CN101628117B - Chewing soft capsule shell, chewing soft capsule drug and prepration method thereof - Google Patents
Chewing soft capsule shell, chewing soft capsule drug and prepration method thereof Download PDFInfo
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- CN101628117B CN101628117B CN2009100909418A CN200910090941A CN101628117B CN 101628117 B CN101628117 B CN 101628117B CN 2009100909418 A CN2009100909418 A CN 2009100909418A CN 200910090941 A CN200910090941 A CN 200910090941A CN 101628117 B CN101628117 B CN 101628117B
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Abstract
The invention relates to a chewing soft capsule shell, a chewing soft capsule drug and a prepration method thereof. The soft capsule shell consists of the following raw materials: 25-35 wt% of gelatin, 15-25 wt% of glycerol, 35-50 wt% of purified water, 0.1-1 wt% of sodium alginate, 0.1-1 wt% of carrageenan, 0.1-1 wt% of pectin, 1.5-2.5 wt% of sorbitol and 2-5 wt% of polyvinyl alcohol 400. The chewing soft capsule shell further comprises the following components: 0.1-0.3 wt% of sweetener, 0.2-0.4 wt% of acidifier, 0.001-0.01 wt% of spice, 0.001-0.01 wt% of preservative and 0.001-0.01 wt% of pigment. The soft capsule shell prepared by the raw materials has the advantages of small mechanical strength and toughness, and the invention further provides the method for preparing the chewing soft capsule drug.
Description
Technical field
The present invention relates to a kind of soft capsule, specifically a kind of chewing soft capsule shell and pharmaceutical capsules thereof belong to medical technical field.
Background technology
Soft capsule in view of its unique closed flexible package speciality, can guarantee the pharmacodynamic stability that content is good as emerging drug delivery system effectively, and the dose controlled that has owing to itself is widely used with portable.In recent years, from improving the purpose of pharmaceutical preparation taking, the demand of the masticatory pattern soft capsule that also can be easy to take even without water is improved day by day.So, realized preparation to masticatory pattern soft capsule skin by in the raw material of soft capsule skin, adding an amount of glycerol and Sorbitol.But but only on the chewiness that improves masticatory pattern soft capsule skin, improve the requirement that also can't satisfy the user far away, the chewing soft capsule product that has arisen at the historic moment thereupon and be exclusively used in fresh breath or improve oral environment and improve the soft capsule mouthfeel.
Chinese patent CN1183904C discloses a kind of masticatory pattern soft capsule that has improved taking, mouthfeel when chewing in order to increase, this technology soft capsule content is set to room temperature and is solid, shaped or semi-solid, and in content, add additives such as sweetener or chocolate base, use capsule shell contents of parcel thing then, thereby when chewing, realize the homogenization of soft capsule skin and content, alleviated the raw material abnormal smells from the patient of soft capsule skin itself to a certain extent.The agent skin of soft capsule is obtained by filling content by gelatin and plasticizer dissolving back in the prior art, because having added a certain amount of plasticizer in gelatin makes that the mechanical strength of chewing soft capsule shell is big, the toughness height, thereby make the user when chewing such soft capsule, cause chewiness not good too firmly owing to the capsule body, chewing difficulty increases, especially concerning old people or child, chew this soft capsule difficulty more.In addition, in the prior art, Chinese patent CN100411614C discloses a kind of tremella-polysaccharose capsules shell, and its composition of raw materials is tremella gum 15-35 part, sodium alginate 15-35 part, carrageenan 40-60 part, glycerol or sorbitol 2-10 part, pure water 60-120 part.The prior art is by using the preparation of tremella gum, sodium alginate, carrageenan, glycerol or sorbitol and pure water realization to capsule shells, higher according to the capsule shells hardness that above-mentioned formulation obtains, therefore above-mentioned prescription of the prior art only is applicable to the making hard capsule case, and is not suitable for the making soft capsule shell.
Summary of the invention
For this reason, technical problem to be solved by this invention is that the mechanical strength of hard capsule of the prior art or chewing soft capsule shell is big, the toughness height, the user chews when chewing such soft capsule that hardness is big, chewiness is not good, thereby provides a kind of mechanical strength and toughness all lower chewing soft capsule.
For solving the problems of the technologies described above, the invention provides a kind of chewing soft capsule shell, described soft capsule suitcase is drawn together following component: 25～35wt% gelatin, 15～25wt% glycerol, 35～50wt% purified water, 0.1～1wt% sodium alginate, 0.1～1wt% carrageenan, 0.1～1wt% pectin, 1.5～2.5wt% sorbitol, 2～5wt% polyvinyl alcohol 400.
Preferred described soft capsule skin is made up of following component: 31wt% gelatin, 20wt% glycerol, 43wt% purified water, 0.2wt% sodium alginate, 0.36wt% carrageenan, 0.44wt% pectin, 2wt% sorbitol, 3wt% polyvinyl alcohol 400.
Above-mentioned chewing soft capsule shell also comprises following component: 0.1～0.3wt% sweetener, 0.2～0.4wt% tart flavour element, 0.001～0.01wt% spice, 0.001～0.01wt% antiseptic, 0.001～0.01wt% pigment.
