CN114948896B - Novel soft capsule material formula - Google Patents
Novel soft capsule material formula Download PDFInfo
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- CN114948896B CN114948896B CN202210747781.5A CN202210747781A CN114948896B CN 114948896 B CN114948896 B CN 114948896B CN 202210747781 A CN202210747781 A CN 202210747781A CN 114948896 B CN114948896 B CN 114948896B
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- soft capsule
- purified water
- gum
- capsule
- wall material
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- 239000007901 soft capsule Substances 0.000 title claims abstract description 49
- 239000000463 material Substances 0.000 title claims abstract description 43
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 34
- 239000008213 purified water Substances 0.000 claims abstract description 28
- 239000002775 capsule Substances 0.000 claims abstract description 26
- FQENQNTWSFEDLI-UHFFFAOYSA-J sodium diphosphate Chemical compound [Na+].[Na+].[Na+].[Na+].[O-]P([O-])(=O)OP([O-])([O-])=O FQENQNTWSFEDLI-UHFFFAOYSA-J 0.000 claims abstract description 18
- 229940048086 sodium pyrophosphate Drugs 0.000 claims abstract description 18
- 235000019818 tetrasodium diphosphate Nutrition 0.000 claims abstract description 18
- 239000001577 tetrasodium phosphonato phosphate Substances 0.000 claims abstract description 18
- 108010010803 Gelatin Proteins 0.000 claims abstract description 14
- 229920000159 gelatin Polymers 0.000 claims abstract description 14
- 239000008273 gelatin Substances 0.000 claims abstract description 14
- 235000019322 gelatine Nutrition 0.000 claims abstract description 14
- 235000011852 gelatine desserts Nutrition 0.000 claims abstract description 14
- 239000011159 matrix material Substances 0.000 claims abstract description 10
- 239000000654 additive Substances 0.000 claims abstract description 9
- 230000000996 additive effect Effects 0.000 claims abstract description 8
- 229920002907 Guar gum Polymers 0.000 claims abstract description 6
- 239000000679 carrageenan Substances 0.000 claims abstract description 6
- 229920001525 carrageenan Polymers 0.000 claims abstract description 6
- 229940113118 carrageenan Drugs 0.000 claims abstract description 6
- 239000000665 guar gum Substances 0.000 claims abstract description 6
- 235000010417 guar gum Nutrition 0.000 claims abstract description 6
- 229960002154 guar gum Drugs 0.000 claims abstract description 6
- 229920001285 xanthan gum Polymers 0.000 claims abstract description 6
- 239000000230 xanthan gum Substances 0.000 claims abstract description 6
- 235000010493 xanthan gum Nutrition 0.000 claims abstract description 6
- 229940082509 xanthan gum Drugs 0.000 claims abstract description 6
- 244000144730 Amygdalus persica Species 0.000 claims abstract description 5
- 235000006040 Prunus persica var persica Nutrition 0.000 claims abstract description 5
- 229920000223 polyglycerol Polymers 0.000 claims abstract description 5
- 229940014259 gelatin Drugs 0.000 claims abstract description 4
- 244000275012 Sesbania cannabina Species 0.000 claims abstract 2
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims description 74
- GWEVSGVZZGPLCZ-UHFFFAOYSA-N Titan oxide Chemical compound O=[Ti]=O GWEVSGVZZGPLCZ-UHFFFAOYSA-N 0.000 claims description 32
- 239000004408 titanium dioxide Substances 0.000 claims description 16
- 229920002565 Polyethylene Glycol 400 Polymers 0.000 claims description 11
- 229940068918 polyethylene glycol 400 Drugs 0.000 claims description 11
- 238000003756 stirring Methods 0.000 claims description 9
- 238000006116 polymerization reaction Methods 0.000 claims description 8
- 239000000203 mixture Substances 0.000 claims description 7
- 238000000034 method Methods 0.000 claims description 6
- 239000003605 opacifier Substances 0.000 claims description 5
