CN105362249A - Calcitriol capsule type drop and preparation method thereof - Google Patents
Calcitriol capsule type drop and preparation method thereof Download PDFInfo
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- CN105362249A CN105362249A CN201410385372.0A CN201410385372A CN105362249A CN 105362249 A CN105362249 A CN 105362249A CN 201410385372 A CN201410385372 A CN 201410385372A CN 105362249 A CN105362249 A CN 105362249A
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- calcitriol
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Abstract
The present invention relates to a calcitriol capsule type drop and a preparation method thereof. The calcitriol capsule type drop comprises contents and a capsule shell, wherein the contents comprise calcitriol, butyl hydroxyanisole, butylated hydroxytoluene, and grease, and the capsule shell comprises gelatin, titanium dioxide, sunset yellow, iron oxide, water, sorbitol and glycerin. Compared with the drop in the prior art, the drop of the present invention has characteristics of high safety, easy use, strong targeting property, and the like.
Description
Technical field
The invention belongs to calcitriol formulation art, relate to medicine of replenishing the calcium, especially a kind of Calcitriol capsule type drop and preparation method thereof.
Technical background
Calcitriol is one of most important metabolic activity product of vitamin D3 in human body, and under normal circumstances, calcitriol solidifies alcohol by its precursor 25-hydroxyl gallbladder and synthesizes at kidney.The calcitriol of human body physiology every day synthesis is about 0.5-1.0ug.Enliven period at bone formation, its synthetic quantity also slightly increases.Calcitriol can promote that intestinal is to the absorption of calcium, and regulates the calcification of sclerotin.At present both at home and abroad without the listing of Calcitriol capsule type drop, the dosage form of listing only has raw material, soft capsule, injection, soft gelatin capsule and ointment type.Calcitriol, as calsium supplement, occupies certain status replenishing the calcium on market, and traditional calcitriol dosage form that market is sold is more difficult for taking child, particularly 0-3 year child.Object of the present invention be just to overcome existing defect, design drop of a kind of capsule-type and preparation method thereof, specifically a kind of soft capsule packaged form of calcitriol drop, namely calcitriol drop soft capsule shell is encapsulated, during use, soft capsule front end is cut off, drip and take.
The present invention compared with prior art, except product is attractive in appearance, also has the following advantages: one is the drop component that the present invention includes a kind of calcitriol, only soft capsule need be cut off and instill in mouth or beverage by soft capsule component during use.Two is encapsulated by drop component soft capsule shell, efficiently solves calcitriol drop and easily cause liquid medicine contamination problem in storage and use procedure; Three is cut off by soft capsule by soft capsule component instillation beverage as in the beverage of milk or other children or dysphagia patients or food, so the infant that to sum up the calcitriol drop of capsule-type is more suitable for dysphagia uses.
Summary of the invention
The object of the invention is to overcome and existingly swallow patient consumes's difficulty weak point, a kind of Calcitriol capsule type drop and preparation method thereof is provided, Calcitriol capsule type drop prepared by the present invention effectively for sufferers of osteoporosis face is replenished the calcium, and can have the feature of the dysphagia patients administrations such as preparation method is simple, convenient for children.
The technical scheme that the present invention realizes is as follows:
A kind of Calcitriol capsule type drop, composition is as follows: calcitriol, Butylated hydroxyanisole, dibenzylatiooluene, oils and fats;
A preparation method for Calcitriol capsule type drop, the step of method is as follows:
(1). take calcitriol, Butylated hydroxyanisole, dibenzylatiooluene, oils and fats by recipe quantity, be uniformly mixed, form the content of stable homogeneous, being uniformly mixed temperature is 0 ~ 4 degree Celsius, blender is inflated with nitrogen in sealed container, without air residual;
(2). by titanium dioxide, medicinal pigment, ferrum oxide, sorbitol, glycerol, methyl parahydroxybenzoate and adding of propyl p-hydroxybenzoate glue tank, be heated to 40 ~ 60 degrees Celsius, drop into gelatin, and be heated to 70 ~ 90 degrees Celsius, stir 30 ~ 40 minutes, leave standstill 30 ~ 60 minutes, filter, screen cloth specification 120 ~ 140 order, glue 55 degrees Celsius of insulations in fluid reservoir are for subsequent use;
(3). the glue input of the content obtain step (1) and step (2) gained is rolled mold pressing type encapsulating machine and is carried out glue bladder type drop, temperature 20 ~ 25 degrees Celsius, relative humidity 5% ~ 40%;
(4). the capsule-type drop that step (3) obtains is transferred to rotating cage Setting drying box and carries out drying, temperature 20 ~ 25 degrees Celsius, relative humidity 5% ~ 40%, drying time 2-3 hour;
(5). the capsule-type drop dried through step (4) is transferred in drying baker and continue dry 10-15 hour, temperature 20 ~ 25 degrees Celsius, relative humidity 5% ~ 40%;
(6). the dried calcitriol soft capsule drop of sizing step 5 obtained is packed after selecting on lamp inspection desk.