Preferred described soft capsule skin is made up of following component: 31.4% gelatin, 20% glycerol, 42% purified water, 0.15% sodium alginate, 0.16% carrageenan, 0.5943% pectin, 1.997% sorbitol, 2.9975% polyvinyl alcohol 400,0.3% sweetener, 0.387% tart flavour element, 0.0062% spice, 0.0064% antiseptic, 0.0016% pigment.
A kind of gum medicine capsule, comprise content and the chewing soft capsule shell that is wrapped in the content outside, it is characterized in that described chewing soft capsule shell comprises following component: 25～35wt% gelatin, 15～25wt% glycerol, 35～50wt% purified water, 0.1～1wt% sodium alginate, 0.1～1wt% carrageenan, 0.1～1wt% pectin, 1.5～2.5wt% sorbitol, 2～5wt% polyvinyl alcohol 400.
Described chewing soft capsule shell also comprises following component: 0.1～0.3wt% sweetener, 0.2～0.4wt% tart flavour element, 0.001～0.01wt% spice, 0.001～0.01wt% antiseptic, 0.001～0.01wt% pigment.
The present invention also on the basis that discloses above-mentioned chewing soft capsule shell and gum medicine capsule, further discloses a kind of method for preparing above-mentioned gum medicine capsule, and it comprises following treatment step:
(1) takes by weighing an amount of raw material for standby, in the glue jar, add purified water, sodium alginate, carrageenan and pectin and fully mixing, in the glue jar, add sorbitol and polyvinyl alcohol 400 then, add gelatin at last, fully mix;
(2) mixture in step (1) the glue jar is changed glue 1～5 hour under 55～75 ℃ temperature, obtain glue;
(3) with changing the steady glue of glue 1～3 hour that glue obtains through step (2) in the glue jar, flow into the glue box through sebific duct, glue flows out in the glue box, flows on the rubber wheel of glue box below, forms the uniform rubber of thickness;
(4) content is compressed on the chewing soft capsule Intradermal of being produced in the step (3), obtains the thick product of gum medicine capsule;
(5) the thick product of being produced in the step (4) of gum medicine capsule being placed temperature is 15～30 ℃, and humidity is in 15～50% the confined space, to store 1～3 day, and intensive drying gets final product.
The gum medicine capsule of being produced in the step (5) is packed, and package temperature is controlled at 15～30 ℃, and packing humidity is controlled at 10～30%.
Mixture in the preferred described step (2) is changed glue 1.5 hours under 68 ℃ temperature.
The steady glue time in the preferred described step (3) is 2.5 hours.
It is 21 ℃ that the thick product of being produced in the preferred described step (4) of gum medicine capsule places temperature, and humidity is in 26% the confined space, to store 2 days.
Preferred described package temperature is controlled to be 21 ℃, and packing humidity is 25%.
Technique scheme of the present invention has the following advantages compared to existing technology:
1) in the chewing soft capsule shell of the present invention, comprises 25～35wt% gelatin, 15～25wt% glycerol, 35～50wt% purified water, 0.1～1wt% sodium alginate, 0.1～1wt% carrageenan, 0.1～1wt% pectin, 1.5～2.5wt% sorbitol, 2～5wt% polyvinyl alcohol 400.Because the mechanical strength and the toughness of general soft capsule skin are bigger, so the present invention adds a certain amount of sodium alginate, pectin, carrageenan, polyvinyl alcohol to reduce the mechanical strength and the toughness of chewing soft capsule shell, what wherein bring into play central role is sodium alginate, polyvinyl alcohol and pectin; The content that carrageenan is less, guaranteed that it has certain thickening power and does not possess skeleton function (when carrageenan content is big in aqueous solvent, it possesses the effect of skeleton in aqueous solvent), thus the mechanical strength and the toughness of soft capsule skin also reduced to a certain extent.Wherein, sodium alginate serves as the framing structure of low mechanical strength in aqueous systems, the mechanical strength of prepared rubber is significantly reduced; But because sodium alginate is strong absorbent material, and its volume of suction back sharply expands, be unfavorable for the dissolving of other compositions, and increased the unstability of system, cause glue can't be used for pelleting, so excessive interpolation sodium alginate can cause the gum medicine capsule to prepare, and make the fragility of chewing soft capsule shell excessive.Pectin possesses certain gelatification, and whole mechanical property of glue system and toughness are reduced.In addition, sorbitol and polyvinyl alcohol possess certain hygroscopicity, add an amount of sorbitol and polyvinyl alcohol in the soft capsule skin and can make that water content suitably rises in the soft capsule skin, but the two addition can not be too much, too much sorbitol and polyvinyl alcohol then can make the chewing soft capsule shell of producing absorb the water in air branch easily and stick together, thereby the reduction product quality, thereby when adding sorbitol and polyvinyl alcohol, also must select suitable addition.An amount of interpolation just because of above-mentioned substance, under the combined effect of above-mentioned chewing soft capsule skin component, the mechanical strength and the toughness of the feasible soft capsule skin for preparing are all less, thereby make the user when chewing such soft gelatin pharmaceutical, chew easily, has preferable chewiness, especially concerning old people or child, chew this soft gelatin pharmaceutical and just be more prone to.