- 238000007789 sealing Methods 0.000 claims description 5
- 238000002156 mixing Methods 0.000 claims description 4
- 239000007884 disintegrant Substances 0.000 claims description 3
- 238000002360 preparation method Methods 0.000 abstract description 15
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 abstract description 12
- 229910052760 oxygen Inorganic materials 0.000 abstract description 12
- 239000001301 oxygen Substances 0.000 abstract description 12
- 239000002994 raw material Substances 0.000 abstract description 5
- 230000009286 beneficial effect Effects 0.000 abstract description 3
- 238000002834 transmittance Methods 0.000 abstract description 3
- 238000004321 preservation Methods 0.000 abstract description 2
- 235000011187 glycerol Nutrition 0.000 description 23
- 230000000052 comparative effect Effects 0.000 description 9
- 229920000591 gum Polymers 0.000 description 7
- 239000003814 drug Substances 0.000 description 6
- 239000011257 shell material Substances 0.000 description 6
- 239000000126 substance Substances 0.000 description 6
- 241000196324 Embryophyta Species 0.000 description 5
- 239000004698 Polyethylene Substances 0.000 description 5
- 238000001035 drying Methods 0.000 description 5
- 230000035699 permeability Effects 0.000 description 5
- -1 polyethylene Polymers 0.000 description 5
- 229920000573 polyethylene Polymers 0.000 description 5
- 241000219782 Sesbania Species 0.000 description 4
- 230000014759 maintenance of location Effects 0.000 description 4
- 238000012360 testing method Methods 0.000 description 4
- 238000004132 cross linking Methods 0.000 description 3
- 238000011156 evaluation Methods 0.000 description 3
- 239000003292 glue Substances 0.000 description 3
- 239000007788 liquid Substances 0.000 description 3
- 239000004014 plasticizer Substances 0.000 description 3
- 238000003825 pressing Methods 0.000 description 3
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 2
- 238000010521 absorption reaction Methods 0.000 description 2
- 239000003795 chemical substances by application Substances 0.000 description 2
- 239000000835 fiber Substances 0.000 description 2
- 238000011049 filling Methods 0.000 description 2
- 238000007689 inspection Methods 0.000 description 2
- 239000010985 leather Substances 0.000 description 2
- 238000004513 sizing Methods 0.000 description 2
- 238000003860 storage Methods 0.000 description 2
- UIAGMCDKSXEBJQ-IBGZPJMESA-N 3-o-(2-methoxyethyl) 5-o-propan-2-yl (4s)-2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate Chemical compound COCCOC(=O)C1=C(C)NC(C)=C(C(=O)OC(C)C)[C@H]1C1=CC=CC([N+]([O-])=O)=C1 UIAGMCDKSXEBJQ-IBGZPJMESA-N 0.000 description 1
- FHKPLLOSJHHKNU-INIZCTEOSA-N [(3S)-3-[8-(1-ethyl-5-methylpyrazol-4-yl)-9-methylpurin-6-yl]oxypyrrolidin-1-yl]-(oxan-4-yl)methanone Chemical compound C(C)N1N=CC(=C1C)C=1N(C2=NC=NC(=C2N=1)O[C@@H]1CN(CC1)C(=O)C1CCOCC1)C FHKPLLOSJHHKNU-INIZCTEOSA-N 0.000 description 1
- 239000013543 active substance Substances 0.000 description 1
- 239000002671 adjuvant Substances 0.000 description 1
- 230000032683 aging Effects 0.000 description 1
- 230000002421 anti-septic effect Effects 0.000 description 1
- 239000003963 antioxidant agent Substances 0.000 description 1
- 230000003078 antioxidant effect Effects 0.000 description 1
- 239000007864 aqueous solution Substances 0.000 description 1
- 230000005540 biological transmission Effects 0.000 description 1
- 238000009835 boiling Methods 0.000 description 1
- 235000010418 carrageenan Nutrition 0.000 description 1
- 238000006243 chemical reaction Methods 0.000 description 1
- 239000011248 coating agent Substances 0.000 description 1
- 238000000576 coating method Methods 0.000 description 1
- 239000000084 colloidal system Substances 0.000 description 1
