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Calcitriol solution and preparation method thereof

A technology of calcitriol and solution, which is applied in bone diseases, pharmaceutical formulations, medical preparations of non-active ingredients, etc., can solve the problems of low bioavailability, poor stability of soft capsules and capsules, and monotonous dosage forms And other issues

Active Publication Date: 2013-06-12
CP PHARMA QINGDAO CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, the main preparation forms of calcitriol are soft capsules and capsules; the dosage form is relatively monotonous, and calcitriol is sensitive to light and air, and has low solubility in common organic solvents. The stability of soft capsules and capsules Not good, extremely low content of active ingredients, low bioavailability
Calcitriol solution is not reported in the prior art, because it cannot exist stably for a long time, and its bioavailability is not high

Method used

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  • Calcitriol solution and preparation method thereof
  • Calcitriol solution and preparation method thereof
  • Calcitriol solution and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Embodiment 1 calcitriol solution

[0024] The prescription is:

[0025]

[0026] The preparation method is:

[0027] 1) Weigh 80% of the prescribed amount of distilled water, add the prescribed amount of polyethylene glycol 400, and stir evenly; continue to add the prescribed amount of meglumine and polyethylene glycol 6000, and stir at 55°C for 25 minutes until completely dissolved;

[0028] 2) Raise the temperature to 70°C, add the prescribed amount of calcitriol at a stirring speed of 1000rpm, and continue stirring for 40 minutes until it is completely dissolved;

[0029] 3) Add distilled water to the full amount, add the prescribed amount of sodium sulfite and aspartame, stir to dissolve; test at room temperature, after passing the test, stir and fill, then label, pack, sample, and store.

Embodiment 2

[0030] Embodiment 2 calcitriol solution

[0031] The prescription is:

[0032]

[0033]

[0034] The preparation method is:

[0035] 1) Weigh 70% of the prescribed amount of distilled water, add the prescribed amount of polyethylene glycol 400, and stir evenly; continue to add the prescribed amount of meglumine and polyethylene glycol 6000, and stir at 45°C for 15 minutes until completely dissolved;

[0036] 2) Raise the temperature to 60°C, add the prescribed amount of calcitriol at a stirring speed of 500rpm, and continue stirring for 20 minutes until it is completely dissolved;

[0037] 3) Add distilled water to the full amount, add the prescribed amount of sodium bisulfite and sucrose, stir to dissolve; test at room temperature, after passing the test, stir and fill, then label, pack, sample, and store.

Embodiment 3

[0038] Embodiment 3 calcitriol solution

[0039] The prescription is:

[0040]

[0041] The preparation method is:

[0042] 1) Weigh 75% of the prescribed amount of distilled water, add the prescribed amount of polyethylene glycol 400, and stir evenly; continue to add the prescribed amount of meglumine and polyethylene glycol 6000, and stir at 50°C for 20 minutes until completely dissolved;

[0043] 2) Raise the temperature to 65°C, add the prescribed amount of calcitriol at a stirring speed of 800rpm, and continue stirring for 30 minutes until it is completely dissolved;

[0044] 3) Add distilled water to the full amount, add the prescribed amount of sodium metabisulfite and stevioside, stir to dissolve; test at room temperature, after passing the test, stir and fill, then label, pack, sample and store.

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Abstract

The invention relates to a calcitriol solution and a preparation method thereof. The solution is prepared from the following ingredients in percentage by weight: 0.0005% of calcitriol, 0.9-1.2% of meglumine, 27-30% of polyethylene glycol 400, 12-14% of polyethylene glycol 6000, 0.2% of antioxidant, 0.5% of flavoring agent and the balance of distilled water. Compared with the prior art, the solution has the advantages that the content of calcitriol is remarkably increased, so that the drug dosage is reduced; and the stability of calcitriol to light and air is improved, and the bioavailability of calcitriol is also remarkably improved.

Description

technical field [0001] The invention relates to the technical field of pharmacy, in particular to a calcitriol solution and a preparation method thereof. Background technique [0002] Calcitriol is a white crystalline powder that is sensitive to light and air. Slightly soluble in methanol, ethanol, ethyl acetate. Tm is 111-115°C. It is one of the most important metabolic active products of vitamin D3 in the human body. It can promote the absorption of calcium in the small intestine and regulate the transport of inorganic salts in the bone. It is mainly used for osteoporosis and renal osteodystrophy in patients with chronic renal failure. , especially in patients requiring long-term hemodialysis; postoperative spontaneous and pseudohypoparathyroidism; vitamin D3-dependent rickets and hypophosphatemic vitamin D-resistant rickets; skin diseases such as psoriasis; and other vitamins D deficiency. Oral absorption of calcitriol is fast, peaking in 3 to 6 hours, t1 / 2 is about 3...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/593A61K47/34A61K47/18A61P3/02A61P3/14A61P19/10A61P19/08A61P17/06A61K47/10
Inventor 王明刚陈阳生任莉
Owner CP PHARMA QINGDAO CO LTD
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