2) the soft capsule skin of gum medicine capsule of the present invention also can add sweetener, tart flavour element, spice, antiseptic and pigment, be used to improve the mouthfeel of chewing soft capsule shell, because of not containing saccharide in the used component of soft capsule skin, so it can be used for packing the medicine that is suitable for the diabetes patient.
3) method that is used for preparing the gum medicine capsule of the present invention, at first take by weighing feed purification water disclosed in this invention, sodium alginate, carrageenan, pectin, sorbitol, polyvinyl alcohol 400, gelatin, also can add sweetener, tart flavour element, spice, antiseptic and pigment according to the production needs and carry out mixing for standby use; Under 55～75 ℃ temperature, change glue 1～5 hour afterwards, preferential glue 1.5 hours of under 68 ℃ temperature, changing, setting this change glue temperature guaranteed that on the one hand above-mentioned raw materials glue is abundant, even and has had suitable chewing toughness and chew pliability with the change glue time, also guaranteed to be unlikely to excessive and make the above-mentioned raw materials glue bond and influence the toughness and the pliability of capsule shell on the other hand, but improved its chewiness because change the glue temperature and time; After changing glue, steady glue 1～3 hour improves the stability of glue, thereby guarantees to obtain the uniform rubber of pliability; Be pressed into ball after changing the glue processing, the content in the gum medicine capsule is pressed in the chewing soft capsule shell, obtain the thick product of gum medicine capsule; The thick product of being produced of gum medicine capsule will be placed temperature at last is 15～30 ℃, humidity is in 15～50% the confined space, store 1～3 day, preferably the thick product of being produced of gum medicine capsule being placed temperature is 21 ℃, humidity is in 26% the confined space, store 2 days, promptly guarantee in the shortest time, to make chewing soft capsule pharmaceutical presentations intensive drying that the moisture in its pharmaceutical capsules is not run off in drying.
After above-mentioned chewing soft capsule medication preparation is finished, because it directly is positioned in the air easily because the passing of time causes the soft capsule skin of gum medicine capsule to take place to go bad, cause the mechanical strength and the pliability of soft capsule skin to change, so preferably the above-mentioned gum medicine capsule of producing is further packed, package temperature is controlled at 15～30 ℃, and packing humidity is controlled at 10～30%; The preferred packaging temperature is controlled to be 21 ℃, and packing humidity is 25%, guarantees the time to make the moisture of gum medicine capsule not run off in packing, has guaranteed further that the soft capsule leatherware for preparing has to chew toughness and pliability preferably.
The specific embodiment
Embodiment 1
A kind of method for preparing the gum medicine capsule, it comprises the steps:
(1) takes by weighing the 31g gelatin, 20g glycerol, 43g purified water, 0.2g sodium alginate, 0.36g carrageenan, 0.44g pectin, 2g sorbitol, 3g polyvinyl alcohol 400, in the glue jar, add purified water, sodium alginate, carrageenan and pectin and fully mixing, in the glue jar, add sorbitol and polyvinyl alcohol 400 then, add gelatin at last, standby after above-mentioned raw materials is fully mixed in the glue jar;
(2) will under 68 ℃ temperature, change glue 1.5 hours through the mixed mixed liquor of step (1), obtain glue;
(3) with changing the steady glue of glue 2 hours that glue obtains through step (2) in the glue jar, flow into the glue box through sebific duct, glue flows out in glue box lower gap, flows on the rubber wheel under the glue box, forms the uniform rubber of thickness;
(4) content is compressed on the chewing soft capsule Intradermal of being produced in the step (3), obtains the thick product of gum medicine capsule;
(5) the thick product of being produced in the step (4) of gum medicine capsule being placed temperature is 21 ℃, and humidity is in 26% the confined space, to store 2 days, makes intensive drying, i.e. the chewing soft capsule drug products.
The above-mentioned chewing soft capsule medicine for preparing comprises content and is wrapped in the capsule shell of content outside, described capsule shell comprises following component: the 31wt% gelatin, 20wt% glycerol, the 43wt% purified water, the 0.2wt% sodium alginate, 0.36wt% carrageenan, 0.44wt% pectin, the 2wt% sorbitol, 3wt% polyvinyl alcohol 400.
Embodiment 2
A kind of method for preparing the gum medicine capsule, it comprises the steps:
(1) takes by weighing the 25g gelatin, 15g glycerol, 49.5g purified water, 1g sodium alginate, the 1g carrageenan, 1g pectin, 2.5g sorbitol, 5g polyvinyl alcohol 400, in the glue jar, add purified water, sodium alginate, carrageenan and pectin and fully mixing, in the glue jar, add sorbitol and polyvinyl alcohol 400 then, add gelatin at last, standby after above-mentioned raw materials is fully mixed in the glue jar;
(2) will under 55 ℃ temperature, change glue 5 hours through the mixed mixed liquor of step (1), obtain glue;
(3) with changing the steady glue of glue 3 hours that glue obtains through step (2) in the glue jar, flow into the glue box through sebific duct, glue flows out in glue box lower gap, flows on the rubber wheel under the glue box, forms the uniform rubber of thickness;
(4) content is compressed on the chewing soft capsule Intradermal of being produced in the step (3), obtains the thick product of gum medicine capsule;
(5) the thick product of being produced in the step (4) of gum medicine capsule being placed temperature is 15 ℃, and humidity is in 15% the confined space, to store 1 day, makes intensive drying, i.e. the chewing soft capsule drug products.
