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Bisolol non intestine medicinal preparation

A bisoprolol preparation technology, applied in the field of parenteral drug preparations, achieves significant effects and less side effects

Inactive Publication Date: 2005-08-10
尚宝虎 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Bisoprolol has not been made into injections for injection

Method used

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  • Bisolol non intestine medicinal preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Embodiment 1 freeze-drying method prepares bisoprolol for injection

[0028] prescription:

[0029] Bisoprolol Fumarate 1g

[0030] Mannitol 100g

[0031] Add water for injection to 1000ml

[0032] A total of 1000 bottles were made

[0033] Preparation Process

[0034] Measure 80% of the total volume of water for injection, add the prescribed amount of mannitol, stir until dissolved, if it is not easy to dissolve, heat until dissolved, add 0.01% (m / v) needle and stir evenly with activated carbon, then take the prescribed amount of fumaric acid Mix bisoprolol with the above-mentioned mannitol; add water for injection to the full amount, stir until it is completely dissolved, absorb for 20 minutes, test after coarse filtration and decarbonization, adjust the pH to 5-7 with a pH regulator if necessary, and pass 0.22 μm microporous filter membrane positive pressure sterilization filtration; semi-finished product passed the inspection, aseptically divided into cleaned a...

Embodiment 2

[0035] Example 2 Bisoprolol fumarate injection, for intramuscular injection.

[0036] prescription:

[0037] Bisoprolol Fumarate 1g

[0038] Add water for injection to 1000ml

[0039]A total of 1000 bottles were made

[0040] Preparation Process

[0041] Take by weighing the bisoprolol fumarate of prescription quantity, add water for injection 900ml, be heated to 80 ℃ and make dissolving, adjust pH to 5~7 with pH adjusting agent if necessary, add water for injection to full amount, add activated carbon for injection 0.01% ( w / v) Stir for 30 minutes, and measure the intermediate content. After passing the test, firstly filter through a sand rod, and then finely filter through a 0.45 μm microporous membrane. ℃ circulation steam sterilization for 30 minutes, light inspection, printing, packaging.

Embodiment 3

[0042] Example 3 Bisoprolol fumarate injection, for intravenous injection.

[0043] prescription:

[0044] Bisoprolol Fumarate 1g

[0045] Sodium chloride 9.0g

[0046] Add water for injection to 1000ml

[0047] A total of 1000 bottles were made

[0048] Preparation Process

[0049] Weigh the prescribed amount of bisoprolol fumarate and sodium chloride, add 900ml of water for injection, heat to 80°C to dissolve 0.1mol / L hydrochloric acid, adjust the pH value to 5-7 with a pH regulator if necessary, add water for injection to For the full amount, add activated carbon 0.01% w / v, stir for 15 minutes, decarburize through a sand rod, and then filter through a 0.45 μm microporous membrane. Stopper, press cap, sterilize with circulating steam at 115°C for 30 minutes, light inspection, and pack.

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Abstract

A bisoprolol in the form of powdered or liquid injection for treating primary hypertension and angina pectoris is prepared from the physiologically acceptable salt of bisoprolol and additive.

Description

technical field [0001] The present invention relates to the improvement of pharmaceutical dosage forms, in particular to parenteral administration preparations of drug bisoprolol and its physiologically acceptable salts. Including bisoprolol for injection and bisoprolol injection. Background technique [0002] Bisoprolol (Bisoprolol, structural formula see the figure below), chemical name: 1-[4-[[2-(1-methylethoxy)ethoxy]methyl]-phenoxy]-3-[( 1-methylethyl)amino]-2-propanol. [0003] [0004] Bisoprolol is selective beta 1 - Adrenergic receptor blockers. No intrinsic sympathomimetic activity and membrane stabilizing effect. Bisoprolol can inhibit the basal and stimulated secretion of renin, and can also reduce the activity of renin in plasma. A single dose can lead to a significant decrease in basal and stimulated renin activity, and this effect can last for 7 days. It also has a protective effect on the myocardium, and it has both anti-myocardial ischemia and good ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/138A61P9/10
Inventor 尚宝虎崔东冬
Owner 尚宝虎
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