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Isotonic composition used for improving stability of teicoplanin for injection and preparation method of isotonic composition

A technology of teicoplanin and composition, applied in the field of osmotic composition and its preparation, can solve problems such as poor clarity, and achieve the effects of improving clarity and improving safety

Inactive Publication Date: 2019-05-14
ZHEJIANG MEDICINE CO LTD XINCHANG PHAMACEUTICAL FACTORY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Isotonic sodium chloride is added to this teicoplanin for injection, which improves the stability of teicoplanin and improves storage conditions, but the clarity becomes worse

Method used

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  • Isotonic composition used for improving stability of teicoplanin for injection and preparation method of isotonic composition
  • Isotonic composition used for improving stability of teicoplanin for injection and preparation method of isotonic composition
  • Isotonic composition used for improving stability of teicoplanin for injection and preparation method of isotonic composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1-5

[0018] Embodiment 1-5: Preparation of Teicoplanin for Injection (0.1g)

[0019] The prescription of teicoplanin for injection (0.1g) is shown in Table 1

[0020] Table 1

[0021] Material name

Example 1

Example 2

Example 3

Example 4

Example 5

Teicoplanin (mg)

100

100

100

100

100

Sodium chloride (mg)

14

10.5

7.5

4.5

0

Glucose (mg)

0

19.5

36

52.8

78

Add water for injection to (ml)

2

2

2

2

2

[0022] Preparation method: add the prescribed amount of sodium chloride and / or glucose into about 80% water for injection cooled to 10°C and stir until completely dissolved to obtain the first solution; add teicoplanin into the first solution, stir to make Dissolve it completely to obtain the second solution; add 1M sodium hydroxide solution to the second solution to adjust the pH to 7.0, then add the remaining water for injection, and stir evenly to obtain an isotonic ...

Embodiment 6-10

[0033] Example 6-10: Preparation of Teicoplanin for Injection (0.2g)

[0034] The prescription of teicoplanin for injection (0.2g) is shown in Table 4

[0035] Table 4

[0036] Material name

Example 6

Example 7

Example 8

Example 9

Example 10

Teicoplanin (mg)

200

200

200

200

200

Sodium chloride (mg)

24

18

15

12

0

Glucose (mg)

0

33.3

50

66.7

134

Add water for injection to (ml)

4

4

4

4

4

[0037] Preparation method: Add the prescribed amount of sodium chloride and / or glucose into about 80% water for injection cooled to 20°C and stir until completely dissolved to obtain the first solution; add teicoplanin into the first solution, stir to make It is completely dissolved to obtain the second solution; 1M sodium hydroxide solution is added to the second solution to adjust the pH to 8.0; then the remaining water for injection is added and stirred evenly to obtain ...

Embodiment 11-15

[0047] Preparation of Teicoplanin for Injection (0.4g)

[0048] The prescription of teicoplanin for injection (0.4g) is shown in Table 7

[0049] Table 7

[0050] Material name

Example 11

Example 12

Example 13

Example 14

Example 15

Teicoplanin (mg)

400

400

400

400

400

Sodium chloride (mg)

24

18

15

12

0

Glucose (mg)

0

33.3

50

66.7

134

Add water for injection to (ml)

6

6

6

6

6

[0051] Preparation method: add the prescribed amount of sodium chloride and / or glucose into about 80% water for injection cooled to 15°C and stir until completely dissolved to obtain the first solution; add teicoplanin into the first solution, stir to make It is completely dissolved to obtain the second solution; 1M sodium hydroxide solution is added to the second solution to adjust the pH to 7.5; then the remaining water for injection is added and stirred evenly to obtain an isotonic ...

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PUM

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Abstract

The invention provides an isotonic composition used for improving the stability of teicoplanin for injection and a preparation method of the isotonic composition. The isotonic composition comprises 0.1 g of the teicoplanin, 0.2 g of sodium chloride and / or glucose and 0.4 g of water for injection, wherein the pH value of the composition is 7.0-8.0. The isotonic composition used for improving the stability of the teicoplanin for injection can effectively improve the clarity, the stability is equivalent to that of a teicoplanin composition for injection only containing sodium chloride, and the isotonic composition can be stored at room temperature.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to an isotonic composition for improving the stability of teicoplanin for injection and a preparation method thereof. The composition involves various specifications. technical background [0002] Teicoplanin is a glycopeptide antibiotic produced by the fermentation of Actinomycetes mobilis, which has good antibacterial activity against Gram-positive (G+) bacteria, including aerobic and anaerobic bacteria. The basic chemical structure is similar to vancomycin, but its lipophilicity is strong, it is easy to penetrate into tissues and cells, and causes bacterial death by hindering the biosynthesis of cell wall. The natural antibacterial spectrum of the drug is aerobic and anaerobic G+ bacteria, especially against methicillin-resistant Staphylococcus aureus (MRSA) and enterococci. Due to the high protein binding rate and long half-life, teicoplanin can be adminis...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/14A61K9/08A61K47/26A61K47/02A61P31/04
Inventor 孟玉芳程亮邹琦谭新衡胡元元
Owner ZHEJIANG MEDICINE CO LTD XINCHANG PHAMACEUTICAL FACTORY
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