The above-mentioned chewing soft capsule medicine for preparing comprises content and is wrapped in the capsule shell of content outside, described capsule shell comprises following component: the 25wt% gelatin, 15wt% glycerol, the 49.5wt% purified water, the 1wt% sodium alginate, 1wt% carrageenan, 1wt% pectin, the 2.5wt% sorbitol, 5wt% polyvinyl alcohol 400.
Embodiment 3
A kind of method for preparing the gum medicine capsule, it comprises the steps:
(1) takes by weighing the 35g gelatin, 25g glycerol, 36.2g purified water, 0.1g sodium alginate, 0.1g carrageenan, 0.1g pectin, 1.5g sorbitol, 2g polyvinyl alcohol 400, in the glue jar, add purified water, sodium alginate, carrageenan and pectin and fully mixing, in the glue jar, add sorbitol and polyvinyl alcohol 400 then, add gelatin at last, standby after above-mentioned raw materials is fully mixed in the glue jar;
(2) will under 75 ℃ temperature, change glue 1 hour through the mixed mixed liquor of step (1), obtain glue;
(3) with changing the steady glue of glue 1 hour that glue obtains through step (2) in the glue jar, flow into the glue box through sebific duct, glue flows out in glue box lower gap, flows on the rubber wheel under the glue box, forms the uniform rubber of thickness;
(4) content is compressed on the chewing soft capsule Intradermal of being produced in the step (3), obtains the thick product of gum medicine capsule;
(5) the thick product of being produced in the step (4) of gum medicine capsule being placed temperature is 30 ℃, and humidity is in 50% the confined space, to store 3 days, makes intensive drying, i.e. the chewing soft capsule drug products.
The above-mentioned chewing soft capsule medicine for preparing comprises content and is wrapped in the capsule shell of content outside, described capsule shell comprises following component: the 35wt% gelatin, 25wt% glycerol, the 36.2wt% purified water, the 0.1wt% sodium alginate, 0.1wt% carrageenan, 0.1wt% pectin, the 1.5wt% sorbitol, 2wt% polyvinyl alcohol 400.
Embodiment 4
A kind of method for preparing the gum medicine capsule, it comprises the steps:
(1) takes by weighing the 33.5g gelatin, 25g glycerol, 35g purified water, 1g sodium alginate, the 1g carrageenan, 1g pectin, 1.5g sorbitol, 2g polyvinyl alcohol 400, in the glue jar, add purified water, sodium alginate, carrageenan and pectin and fully mixing, in the glue jar, add sorbitol and polyvinyl alcohol 400 then, add gelatin at last, standby after above-mentioned raw materials is fully mixed in the glue jar;
(2) will under 60 ℃ temperature, change glue 1.2 hours through the mixed mixed liquor of step (1), obtain glue;
(3) with changing the steady glue of glue 1.5 hours that glue obtains through step (2) in the glue jar, flow into the glue box through sebific duct, glue flows out in glue box lower gap, flows on the rubber wheel under the glue box, forms the uniform rubber of thickness;
(4) content is compressed on the chewing soft capsule Intradermal of being produced in the step (3), obtains the thick product of gum medicine capsule;
(5) the thick product of being produced in the step (4) of gum medicine capsule being placed temperature is 21 ℃, and humidity is in 26% the confined space, to store 2 days, makes intensive drying, promptly gets the chewing soft capsule drug products.
The above-mentioned chewing soft capsule medicine for preparing comprises content and is wrapped in the capsule shell of content outside, described capsule shell comprises following component: the 33.5wt% gelatin, 25wt% glycerol, the 35wt% purified water, the 1wt% sodium alginate, 1wt% carrageenan, 1wt% pectin, the 1.5wt% sorbitol, 2wt% polyvinyl alcohol 400.
Embodiment 5
A kind of method for preparing the gum medicine capsule, it comprises the steps:
(1) takes by weighing the 25g gelatin, 17.2g glycerol, 50g purified water, 0.1g sodium alginate, 0.1g carrageenan, 0.1g pectin, 2.5g sorbitol, 5g polyvinyl alcohol 400, in the glue jar, add purified water, sodium alginate, carrageenan and pectin and fully mixing, in the glue jar, add sorbitol and polyvinyl alcohol 400 then, add gelatin at last, standby after above-mentioned raw materials is fully mixed in the glue jar;
(2) will under 70 ℃ temperature, change glue 1 hour through the mixed mixed liquor of step (1), obtain glue;
(3) with changing the steady glue of glue 1 hour that glue obtains through step (2) in the glue jar, flow into the glue box through sebific duct, glue flows out in glue box lower gap, flows on the rubber wheel under the glue box, forms the uniform rubber of thickness;
(4) content is compressed on the chewing soft capsule Intradermal of being produced in the step (3), obtains the thick product of gum medicine capsule;
(5) the thick product of being produced in the step (4) of gum medicine capsule being placed temperature is 20 ℃, and humidity is in 25% the confined space, to store 1.5 days, makes intensive drying, promptly gets the chewing soft capsule drug products.
