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Eyer calciferol soft capsule preparation method

A technology of alcalcidol and soft capsules, applied in capsule delivery, medical preparations containing active ingredients, bone diseases, etc., to achieve good therapeutic effect

Inactive Publication Date: 2017-11-03
北京美福润医药科技股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But the disadvantage is that the organic solvent absolute ethanol is inevitably introduced in the preparation composition, which is a great pity for patients with alcohol allergies

Method used

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  • Eyer calciferol soft capsule preparation method
  • Eyer calciferol soft capsule preparation method
  • Eyer calciferol soft capsule preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] Recipe composition:

[0038]

[0039]

[0040] Production Process:

[0041] (1) Capsule skin preparation:

[0042] 11. Weigh the prescribed amount of purified water and heat it to 80°C-90°C;

[0043] 12. Add sorbitol and glycerin one by one and stir to dissolve, then add titanium dioxide and stir until there are no particles;

[0044] 13. Add gelatin and stir well for about 2 hours;

[0045] 14. Turn on the vacuum pump, evacuate until there are no bubbles, and keep warm at 50°C to 60°C for about 10 hours.

[0046] (2) Content preparation:

[0047] 21. Take the formula amount of Alcalciferol, add it to absolute ethanol, and stir it with a glass rod until it is clear and transparent, that is, it is completely dissolved;

[0048] 22. Transfer the medium-chain triglycerides with a total amount of 20% of the formula to the above solution, and add vitamin E. Using an electric stirrer, the stirring speed should be as fast as possible without involving a lot of air, ...

Embodiment 2

[0058] Recipe composition:

[0059]

[0060] Production Process:

[0061] (1) Capsule skin preparation:

[0062] 11. Weigh the purified water of the formula amount and heat it to 80℃~90℃;

[0063] 12. Add sorbitol and glycerin one by one and stir to dissolve, then add titanium dioxide and stir until there are no particles;

[0064] 13. Add gelatin and stir well for about 2 hours;

[0065] 14. Turn on the vacuum pump, evacuate until there are no bubbles, and keep warm at 50°C to 60°C for about 10 hours.

[0066] (2) Content preparation:

[0067] 21. Take the formula amount of Alcalciferol, add it to absolute ethanol, and stir it with a glass rod until it is clear and transparent, that is, it is completely dissolved;

[0068] 22. Transfer the medium-chain triglycerides with a total amount of 20% of the formula to the above solution, and add vitamin E. Using an electric stirrer, the stirring speed should be as fast as possible without involving a lot of air, and stir for ...

Embodiment 3

[0078] Recipe composition:

[0079]

[0080]

[0081] Production Process:

[0082] (1) Capsule skin preparation:

[0083] 11. Weigh the purified water of the formula amount and heat it to 80℃~90℃;

[0084] 12. Add sorbitol and glycerin one by one and stir to dissolve, then add titanium dioxide and stir until there are no particles;

[0085] 13. Add gelatin and stir well for about 2 hours;

[0086] 14. Turn on the vacuum pump, evacuate until there are no bubbles, and keep warm at 50°C to 60°C for about 10 hours.

[0087] (2) Content preparation:

[0088] 21. Take the formula amount of Alcalciferol, add it to absolute ethanol, and stir it with a glass rod until it is clear and transparent, that is, it is completely dissolved;

[0089] 22. Transfer the medium-chain triglycerides with a total amount of 20% of the formula to the above solution, and add vitamin E. Using an electric stirrer, the stirring speed should be as fast as possible without involving a lot of air, a...

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Abstract

The invention discloses an Eyer calciferol soft capsule preparation method which includes the steps: preparing capsule shells; preparing contents; pressing soft capsules. A preparation method of the contents includes the steps: taking Eyer calciferol, adding absolute ethyl alcohol, and stirring and dissolving mixture by the aid of a glass bar; adding median chain triglyceride oil and vitamin E, and electrically stirring mixture for 1-2 hours; transferring solution to a rotary evaporator, rotatably evaporating the solution at the temperature of 40-60 DEG C and at the pressure of 0.08-0.1Mpa, and enabling residue content to be lower than 0.5% according to detection; transferring solution to a stirring tank, and adding and stirring the median chain triglyceride oil; adjusting filled volume and pressing pills. A lot of experimental researches are implemented, temperature, pressure and time of rotary evaporation are controlled, residue of the absolute ethyl alcohol is controlled, and the absolute ethyl alcohol is removed. The Eyer calciferol soft capsule without ethyl alcohol can have effect on more patients, and particularly, alcoholic allergy people can be more effectively treated.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a preparation method of Alcalcitol soft capsules. Background technique [0002] Alcalcidol Soft Capsules is a drug for the treatment of osteoporosis. The Ministry of Health and Welfare of Japan approved the production and marketing of Chugai Pharmaceutical Co., Ltd. in January 2011. The active substance Alcalcidol is another new product after alfacalcidol. Active vitamin D3 derivatives for the treatment of osteoporosis. A 3-year phase III clinical data involving 1,054 patients with osteoporosis showed that alcalcidol is more effective than alfacalcidol, and its safety is similar to that of alfacalcidol. application prospects. [0003] Chinese name: Alcalciferol [0004] Structural formula: [0005] [0006] Molecular formula: C 30 h 50 o 5 [0007] Molecular weight: 490.72 [0008] The active ingredient of this product, Alcalcitol, is easily soluble in N, N-...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K31/592A61K47/22A61K47/14A61P19/10
CPCA61K9/4833A61K9/4858A61K31/592
Inventor 李淑君张金成李亚玲
Owner 北京美福润医药科技股份有限公司
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