the clear and bright or slightly opalescent solution of thickness in 60~80 ℃ hot water.Dissolve each other with gelatin solution, can improve the performance (improving the viscosity and the gel strength of gelatin solution) of gelatin.This product has characteristic and effects such as emulsifying, thickening, suspending, gelling, complexation, film forming.Carrageenan can only imbibition in cold water and can not dissolve, and the gel that carrageenan forms has reversibility, and gel becomes solution when promptly heating, and forms gel again during the solution cooling, and this character and gelatin are basic identical.
Adding antiseptic (methyl parahydroxybenzoate and/or propyl p-hydroxybenzoate) in the present invention's prescription is in order to prolong guaranteeing the quality the time of soft capsule rubber.Because it is high that the ratio of viscosities gelatin of chitosan or alginate jelly is wanted, interpolation chitosan or alginate jelly (both can not add simultaneously) can improve gelatin viscosity and gel strength in the prescription.
The present invention adopts sorbitol replacement glycerol to form a kind of soft capsule material and newly fills a prescription, and has the following advantages:
1, sorbitol is good plasticizer, and its performance of keeping humidity and effect more tend towards stability than glycerol, and than low humidity the time, the moisture that sorbitol scatters and disappears is low than glycerol; When higher levels of humidity, the moisture of absorption is also low than glycerol.New prescription of the present invention can make the soft capsule utricule keep certain moisture, can effectively prevent utricule drying, aging, has improved the moisture retention of utricule, has improved the utricule quality.
2, the viscosity of sorbitol also has the froth breaking effect a little more than glycerol, helps the preparation of soft capsule material.
3, the soft capsule material made from new prescription of the present invention is higher than conventional formulation than intensity and elasticity with fixed attention.
4, sorbitol is a pharmaceutic adjuvant, also is food additive, and price is also cheap, is generally about half of glycerol price.
The specific embodiment
Determine the usage ratio of sorbitol according to the hard soft requirement of producing soft capsule material.If when needing the capsule material of production hard, it is big that the consumption of gelatin is wanted, the ratio of sorbitol is corresponding hangs down; If when needing the capsule material of production softer, the consumption of gelatin is smaller, the ratio of sorbitol is corresponding higher.Making dissolving method is to determine in will filling a prescription earlier in joining of the pure water glue container of ratio, add sorbitol (solid or liquid all can) then, agitating heating makes it become uniform solution and is warming up to 60~70 ℃, under the evacuation condition, add gelatin, chitosan or alginate jelly again, continue stirring and dissolving and become uniform liquid.Antiseptic can add with gelatin.The course of dissolution time is greatly about 1~1.5 hour.The glue that prepare this moment can enter the insulation froth breaking stabilization sub stage, and subsequent processing to be entered is produced filling machine with soft capsule and made soft capsule rubber.
Be the embodiment of some different proportion components below.
Embodiment 1:
Earlier with in 40 kilograms of joining of pure water glue containers, 78 kilograms of liquid sorbitols that add 50% content then, agitating heating makes it become uniform solution and is warming up to 60~65 ℃, under the evacuation condition, add 19 kilograms in gelatin, 2 kilograms of carrageenans again, continue stirring and dissolving and become uniform liquid.About 1 hour of course of dissolution time.The glue that prepare this moment can enter the insulation froth breaking stabilization sub stage, and subsequent processing to be entered is produced filling machine with soft capsule and made soft capsule rubber.
Embodiment 2:
Earlier with in 45 kilograms of joining of pure water glue containers, 34 kilograms of liquid sorbitols that add 70% content then, agitating heating makes it become uniform solution and is warming up to 65~70 ℃, under the evacuation condition, add 0.2 kilogram of propyl p-hydroxybenzoate and 30 kilograms in gelatin, 1 kilogram of carrageenan more simultaneously, continue stirring and dissolving and become uniform liquid.About 1 hour 15 minutes course of dissolution time.The glue that prepare this moment can enter the insulation froth breaking stabilization sub stage, and subsequent processing to be entered is produced filling machine with soft capsule and made soft capsule rubber.
Embodiment 3:
With in 50 kilograms of joining of pure water glue containers, add 5 kilograms of Neosorbs then earlier, agitating heating makes it become uniform solution and is warming up to 60~70 ℃, adds 45 kilograms in gelatin again under the evacuation condition, continues stirring and dissolving and becomes uniform liquid.About 1 hour 30 minutes course of dissolution time.The glue that prepare this moment can enter the insulation froth breaking stabilization sub stage, and subsequent processing to be entered is produced filling machine with soft capsule and made soft capsule rubber.
Embodiment 4:
Earlier with in 41 kilograms of joining of pure water glue containers, add 18.3 kilograms of Neosorbs then, agitating heating makes it become uniform solution and is warming up to 60~63 ℃, under the evacuation condition, add 40 kilograms in 0.4 kilogram of methyl parahydroxybenzoate, 0.1 kilogram of propyl p-hydroxybenzoate and gelatin more simultaneously, 0.2 kilogram of chitosan (should be made into 2% concentration solution with 0.1 kilogram of acetic acid earlier) continues stirring and dissolving and becomes uniform liquid.About 1 hour of course of dissolution time.The glue that prepare this moment can enter the insulation froth breaking stabilization sub stage, and subsequent processing to be entered is produced filling machine with soft capsule and made soft capsule rubber.
Embodiment 5:
Earlier with in 44 kilograms of joining of pure water glue containers, add 30 kilograms of Neosorbs then, agitating heating makes it become uniform solution and is warming up to 63~66 ℃, under the evacuation condition, add 24.2 kilograms in 0.3 kilogram of methyl hydroxybenzoate and gelatin more simultaneously, 1.5 kilograms of sodium alginates continue stirring and dissolving and become uniform liquid.About 1 hour of course of dissolution time.The glue that prepare this moment can enter the insulation froth breaking stabilization sub stage, and subsequent processing to be entered is produced filling machine with soft capsule and made soft capsule rubber.
Embodiment 6:
Earlier with in 48 kilograms of joining of pure water glue containers, add 17.4 kilograms of Neosorbs then, agitating heating makes it become uniform solution and is warming up to 66~70 ℃, under the evacuation condition, add 33 kilograms in 0.4 kilogram of propyl p-hydroxybenzoate and gelatin more simultaneously, 1.2 kilograms of Furcellaran continue stirring and dissolving and become uniform liquid.About 1 hour of course of dissolution time.The glue that prepare this moment can enter the insulation froth breaking stabilization sub stage, and subsequent processing to be entered is produced filling machine with soft capsule and made soft capsule rubber.
Embodiment 7:
Earlier with in 49 kilograms of joining of pure water glue containers, add 27.2 kilograms of Neosorbs then, agitating heating makes it become uniform solution and is warming up to 60~70 ℃, under the evacuation condition, add 22 kilograms in 0.2 kilogram of propyl p-hydroxybenzoate and gelatin more simultaneously, 1.6 kilograms of sodium alginates continue stirring and dissolving and become uniform liquid.About 1 hour of course of dissolution time.The glue that prepare this moment can enter the insulation froth breaking stabilization sub stage, and subsequent processing to be entered is produced filling machine with soft capsule and made soft capsule rubber.
Embodiment 8:
Earlier with in 42 kilograms of joining of pure water glue containers, add 22.2 kilograms of Neosorbs then, agitating heating makes it become uniform solution and is warming up to 60~70 ℃, adds 35 kilograms in gelatin again under the evacuation condition, 0.8 kilogram of carrageenan continues stirring and dissolving and becomes uniform liquid.About 1 hour of course of dissolution time.The glue that prepare this moment can enter the insulation froth breaking stabilization sub stage, and subsequent processing to be entered is produced filling machine with soft capsule and made soft capsule rubber.