The above-mentioned chewing soft capsule medicine for preparing comprises content and is wrapped in the capsule shell of content outside, described capsule shell comprises following component: the 25wt% gelatin, 17.2wt% glycerol, the 50wt% purified water, the 0.1wt% sodium alginate, 0.1wt% carrageenan, 0.1wt% pectin, the 2.5wt% sorbitol, 5wt% polyvinyl alcohol 400.
Embodiment 6
Also can add the low amount of sweet gourmet powder in the above-described embodiments according to needs of production, the tart flavour element, spice, antiseptic and pigment are used to adjust the chewing soft capsule taste of medicine.
The method that promptly prepares the gum medicine capsule comprises the steps:
(1) takes by weighing the 31.4g gelatin, 20g glycerol, 42g purified water, 0.15g sodium alginate, 0.16g carrageenan, 0.5943g pectin, 1.997g sorbitol, 2.9975g polyvinyl alcohol 400,0.3g sweetener, 0.387g tart flavour element, 0.0062g spice, 0.0064g antiseptic, 0.0016g pigment adds purified water, sodium alginate, carrageenan and pectin and fully mixing in the glue jar, add sorbitol and polyvinyl alcohol 400 then in the glue jar, add gelatin at last, sweetener, tart flavour element, spice, antiseptic and pigment, fully the mixing back is standby in the glue jar with above-mentioned raw materials;
(2) will under 68 ℃ temperature, change glue 1.5 hours through the mixed mixed liquor of step (1), obtain glue;
(3) with changing the steady glue of glue 2 hours that glue obtains through step (2) in the glue jar, flow into the glue box through sebific duct, glue flows out in glue box lower gap, flows on the rubber wheel under the glue box, forms the uniform rubber of thickness;
(4) content is compressed on the chewing soft capsule Intradermal of being produced in the step (3), obtains the thick product of gum medicine capsule;
(5) the thick product of being produced in the step (4) of gum medicine capsule being placed temperature is 21 ℃, and humidity is in 26% the confined space, to store 2 days, makes intensive drying;
(6) the gum medicine capsule of being produced in the step (5) is packed, package temperature is controlled at 21 ℃, and packing humidity is controlled at 25%, finally obtains the chewing soft capsule drug products.
The above-mentioned chewing soft capsule medicine for preparing comprises content and is wrapped in the capsule shell of content outside that described capsule shell comprises following component: 31.4% gelatin, 20% glycerol, 42% purified water, 0.15% sodium alginate, 0.16% carrageenan, 0.5943% pectin, 1.997% sorbitol, 2.9975% polyvinyl alcohol, 400,0.3% sweeteners, 0.387% tart flavour element, 0.0062% spice, 0.0064% antiseptic, 0.0016% pigment.
Embodiment 7
A kind of method for preparing the gum medicine capsule, it comprises the steps:
(1) takes by weighing the 25g gelatin, 15g glycerol, 48.77g purified water, the 1g sodium alginate, the 1g carrageenan, 1g pectin, 2.5g sorbitol, 5g polyvinyl alcohol 400,0.3g sweetener, 0.4g tart flavour element, 0.01g spice, 0.01g antiseptic, 0.01g pigment adds purified water, sodium alginate, carrageenan and pectin and fully mixing in the glue jar, add sorbitol and polyvinyl alcohol 400 then in the glue jar, add gelatin at last, sweetener, tart flavour element, spice, antiseptic and pigment, fully the mixing back is standby in the glue jar with above-mentioned raw materials;
(2) will under 55 ℃ temperature, change glue 5 hours through the mixed mixed liquor of step (1), obtain glue;
(3) with changing the steady glue of glue 3 hours that glue obtains through step (2) in the glue jar, flow into the glue box through sebific duct, glue flows out in glue box lower gap, flows on the rubber wheel under the glue box, forms the uniform rubber of thickness;
(4) content is compressed on the chewing soft capsule Intradermal of being produced in the step (3), obtains the thick product of gum medicine capsule;
(5) the thick product of being produced in the step (4) of gum medicine capsule being placed temperature is 15 ℃, and humidity is in 15% the confined space, to store 1 day, makes intensive drying;
(6) the gum medicine capsule of being produced in the step (5) is packed, package temperature is controlled at 15 ℃, and packing humidity is controlled at 10%, finally obtains the chewing soft capsule drug products.
The above-mentioned chewing soft capsule medicine for preparing comprises content and is wrapped in the capsule shell of content outside that described capsule shell comprises following component: 25wt% gelatin, 15wt% glycerol, the 48.77wt% purified water, 1wt% sodium alginate, 1wt% carrageenan, 1wt% pectin, the 2.5wt% sorbitol, 5wt% polyvinyl alcohol 400,0.3wt% sweetener, 0.4wt% tart flavour element, 0.01wt% spice, 0.01wt% antiseptic, 0.01wt% pigment.