- 239000003086 colorant Substances 0.000 description 1
- 150000001875 compounds Chemical class 0.000 description 1
- 238000013270 controlled release Methods 0.000 description 1
- 239000002537 cosmetic Substances 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 238000004043 dyeing Methods 0.000 description 1
- 239000000839 emulsion Substances 0.000 description 1
- 230000007613 environmental effect Effects 0.000 description 1
- 210000001035 gastrointestinal tract Anatomy 0.000 description 1
- 150000004676 glycans Chemical class 0.000 description 1
- 238000010438 heat treatment Methods 0.000 description 1
- 230000002209 hydrophobic effect Effects 0.000 description 1
- 230000000873 masking effect Effects 0.000 description 1
- 229910052751 metal Inorganic materials 0.000 description 1
- 239000002184 metal Substances 0.000 description 1
- 229960000715 nimodipine Drugs 0.000 description 1
- 239000000049 pigment Substances 0.000 description 1
- 239000002861 polymer material Substances 0.000 description 1
- 229920005862 polyol Polymers 0.000 description 1
- 150000003077 polyols Chemical class 0.000 description 1
- 229920001282 polysaccharide Polymers 0.000 description 1
- 239000005017 polysaccharide Substances 0.000 description 1
- 238000005096 rolling process Methods 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
- 238000013112 stability test Methods 0.000 description 1
- 229910001220 stainless steel Inorganic materials 0.000 description 1
- 239000010935 stainless steel Substances 0.000 description 1
- 150000005846 sugar alcohols Polymers 0.000 description 1
- 230000002459 sustained effect Effects 0.000 description 1
- 238000013268 sustained release Methods 0.000 description 1
- 238000005406 washing Methods 0.000 description 1
- UHVMMEOXYDMDKI-JKYCWFKZSA-L zinc;1-(5-cyanopyridin-2-yl)-3-[(1s,2s)-2-(6-fluoro-2-hydroxy-3-propanoylphenyl)cyclopropyl]urea;diacetate Chemical compound [Zn+2].CC([O-])=O.CC([O-])=O.CCC(=O)C1=CC=C(F)C([C@H]2[C@H](C2)NC(=O)NC=2N=CC(=CC=2)C#N)=C1O UHVMMEOXYDMDKI-JKYCWFKZSA-L 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- 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
- A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
-
- A—HUMAN NECESSITIES
- 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
- A61K47/02—Inorganic compounds
-
- A—HUMAN NECESSITIES
- 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
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Pharmacology & Pharmacy (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Inorganic Chemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Medicinal Preparation (AREA)
Abstract
The invention discloses a novel soft capsule material formula, which belongs to the technical field of medicinal materials, wherein the capsule material comprises the following components in percentage by weight based on the total weight of the capsule material: 30-50% of matrix, 10-22% of polyglycerol, 0.6-1.6% of sodium pyrophosphate, 35-55% of purified water and 1-5% of additive; the matrix is one of sesbania gum, xanthan gum, K-carrageenan, gelatin, guar gum and peach gum, and the combination of any two or more. The preparation process is simple, the sources of raw materials are rich, and the preparation method is environment-friendly; the capsule wall material provided by the invention has low oxygen transmittance, good heat preservation performance and excellent disintegration rate; the capsule wall material provided by the invention has the advantages of high safety, wide applicability and high stability, and is beneficial to protecting the content of the soft capsule which is easy to oxidize.
Description
Technical Field
The invention belongs to the technical field of medicinal materials, and particularly relates to a novel soft capsule shell material formula.