Advantage of the present invention and beneficial effect as follows:
1. the content of this product is grease, and the effective ingredient of product is calcitriol is fat-soluble, and material liquid is oily, is therefore suitable for this one dosage type low temperature of capsule-type drop.Capsule-type drop has the dysphagia patients administrations such as convenient for children, dosage is easy to the features such as control.Calcitriol has meets the characteristic such as light, air instability, and make the capsule-type drop of sealing, softgel shell color is bronzing, and the stability that can increase product prevents oxidation and the decomposition of effective ingredient.
2. Calcitriol capsule type drop of the present invention waits dysphagia patients to take calcitriol soft capsule according to current child both at home and abroad, the new dosage form of the feature designs such as dosage is wayward, and administration is inconvenient.
3. replenish the calcium compared with series products with other children, active component calcitriol of the present invention is one of most important metabolic activity product of vitamin D3 in human body, can promote that intestinal is to the absorption of calcium, and regulate the calcification of sclerotin, have that safety is high, good absorbing, the feature such as with strong points.
Accompanying drawing explanation
Accompanying drawing is the front view of the Calcitriol capsule type drop of patent Example of the present invention.
Detailed description of the invention
Below in conjunction with the embodiments, further illustrate a kind of Calcitriol capsule type drop of the present invention and preparation method thereof, following embodiment is illustrative, is not determinate, can not limit protection scope of the present invention with following embodiment.
Embodiment 1
A kind of Calcitriol capsule type drop, composition is as follows: calcitriol, Butylated hydroxyanisole, dibenzylatiooluene, medium chain triglyceride.The wherein every 0.1 milliliter of content of calcitriol content 0.25 microgram.
A preparation method for Calcitriol capsule type drop, the step of method is as follows:
(1). take calcitriol, Butylated hydroxyanisole, dibenzylatiooluene, soybean oil by recipe quantity, the wherein every 0.1 milliliter of content of calcitriol content 0.25 microgram, be uniformly mixed, form the content of stable homogeneous, being uniformly mixed temperature is 0 ~ 4 degree Celsius, blender is inflated with nitrogen in sealed container, without air residual;
(2). by titanium dioxide, medicinal pigment, ferrum oxide, sorbitol, glycerol, methyl parahydroxybenzoate and adding of propyl p-hydroxybenzoate glue tank, be heated to 40 ~ 60 degrees Celsius, drop into gelatin, and be heated to 70 ~ 90 degrees Celsius, stir 30 ~ 40 minutes, leave standstill 30 ~ 60 minutes, filter, screen cloth specification 120 ~ 140 order, glue 55 degrees Celsius of insulations in fluid reservoir are for subsequent use;
(3). the glue input of the content obtain step (1) and step (2) gained is rolled mold pressing type encapsulating machine and is carried out glue bladder type drop, temperature 20 degrees Celsius, relative humidity 20%;
(4). the capsule-type drop that step (3) obtains is transferred to rotating cage Setting drying box and carries out drying, temperature 20 degrees Celsius, relative humidity 30%, 3 hours drying times;
(5). the capsule-type drop dried through step (4) is transferred in drying baker and continue dry 12 hours, temperature 20 degrees Celsius, relative humidity 30%;
(6). the dried calcitriol soft capsule drop of sizing step 5 obtained is packed after selecting on lamp inspection desk.
