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Method and system for determining dissolution rate of calcitriol soft capsules

A technology for calcitriol and soft capsules, which is applied in the field of medicine and can solve the problems that calcitriol soft capsules need to be improved.

Inactive Publication Date: 2018-03-09
HUMANWELL PURACAP PHARM WUHAN CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] However, the current research on calcitriol soft capsules still needs to be improved

Method used

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  • Method and system for determining dissolution rate of calcitriol soft capsules
  • Method and system for determining dissolution rate of calcitriol soft capsules
  • Method and system for determining dissolution rate of calcitriol soft capsules

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0077] In this example, various dissolution media are compared to determine the optimal dissolution media. Wherein, the inventor has selected the phosphate buffer solution of 4.0% by weight SDS, water and pH=6.8, uses different dissolution media to measure the dissolution rate of calcitriol soft capsule according to the description of general method, and the results are as follows:

[0078] The dissolution rate of calcitriol soft capsules when the dissolution medium of table 1 is 4.0% by weight SDS

[0079]

[0080] Dissolution rate of calcitriol soft capsules when table 2 dissolution medium is water condition

[0081]

[0082] The dissolution rate of calcitriol soft capsules when the dissolution medium of table 3 is the phosphate buffer of pH=6.8

[0083]

[0084] As can be seen from the above table, the reference image 3 , the dissolution effect of calcitriol capsules in 4.0% by weight SDS is the best.

Embodiment 2

[0086] In this example, the flow rates of various dissolution media are compared to determine the optimal dissolution rate. Wherein, the dissolution rate selected by the inventor is 14 milliliters / minute, 16 milliliters / minute and 18 milliliters / minute, and uses different dissolution media to measure the dissolution rate of calcitriol soft capsule according to the description of the general method, and the results are as follows:

[0087] The dissolution rate of calcitriol soft capsule when table 4 dissolution rate is 14 milliliters / minute

[0088]

[0089] The dissolution rate of calcitriol soft capsule when table 5 dissolution rate is 16 milliliters / minute

[0090]

[0091] The dissolution rate of calcitriol soft capsule when table 6 dissolution rate is 18 milliliters / minute

[0092]

[0093] As can be seen from the above table, the reference Figure 4 , the dissolution effect of calcitriol capsules is the best when the flow rate of the dissolution medium 4.0% by ...

Embodiment 3

[0095] In this example, the volumes of various dissolution media are compared to determine the optimal dissolution volume. Wherein, the volume of the dissolution medium selected by the inventor is 30 milliliters, 40 milliliters and 50 milliliters, according to the description of the general method, use different dissolution mediums to measure the dissolution rate of calcitriol soft capsules, the results are as follows:

[0096] The dissolution rate of calcitriol soft capsule when table 7 dissolution volume is 30 milliliters

[0097]

[0098] The dissolution rate of calcitriol soft capsules when the dissolution volume of table 8 is 40 milliliters

[0099]

[0100] The dissolution rate of calcitriol soft capsules when the dissolution volume of table 9 is 50 milliliters

[0101]

[0102] As can be seen from the above table, the reference Figure 5 , the dissolution effect of calcitriol capsules is the best under the condition that the volume of dissolution medium is 40...

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Abstract

The invention discloses a method and a system for determining a dissolution rate of calcitriol soft capsules. The method comprises the following steps: (1) performing dissolution treatment on to-be-determined calcitriol soft capsules by utilizing a dissolution medium so as to conveniently obtain dissolution liquor, wherein the dissolution medium is 4.0wt% of SDS aqueous solution; (2) detecting thecontent of calcitriol in the dissolution liquor; (3) determining the dissolution rate of the calcitriol soft capsules based on the detection result of the to-be-determined calcitriol soft capsules inthe step (2). According to the method for determining the dissolution rate of the calcitriol soft capsules provided by the invention, an in-vivo dissolution behavior can be effectively simulated to determine the dissolution rate of the calcitriol soft capsules.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a method and a system for determining the dissolution rate of calcitriol soft capsules. Background technique [0002] Calcitriol is Vitamin D 3 analogue of vitamin D in the human body 3 One of the most important metabolically active products. Normally, calcitriol is synthesized in the kidneys from its precursor, dihydroxycholecalciferol. The body's daily physiological synthesis of calcitriol is about 0.5 to 1.0 micrograms. Calcitriol synthesis is also slightly increased during periods of active bone formation (such as growth or pregnancy). [0003] Calcitriol can promote intestinal absorption of calcium and regulate bone calcification. For severe renal failure, especially in patients receiving long-term hemodialysis, the synthesis of endogenous calcitriol is significantly reduced or even completely stopped. Calcitriol deficiency plays a key role in the development of renal osteodyst...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
CPCG01N30/02
Inventor 李琳蔡波涛文学智秦巨波高婷
Owner HUMANWELL PURACAP PHARM WUHAN CO LTD
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