CN111773198A - Novel soft capsule of eldecalcitol and preparation method thereof - Google Patents
Novel soft capsule of eldecalcitol and preparation method thereof Download PDFInfo
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- CN111773198A CN111773198A CN202010609699.7A CN202010609699A CN111773198A CN 111773198 A CN111773198 A CN 111773198A CN 202010609699 A CN202010609699 A CN 202010609699A CN 111773198 A CN111773198 A CN 111773198A
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- Prior art keywords
- soft capsule
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- novel
- filling liquid
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- 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
- A61K9/4808—Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/59—Compounds containing 9, 10- seco- cyclopenta[a]hydrophenanthrene ring systems
- A61K31/593—9,10-Secocholestane derivatives, e.g. cholecalciferol, i.e. vitamin D3
-
- 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
-
- 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
- A61K9/4825—Proteins, e.g. gelatin
-
- 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
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4858—Organic compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
- A61P19/10—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis
Abstract
The invention discloses a novel adicalciferol soft capsule and a preparation method thereof, and particularly relates to the technical field of pharmaceutical preparations, wherein the soft capsule comprises a soft capsule filling liquid and a soft capsule shell, and the filling liquid consists of adicalciferol, refined vegetable oil, an antioxidant, a buffering agent and a flavoring agent; the capsule shell comprises gelatin, thickener, correctant, water, and opacifier. The prepared alditol soft capsule filling liquid has stable quality, the capsule shell can not absorb water and soften, the capsule can be taken by chewing, the capsule is used for treating osteoporosis, rickets and the like, the disintegration time is shortest, the effect is quick, and the bioavailability is high, so that the alditol soft capsule disclosed by the invention is obviously superior to the existing products.
Description
Technical Field
The invention relates to the technical field of medicinal preparations, in particular to a novel soft capsule of adicalcitol for treating osteoporosis and a preparation method thereof.
Background
The use of the eldecalcitol for the treatment of osteoporosis was jointly developed by the japan external pharmaceutical company and japan positive pharmaceutical company, and was approved in japan for marketing in 2011. The eldercalciferol is a new active vitamin D3 derivative for treating osteoporosis after alfacalcidol and calcitriol, can promote the absorption of calcium by small intestine, increase the blood calcium concentration, improve the bone metabolism and promote the calcium absorption, has better curative effect than alfacalcidol and calcitriol, and has better application prospect.
The existing eldecalcitol preparation mainly comprises a soft capsule and an injection, has single dosage form and has less choice for patients. The injection is inconvenient to administer and limited in use; the soft capsule has poor stability, and is easy to absorb moisture to influence disintegration and content after long-term storage, thereby influencing bioavailability and curative effect.
Disclosure of Invention
In order to overcome the above defects in the prior art, the embodiments of the present invention provide a novel soft capsule of eldecalcitol and a preparation method thereof, and the technical problems to be solved by the present invention are: how to reduce the disintegration time of the soft capsule of the elderliness and improve the stability of the soft capsule when being taken.
In order to achieve the purpose, the invention provides the following technical scheme: a novel adicalcitol soft capsule is characterized in that: comprises a soft capsule filling liquid and a soft capsule shell, wherein the soft capsule filling liquid comprises, by weight, 0.001-0.01 part of eldecalcitol, 30000 parts of refined vegetable oil 20000-containing material, 10-20 parts of a buffering agent, 2-8 parts of a flavoring agent and 10-20 parts of absolute ethyl alcohol; the soft capsule shell is composed of 20-40 parts by weight of gelatin, 10-20 parts by weight of thickening agent, 10-20 parts by weight of flavoring agent, 30-50 parts by weight of water and a proper amount of opacifier.
More preferably, the soft capsule filling liquid consists of 0.005 part by weight of the eldecalcitol, 25000 parts by weight of the refined vegetable oil, 15 parts by weight of the buffering agent, 6 parts by weight of the flavoring agent and 18 parts by weight of the absolute ethyl alcohol; the soft capsule shell comprises 36 parts by weight of gelatin, 16 parts by weight of thickening agent, 16 parts by weight of flavoring agent, 40 parts by weight of water and 4 parts by weight of opacifier.
In the component formula of the specific soft capsule filling liquid, the refined vegetable oil is any one or more of salad oil, corn oil and peanut oil; the buffering agent is tartaric acid; the flavoring agent is essence and sweetener.