Claims (3)

1. a capsule material formula of soft capsule comprises gelatin and water, it is characterized in that also containing sorbitol, and the percentage by weight of described each component is: gelatin 19~45%, water 40~50%, sorbitol 5~40%, antiseptic 0~0.5%.
2. capsule material formula of soft capsule as claimed in claim 1 is characterized in that also containing chitosan or alginate jelly, and the weight percent content of described chitosan or alginate jelly is 0.2~2%.
3. capsule material formula of soft capsule as claimed in claim 2 is characterized in that employed water is pure water, and described antiseptic is methyl parahydroxybenzoate and/or propyl p-hydroxybenzoate, and described alginate jelly is carrageenin or sodium alginate or Furcellaran.
CNA2006101282208A 2006-11-15 2006-11-15 Capsule material formula of soft capsule Pending CN101185760A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CNA2006101282208A CN101185760A (en) 2006-11-15 2006-11-15 Capsule material formula of soft capsule

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CNA2006101282208A CN101185760A (en) 2006-11-15 2006-11-15 Capsule material formula of soft capsule

Publications (1)

Publication Number Publication Date
CN101185760A true CN101185760A (en) 2008-05-28

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Country Status (1)

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101444300B (en) * 2008-12-29 2012-08-08 陈金显 Chewable soft capsule
CN106729235A (en) * 2016-12-15 2017-05-31 贵州恒和制药有限公司 A kind of medicament capsule with relieving cough and reducing sputum function and preparation method thereof
CN112826807A (en) * 2021-01-29 2021-05-25 北京航洋健康科技有限公司 Soft capsule shell, soft capsule prepared from soft capsule shell and preparation method of soft capsule

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101444300B (en) * 2008-12-29 2012-08-08 陈金显 Chewable soft capsule
CN106729235A (en) * 2016-12-15 2017-05-31 贵州恒和制药有限公司 A kind of medicament capsule with relieving cough and reducing sputum function and preparation method thereof
CN112826807A (en) * 2021-01-29 2021-05-25 北京航洋健康科技有限公司 Soft capsule shell, soft capsule prepared from soft capsule shell and preparation method of soft capsule

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Open date: 20080528