Background
The soft capsule is prepared by mixing the extract of medicinal materials and liquid medicine or with appropriate adjuvant, and making into spherical, elliptic or other dosage forms by dripping or pressing. The soft capsule is suitable for unstable medicinal substances, such as chemical components which are sensitive to light, volatile, unstable when exposed to damp and heat and easy to oxidize, and also suitable for medicinal substances with uncomfortable taste and bad smell. After the soft capsule is orally taken, the medicine is wrapped by the hydrophilic gelatin skin and quickly disintegrates in the digestive tract, so that the medicine is released quickly. The prescription of the soft capsule shell material comprises four substances, namely sizing material, plasticizer, water and additive, wherein the sizing material is a main component for forming the shell, such as gelatin, gelatin substitute material and the like; the plasticizer is usually glycerol and polyalcohol, and can be used singly or in combination; the additives include antiseptic, colorant, disintegrating agent, opacifier, antioxidant, etc. to maintain the quality stability of the medicine and soft capsule. The traditional soft capsule material formula mainly comprises gelatin, water, glycerol and selected pigments, and the soft capsule is prepared from the capsule material prepared by the traditional formula, and has general quality.
The polymerized glycerol is colorless and viscous liquid or semisolid, is soluble in water and ethanol, has slightly lower hygroscopicity than glycerol, and is a polyol. The polyglycerol has the characteristics of higher viscosity and boiling point than glycerol, low volatility and hygroscopicity, good moisture retention and improved emulsion stability. The moisture absorption and moisture retention characteristics can be used as raw materials of cosmetics; immersing the fibers in an aqueous solution of polymeric glycerol and other compounds improves the surface flexibility and hydrophilicity of the hydrophobic fibers and serves as a dyeing aid for the water-insoluble dye. The colloid, the polymerized glycerol and the sodium pyrophosphate are crosslinked to form a brand new crosslinking substance, the toughness is better, the oxygen penetrability of the capsule shell taking the glycerol as the plasticizer is strong, and the crosslinking substance provided by the invention can obviously reduce the oxygen penetrability, thereby preventing the capsule shell from aging too fast.
The plant soft capsule material comprises sesbania gum, xanthan gum, carrageenan, gelatin and guar gum, is prepared by taking plant polysaccharide instead of animal gelatin as raw material, and retains all advantages of standard animal capsule material, such as convenient administration, effective taste and smell masking, transparent and visible content, etc. In addition, the plant capsule material has better coating property, and the plant material has better affinity with most high polymer materials, thus being particularly suitable for preparing sustained and controlled release coated capsules. Compared with the traditional gelatin soft capsule material, the plant soft capsule material has the advantages of high safety, wide applicability, high stability and no crosslinking reaction.
Disclosure of Invention
The invention provides a novel soft capsule shell material formula, which has high safety, wide applicability and high stability; low oxygen permeability, good moisture retention and excellent disintegration rate. The preparation method has the advantages of rich raw material sources, environmental protection and the like, is simple in process, can be used for filling and producing the capsules of the oxygen-sensitive drug active substances, and has good application prospect in the field of capsule preparations.
The invention provides a novel soft capsule material formula, which comprises the following components in percentage by weight based on the total weight of the capsule material: 30-50% of matrix, 10-22% of polyglycerol, 0.6-1.6% of sodium pyrophosphate, 35-55% of purified water and 1-5% of additive;
the matrix is one of sesbania gum, xanthan gum, K-carrageenan, gelatin, guar gum and peach gum, and the combination of any two or more.
Further, the polymerization degree of the polymerized glycerin is 10 to 12.
Further, the additive is opacifier titanium dioxide and disintegrant polyethylene glycol-400.
Further, the disintegrating agent accounts for 2-5% of the total weight of the capsule wall material, and the weight ratio of the opacifier to the matrix is 0.002-0.01:1.
Further, the preparation method of the capsule wall material comprises the following steps: mixing the matrix, the polymerized glycerol and the sodium pyrophosphate, adding the mixture into purified water at 50-90 ℃, adding the additive, stirring for 1-3 h, preserving heat for 0.5-2 h at 50-60 ℃, standing for defoaming, and sealing for standby.
Further, the temperature of the purified water is 50 to 90 ℃, preferably 70 to 85 ℃; the heat preservation time is 0.5-2 h, preferably 1.5-2 h.
Compared with the prior art, the invention has the beneficial effects that:
(1) The preparation process is simple, the raw material sources are rich, and the environment is protected.