Embodiment 8
A kind of method for preparing the gum medicine capsule, it comprises the steps:
(1) takes by weighing the 35g gelatin, 25g glycerol, 35.897g purified water, 0.1g sodium alginate, 0.1g carrageenan, 0.1g pectin, 1.5g sorbitol, 2g polyvinyl alcohol 400,0.1g sweetener, 0.2g tart flavour element, 0.001g spice, 0.001g antiseptic, 0.001g pigment adds purified water, sodium alginate, carrageenan and pectin and fully mixing in the glue jar, add sorbitol and polyvinyl alcohol 400 then in the glue jar, add gelatin at last, sweetener, tart flavour element, spice, antiseptic and pigment, fully the mixing back is standby in the glue jar with above-mentioned raw materials;
(2) will under 75 ℃ temperature, change glue 1 hour through the mixed mixed liquor of step (1), obtain glue;
(3) with changing the steady glue of glue 1 hour that glue obtains through step (2) in the glue jar, flow into the glue box through sebific duct, glue flows out in glue box lower gap, flows on the rubber wheel under the glue box, forms the uniform rubber of thickness;
(4) content is compressed on the chewing soft capsule Intradermal of being produced in the step (3), obtains the thick product of gum medicine capsule;
(5) the thick product of being produced in the step (4) of gum medicine capsule being placed temperature is 30 ℃, and humidity is in 50% the confined space, to store 3 days, makes intensive drying;
(6) the gum medicine capsule of being produced in the step (5) is packed, package temperature is controlled at 30 ℃, and packing humidity is controlled at 30%, finally obtains the chewing soft capsule drug products.
The above-mentioned chewing soft capsule medicine for preparing comprises content and is wrapped in the capsule shell of content outside that described capsule shell comprises following component: 35wt% gelatin, 25wt% glycerol, the 35.897wt% purified water, 0.1wt% sodium alginate, 0.1wt% carrageenan, 0.1wt% pectin, the 1.5wt% sorbitol, 2wt% polyvinyl alcohol 400,0.1wt% sweetener, 0.2wt% tart flavour element, 0.001wt% spice, 0.001wt% antiseptic, 0.001wt% pigment.
Embodiment 9
A kind of method for preparing the gum medicine capsule, it comprises the steps:
(1) takes by weighing the 28.77g gelatin, 25g glycerol, 35g purified water, the 1g sodium alginate, the 1g carrageenan, 1g pectin, 2.5g sorbitol, 5g polyvinyl alcohol 400,0.3g sweetener, 0.4g tart flavour element, 0.01g spice, 0.01g antiseptic, 0.01g pigment adds purified water, sodium alginate, carrageenan and pectin and fully mixing in the glue jar, add sorbitol and polyvinyl alcohol 400 then in the glue jar, add gelatin at last, sweetener, tart flavour element, spice, antiseptic and pigment, fully the mixing back is standby in the glue jar with above-mentioned raw materials;
(2) will under 60 ℃ temperature, change glue 1.2 hours through the mixed mixed liquor of step (1), obtain glue;
(3) with changing the steady glue of glue 1.5 hours that glue obtains through step (2) in the glue jar, flow into the glue box through sebific duct, glue flows out in glue box lower gap, flows on the rubber wheel under the glue box, forms the uniform rubber of thickness;
(4) content is compressed on the chewing soft capsule Intradermal of being produced in the step (3), obtains the thick product of gum medicine capsule;
(5) the thick product of being produced in the step (4) of gum medicine capsule being placed temperature is 21 ℃, and humidity is in 26% the confined space, to store 2 days, makes intensive drying, promptly gets the chewing soft capsule drug products.
The above-mentioned chewing soft capsule medicine for preparing comprises content and is wrapped in the capsule shell of content outside that described capsule shell comprises following component: take by weighing the 28.77wt% gelatin, 25wt% glycerol, the 35wt% purified water, 1wt% sodium alginate, 1wt% carrageenan, 1wt% pectin, the 2.5wt% sorbitol, 5wt% polyvinyl alcohol 400,0.3wt% sweetener, 0.4wt% tart flavour element, 0.01wt% spice, 0.01wt% antiseptic, 0.01wt% pigment.
Embodiment 10
A kind of method for preparing the gum medicine capsule, it comprises the steps:
(1) takes by weighing the 25g gelatin, 20.897g glycerol, 50g purified water, 0.1g sodium alginate, 0.1g carrageenan, 0.1g pectin, 1.5g sorbitol, 2g polyvinyl alcohol 400,0.1g sweetener, 0.2g tart flavour element, 0.001g spice, 0.001g antiseptic, 0.001g pigment adds purified water, sodium alginate, carrageenan and pectin and fully mixing in the glue jar, add sorbitol and polyvinyl alcohol 400 then in the glue jar, add gelatin at last, sweetener, tart flavour element, spice, antiseptic and pigment, fully the mixing back is standby in the glue jar with above-mentioned raw materials;
(2) will under 62 ℃ temperature, change glue 1.3 hours through the mixed mixed liquor of step (1), obtain glue;
(3) with changing the steady glue of glue 2.2 hours that glue obtains through step (2) in the glue jar, flow into the glue box through sebific duct, glue flows out in glue box lower gap, flows on the rubber wheel under the glue box, forms the uniform rubber of thickness;
(4) content is compressed on the chewing soft capsule Intradermal of being produced in the step (3), obtains the thick product of gum medicine capsule;
(5) the thick product of being produced in the step (4) of gum medicine capsule being placed temperature is 23 ℃, and humidity is in 25% the confined space, to store 2 days, makes intensive drying, promptly gets the chewing soft capsule drug products.
