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Novel tiopronin freeze drying powder preparation and its prepn. process

A technology of tiopronin and freeze-dried powder, which is applied in freeze-dried delivery, medical preparations containing active ingredients, powder delivery, etc., can solve the problems of inconvenient clinical use, short storage time, and short validity period, and achieve clinical use. The effect of convenience, low production cost and good stability

Inactive Publication Date: 2006-09-20
ANHUI ZHIFEI LONGCOM BIOPHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The intravenous injection preparation has the characteristics of quick onset, high bioavailability, and good curative effect, but because tiopronin has poor stability in water and is prone to oxidation reaction, so the aqueous solution injection has the disadvantages of short storage time, short valid period of use, and influence the safe and effective use of this product
[0003] Freeze-dried powder preparation can solve the stability problem of above-mentioned tiopronin, although Chinese patent " tiopronin freeze-dried powder injection " (publication number CN 1488343A) and " tiopronin preparation " (publication number CN 1404827A) all The preparation method of tiopronin freeze-dried powder is provided, but the pH of the preparation prepared by this method is 1.5-2.5, and the acidity is strong, so special requirements are put forward for the use of packaging materials and preparations: a. Through acid treatment, to improve the stability and acid resistance of control vials, higher requirements have been proposed for packaging materials, which has increased production costs; b, preparations are used earlier with 2ml 5% sodium bicarbonate injection ( After dissolving, add it to the infusion set for intravenous infusion, which brings inconvenience to clinical use and is easy to cause pollution

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0049] Embodiment 1: Tiopronin freeze-dried powder preparation

[0050] prescription

[0051] Tiopronin 100.0g

[0052] Mannitol 180.0g

[0053] Add water for injection to 1.0L

[0054] Made into 1000 bottles of freeze-dried product

[0055] Preparation Process

[0056] ① Put the water for injection into the batching bucket, weigh the mannitol, stir to dissolve, then take the raw material drug and add it to the above solution, stir to dissolve.

[0057] ② Adjust the pH value of the above solution to 3.0-6.0 with 10mol / L sodium hydroxide solution, and add water for injection to the full amount.

[0058] ③ Add 0.05% (w / v) activated carbon for needles to the above solution, stir at 50°C for 15 minutes, filter, and decarbonize.

[0059] ④Measure the intermediate content and pH value. After passing the test, pass through a 0.22μm microporous membrane to sterilize and filter, then divide the medicinal solution into vials and freeze-dry it.

Embodiment 2

[0060] Embodiment 2: Tiopronin freeze-dried powder preparation

[0061] prescription

[0062] Tiopronin 100.0g

[0063] Dextran 80.0g

[0064] Add water for injection to 1.0L

[0065] Made into 1000 bottles of freeze-dried product

[0066] Preparation Process

[0067] ①Take water for injection and put it in the batching bucket, weigh dextran, stir to dissolve, then take the raw material medicine and add it to the above solution, stir to dissolve it.

[0068] ② Adjust the pH value of the above solution to 3.0-6.0 with 10mol / L sodium bicarbonate solution, and add water for injection to the full amount.

[0069] ③ Add 0.1% (w / v) activated carbon for needles to the above solution, stir at 50°C for 15 minutes, filter, and decarbonize.

[0070] ④Measure the intermediate content and pH value. After passing the test, pass through a 0.22μm microporous membrane to sterilize and filter, then divide the medicinal solution into vials and freeze-dry it.

Embodiment 3

[0071] Embodiment 3: preparation of tiopronin freeze-dried powder

[0072] prescription

[0073] Tiopronin 100.0g

[0074] L-cysteine ​​10.0g

[0075] Mannitol 150.0g

[0076] Add water for injection to 1.0L

[0077] Made into 1000 bottles of freeze-dried product

[0078] Preparation Process

[0079] ①Take water for injection and put it in the batching bucket, weigh L-cysteine, stir to dissolve, then take the raw material medicine and add it to the above solution, stir to dissolve it.

[0080] ② Adjust the pH value of the above solution to 3.0-6.0 with 10mol / L sodium hydroxide solution, and add water for injection to the full amount.

[0081] ③ Add 0.1% (w / v) activated carbon for needles to the above solution, stir at 50°C for 15 minutes, filter, and decarbonize.

[0082] ④Measure the intermediate content and pH value. After passing the test, pass through a 0.22μm microporous membrane to sterilize and filter, then divide the medicinal solution into vials and freeze-dry ...

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PUM

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Abstract

A freeze-dried powder injection of tiopronin is prepared from tiopronin and the human body receptable non-active carrier chosen from dextran, glucose, mannitol, xylitol, lactose, amino acid, etc through preparing liquid medicine, regulating pH value, removing heat source and bacteria, filling in bottles and freeze drying.

Description

technical field [0001] The tiopronin freeze-dried powder preparation and preparation method involved in the present invention aim to provide a stable freeze-dried powder preparation and a simple preparation method thereof, so as to overcome the cumbersome preparation process and relatively high production cost of the existing freeze-dried powder preparation. Shortcomings of instability of tiopronin in Gaoheshui injection preparations. The preparation method of the freeze-dried powder preparation is as follows: after dissolving the medicine, adding an appropriate protective agent, adjusting the pH value of the medicine solution to a range acceptable to the human body, and then freeze-drying to form a loose block. When the preparation is used clinically, it can be directly dissolved and diluted with physiological saline, and no proprietary solvent is required. technical background [0002] Tiopronin is a metabolic improving regulator mainly used to ...

Claims

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Application Information

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IPC IPC(8): A61K31/197A61K9/19A61P1/16
Inventor 王健吕玲
Owner ANHUI ZHIFEI LONGCOM BIOPHARM CO LTD
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