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Composition capable of eliminating HS15 clouding formation phenomenon and application of composition in medicinal preparation

A composition and phenomenon technology, applied in the field of pharmaceutical preparations, can solve problems such as loss of manpower, material resources, financial resources, discount of application prospects, scrapping and the like

Inactive Publication Date: 2014-05-21
SHENYANG PHARMA UNIVERSITY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0013]In the case of large-scale industrial production, the serious consequences that may be caused by the HS15 flash phenomenon are: the scrapping of a batch or even several batches of HS15-related preparations will not only cause the enterprise manpower, Multiple unnecessary losses in material and financial resources, and also lead to uncontrollable process and randomness of qualified preparations in the preparation process of HS15 related preparations
[0014] In addition, the HS15 flash phenomenon may also lead to serious consequences that greatly reduce its application prospects

Method used

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  • Composition capable of eliminating HS15 clouding formation phenomenon and application of composition in medicinal preparation
  • Composition capable of eliminating HS15 clouding formation phenomenon and application of composition in medicinal preparation
  • Composition capable of eliminating HS15 clouding formation phenomenon and application of composition in medicinal preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Example 1 : Coenzyme Q without flashing phenomenon solubilized by HS15 10 Preparation of injection (fix HS15:F68=1:2(m / m), choose different amount of propylene glycol for polyol)

[0035] prescription:

[0036] Prescription 1 Prescription 2 Prescription 3 Prescription 4 Prescription 5 Prescription 6 coenzyme Q 10 75mg 75mg 75mg 75mg 75mg 75mg HS15 600mg 600mg 600mg 600mg 600mg 600mg F68 1200mg 1200mg 1200mg 1200mg 1200mg 1200mg Propylene Glycol 1800mg 2400mg 3000mg 3600mg 4800mg 6000mg Water for Injection Add to 30ml Add to 30ml Add to 30ml Add to 30ml Add to 30ml Add to 30ml

[0037] Process:

[0038] Weigh the prescribed amount of coenzyme Q 10 , HS15 to form the oil phase; take the prescribed amount of F68, propylene glycol and water for injection as the water phase, and heat the two phases to 55°C respectively. After the substances in the two phases ...

Embodiment 2

[0042] Example 2: Coenzyme Q Solubilized with HS15 without Emergence 10 Preparation of injections (fix HS15:F68=1:3(m / m), polyols choose different amounts of glycerol)

[0043] prescription:

[0044] Prescription 7 Prescription 8 Prescription 9 Prescription 10 Prescription 11 Prescription 12 coenzyme Q 10 75mg 75mg 75mg 75mg 75mg 75mg HS15 600mg 600mg 600mg 600mg 600mg 600mg F68 1800mg 1800mg 1800mg 1800mg 1800mg 1800mg glycerin 1800mg 2400mg 3000mg 3600mg 4800mg 6000mg Water for Injection Add to 30ml Add to 30ml Add to 30ml Add to 30ml Add to 30ml Add to 30ml

[0045] Process:

[0046] Weigh the prescribed amount of coenzyme Q 10 , HS15 to form the oil phase; measure the prescribed amount of F68, glycerin and water for injection as the water phase, and heat the two phases to 55°C respectively. After the substances in the two phases are completely dissolved, u...

Embodiment 3

[0050] Example 3: Coenzyme Q Solubilized with HS15 without Emergence 10 Preparation of injections (fix HS15:F68=1:4(m / m), choose different amounts of PEG400 for polyols)

[0051] prescription:

[0052] Prescription 13 Prescription 14 Prescription 15 Prescription 16 Prescription 17 Prescription 18 coenzyme Q 10 75mg 75mg 75mg 75mg 75mg 75mg HS15 600mg 600mg 600mg 600mg 600mg 600mg F68 2400mg 2400mg 2400mg 2400mg 2400mg 2400mg PEG400 1800mg 2400mg 3000mg 3600mg 4800mg 6000mg Water for Injection Add to 30ml Add to 30ml Add to 30ml Add to 30ml Add to 30ml Add to 30ml

[0053] Process:

[0054] Weigh the prescribed amount of coenzyme Q 10 , HS15 to form the oil phase; measure the prescribed amount of F68, PEG400 and water for injection as the water phase, and heat the two phases to 55°C respectively. After the substances in the two phases are completely dissolved, ...

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PUM

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Abstract

The invention relates to a composition capable of eliminating clouding formation phenomenon of HS15 (polyethylene 10% w / v glycol 660 hydroxy stearate), which comprises a lipid soluble drug, HS15, a polyethylene oxide-polypropylene oxide copolymer, a polyhydroxylated compound and water, wherein the weight ratio of insoluble drug to HS15 to polyethylene oxide-polypropylene oxide copolymer to the polyhydroxylated compound is (0.001-2):1:(0.5-5):(2-20), and the rest is water. When the composition is used for preparing injection of common insoluble drug, the obtained preparation can bear sterilization at 100DEG C for 30 min and 121DEG C for 8 min without clouding formation, so as to ensure the controllability of the entire preparation process and avoid negative results arising from clouding formation phenomenon during sterilization of the preparation. The composition disclosed by the invention eliminates the clouding formation phenomenon of HS15, and solves the serious problem when HS15 is applied to industrial production.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and specifically relates to a combination capable of eliminating HS15 epilepsy and its application in pharmaceutical preparations. Background technique [0002] Surfactant refers to a substance that has fixed hydrophilic and lipophilic groups, can be aligned on the surface of the solution, and can significantly reduce the surface tension. According to the dissociation properties of polar groups, they can be divided into anionic surfactants, cationic surfactants, zwitterionic surfactants, and nonionic surfactants. [0003] Among different types of surfactants, the application of nonionic surfactants in pharmacy is more prominent, especially polyoxyethylene nonionic surfactants, whose performance is superior to other types of surfactants in many aspects , It has high stability, is not affected by strong electrolytes, acids, alkalis, and salts, and has good compatibility with ...

Claims

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Application Information

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IPC IPC(8): A61K47/34
Inventor 邓意辉程晓波王春玲王宇付强
Owner SHENYANG PHARMA UNIVERSITY