(6) the gum medicine capsule of being produced in the step (5) is packed, package temperature is controlled at 25 ℃, and packing humidity is controlled at 24%, finally obtains the chewing soft capsule drug products.
The above-mentioned chewing soft capsule medicine for preparing comprises content and is wrapped in the capsule shell of content outside that described capsule shell comprises following component: 25wt% gelatin, 20.897wt% glycerol, the 50wt% purified water, 0.1wt% sodium alginate, 0.1wt% carrageenan, 0.1wt% pectin, the 1.5wt% sorbitol, 2wt% polyvinyl alcohol 400,0.1wt% sweetener, 0.2wt% tart flavour element, 0.001wt% spice, 0.001wt% antiseptic, 0.001wt% pigment.
Wherein, embodiment 1 and embodiment 6 are priority scheme, embodiment 1 has taken into full account the setting of changing glue time and drying time, promptly guarantee to have shortened the production cycle, simultaneously guaranteed that also the soft capsule leatherware of gum medicine capsule has good flexibility and soft low toughness, but thereby improved chewiness better, embodiment 6 on the basis of embodiment 1 by when packing to temperature and temperature controlling, to have very flexibility and soft low flexible gum medicine capsule is packed, thereby guarantee the flexibility and the soft low flexible external action that is not subjected to of gum medicine capsule in packaging process.
Evaluation Example
The present invention has also carried out the test of relevant mechanical strength to the chewing soft capsule shell for preparing in the foregoing description 1～10, test condition is as follows:
Owing to domestic this area research is in blank substantially,, the chewing soft capsule shell of preparation is carried out the test of pulling force and hardness, to judge the mechanical strength and the toughness of chewing soft capsule shell according to " HG 2369-1992 ", " HG2117-1991 " relevant criterion.The chewing soft capsule shell of being tested is according to the method preparation for preparing the gum medicine capsule of the present invention, the unified size that adopts 14cm * 8cm * 0.7cm of chewing soft capsule shell.
As reference standard, with gelatin 38wt%, purified water 40wt%, the proportioning of glycerol 22wt%, in 65 ℃ of followingization glue 1.5 hours, steady glue 2 hours, it is 20 ℃ with temperature then, humidity is in 25% the confined space, and storing the chewing soft capsule shell for preparing under 2 days the process conditions is reference substance, is benchmark data with its mechanical performance data that measures.
Data are as follows after tested:
| Embodiment | Mechanical strength (%) | Toughness (%) |
| Reference substance | 100 | 100 |
| 1 | 84 | 88 |
| 2 | 67 | 70 |
| 3 | 83 | 86 |
| 4 | 70 | 72 |
| 5 | 88 | 84 |
| 6 | 78 | 85 |
| 7 | 63 | 72 |
| 8 | 80 | 84 |
| 9 | 71 | 75 |
| 10 | 83 | 80 |
Show have three class factors that the mechanical property of chewing capsule shell and the toughness of preparation are produced bigger influence through above-mentioned test data.The one, the consumption of sodium alginate and pectin exerts an influence to the mechanical property and the toughness of chewing soft capsule shell, and is especially bigger to latter's influence; The 2nd, polyvinyl alcohol 400, the consumption of glycerol and carrageenan exerts an influence to the mechanical property and the toughness of chewing soft capsule shell, and is especially bigger to the former influence; The 3rd, change the glue temperature and time, control suitable temperature and time, can make chewing soft capsule shell mechanical property and flexible change that correspondence is more arranged, especially bigger to latter's influence.
Obviously, the foregoing description only is for example clearly is described, and is not the qualification to embodiment.For those of ordinary skill in the field, can also make other changes in different forms on the basis of the above description.Here need not also can't give exhaustive to all embodiments.And conspicuous variation of being extended out thus or change still are among the protection domain of the invention.
Claims (12)
1. chewing soft capsule shell, it is characterized in that: described soft capsule suitcase is drawn together following component: 25～35wt% gelatin, 15～25wt% glycerol, 35～50wt% purified water, 0.1～1wt% sodium alginate, 0.1～1wt% carrageenan, 0.1～1wt% pectin, 1.5～2.5wt% sorbitol, 2～5wt% polyvinyl alcohol 400.
2. chewing soft capsule shell according to claim 1, it is characterized in that: described soft capsule skin is made up of following component: the 31wt% gelatin, 20wt% glycerol, the 43wt% purified water, the 0.2wt% sodium alginate, 0.36wt% carrageenan, 0.44wt% pectin, the 2wt% sorbitol, 3wt% polyvinyl alcohol 400.
3. chewing soft capsule shell according to claim 1, it is characterized in that: described chewing soft capsule shell also comprises following component: 0.1～0.3wt% sweetener, 0.2～0.4wt% tart flavour element, 0.001～0.01wt% spice, 0.001～0.01wt% antiseptic, 0.001～0.01wt% pigment.