(2) The capsule wall material provided by the invention has the advantages of low oxygen transmittance, good moisture retention performance and excellent disintegration rate.
(3) The capsule wall material provided by the invention has the advantages of high safety, wide applicability and high stability, and is beneficial to protecting the content of the soft capsule which is easy to oxidize.
Detailed Description
1. Preparation of novel soft capsule material
Example 1
A novel soft capsule material formula comprises:
52.5g of K-carrageenan;
19.8g of polymerized glycerol;
1.2g of sodium pyrophosphate;
72g of purified water;
polyethylene glycol-400.05 g;
Titanium dioxide 0.45g.
The preparation method comprises the following steps: when 72g of purified water is heated to 75 ℃, 52.5g of K-carrageenan, 19.8g of polymerized glycerol (polymerization degree is 10) and 1.2g of sodium pyrophosphate are mixed and added into the purified water, then 0.45g of titanium dioxide and 4.05g of polyethylene glycol-400 are added, after stirring for 2 hours, the mixture is kept at 55 ℃ for 2 hours, and the mixture is kept stand for defoaming and sealed for later use.
Example 2
A novel soft capsule material formula comprises:
60g of sesbania gum;
22.22g of polymerized glycerol;
1.78g of sodium pyrophosphate;
60g of purified water;
Polyethylene glycol-400.7 g;
Titanium dioxide 0.3g.
The preparation method comprises the following steps: 60g of purified water is heated to 80 ℃, 60g of sesbania gum, 22.22g of polymerized glycerol (polymerization degree is 10) and 1.78g of sodium pyrophosphate are mixed and then added into the purified water, 0.3g of titanium dioxide and 5.7g of polyethylene glycol-400 are added, after stirring for 2 hours, the temperature is kept for 1.5 hours at 55 ℃, standing for defoaming, and sealing is carried out for standby.
Example 3
A novel soft capsule material formula comprises:
67.5g of gelatin;
17.04g of polymerized glycerol;
1.71g of sodium pyrophosphate;
60g of purified water;
polyethylene glycol-400.6 g;
titanium dioxide 0.15g.
The preparation method comprises the following steps: 60g of purified water is heated to 60 ℃, 67.5g of gelatin, 17.04g of polymerized glycerol (polymerization degree is 10) and 1.71g of sodium pyrophosphate are mixed and then added into the purified water, 0.15g of titanium dioxide and 3.6g of polyethylene glycol-400 are added, after stirring for 2 hours, the temperature is kept for 0.5 hour at 55 ℃, standing and defoaming are carried out, and the mixture is sealed for standby.
Example 4
A novel soft capsule material formula comprises:
60g of peach gum;
18.09g of polymerized glycerol;
1.26g of sodium pyrophosphate;
67.5g of purified water;
polyethylene glycol-400 g;
titanium dioxide 0.15g.
The preparation method comprises the following steps: 67.5g of purified water is heated to 85 ℃, 60g of peach gum, 18.09g of polymerized glycerol (polymerization degree is 11) and 1.26g of sodium pyrophosphate are mixed and then added into the purified water, 0.15g of titanium dioxide and 3g of polyethylene glycol-400 are added, after stirring for 2 hours, the temperature is kept for 1.5 hours at 55 ℃, and the mixture is kept stand for defoaming and sealed for standby.
Example 5
A novel soft capsule material formula comprises:
45g of xanthan gum;
18.42g of polyglycerol;
sodium pyrophosphate 0.93g;
82.5g of purified water;
polyethylene glycol-400 g;
titanium dioxide 0.15g.
The preparation method comprises the following steps: 82.5g of purified water is heated to 50 ℃, 45g of xanthan gum, 18.42g of polymerized glycerol (polymerization degree is 12) and 0.93g of sodium pyrophosphate are mixed and then added into the purified water, 0.15g of titanium dioxide and 3g of polyethylene glycol-400 are added, after stirring for 1h, the temperature is kept for 1h at 55 ℃, standing for defoaming, and sealing is carried out for standby.
