Medicine composition for treating metabolic bone diseases

A bone disease and drug technology, applied in the field of medicine, can solve problems such as inconvenient administration methods, and achieve the effects of convenient medication, convenience for patients, and good therapeutic effect.

Active Publication Date: 2011-10-12
JIANGSU CAREFREE PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, due to the inconvenient way of administration, only about 57% of patients have good compliance
There are no related reports about the combination of minodronic acid and alfacalcidol / calcitriol

Method used

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  • Medicine composition for treating metabolic bone diseases
  • Medicine composition for treating metabolic bone diseases
  • Medicine composition for treating metabolic bone diseases

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Example 1 Effect of Minodronic Acid and Alfacalcidol / Calcitriol on Metabolic Bone Disease in Rats

[0028] (1), the method of administration

[0029] Take 110 healthy, clean, mature and roughly identical female rats, divide them into 11 groups, 10 rats in each group, keep one group as the blank group after one week of normal feeding, and the remaining 10 groups undergo ovariectomy, and take oral administration, respectively. It is: minodronic acid, alfacalcidol, calcitriol and their combination drugs are administered alone, and the administration time is 8 weeks, once a week. The dosage is shown in Table 1.

[0030] (2), determination method

[0031] Urine samples from rats were collected for 24 hours, centrifuged, and stored at low temperature. Take blood, centrifuge, collect serum, and store at low temperature. Calcium determination kit (ARSENAZO III method) was used to measure blood calcium concentration and urinary calcium (24h) concentration.

[0032] Rat tibi...

Embodiment 2-3

[0041] The preparation of embodiment 2-3 minodronic acid and calcitriol tablet

[0042] Prepare bare chips according to the composition and content shown in Table 3.

[0043] First, D-mannitol was added to a mixture of calcitriol and ethanol, followed by ethanol, antioxidants, and binders. Separately from the step of preparing calcitriol, the other ingredients minodronic acid, mannitol, absorption enhancer are mixed; ethanol and binder are then added thereto. The calcitriol and minodronic acid are then mixed, then a disintegrant and lubricant are added, and the tablet is compressed.

Embodiment 4-5

[0044] The preparation of embodiment 4-5 minodronic acid and alfacalcidol capsules

[0045] Capsules were prepared as shown in Table 4.

[0046] First, add xylitol to a mixture consisting of alfacalcidol and ethanol, then add ethanol, antioxidants and binders, use a conventional pulverizer to pulverize the whole mixture into 16-50 mesh size and dry at 40°C to obtain alfacalcidol granules. Separately from the step of preparing calcitriol, the other ingredients minodronic acid, xylitol, absorption enhancer are mixed; ethanol and binder are then added to the above mixture. The whole mixture was then pulverized into a 16-50 mesh size using a conventional pulverizer and dried at 40°C to obtain minodronic acid granules. The alfacalcidol and minodronic acid are then mixed, then a disintegrant and a lubricant are added, and the capsules are filled.

[0047] table 3

[0048]

[0049] Table 4

[0050]

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PUM

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Abstract

The invention relates to a medicine composition for treating metabolic bone diseases and a preparing method thereof. The composition comprises minodronate, cholecalciferol compounds and a proper quantity of composite medicines of other additives. The composition comprises two active components, such as minodronate and the cholecalciferol compounds which can work cooperatively, and is added with the proper quantity of additives. The medicine composition disclosed by the invention can be used for inhibiting hypercalcemia caused by using cholecalciferol compounds only; due to the existence of the cholecalciferol compounds, inhibition to bone reconstruction activity caused by the minodronate can be compensated and compliance to side effects, and the like, of alimentary canal can be reduced.

Description

technical field [0001] The invention relates to a pharmaceutical composition for treating metabolic bone disease and a preparation method thereof, wherein the composition is made into a composite drug containing minodronic acid, cholecalciferol compounds and appropriate amount of other additives, belonging to field of medical technology. Background technique [0002] Osteoporosis (OP) is a disease characterized by decreased bone tissue content and increased fracture risk. In October 1990, a clear definition was given at the Third International Osteoporosis (OP) Conference held in Copenhagen, Denmark: OP is defined as osteopenia, damage to the microstructure of bone tissue and the consequent risk of fracture. A disease of increased sex. The disease has been more and more people's attention. At present, about 200 million people in the world suffer from osteoporosis, and its incidence rate has leapt to the seventh among common diseases and frequently-occurring diseases. The...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/675A61K31/047A61P19/10A61P19/08
Inventor 秦引林
Owner JIANGSU CAREFREE PHARM CO LTD
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