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Betamethasone sodium phosphate injection and preparation method and application thereof

A technology of sodium metasone phosphate and injection, which can be used in pharmaceutical formulations, medical preparations without active ingredients, and medical preparations containing active ingredients, etc., and can solve problems such as safety issues

Pending Publication Date: 2021-09-07
北京鑫开元医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] In order to overcome the above-mentioned deficiencies existing in the prior art, the object of the present invention is to provide a kind of betamethasone sodium phosphate injection and its preparation method and application, to solve the problem of adding organic solvent and anti-infection in the existing betamethasone sodium phosphate injection. Safety issues posed by oxidizing agents

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  • Betamethasone sodium phosphate injection and preparation method and application thereof
  • Betamethasone sodium phosphate injection and preparation method and application thereof
  • Betamethasone sodium phosphate injection and preparation method and application thereof

Examples

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preparation example Construction

[0036] In a second aspect, embodiments of the present invention provide a method for preparing betamethasone sodium phosphate injection according to the first aspect, comprising the following steps:

[0037] S1: Betamethasone sodium phosphate, edetate disodium, disodium hydrogen phosphate and 1% phosphoric acid solution are prepared in formula quantities;

[0038] S2: Add water for injection with a formula amount of 60% to 90% into the liquid preparation tank, fill with nitrogen, then add and dissolve the edetate disodium, the betamethasone sodium phosphate, the disodium hydrogen phosphate and The 1% phosphoric acid solution is supplemented with the water for injection to the prescribed amount to obtain a medicinal solution;

[0039] S3: Pass the medicinal solution through a sterilizing filter and put it into a vial or ampoule purged with nitrogen to obtain an injection with a residual oxygen content in the headspace ≤ 4%, and the pH of the injection is 8.2- 8.5.

[0040] Th...

Embodiment 1～4

[0061] Based on 1000 mL of betamethasone sodium phosphate injection, the contents of the components of the betamethasone sodium phosphate injection provided in Examples 1-4 are shown in Table 1.

[0062] Table 1

[0063]

[0064] Betamethasone sodium phosphate injection was prepared respectively according to Preparation Method 2. It can be seen from Table 1 that when the dosage of disodium hydrogen phosphate is 6.65-7.35 mg / mL, the osmotic pressure is consistent with that of the reference preparation, and the dosage of disodium hydrogen phosphate is 6 mg / mL , the osmotic pressure differed greatly from that of the reference preparation.

Embodiment 5～8

[0066] Based on 1000 mL of betamethasone sodium phosphate injection, the contents of the components of the betamethasone sodium phosphate injection provided in Examples 5-8 are shown in Table 2.

[0067] Table 2

[0068]

[0069] Prepare betamethasone sodium phosphate injection respectively according to preparation method 8, respectively take the betamethasone sodium phosphate injection prepared in Examples 5 to 8, at a temperature of 40°C ± 2°C and a relative humidity of 75% ± 5%. Stand for 30 days, carry out accelerated test, measure impurity and main drug content in betamethasone sodium phosphate injection according to high performance liquid chromatography (Chinese Pharmacopoeia 2020 edition four general rules 0512), measurement result is shown in Table 3.

[0070] table 3

[0071]

[0072] It can be seen from Table 3 that when the dosage of edetate disodium is 0.095-0.105mg / mL, the growth rate of betamethasone and total impurities is small, and the stability of the...

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Abstract

The invention belongs to the field of medicines, and particularly relates to a betamethasone sodium phosphate injection and a preparation method and application thereof. Every 1000 milliliters of the injection comprises: 5-6 grams of betamethasone sodium phosphate; 0.09 to 0.15 g of disodium edetate; 6 to 8 g of disodium hydrogen phosphate; a proper amount of 1% phosphoric acid solution; and water for injection, which is added to 1000mL. The preparation method of the injection comprises the following steps: preparing the betamethasone sodium phosphate, the edetate disodium, the disodium hydrogen phosphate and 1% phosphoric acid solution according to the formula amounts; adding a proper volume of water for injection into a liquid preparation tank, introducing nitrogen for bubbling, then sequentially adding and dissolving the components, and supplementing the water for injection to the formula amount to obtain a liquid medicine; and processing the liquid medicine through a sterilization filter, and filling the liquid medicine into a tube bottle or an ampoule which is purged by nitrogen, so as to obtain the injection. The injection does not contain an organic solvent or an antioxidant and is low in safety risk, and better stability can be achieved on the premise that the injection does not contain the antioxidant.

Description

technical field [0001] The invention belongs to the field of medicines, and in particular relates to a betamethasone sodium phosphate injection and a preparation method and application thereof. Background technique [0002] Betamethasone Sodium Phosphate is an adrenal cortex hormone drug, which is suitable for the treatment of eczema, contact dermatitis, neurodermatitis, solar dermatitis and senile pruritus. The common dosage form is injection. Betamethasone Sodium Phosphate Injection was first launched in Belgium in 1962, specification: 4mg / mL, licensed by MSD Belgium BVBA. [0003] However, betamethasone sodium phosphate is prone to degradation reaction in aqueous solution, producing betamethasone and other impurities. In order to prevent its degradation, a large amount of organic solvents (such as propylene glycol) and antioxidants (such as sodium bisulfite) are mostly used in existing preparations, but studies have shown that propylene glycol has certain irritation to s...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/573A61K47/02A61K47/18A61K47/04A61P17/00A61P17/04A61P17/16A61P25/00
CPCA61K31/573A61K9/0019A61K9/08A61K47/183A61K47/02A61P17/00A61P17/04A61P25/00A61P17/16
Inventor 刘春梅王志超惠樊静郎福双戴信敏
Owner 北京鑫开元医药科技有限公司
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