Example 6
A novel soft capsule material formula comprises:
Guar gum 60g;
27.78g of polymerized glycerol;
Sodium pyrophosphate 2.22g;
52.5g of purified water;
Polyethylene glycol-400.35 g;
titanium dioxide 0.15g.
The preparation method comprises the following steps: 52.5g of purified water is heated to 70 ℃, 60g of guar gum, 27.78g of polymerized glycerol (polymerization degree is 11) and 2.22g of sodium pyrophosphate are mixed and then added into the purified water, 0.15g of titanium dioxide and 7.35g of polyethylene glycol-400 are added, after stirring for 3 hours, the temperature is kept for 1 hour at 55 ℃, and the mixture is kept stand for defoaming and sealed for standby.
Comparative example 1
A novel soft capsule material formula comprises:
67.5g of gelatin;
18.75g of glycerol;
60g of purified water;
polyethylene glycol-400.6 g;
titanium dioxide 0.15g.
The preparation method comprises the following steps: heating 60g of purified water to 60 ℃, mixing 67.5g of gelatin and 18.75g of glycerol, adding into the purified water, adding 0.15g of titanium dioxide and 3.6g of polyethylene glycol-400, stirring for 2 hours, preserving heat for 0.5 hour at 55 ℃, standing for defoaming, and sealing for later use.
2. Oxygen transmittance evaluation of Soft Capsule Material
Wet skins were prepared by using a capsule machine for each of examples 1 to 6 and comparative example 1: thickness was 0.25mm (about 0.15mm after drying) and 0.75mm (about 0.50mm after drying), respectively; after drying to 9.0% -12.0% moisture, the oxygen permeability of the capsules was measured by an oxygen permeability tester (note: RH is relative humidity, h is hours, cc is volume/volume unit cubic centimeter, cc/m 2.24 h is unit of oxygen permeability).
Table 1 oxygen transmission rates of the soft capsule materials of examples 1 to 6 and comparative example 1
The data results in table 1 above show that: the oxygen permeability of the soft capsule wall material of the embodiment of the invention is obviously reduced.
3. Evaluation of disintegration time of Soft Capsule
Soft capsule preparation of the same content: the glue solutions of the examples 1-6 and the comparative example 1 are respectively introduced into a pressing type soft capsule machine for pressing, the formed glue leather enters a rolling die, the content (such as nimodipine liquid medicine) is injected from the two glue leather, and 100 soft capsules of the examples 1-6 and the comparative example 1 are respectively obtained after washing and drying.
Evaluation method of disintegration time: taking 6 capsules of the product, taking a disintegration time limit inspection method (a capsule method, namely hanging a hanging basket of a disintegration tester on a metal bracket through a stainless steel shaft at the upper end, immersing the hanging basket in a 1000ml beaker, adjusting the position of the hanging basket to ensure that a screen is 25mm away from the bottom of the beaker when the hanging basket descends, filling water with the temperature of 37+/-1 ℃ in the beaker, adjusting the water level to ensure that the screen is 15mm below the water surface when the hanging basket ascends), adding a baffle, starting the disintegration tester for inspection, and completely disintegrating the soft capsules within 1 hour, wherein if 1 capsule cannot be completely disintegrated, 6 capsules are taken for retesting, and the requirements are met.
Table 2 disintegration time limits of the soft capsules of examples 1-6 and comparative example 1
| Examples | Disintegration time (min) |
| Example 1 | 8.3 |
| Example 2 | 8 |
| Example 3 | 9.3 |
| Example 4 | 8.5 |
| Example 5 | 9.7 |
| Example 6 | 9 |
| Comparative example 1 | 15.2 |
The data results in table 2 above show that: the soft capsule of the embodiment of the invention has excellent disintegration rate.
4. Stability test of Soft Capsule
The soft capsules of examples 1 to 6 and comparative example 1, into which the contents were introduced, were used as test samples, and stability of the test samples under various conditions was tested. Wherein the room temperature drying storage condition is 25 ℃ and the relative humidity is 20%, the high temperature and high humidity storage condition is 60 ℃ and the relative humidity is 90%, the shaking condition is 100 times/min shaking and shaking, and 20 samples are taken for each test.
