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Freeze dry tiopronin preparation without adjuvant for intravenous injection and its preparation process

A technique for tiopronin and freeze-dried preparations, which is applied in the field of freeze-dried preparations for intravenous injection of tiopronin and the preparation process, which can solve the problems of physical harm to patients, increased production costs of preparations, complexity of prescriptions and difficulty in drug quality control, etc. , to achieve the effects of guaranteed safety, easy control of preparation quality, and reduced production costs

Inactive Publication Date: 2006-02-15
苑振亭
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Adding excipients to the lyophilized preparation is beneficial to the molding of the preparation and the feasibility of the process, but the addition of excipients is obviously insufficient: (1) increases the production cost of the preparation; (2) increases the complexity of the formulation and improves the quality control of the drug (3) A large amount of exogenous substances are artificially introduced into the human body during the intravenous injection of the patient, which increases the possibility of harming the patient's body
There is no report on the freeze-dried formulation of tiopronin for intravenous injection without excipients in the literature

Method used

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  • Freeze dry tiopronin preparation without adjuvant for intravenous injection and its preparation process
  • Freeze dry tiopronin preparation without adjuvant for intravenous injection and its preparation process
  • Freeze dry tiopronin preparation without adjuvant for intravenous injection and its preparation process

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] 1. Preparation prescription:

[0019]

[0020] Second, the preparation process:

[0021] (1) Preparation of liquid medicine

[0022] 1. Take an appropriate amount of freshly prepared water for injection (about 80% of the prescription), lower the temperature to below 30°C, add the prescribed amount of tiopronin, and stir to dissolve;

[0023] 2. Add activated carbon (0.2% w / v), stir and adsorb for 10 minutes, and decarbonize by filtration with a 0.45 μm microporous membrane.

[0024] 3. Add water for injection below 30°C to the prescribed amount and stir well;

[0025] 4. Detect the drug content of the filtrate, and use a 0.22μm microporous membrane to filter and sterilize;

[0026] 5. After the clarity is qualified, it is divided into small glass bottles (1ml / bottle, the dose is 100mg).

[0027] (2) freeze-drying process

[0028] 1. Put the sample into the freeze-drying box, lower it to -40°C (1°C to 2°C per minute), and keep it warm for 2 hours; start vacuumi...

Embodiment 2

[0032] 1. Preparation prescription:

[0033]

[0034] Second, the preparation process:

[0035] (1) Preparation of liquid medicine

[0036] 1. Take an appropriate amount of freshly prepared water for injection (about 80% of the prescription), lower the temperature to below 30°C, add the prescribed amount of tiopronin, and stir to dissolve;

[0037] 2. Add activated carbon (0.2% w / v), stir and adsorb for 10 minutes, and decarbonize by filtration with a 0.45 μm microporous membrane.

[0038] 3. Add water for injection below 30°C to the prescribed amount and stir well;

[0039] 4. Detect the drug content of the filtrate, and use a 0.22μm microporous membrane to filter and sterilize;

[0040] 5. After the clarity is qualified, it is divided into small glass bottles (2ml / bottle, the dose is 200mg).

[0041] (2) freeze-drying process

[0042] 1. Put the sample into the freeze-drying box, lower it to -60°C (1°C to 2°C per minute), and keep it warm for 2 hours; start vacuumi...

Embodiment 3

[0045] 1. Preparation prescription:

[0046]

[0047] Second, the preparation process:

[0048] (1) Preparation of liquid medicine

[0049] 1. Take an appropriate amount of freshly prepared water for injection (about 80% of the prescription), lower the temperature to below 30°C, add the prescribed amount of tiopronin, and stir to dissolve;

[0050] 2. Add activated carbon (0.2% w / v), stir and adsorb for 10 minutes, and decarbonize by filtration with a 0.45 μm microporous membrane.

[0051] 3. Add water for injection below 30°C to the prescribed amount and stir well;

[0052] 4. Detect the drug content of the filtrate, and use a 0.22μm microporous membrane to filter and sterilize;

[0053] 5. After the clarity is qualified, it is divided into small glass bottles (0.5ml / bottle, the dose is 100mg).

[0054] (2) freeze-drying process

[0055] 1. Put the sample into the freeze-drying box, lower it to -40°C (1°C to 2°C per minute), and keep it warm for 2 hours; start vacuu...

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PUM

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Abstract

The invention relates to a freeze dry tiopronin preparation without adjuvant for intravenous injection and its preparation process, wherein the preparation contains only medicinal Tiopronin but no addition agent of any kinds, one dosage unit of the freeze-dried preparation contains 10-1000mg of Tiopronin. The ratio of the medicament and water in the freeze-dried preparation can be 1:100 to 1:1, the purity of the Tiopronin medicament can be 85-100%.

Description

Technical field: [0001] The invention relates to the technical field of pharmaceutical preparations and preparation processes, and relates to a freeze-dried preparation of tiopronin for intravenous injection without auxiliary materials and a preparation process. Background technique: [0002] Tiopronin, chemical name: N-(2-mercaptopropionyl)-glycine; English name: tiopronin, [0003] The chemical structural formula is: [0004] [0005] As a liver function improving agent, tiopronin has achieved good results in the treatment of long-term clinical liver diseases. It was first launched in Japan, and then Germany, Italy, the United States, Switzerland and other countries have successively used it in clinical practice as a drug for improving liver function. Domestic research began in the early 1990s, and mass production began in the mid-1990s, and some products were launched. It is available as tablet (enteric-coated) and injection (lyophilized powder). [0006] Tiopronin ...

Claims

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Application Information

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IPC IPC(8): A61K31/197A61K9/19A61P1/16
Inventor 苑振亭丁平田
Owner 苑振亭
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