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Pharmaceutical preparation containing alendronate sodium and cholecalciferol-cholesterol

A technology of alendronate sodium and cholvitin, which is applied in the field of pharmaceutical preparations containing alendronate sodium and cholvitin, can solve the problems of oral dosage form limitation, inconvenient production and storage, unstable raw material of vitamin D3, etc. The effect of improving stability

Active Publication Date: 2009-06-03
SHANGHAI SINE PHARMA LAB
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the raw material of vitamin D3 is unstable. In addition to causing a lot of inconvenience to production and storage, it also restricts oral dosage forms. Currently, the vitamin D3 products approved by the national SFDA only have injection dosage forms, and there are no other dosage forms.
[0021] The compound product of cholevetin and alendronate sodium is not disclosed in the prior art

Method used

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  • Pharmaceutical preparation containing alendronate sodium and cholecalciferol-cholesterol
  • Pharmaceutical preparation containing alendronate sodium and cholecalciferol-cholesterol
  • Pharmaceutical preparation containing alendronate sodium and cholecalciferol-cholesterol

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0072] Example 1: Alendronate Sodium Cholevetin Ordinary Tablets or Capsules

[0073] Specifications: Alendronate Sodium 70mg / 0.14mg Cholevetin (Equivalent to 2800IU Vitamin D3)

[0074] And alendronate sodium 70mg / 0.28mg cholevetin (equivalent to 5600IU vitamin D3)

[0075] prescription:

[0076] Name of raw material Dosage per tablet source monosodium alendronate trihydrate

Salt

Salt 91.37mg (equivalent to each tablet containing

70mg of alendronate)

Shaanxi Hanjiang Pharmaceutical Co., Ltd.

Cilivitin 0.14mg or 0.28mg Chongqing Kerui Pharmaceutical Co., Ltd. microcrystalline cellulose

(pH301) 30mg

Asahi Kasei Corporation

anhydrous lactose 43mg new zealand lactose co. Croscarmellose Sodium 15mg Anhui Shanhe Pharmaceutical Excipients Co., Ltd. sucrose 10mg Huzhou Prospect Pharmaceutical Co., Ltd. colloidal silica 0.5mg Huzhou Prospect Pharmaceutical Co., Ltd. Magnesi...

Embodiment 2

[0085] Example 2: Alendronate Sodium Cholevetin Oral Emulsion

[0086] Specifications: 10ml: alendronate sodium 70mg / 0.14mg cholevetin (equivalent to 2800IU vitamin D3)

[0087] And 10ml: alendronate sodium 70mg / 0.28mg cholevetin (equivalent to 5600IU vitamin D3)

[0088] prescription:

[0089] Name of raw material Amount per bottle source monosodium alendronate trihydrate

Salt

Salt 91.37mg (equivalent to each tablet containing

70mg of alendronate)

Shaanxi Hanjiang Pharmaceutical Co., Ltd.

Cilivitin 0.14mg or 0.28mg Chongqing Kerui Pharmaceutical Co., Ltd. tea oil

0.75g

Juxing Grain and Oil Medicalization in Longyou County, Zhejiang Province

Industrial Co., Ltd. Tween 80

0.6g

Zhejiang Longyou Juxing Grain and Oil Pharmaceutical Chemicals

limited company Span-85 0.15g Shanghai Shenyu Pharmaceutical Chemical Co., Ltd. B.H.A (tert-butyl-4-

Hydroxyanisole) 0.01g

Shanghai S...

Embodiment 3

[0096] Embodiment 3: Alendronate Sodium Cholevetin Dropping Pills

[0097] Specifications: Alendronate Sodium 70mg / 0.14mg Cholevetin (Equivalent to 2800IU Vitamin D3)

[0098] And alendronate sodium 70mg / 0.28mg cholevetin (equivalent to 5600IU vitamin D3)

[0099] prescription:

[0100] Name of raw material Amount per bottle source Alendronic acid trihydrate

sodium salt 91.37mg (equivalent to each tablet containing

70mg of alendronate) Shaanxi Hanjiang Pharmaceutical Co., Ltd.

Cilivitin 0.14mg or 0.28mg Chongqing Kerui Pharmaceutical Co., Ltd. L-cysteine ​​hydrochloride 0.25mg Shanghai Ajinomoto Co., Ltd. PEG6000 900mg Shanghai Pudong Gaonan Chemical Factory

[0101] Preparation method:

[0102] (1) Take 900g of PEG 6000 oil bath and heat it to 135°C, then add 0.14g of cholevetin, 91.37g of alendronate monosodium trihydrate and 0.3g of L-cysteine ​​hydrochloride into PEG6000 while stirring Make all dissolved...

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PUM

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Abstract

The invention provides a pharmaceutical composition which contains alendronate sodium, cholecalciferol-cholesterol, antioxidizer and a pharmaceutically acceptable carrier. The invention also provides the usage of the pharmaceutical composition in treating osteoporosis.

Description

field of invention [0001] The invention relates to a pharmaceutical preparation for treating osteoporosis, in particular to a pharmaceutical preparation comprising alendronate sodium and cholevedin. Background technique [0002] The commonly used "basic treatment" and "strong treatment" for osteoporosis in clinical practice are different treatment plans formulated according to the different degrees and stages of osteoporosis and individual differences. [0003] Basic treatment generally refers to treatment with vitamin D. According to daily diet and living habits, people's daily intake of calcium and vitamin D is often insufficient, especially for the elderly. Even with adequate calcium nutrition, insufficient vitamin D intake often limits adequate calcium absorption. [0004] The recommended daily intake of vitamin D is 400-1000 IU. "Basic treatment" can not only prevent the occurrence of osteoporosis, but also effectively prevent the bone loss caused by secondary hyperp...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/662A61K31/593A61K9/00A61P19/10
Inventor 高原乌旭琼陈彬华朱正鸣徐庆源沈康宁
Owner SHANGHAI SINE PHARMA LAB
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