Oral solution containing calcitriol and preparation method thereof

A technology of calcitriol and oral solution, which is applied in medical preparations containing active ingredients, medical preparations without active ingredients, and liquid treatment, etc., can solve the problem that calcitriol oral solution is not imported into China, and achieve The effect of a high degree of automation and a faster replenishment

Active Publication Date: 2022-08-02
CP PHARMA QINGDAO CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Calcitriol capsules have been imported into China, but calcitriol oral solution has not yet been imported into China

Method used

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  • Oral solution containing calcitriol and preparation method thereof
  • Oral solution containing calcitriol and preparation method thereof
  • Oral solution containing calcitriol and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0076] An oral solution containing calcitriol, comprising the following components by weight:

[0077] Calcitriol: 0.290 parts;

[0078] Butyl hydroxyanisole: 29.7 parts;

[0079] Dibutylhydroxytoluene: 29.8 parts;

[0080] Medium-chain triglycerides: 299,987 parts.

[0081] A preparation method of the above-mentioned oral solution containing calcitriol, comprising the steps:

[0082] S100, weighing: turn on the yellow light in the weighing room, weigh calcitriol, medium-chain triglycerides, butylated hydroxyanisole, and dibutylated hydroxytoluene according to parts by weight, and double-check;

[0083] S200, preparation: wherein, the preparation of solution one:

[0084] Turn on the vacuum pump to evacuate, make the pressure in the dosing tank reach -0.06 ~ MPa, close the vacuum pump; add 85% of the total feeding amount of medium chain triglycerides into the dosing tank through vacuum feeding;

[0085] Open the breathing valve to restore the air pressure in the tank to a...

Embodiment 2

[0100] An oral solution containing calcitriol, comprising the following components by weight:

[0101] Calcitriol: 0.305 parts;

[0102] Butyl hydroxyanisole: 30.3 parts;

[0103] Dibutylhydroxytoluene: 30.2 parts;

[0104] Medium-chain triglycerides: 300,012 servings.

[0105] A preparation method of the above-mentioned oral solution containing calcitriol, comprising the steps:

[0106] S100, weighing: turn on the yellow light in the weighing room, weigh calcitriol, medium-chain triglycerides, butylated hydroxyanisole, and dibutylated hydroxytoluene according to parts by weight, and double-check;

[0107] S200, preparation: wherein, the preparation of solution one:

[0108] Turn on the vacuum pump to evacuate, make the pressure in the dosing tank reach -0.1MPa, and close the vacuum pump; add 85% of the medium chain triglycerides of the total feeding amount into the dosing tank through vacuum feeding;

[0109] Open the breathing valve to restore the air pressure in the ta...

Embodiment 3

[0124] An oral solution containing calcitriol, comprising the following components by weight:

[0125] Calcitriol: 0.300 parts;

[0126] Butyl hydroxyanisole: 30.0 parts;

[0127] Dibutylhydroxytoluene: 30.0 parts;

[0128] Medium chain triglycerides: 2,300,000 servings.

[0129] A preparation method of the above-mentioned oral solution containing calcitriol, comprising the steps:

[0130] S100, weighing: turn on the yellow light in the weighing room, weigh calcitriol, medium-chain triglycerides, butylated hydroxyanisole, and dibutylated hydroxytoluene according to parts by weight, and double-check;

[0131] S200, preparation: wherein, the preparation of solution one:

[0132] Turn on the vacuum pump to evacuate, make the pressure in the dosing tank reach -0.08MPa, and close the vacuum pump; add 85% of the medium chain triglycerides of the total feeding amount into the dosing tank through vacuum feeding;

[0133] Open the breathing valve to restore the air pressure in the...

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Abstract

The invention relates to the technical field of calcitriol, in particular to an oral solution containing calcitriol and a preparation method of the oral solution, and the oral solution containing calcitriol comprises the following components in parts by weight: 0.290-0.305 part of calcitriol; 29.7 to 30.3 parts of butyl hydroxy anisole; 29.8 to 30.2 parts of butylated hydroxytoluene (BHM); and 299987 to 300012 parts of medium chain triglycerides. The preparation method of the oral solution containing calcitriol comprises the following steps: S100, weighing: turning on a yellow light lamp in a weighing room, weighing calcitriol, medium chain triglyceride, butylated hydroxyanisole and butylated hydroxytoluene according to parts by weight, and carrying out double-person rechecking; compared with the prior art, the oral solution containing calcitriol has the following beneficial effects that the oral solution containing calcitriol can make up the blank in the field of treating secondary hyperparathyroidism of patients with moderate to severe chronic renal failure before dialysis and follow-up metabolic bone diseases and hypoparathyroidism in domestic children medication, and the clinical requirements are met.

Description

technical field [0001] The present invention relates to the technical field of calcitriol, more particularly, to an oral solution containing calcitriol and a preparation method thereof. Background technique [0002] Calcitriol (Calcitriol), also known as: 1α, 25-dihydroxyvitamin D3. In 1970, it was found that vitamin D3 was metabolized in the liver and kidney to produce calcitriol, which is the active form of vitamin D3, but the synthesis is very difficulty. In 1975, Roche Company synthesized calcitriol and developed the preparation calcitriol capsules (0.25μg / grain, 0.5μg / grain), which were approved for listing in Switzerland and the United States in August 1978. Calcitriol Oral Solution Rocaltrol® (Calcitriol Oral Solution, 15ml:15μg) was approved by the US FDA on November 20, 1998, with the approval number of NDA021068, and the preparation is marked as RS and RLD in the American Orange Book. [0003] Calcitriol capsules have been imported into China, but calcitriol oral...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/593A61K47/10A61K47/12A61P5/20A61P3/00A61P19/08A61P5/18B67C3/06B67C3/28B67C3/22B67C7/00B65C3/18B65C9/00
CPCA61K9/0095A61K31/593A61K47/10A61K47/12A61P5/20A61P3/00A61P19/08A61P5/18B67C3/06B67C3/28B67C3/22B67C7/00B65C3/18B65C9/00Y02A50/30
Inventor 陈阳生孙桂玉臧云龙刘晓霞王明刚杜昌余王贤贤王清亭刘振玉姜永杰
Owner CP PHARMA QINGDAO CO LTD
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