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Spectinomycin and lincomycin soluble powder capable of being completely dissolved in various solvents and preparation method

A spectinomycin, complete dissolution technology, applied in non-active ingredient medical preparations, medical preparations containing active ingredients, powder delivery, etc., can solve severe pain, animal stress response, increase injection dose and other problems, to achieve the effects of strong antibacterial spectrum and activity, repair of cell membrane damage, and stable dispersion properties

Active Publication Date: 2020-12-08
XIAMEN HUIYING ANIMAL PHARMA
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, spectinomycin lincomycin soluble powder is used clinically to dissolve the drug in a certain amount of water for injection or Marek diluent, and then mix it with the vaccine, but the drug may be unevenly dispersed after mixing. Increased injection dose, crystallization, and poor needle penetration; in practical applications, the conventional spectinomycin lincomycin formulation will change the pH of the vaccine, usually from neutral to below 5.0, causing stress reactions in animals and severe Pain etc.

Method used

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  • Spectinomycin and lincomycin soluble powder capable of being completely dissolved in various solvents and preparation method
  • Spectinomycin and lincomycin soluble powder capable of being completely dissolved in various solvents and preparation method
  • Spectinomycin and lincomycin soluble powder capable of being completely dissolved in various solvents and preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 15

[0035] Example 15: Appearance stability of spectinomycin lincomycin soluble powder powder involved in the present invention

[0036] Test spectinomycin lincomycin soluble powder: prepared by the methods of Comparative Examples 1-5 and Examples 1-14.

[0037] Test conditions:

[0038] (1) High-temperature, high-humidity test: The sample is placed in a closed container with constant humidity, and placed at 60°C for 10 days at a relative humidity of 95%±5%, and samples are taken on the 5th and 10th days.

[0039] (2) Accelerated test: place for six months at a temperature of 40°C±2°C and a humidity of 75%±5%, and take samples at the end of the first month, second month, third month, and sixth month.

[0040] The test results are shown in Table 2:

[0041] Note: " / " means no test

[0042] Table 2

[0043]

[0044]

Embodiment 16

[0045] Example 16: Stability Test of Spectinomycin Lincomycin Soluble Powder Dissolved in Various Solvents

[0046] Test spectinomycin lincomycin soluble powder: prepared by the methods of Comparative Example 1-5, Example 2, and 5-14.

[0047] Seedlings: Recombinant avian influenza virus (H5+H7) trivalent inactivated seedlings (H5N1 Re-11 strain + Re-12 strain, H7N9 H7-Re2 strain): batch number 01924058, Zhaoqing Dahuanong Biopharmaceutical Co., Ltd.

[0048] Marek's Diluent: Chicken Marek's Disease Vaccine Diluent: Lot No. S18041903, Merial Animal Health Ltd.

[0049] Test conditions: (1) Add 10g of spectinomycin lincomycin soluble powder to 30ml of water, 0.9% sodium chloride solution, and Marek diluent at 25°C, and observe the dissolution within 5 minutes;

[0050] (2) At 25°C, add 40g of spectinomycin lincomycin soluble powder to 100ml of water, 0.9% sodium chloride solution, and Marek diluent, and observe the dissolution within 5 minutes;

[0051] (3) Add 10 g of specti...

Embodiment 17

[0056] Embodiment 17: The pH test situation of spectinomycin lincomycin soluble powder dissolved in various solvents involved in the present invention

[0057] Test spectinomycin lincomycin soluble powder: prepared by the methods of Comparative Examples 1-5 and Examples 8-14.

[0058] Seedlings: Recombinant avian influenza virus (H5+H7) trivalent inactivated seedlings (H5N1 Re-11 strain + Re-12 strain, H7N9 H7-Re2 strain): batch number 01924058, Zhaoqing Dahuanong Biopharmaceutical Co., Ltd.

[0059] Marek's Diluent: Chicken Marek's Disease Vaccine Diluent: Lot No. S18041903, Merial Animal Health Ltd.

[0060] Test conditions: (1) 10g spectinomycin lincomycin soluble powder was added to 30ml water, 0.9% sodium chloride solution, Marek diluent, and the pH of the solution was tested at a temperature of 25°C;

[0061] (2) Add 40 g of spectinomycin lincomycin soluble powder to 100 ml of water, 0.9% sodium chloride solution, and Marek diluent, and test the pH of the solution at a te...

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Abstract

The invention provides spectinomycin and lincomycin soluble powder capable of being completely dissolved in various solvents. The spectinomycin and lincomycin soluble powder comprises the following components in parts by weight: 62.5 parts of spectinomycin hydrochloride, 25 parts of lincomycin hydrochloride, 2.0-6.0 parts of a solubilizer, 3.0-6.0 parts of a pH regulator and 0.5-6.5 parts of auxiliary materials. The method comprises the steps of smashing, sieving, mixing and the like. The spectinomycin and lincomycin soluble powder is scientific and reasonable in formula composition and simplein process, is different from common spectinomycin and lincomycin soluble powder, can be completely dissolved in water, a 0.9% sodium chloride solution and a Marek diluent, and can also be directly and completely dissolved in oil seepage; the spectinomycin and lincomycin soluble powder has stable dispersing property after being mixed with medicine, and has gentle settling velocity and good medicine dispersity and redispersibility within 240min; the spectinomycin and lincomycin soluble powder has no obvious volume change and hardly influences the injection dosage after being dissolved into oilseepage; after the spectinomycin and lincomycin soluble powder dissolved in the oil seedlings, the dripping time of the same volume is not longer than that of an oil seepage stock solution, and the needle passing performance of the oil seepage is not influenced; and the pH of an original solvent and the immune titer of a vaccine are not influenced.

Description

technical field [0001] The invention relates to the technical field of veterinary drug preparations, in particular to spectinomycin lincomycin soluble powder which can be completely dissolved in various solvents and a preparation method thereof. Background technique [0002] Spectinomycin and lincomycin are broad-spectrum antibacterial drugs, which have strong and efficient killing effects on Gram-positive bacteria, Gram-negative bacteria and mycoplasma. The combined application of lincomycin hydrochloride and spectinomycin hydrochloride makes the antimicrobial spectrum and activity wider and stronger than single preparations, and is less likely to produce drug resistance. It is one of the few perfect combinations in the combined application of antibiotics, and the effect is far better than single Antibiotic products. [0003] At present, spectinomycin lincomycin soluble powder is used clinically to dissolve the drug in a certain amount of water for injection or Marek dilue...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/7056A61K31/357A61K9/14A61K47/10A61K47/02A61K47/20A61P31/04A61K31/185
CPCA61K9/143A61K9/145A61K9/146A61K31/185A61K31/357A61K31/7056A61P31/04A61K2300/00
Inventor 骆桂红胡晓晖吴笑倩廖源浩刘冰
Owner XIAMEN HUIYING ANIMAL PHARMA
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