TABLE 3 stability of Soft Capsule of examples 1-6 and comparative example 1 under different conditions
Note that: in the high-temperature high-humidity test, no obvious change is caused, after 3 months, the surface of the soft capsule has the phenomenon of moisture absorption and softening, but the soft capsule does not deform, and after the soft capsule is dried, the soft capsule has no change from an initial state.
The data in table 3 above shows that: the soft capsule of the embodiment of the invention has high stability.
Claims (6)
1. The soft capsule wall material is characterized in that the capsule wall material comprises the following components in percentage by weight based on the total weight of the capsule wall material: 30-50% of matrix, 10-22% of polyglycerol, 0.6-1.6% of sodium pyrophosphate, 35-55% of purified water and 1-5% of additive;
the matrix is one of sesbania gum, xanthan gum, K-carrageenan, gelatin, guar gum and peach gum, and the combination of any two or more.
2. The soft capsule wall material of claim 1, wherein the degree of polymerization of the polymerized glycerol is 10-12.
3. The soft capsule wall material according to claim 1, wherein the additive is opacifier titanium dioxide, disintegrant polyethylene glycol-400.
4. A soft capsule according to claim 3, wherein the disintegrant is 2-5% by weight of the total capsule weight, and the weight ratio of opacifier to matrix is 0.002-0.01:1.
5. A method for preparing a soft capsule shell according to any one of claims 1 to 4, wherein the method comprises the steps of: mixing the matrix, the polymerized glycerol and the sodium pyrophosphate, adding the mixture into purified water at 50-90 ℃, adding the additive, stirring for 1-3 h, preserving heat for 0.5-2 h at 50-60 ℃, standing for defoaming, and sealing for standby.
6. The method according to claim 5, wherein the purified water has a temperature of 70 to 85℃and a holding time of 1.5 to 2 hours.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202210747781.5A CN114948896B (en) | 2022-06-22 | 2022-06-22 | Novel soft capsule material formula |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202210747781.5A CN114948896B (en) | 2022-06-22 | 2022-06-22 | Novel soft capsule material formula |
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| Publication Number | Publication Date |
|---|---|
| CN114948896A CN114948896A (en) | 2022-08-30 |
| CN114948896B true CN114948896B (en) | 2024-04-30 |
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| CN116531444B (en) * | 2023-07-06 | 2023-10-10 | 健码制药（广东）有限公司 | Cough-relieving lung-heat-clearing soft capsule and preparation process thereof |
Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0876816A1 (en) * | 1997-05-09 | 1998-11-11 | Daiichi Kasei Co., Ltd. | Capsule containing whey protein |
| EP1045022A1 (en) * | 1999-04-15 | 2000-10-18 | Greither, Peter | Use of gelatine in washing agents |
| CN102499910A (en) * | 2011-12-15 | 2012-06-20 | 山西吉呈生物技术有限公司 | Hard-shell capsule based on pullulan |
| DE102016110089A1 (en) * | 2016-06-01 | 2017-12-07 | Christine Konert | Capsule for the portionwise preparation of a drink |
| CN111265712A (en) * | 2020-03-27 | 2020-06-12 | 浙江工业大学 | Hydrogel loaded with plant essential oil and preparation method thereof |
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Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0876816A1 (en) * | 1997-05-09 | 1998-11-11 | Daiichi Kasei Co., Ltd. | Capsule containing whey protein |
| EP1045022A1 (en) * | 1999-04-15 | 2000-10-18 | Greither, Peter | Use of gelatine in washing agents |
| CN102499910A (en) * | 2011-12-15 | 2012-06-20 | 山西吉呈生物技术有限公司 | Hard-shell capsule based on pullulan |
| DE102016110089A1 (en) * | 2016-06-01 | 2017-12-07 | Christine Konert | Capsule for the portionwise preparation of a drink |
| CN111265712A (en) * | 2020-03-27 | 2020-06-12 | 浙江工业大学 | Hydrogel loaded with plant essential oil and preparation method thereof |
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