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Dexamethasone sodium phosphate injection intermediate testing method

A technology of dexamethasone sodium phosphate and testing methods, which is applied in the field of pharmaceutical chemistry, can solve the problems of small production batches and high production costs, and achieve the effects of shortening testing time and saving labor costs

Inactive Publication Date: 2015-12-09
安徽城市药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

At present, in order to ensure the quality of the final product, the production batch is small in actual production and the production cost is high

Method used

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  • Dexamethasone sodium phosphate injection intermediate testing method
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  • Dexamethasone sodium phosphate injection intermediate testing method

Examples

Experimental program
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Effect test

Embodiment 1

[0023] Dexamethasone Sodium Phosphate Injection Intermediate Test Method, comprising the following steps:

[0024] Step 1: Take the dexamethasone sodium phosphate injection intermediate sample and dissolve it in the unsaturated organic solution of dimethyl sulfoxide, the unsaturated organic solution is propylene glycol, and prepare sample solutions with different concentrations, as shown in Table 1 below; use the wavelength range Scan the sample solution in the range of 200-300nm,

[0025] Step 2: In order to suppress the shielding effect of excipients on the intermediate of dexamethasone sodium phosphate injection as much as possible, prepare sample solutions of 0.06%, 0.08%, 0.10%, 0.12%, and 0.14%, and put them into a UV spectrophotometer for detection , the detection wavelength is 242nm,

[0026]

[0027] The obtained absorbance draws a standard curve, and draws a linear regression equation according to the Beer-Lambert law according to the standard curve; 8 L / mol cm;...

Embodiment 2

[0033] The difference between this embodiment and Example 1 is that the unsaturated organic acid used is methanol, using 0.06% sample methanol solution, the concentration is 2000mg / L, after detection, the content of dexamethasone sodium phosphate injection intermediate is obtained , as shown in Table 4.

[0034]

Embodiment 3

[0036] The difference between this embodiment and Example 1 is that the unsaturated organic acid used is acetonitrile, using 0.06% sample acetonitrile solution, the concentration is 2000mg / L, after detection, the content of dexamethasone sodium phosphate injection intermediate is obtained , as shown in Table 5.

[0037]

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Abstract

The invention discloses a dexamethasone sodium phosphate injection intermediate testing method. The dexamethasone sodium phosphate injection intermediate testing method comprises following steps: a dexamethasone sodium phosphate injection intermediate sample is dissolved in a 0.06-0.15% dimethyl sulfoxide unsaturated organic solution so as to prepare sample solutions of different concentration, wherein the concentration of the sample solutions ranges from 1000 to 3000mg / L; the sample solutions are delivered into an ultraviolet spectrophotometer for detection, a standard curve is drawn based on obtained absorbance values, and a linear regression equation is obtained according to the standard curve based on Beer-Lambert law; a sample to be tested is prepared into a solution according to the step 1, and then is subjected to absorbance value detection at a wavelength ranging from 200 to 300nm, and then the content of the dexamethasone sodium phosphate injection intermediate is calculated based on the linear regression equation. With equal labor and environment investment, yield of each batch is increased by 20%, production cost is reduced, and at the same time product yield is improved.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical chemistry, and in particular relates to a method for testing an intermediate of dexamethasone sodium phosphate injection. Background technique [0002] Dexamethasone Sodium Phosphate Injection belongs to glucocorticoid drugs and is mainly used to treat allergic and autoimmune inflammation and other diseases. reputation. It is mainly used for allergic and autoimmune confirmed diseases. It is mostly used for connective tissue diseases, active rheumatism, rheumatoid arthritis, lupus erythematosus, severe bronchial asthma, severe dermatitis, ulcerative colitis, acute leukemia, etc. It is also used for some serious infections, poisoning, and malignant lymphoma. Comprehensive Treatment. Dexamethasone sodium phosphate belongs to the class of adrenal corticosteroids. It has anti-inflammatory, anti-allergic, anti-rheumatic, and immunosuppressive effects, and its mechanism of action is as follows...

Claims

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Application Information

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IPC IPC(8): G01N21/31
Inventor 吴延柱吴鹏杨红丽邓晓云
Owner 安徽城市药业股份有限公司
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