In a preferred embodiment, the above soft capsule filling liquid has a formula of a mixture of salad oil and corn oil, and the ratio of salad oil to corn oil is 2: 3.
A novel alditol soft capsule comprises a soft capsule shell, wherein a thickener is one or more of low-fat pectin, gellan gum and xanthan gum; the flavoring agent is essence and sweetener; the opacifier is edible pigment.
Preferably, in the above formulation of the soft capsule shell, the thickener is low-fat pectin, gellan gum, xanthan gum, and low-fat pectin: gellan gum: the amount ratio of xanthan gum is 2:1: 1.
A novel adicalcitol soft capsule is characterized in that: the dosage ratio of the essence and the sweetener in the flavoring agent in the soft capsule filling liquid and the soft capsule shell is 2: 3.
The invention also provides a preparation method of the novel eldecalcitol soft capsule, which comprises the following operation steps:
the method comprises the following steps: mixing the elderberry, the buffering agent and the flavoring agent, dissolving the mixture with absolute ethyl alcohol, and then fully mixing the mixture with refined vegetable oil to obtain soft capsule filling liquid;
step two: dissolving the sunscreen agent with a small amount of water; stirring and mixing correctant and water in a gelatin melting tank, heating in water bath, and heating to above 60 deg.C; adding gelatin and thickener, adding opacifier solution, and stirring; heating to 75 ℃, vacuumizing to a vacuum degree of-0.4 bar to-0.8 bar, and vacuumizing for 20 minutes; filtering with 100 mesh net, keeping the temperature at 60 + -5 deg.C, and removing air bubbles to obtain soft capsule shell material;
step three: making into soft capsule by soft capsule machine, and drying.
According to the elderliness soft capsule prepared by adopting the raw material formula, the soft capsule skin adopts a formula of matching gelatin, low-fat pectin, gellan gum and xanthan gum in proportion, so that the gel hardness is reduced, the elasticity is enhanced, the strength, the thickness and the toughness of the capsule skin are proper, and different amounts of flavoring agents are added into the soft capsule skin and the soft capsule filling liquid, so that the soft capsule disclosed by the invention is good in taste and smell and good in chewiness; the soft capsule shell can not absorb water to soften or deform and be brittle, and the stability is obviously enhanced. The eldecalcitol soft capsule is a chewing soft capsule, greatly shortens the disintegration time, and has the advantages of quick effect, high bioavailability and obvious advantages compared with similar products.
Detailed Description
The technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
Example 1
The soft capsule is prepared according to the method in the invention.
Example 2
The soft capsule is prepared according to the method in the invention.
Example 3
The soft capsule is prepared according to the method in the invention.
Example 4
The soft capsule is prepared according to the method in the invention.
And (3) selecting 20 persons to evaluate the samples in the embodiment, and evaluating according to the standard that 1-5 points respectively represent very poor, medium, good and good, wherein the average value is listed in table 1.
TABLE 1 sensory evaluation Table
TABLE 2 disintegration time limit
TABLE 3 Long term stability
Therefore, the chewable elderberry soft capsule prepared by the formula provided by the invention has the advantages of good skin color, fragrance and taste, fast disintegration, good chewiness and good long-term stability, and can meet the requirements of consumers.
Finally, it should be noted that: although the present invention has been described in detail with reference to the general description and the specific embodiments, on the basis of the present invention, the above embodiments are only used for illustrating the technical solutions of the present invention, and not for limiting the same; while the invention has been described in detail and with reference to the foregoing embodiments, it will be understood by those skilled in the art that: the technical solutions described in the foregoing embodiments may still be modified, or some or all of the technical features may be equivalently replaced; and the modifications or the substitutions do not make the essence of the corresponding technical solutions depart from the scope of the technical solutions of the embodiments of the present invention.
Claims (9)
1. A novel adicalcitol soft capsule is characterized in that: comprises a soft capsule filling liquid and a soft capsule shell, wherein the soft capsule filling liquid comprises, by weight, 0.001-0.01 part of eldecalcitol, 30000 parts of refined vegetable oil 20000-containing material, 10-20 parts of a buffering agent, 2-8 parts of a flavoring agent and 10-20 parts of absolute ethyl alcohol; the soft capsule shell is composed of 20-40 parts by weight of gelatin, 10-20 parts by weight of thickening agent, 10-20 parts by weight of flavoring agent, 30-50 parts by weight of water and a proper amount of opacifier.
