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Calcitriol ointment and preparation method thereof

A technology for calcitriol and ointment, applied in ointment delivery, bone diseases, pharmaceutical formulations, etc., can solve problems such as low solubility of common organic solvents, monotonous dosage forms, and inability to exist stably for a long time

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 ointment 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 ointment and preparation method thereof
  • Calcitriol ointment and preparation method thereof
  • Calcitriol ointment and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] Embodiment 1 calcitriol ointment

[0023] The prescription is:

[0024]

[0025]

[0026] The preparation method is:

[0027] 1) Mix the prescribed amount of xanthan gum, propylene glycol and di-tert-butyl-p-cresol, heat and stir at 60°C to dissolve, and obtain the base material;

[0028] 2) Pass the prescribed amount of calcitriol, meglumine, polyethylene glycol 400 and polyethylene glycol 6000 through a 80-mesh sieve, mix well, add the obtained mixture to the above base material at 60°C, and stir After 15 minutes until uniform, the temperature was lowered to 20°C to obtain the finished product.

Embodiment 2

[0029] Embodiment 2 calcitriol ointment

[0030] The prescription is:

[0031]

[0032] The preparation method is:

[0033] 1) Mix the prescribed amount of guar gum, glycerin and tert-butyl hydroxyanisole, heat and stir at 80°C to dissolve to obtain the base material;

[0034] 2) Pass the prescribed amount of calcitriol, meglumine, polyethylene glycol 400 and polyethylene glycol 6000 through a 120-mesh sieve, mix well, add the obtained mixture to the above base material at 80°C, and stir After 45 minutes until uniform, the temperature was lowered to 40°C to obtain the finished product.

Embodiment 3

[0035] Embodiment 3 calcitriol ointment

[0036] The prescription is:

[0037]

[0038] The preparation method is:

[0039] 1) Mix the prescribed amount of locust bean gum, sorbitol and sodium sorbate, heat and stir at 70°C to dissolve to obtain the base material;

[0040] 2) Pass the prescribed amount of calcitriol, meglumine, polyethylene glycol 400 and polyethylene glycol 6000 through a 100-mesh sieve, mix well, add the obtained mixture to the above base material at 70°C, and stir After 30 minutes until uniform, the temperature is lowered to 20-40°C to obtain the finished product.

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Abstract

The invention relates to calcitriol ointment and a preparation method thereof. The ointment is prepared from the following ingredients in percentage by weight: 0.0005% of calcitriol, 0.7-1.2% of meglumine, 25-35% of polyethylene glycol 400, 1.5-2.5% of polyethylene glycol 6000, 50-70% of thickener, 3.0% of humectant and an appropriate amount of antioxidant. According to the ointment, 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 ointment 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): A61K9/06A61K31/593A61K47/34A61K47/26A61P3/02A61P19/10A61P19/08A61P17/06A61K47/10
Inventor 王明刚陈阳生任莉
Owner CP PHARMA QINGDAO CO LTD
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