Operation in the present embodiment is all carried out at 100,000 grades of GMP soft capsules.
Embodiment 2
A preparation method for Calcitriol capsule type drop, the step of method is as follows:
(1). take calcitriol, Butylated hydroxyanisole, dibenzylatiooluene, medium chain triglyceride by recipe quantity, the wherein every 1.0 milliliters of contents of calcitriol content 0.5 microgram, be uniformly mixed, form the content of stable homogeneous, being uniformly mixed temperature is 0 ~ 4 degree Celsius, blender is inflated with nitrogen in sealed container, without air residual;
(2). by titanium dioxide, medicinal pigment, ferrum oxide, sorbitol, glycerol, methyl parahydroxybenzoate and adding of propyl p-hydroxybenzoate glue tank, be heated to 40 ~ 60 degrees Celsius, drop into gelatin, and be heated to 70 ~ 90 degrees Celsius, stir 30 ~ 40 minutes, leave standstill 30 ~ 60 minutes, filter, screen cloth specification 120 ~ 140 order, glue 55 degrees Celsius of insulations in fluid reservoir are for subsequent use;
(3). the glue input of the content obtain step (1) and step (2) gained is rolled mold pressing type encapsulating machine and is carried out glue bladder type drop, temperature 25 degrees Celsius, relative humidity 30%;
(4). the capsule-type drop that step (3) obtains is transferred to rotating cage Setting drying box and carries out drying, temperature 25 degrees Celsius, relative humidity 40%, 3 hours drying times;
(5). the capsule-type drop dried through step (4) is transferred in drying baker and continue dry 12 hours, temperature 25 degrees Celsius, relative humidity 40%;
(6). the dried calcitriol soft capsule drop of sizing step 5 obtained is packed after selecting on lamp inspection desk.
Claims (11)
1. a Calcitriol capsule type drop, is made up of content and softgel shell, it is characterized in that a kind of capsule-type drop of Ergocalciferols medicine.
2. a kind of Calcitriol capsule type drop according to claims 1, it is characterized in that content active component is: calcitriol, the active component of content is with parts by weight: 0.1% ~ 5%.
3. a kind of Calcitriol capsule type drop according to claim 1, it is characterized in that, described content comprises: Butylated hydroxyanisole, dibenzylatiooluene, oils and fats.
4. a kind of Calcitriol capsule type drop according to claim 1, it is characterized in that, described content oils and fats is: soybean oil, Semen Maydis oil, Semen arachidis hypogaeae wet goods vegetable oil and animal oil, at content with parts by weight: 60% ~ 98%.
5. a kind of Calcitriol capsule type drop according to claim 1, it is characterized in that, content volume is: 0.1 ~ 5.0 milliliter.
6. a kind of Calcitriol capsule type drop according to claim 1, it is characterized in that, described softgel shell raw material is: gelatin, titanium dioxide, medicinal pigment, ferrum oxide, sorbitol, glycerol, water, methyl parahydroxybenzoate and propyl p-hydroxybenzoate.
7. a kind of Calcitriol capsule type drop according to claim 1, it is characterized in that, described softgel shell face shaping is: spheroid or ellipsoid are provided with the projection that inner chamber is taper.
8. a kind of Calcitriol capsule type drop according to claim 1 and 7, it is characterized in that, described softgel shell face shaping is: the bottom of cone links up with spheroid or ellipsoid.
9. a kind of Calcitriol capsule type drop according to claim 1,7 and 8, it is characterized in that, described softgel shell face shaping is: overall length 15-20 millimeter, diameter 4-8 millimeter, the long 6-10 millimeter of cone.