2. The novel eldecalcitol soft capsule according to claim 1, characterized in that: the soft capsule filling liquid consists of 0.005 part by weight of elderberry, 25000 parts by weight of refined vegetable oil, 15 parts by weight of buffering agent, 6 parts by weight of flavoring agent and 18 parts by weight of absolute ethyl alcohol; the soft capsule shell comprises 36 parts by weight of gelatin, 16 parts by weight of thickening agent, 16 parts by weight of flavoring agent, 40 parts by weight of water and 4 parts by weight of opacifier.
3. A novel eldecalcitol soft capsule according to claims 1 or 2, characterized in that: in the component formula of the soft capsule filling liquid, the refined vegetable oil is any one or more of salad oil, corn oil and peanut oil; the buffering agent is tartaric acid; the flavoring agent is essence and sweetener.
4. A novel eldecalcitol soft capsule according to claims 1 or 2, characterized in that: in the component formula of the soft capsule shell, the thickening agent is one or more of low-fat pectin, gellan gum and xanthan gum; the flavoring agent is essence and sweetener; the opacifier is edible pigment.
5. A novel adicalcitol soft capsule according to claim 3, characterized in that: in the component formula of the soft capsule filling liquid, the refined vegetable oil is a mixture of salad oil and corn oil, and the dosage ratio of the salad oil to the corn oil is 2: 3.
6. A novel adicalcitol soft capsule according to claim 3, characterized in that: in the component formula of the soft capsule filling liquid, the buffering agent is tartaric acid.
7. A novel adicalcitol soft capsule according to claim 4, characterized in that: in the formula of the soft capsule shell, the thickening agent is low-fat pectin, gellan gum and xanthan gum, and the low-fat pectin: gellan gum: the amount ratio of xanthan gum is 2:1: 1.
8. A novel eldecalcitol soft capsule according to claims 1-3 characterized in that: the dosage ratio of the essence and the sweetener in the flavoring agent in the soft capsule filling liquid and the soft capsule shell is 2: 3.
9. A preparation method of a novel adicalcitol soft capsule is characterized by comprising the following steps: the method specifically comprises the following operation steps:
the method comprises the following steps: mixing the elderberry, the buffering agent and the flavoring agent, dissolving the mixture with absolute ethyl alcohol, and then fully mixing the mixture with refined vegetable oil to obtain soft capsule filling liquid;
step two: dissolving the sunscreen agent with a small amount of water; stirring and mixing correctant and water in a gelatin melting tank, heating in water bath, and heating to above 60 deg.C; adding gelatin and thickener, adding opacifier solution, and stirring; heating to 75 ℃, vacuumizing to a vacuum degree of-0.4 bar to-0.8 bar, and vacuumizing for 20 minutes; filtering with 100 mesh net, keeping the temperature at 60 + -5 deg.C, and removing air bubbles to obtain soft capsule shell material;
step three: making into soft capsule by soft capsule machine, and drying.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202010609699.7A CN111773198A (en) | 2020-06-30 | 2020-06-30 | Novel soft capsule of eldecalcitol and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202010609699.7A CN111773198A (en) | 2020-06-30 | 2020-06-30 | Novel soft capsule of eldecalcitol and preparation method thereof |
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| Publication Number | Publication Date |
|---|---|
| CN111773198A true CN111773198A (en) | 2020-10-16 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202010609699.7A Withdrawn CN111773198A (en) | 2020-06-30 | 2020-06-30 | Novel soft capsule of eldecalcitol and preparation method thereof |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN116440097A (en) * | 2023-04-21 | 2023-07-18 | 正大制药（青岛）有限公司 | Aidi calcitol soft capsule and preparation method thereof |
-
2020
- 2020-06-30 CN CN202010609699.7A patent/CN111773198A/en not_active Withdrawn
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN116440097A (en) * | 2023-04-21 | 2023-07-18 | 正大制药（青岛）有限公司 | Aidi calcitol soft capsule and preparation method thereof |
| CN116440097B (en) * | 2023-04-21 | 2023-12-12 | 正大制药（青岛）有限公司 | Aidi calcitol soft capsule and preparation method thereof |
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Application publication date: 20201016 |