Auxiliary material used for injection or oral administration

A molecular structure, surfactant technology, applied in the field of excipients to improve its stability and/or drug safety, and can solve problems such as toxicity

Pending Publication Date: 2016-05-04
钟术光
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

These alcohols may be toxic and cannot be completely ignored, and restrictions on alco

Method used

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  • Auxiliary material used for injection or oral administration
  • Auxiliary material used for injection or oral administration
  • Auxiliary material used for injection or oral administration

Examples

Experimental program
Comparison scheme
Effect test

Embodiment T

[0138] Example T p(p＝1～11)

[0139] Embodiment T is polyoxyethylene ((20)) sorbitan (mono) oleate (illustration: (20) represents that the (average) polymerization degree (n) of polyoxyethylene group is 20, can also be 10 ~30, or 15~25, or 17~23, or 18~22, or 19~22, etc., all of which have this meaning below, not otherwise specified),

[0140] Wherein, peroxide (substance 1, implementation (point) example (p=) 1), or epoxy compound (substance 2, implementation (point) example (p=) 2), or compound containing aldehyde group in molecular structure ( Aldehyde compounds) or / and formate (substance 3, implementation (point) example (p=)3), or carbonate (substance 4, implementation (point) example (p=)4), or the oxidation products mentioned above Esters other than carbonates and formates (substance 5, implementation (point) example (p=) 5), or methoxy compounds (substance 6, implementation (point) example (p=) 6), or sub Methylenedioxy compound (substance 7, implementation (point) e...

Embodiment V

[0145] Example V p(p＝1～2)-q(q＝1～4)

[0146] Embodiment V is polyoxyethylene ((20)) sorbitan (mono) oleate, wherein, the compound (embodiment sub-example (p=) 1) or molecule containing aldehyde group and polyoxyethylene group in molecular structure The compound (implementation sub-example (p=) 2) (the embodiment itself) oxidation product containing aldehyde group but not polyoxyethylene group in the structure is in each embodiment sub-example (V p(p＝1～2)-q(q＝1～4) ) content (respectively based on the aldehyde group contained therein) is 0.3mmol / kg (V p(p＝1～2)-(q＝)1 ), 3mmol / kg (V p(p＝1～2)-(q＝)2 ), 10mmol / kg (V p(p＝1～2)-(q＝)3 ), 30mmol / kg (V p(p＝1～2)-(q＝)4 ) (fluctuation within 100±2%).

Embodiment U

[0147] Example U p(p＝1～3)-q(q＝1～5)

[0148] Embodiment U is polyoxyethylene ((20)) sorbitan (mono) oleate,

[0149] Wherein, epoxide ((self) oxidation product 1) is in each embodiment sub-example (U p1-q(q＝1～5) ) in the content (respectively based on the epoxy group contained therein) is 0.03mmol / kg (U p1-q1 ), 0.3mmol / kg (U p1-q2 ), 3mmol / kg (U p1-q3 ), 10mmol / kg (U p1-q4 ), 30mmol / kg (U p1-q5 ) (100 ± 2% inner fluctuation) (for the convenience of distinguishing, p1 represents p=1 in the present embodiment, q1 represents q=1, and others are deduced by analogy, no longer illustrate);

[0150]Or (containing) aldehyde compound ((self) oxidation product 2) in each embodiment sub-example (U p2-q(q＝1～5) ) content (respectively based on the aldehyde group contained therein) is 0.03mmol / kg (U p2-q1 ), 0.3mmol / kg (U p2-q2 ), 3mmol / kg (U p2-q3 ), 10mmol / kg (U p2-q4 ), 30mmol / kg (U p2-q5 ) (within 100±2% fluctuation);

[0151] Or epoxides and (containing) aldehyde compounds...

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Abstract

The invention relates to an auxiliary material used for injection or oral administration. Basic component of the surface active agent is polyoxyethylene sorbitan (mono)oleate, wherein total content of carbonyls contained in aldehyde compounds and one compounds is not more than 20meq/kg, or/and total content of epoxy groups is not more than 10meq/kg, or/and total content of alkane compounds and olefin compounds is not more than 10meq/kg, and total content of peroxyl groups contained in peroxides is not more than 20meq/kg. The auxiliary material has relatively high safety and is used for improving safety and/or stability of a preparation used for injection or oral administration. In addition, the invention also relates to a preparation method and quality standard of the auxiliary material.

Description

【Technical field】 [0001] The invention relates to an auxiliary material for injection or oral use. More specifically, the present invention relates to an excipient for injection or oral administration to improve its stability and / or drug safety. 【technical background】 [0002] For injection or oral preparations, especially injections, especially traditional Chinese medicine injections, these situations often occur: the active ingredient is insoluble, or although it is soluble in a hydrophilic solvent, it is mixed with other insoluble ingredients, or although it is soluble in a hydrophilic solvent Aqueous solvents but their or other miscellaneous components produce insoluble products during production or storage. Therefore, it is necessary to add solubilizing auxiliary materials, such as polysorbate (80) (polyoxyethylene sorbitan ester or Tween 80), to solve the problems such as active ingredients are insoluble in water and / or preparation stability is poor, but Bring hidden...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K9/10A61K9/127A61K9/19A61K47/26C08G65/28
CPCA61K47/26A61K9/0019A61K9/08A61K9/10A61K9/127A61K9/19C08G65/2609
Inventor 钟术光
Owner 钟术光
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