10. a preparation method for Calcitriol capsule type drop as claimed in claim 1, it is characterized in that, the method comprises the following steps:
(1). take calcitriol, Butylated hydroxyanisole, dibenzylatiooluene, oils and fats by recipe quantity, be uniformly mixed, form the content of stable homogeneous, being uniformly mixed temperature is 0 ~ 4 degree Celsius, blender is inflated with nitrogen in sealed container, without air residual;
(2). by titanium dioxide, medicinal pigment, ferrum oxide, sorbitol, glycerol, methyl parahydroxybenzoate and adding of propyl p-hydroxybenzoate glue tank, be heated to 40 ~ 60 degrees Celsius, drop into gelatin, and be heated to 70 ~ 90 degrees Celsius, stir 30 ~ 40 minutes, leave standstill 30 ~ 60 minutes, filter, screen cloth specification 120 ~ 140 order, glue 55 degrees Celsius of insulations in fluid reservoir are for subsequent use;
(3). the glue input of the content obtain step (1) and step (2) gained is rolled mold pressing type encapsulating machine and is carried out glue bladder type drop, temperature 20 ~ 25 degrees Celsius, relative humidity 5% ~ 40%;
(4). the capsule-type drop that step (3) obtains is transferred to rotating cage Setting drying box and carries out drying, temperature 20 ~ 25 degrees Celsius, relative humidity 5% ~ 40%, drying time 2-3 hour;
(5). the capsule-type drop dried through step (4) is transferred in drying baker and continue dry 10-15 hour, temperature 20 ~ 25 degrees Celsius, relative humidity 5% ~ 40%;
(6). the dried calcitriol soft capsule drop of sizing step 5 obtained is packed after selecting on lamp inspection desk.
The preparation method of 11. Calcitriol capsule type drops according to claim 10, is characterized in that the mix and blend temperature described in step (1) is 0 ~ 4 degree Celsius, and mixing agitator is sealed container and interior inflated with nitrogen, without air residual.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201410385372.0A CN105362249A (en) | 2014-08-07 | 2014-08-07 | Calcitriol capsule type drop and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201410385372.0A CN105362249A (en) | 2014-08-07 | 2014-08-07 | Calcitriol capsule type drop and preparation method thereof |
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| CN105362249A true CN105362249A (en) | 2016-03-02 |
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| CN201410385372.0A Pending CN105362249A (en) | 2014-08-07 | 2014-08-07 | Calcitriol capsule type drop and preparation method thereof |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107782810A (en) * | 2016-08-26 | 2018-03-09 | 人福普克药业（武汉）有限公司 | The method for detecting calcitriol content in calcitriol soft capsule |
| CN109276556A (en) * | 2018-11-26 | 2019-01-29 | 正大制药（青岛）有限公司 | A kind of calcitriol soft capsule |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1586484A (en) * | 2004-07-12 | 2005-03-02 | 北京瑞伊人科技发展有限公司 | Dipyridamole soft capsule preparation and its preparing method |
| CN103784419A (en) * | 2012-10-31 | 2014-05-14 | 成都国弘医药有限公司 | Softgel containing calcitriol and preparation method |
-
2014
- 2014-08-07 CN CN201410385372.0A patent/CN105362249A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1586484A (en) * | 2004-07-12 | 2005-03-02 | 北京瑞伊人科技发展有限公司 | Dipyridamole soft capsule preparation and its preparing method |
| CN103784419A (en) * | 2012-10-31 | 2014-05-14 | 成都国弘医药有限公司 | Softgel containing calcitriol and preparation method |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107782810A (en) * | 2016-08-26 | 2018-03-09 | 人福普克药业（武汉）有限公司 | The method for detecting calcitriol content in calcitriol soft capsule |
| CN109276556A (en) * | 2018-11-26 | 2019-01-29 | 正大制药（青岛）有限公司 | A kind of calcitriol soft capsule |
| CN109276556B (en) * | 2018-11-26 | 2021-02-19 | 正大制药（青岛）有限公司 | Calcitriol soft capsule |
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Effective date of registration: 20161124 Address after: 475000 Henan city seven street and two Longhai Road Interchange Applicant after: HENAN TAIFENG BIOTECHNOLOGY CO., LTD. Address before: Lhasa City Jinzhu West Road 850000 Tibet Tibetan Autonomous District No. 158 sunshine new town A District 4 Building 2 unit 1-1 No. Applicant before: TIBET TONGTAI PHARMACEUTICAL CO., LTD. |
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Application publication date: 20160302 |