4. chewing soft capsule shell according to claim 3 is characterized in that: described soft capsule skin is made up of following component: 31.4% gelatin, 20% glycerol, 42% purified water, 0.15% sodium alginate, 0.16% carrageenan, 0.5943% pectin, 1.997% sorbitol, 2.9975% polyvinyl alcohol, 400,0.3% sweeteners, 0.387% tart flavour element, 0.0062% spice, 0.0064% antiseptic, 0.0016% pigment.
5. gum medicine capsule, comprise content and the chewing soft capsule shell that is wrapped in the content outside, it is characterized in that described chewing soft capsule shell comprises following component: 25～35wt% gelatin, 15～25wt% glycerol, 35～50wt% purified water, 0.1～1wt% sodium alginate, 0.1～1wt% carrageenan, 0.1～1wt% pectin, 1.5～2.5wt% sorbitol, 2～5wt% polyvinyl alcohol 400.
6. gum medicine capsule according to claim 5, it is characterized in that: described chewing soft capsule shell also comprises following component: 0.1～0.3wt% sweetener, 0.2～0.4wt% tart flavour element, 0.001～0.01wt% spice, 0.001～0.01wt% antiseptic, 0.001～0.01wt% pigment.
7. method for preparing claim 5 or 6 described gum medicine capsules, it comprises following treatment step:
(1) takes by weighing an amount of raw material for standby, in the glue jar, add purified water, sodium alginate, carrageenan and pectin and fully mixing, in the glue jar, add sorbitol and polyvinyl alcohol 400 then, add gelatin at last, fully mix;
(2) mixture in step (1) the glue jar is changed glue 1～5 hour under 55～75 ℃ temperature, obtain glue;
(3) with changing the steady glue of glue 1～3 hour that glue obtains through step (2) in the glue jar, flow into the glue box through sebific duct, glue flows out in the glue box, flows on the rubber wheel of glue box below, forms the uniform rubber of thickness;
(4) content is compressed on the chewing soft capsule Intradermal of being produced in the step (3), obtains the thick product of gum medicine capsule;
(5) the thick product of being produced in the step (4) of gum medicine capsule being placed temperature is 15～30 ℃, and humidity is in 15～50% the confined space, to store 1～3 day, and intensive drying gets final product.
8. the method for preparing the gum medicine capsule according to claim 7 is characterized in that: the gum medicine capsule of being produced in the step (5) is packed, and package temperature is controlled at 15～30 ℃, and packing humidity is controlled at 10～30%.
9. the method for preparing the gum medicine capsule according to claim 7 is characterized in that: the mixture in the described step (2) is changed glue 1.5 hours under 68 ℃ temperature.
10. the method for preparing the gum medicine capsule according to claim 7 is characterized in that: the steady glue time in the described step (3) is 2.5 hours.
11. the method for preparing the gum medicine capsule according to claim 7 is characterized in that: it is 21 ℃ that the thick product of being produced in the described step (4) of gum medicine capsule places temperature, and humidity is in 26% the confined space, to store 2 days.
12. the method for preparing the gum medicine capsule according to claim 8 is characterized in that: described package temperature is controlled to be 21 ℃, and packing humidity is 25%.
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| CN101810336B (en) * | 2010-04-30 | 2012-03-21 | 广东仙乐制药有限公司 | Chewable soft capsules and method for preparing same |
| CN101961495B (en) * | 2010-09-28 | 2012-10-31 | 北京航洋健康科技有限公司 | Plant soft capsule material and preparation method thereof |
| CN103157415B (en) * | 2011-12-14 | 2015-05-06 | 金红叶纸业集团有限公司 | Colored microcapsule and its preparation method |
| AR089441A1 (en) | 2011-12-22 | 2014-08-20 | Baes Erik | GELATIN / ALGINATE CAPSULES OF DELAYED LIBERATION THAT INCLUDE OMEGA-3 FATTY ACIDS AND METHODS AND USES OF THE SAME, MANUFACTURE METHOD, PHARMACEUTICAL COMPOSITION |
| MX359887B (en) * | 2013-02-14 | 2018-10-15 | Sanofi Sa | Chewable composition for oral administration and process for preparing thereof. |
| CN103750523B (en) * | 2014-01-28 | 2016-01-13 | 黄遂深 | Candy-type soft capsule |
| CN104644609B (en) * | 2015-01-28 | 2017-06-16 | 龙标兵 | A kind of feature masticatory pattern soft capsule skin |
| MX2015014524A (en) * | 2015-10-15 | 2017-04-14 | Centro De Investigación Y Asistencia En Tecnología Y Diseño Del Estado De Jalisco A C | Polymer composition. |
| EP3549579A1 (en) * | 2018-04-03 | 2019-10-09 | Sanofi Winthrop Industrie | Oral gum formulation and fabrication process thereof |
| CN114632068A (en) * | 2020-12-16 | 2022-06-17 | 李振全 | Composition of chewing type capsule |
| CN113575939A (en) * | 2021-07-09 | 2021-11-02 | 安徽济生元药业有限公司 | Cod liver oil soft capsule for enhancing immunity and preparation method thereof |
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