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Calculation method of content in doxercalciferol injection

A technology for docalciferol and alcohol injection, which is applied in the field of biomedicine, and can solve the problems of out-of-synchronization of the percentage content of precursors and the inability to calculate the content of docalciferol in injections, etc.

Active Publication Date: 2019-04-23
NANJING KING FRIEND BIOCHEM PHARMA CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, precursors are produced in the standard solution based on the doxercalciferol standard and in the doxercalciferol injection, and the percentage content of the precursors is not synchronized, so the traditional external standard method cannot be used to calculate the Docecalcidol content

Method used

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  • Calculation method of content in doxercalciferol injection
  • Calculation method of content in doxercalciferol injection
  • Calculation method of content in doxercalciferol injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0075] Weigh 5.02mg of docecalcidol standard substance (batch number: DOS150224, content 99.9%) into a 50ml brown volumetric flask, add 40ml of acetonitrile, ultrasonicate in an ice-water bath for 10min, and then dilute to room temperature with acetonitrile to obtain a doxone standard substance reserve solution (batch number: NRD20150415). Take 2.0ml of this stock solution in a 100ml brown volumetric flask, dilute with acetonitrile to obtain a standard solution of doxercalciferol, take 50 μl of this solution and inject it into a liquid chromatograph, and the peak area of ​​the doxercalciferol standard is measured to be 586217 , precursor 585, total 586802:

[0076] F degree=5.02mg*99.9% / 50ml / 50 / 586802=0.342*10 -5 ug / ml.

[0077]Weigh 5.10 mg of 5,6-trans-calciferol standard substance (batch number: DTS150229, content 99.5%) into a 50 ml brown volumetric flask, add 40 ml of acetonitrile, ultrasonicate in an ice-water bath for 10 min, let it cool to room temperature and then d...

Embodiment 2

[0090] A batch of doxercalciferol injection was taken, and the traditional external standard method was used to calculate the doxercalciferol content in the injection to be 93.5%, and the method in Example 1 was used to calculate the total doxercalcidol content to be 96.7%.

[0091] Calculation process: the concentration of moderate calciferol in the reference solution is 1.991ug / ml, the peak area of ​​peak calciferol is 306155, and the peak area of ​​peak calciferol precursor is 308; the marked amount of moderate calciferol injection It is 2ug / ml, the peak area of ​​calciferol is 287658, and the peak area of ​​calciferol precursor is 10133.

[0092] The traditional external standard method is adopted to calculate the content of doxercalciferol in the injection:

[0093] %=(287658*1.991ug / ml / 306155) / 2ug / ml=93.5%

[0094] Adopt the method for embodiment 1 to calculate total calciferol content:

[0095] %=[(287658+10133)*1.991ug / ml / (306155+308)] / 2ug / ml=96.7%

Embodiment 3

[0097] The traditional external standard method was used to calculate the content of doxacalciferol in the near-effective product of the original research injection (HECTOROL, batch number: 6R1002), which was 91.8%, and the method of Example 1 was used to calculate the content of doxacalcitol as 95.2%.

[0098] Calculation process: the concentration of moderate calciferol in the reference solution is 1.991ug / ml, the peak area of ​​peak calciferol is 306155, and the peak area of ​​peak calciferol precursor is 308; the marked amount of moderate calciferol injection It is 2ug / ml, the peak area of ​​calciferol is 282386, and the peak area of ​​calciferol precursor is 10822.

[0099] The traditional external standard method is adopted to calculate the content of doxercalciferol in the injection:

[0100] %=(282386*1.991ug / ml / 306155) / 2ug / ml=91.8%

[0101] Adopt the method for embodiment 1 to calculate total calciferol content:

[0102] %=[(282386+10822)*1.991ug / ml / (306155+308)] / 2u...

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Abstract

The invention discloses a content calculation method of a doxercalciferol injection. The method comprises: destroying doxercalciferol by means of a sodium hydroxide water solution to generate a doxercalciferol precursor and 5,6-trans-doxercalciferol, and doxercalciferol and 5,6-trans-doxercalciferol response factors under given chromatographic conditions; calculating the concentration of a doxercalciferol standard substance before destroying, the concentration of the 5,6-trans-doxercalciferol generated after destroying, and the concentration of the non-destroyed doxercalciferol, so as to obtain the concentration of the doxercalciferol precursor after destroying; calculating a precursor response factor according to the peak area of the doxercalciferol precursor after destroying, so that the precursor response factor can be converted into a correction factor of the doxercalciferol, and the correction factor can be directly substituted for calculation when the content of the injection is tested. The method has operability through practice test, the degree of transforming the doxercalciferol into the precursor is not required, the accuracy is high, the method is simple and convenient, and the content of the doxercalciferol in the injection can be effectively controlled.

Description

technical field [0001] The invention belongs to the field of biomedicine, in particular to a method for calculating the content of doxercalciferol injection. Background technique [0002] Doxercalciferol injection, trade name: HECTOROL, common name: DOXERCALCIFEROL, molecular formula: C 28 h 44 o 2 , molecular weight: 412.65, its structural formula is: [0003] [0004] Docalcitol Injection was first marketed by GENZYME CORP (Sanofi) in the United States in 2000, and the indication is "treatment of secondary hyperparathyroidism". At present, the domestic mainstream products for the treatment of secondary hyperparathyroidism caused by chronic kidney disease are alfacalcidol and calcitriol, which have been on the market for some time. In recent years, many clinical studies have found that doxercalciferol is safer and more effective in this indication. Docalciferol has been on the market abroad for more than ten years and has been widely accepted by patients. [0005] ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02G01N30/86G01N30/06
CPCG01N30/02G01N30/06G01N30/86G01N30/8631G01N2030/067
Inventor 唐咏群黄锡伟田欣欣胡铮娄媛媛
Owner NANJING KING FRIEND BIOCHEM PHARMA CO LTD
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