Detection method of compound preparation containing compound Zingiber corallinum Hance solution and urea miconazole ointment

Abstract

The invention discloses a detection method of a compound preparation containing a compound Zingiber corallinum Hance solution and a urea miconazole ointment. The detection method comprises items of characters, inspection, identification and content determination. The identification comprises a qualitative identification, a thin-layer chromatography identification with a contrast of Zingiber corallinum Hance reference medicine, an efficient liquid chromatography identification with contrasts of a salicylic acid reference substance, a Zingiber corallinum Hance reference substance and a miconazole nitrate reference substance, and a gas chromatography identification with a contrast of a borneol reference substance. The content determination is for determining content of Zingiber corallinum Hance, salicylic acid, borneol, urea and miconazole nitrate in the preparation. The invention is scientific and reasonable, has high accuracy and strong feasibility, improves stability of the compound preparation containing compound Zingiber corallinum Hance solution and urea miconazole ointment, and effectively controls quality of the compound preparation containing compound Zingiber corallinum Hance solution and urea miconazole ointment, thus ensuring clinical efficacy of the compound preparation.

Description

technical field

[0001] The invention relates to a detection method of compound coral ginger solution urea miconazole ointment compound preparation, belonging to the technical field of traditional Chinese medicine quality detection. Background technique

[0002] Compound coral ginger solution urea miconazole ointment compound preparation is composed of compound coral ginger solution and urea miconazole ointment. It is mainly used to treat tinea manus, pedis and onychomycosis. book), standard number WS-10001-(HD-0360)-2002. The inventor finds through research that in the existing compound coral ginger solution urea miconazole ointment composite preparation quality standard, the determination of salicylic acid content is a titration analysis method, the sampling amount is small, and the amount of the sodium hydroxide amount titration solution consumed is relatively large. less, the error of the measurement results is large; and there is salicylic acid interference in the curre...

Examples

Embodiment 1

[0257] Embodiment 1: the quality detection method of the present invention is:

[0258] traits:

[0259] Compound Coral Ginger Solution is a brownish-yellow to yellow clear solution, with a jasmine aroma, pungent after a long time smell, and volatile; urea miconazole ointment is light yellow ointment;

[0260] Identification:

[0261] (1) Take 2ml of this product, after sublimation, add vanillin sulfuric acid solution dropwise to the sublimated product, and the purple color will appear immediately;

[0262] (2) Take 5ml of this product, put it in an evaporating dish and evaporate it to dryness in a water bath, dissolve the residue with 5ml of diethylamine aqueous solution with a volume ratio of 20%, transfer it to a separating funnel, and shake it with ether to extract twice, 5ml each time , Separate the ether solution, evaporate to dryness in a water bath, dissolve the residue with 0.5ml of absolute ethanol, and then wave it to about 0.2ml, as the test solution. In additio...

Embodiment 2

[0289] Embodiment 2: the quality detection method of the present invention is:

[0290] traits:

[0291] Compound Coral Ginger Solution is a brownish-yellow to yellow clear solution, with a jasmine aroma, pungent after a long time smell, and volatile; urea miconazole ointment is light yellow ointment;

[0292] Identification:

[0293] (1) Take 10ml of this product, after sublimation, add vanillin sulfuric acid solution dropwise to the sublimation product, and the purple color will appear immediately;

[0294] (2) Take 20ml of this product, put it in an evaporating dish and evaporate it to dryness in a water bath, dissolve the residue with 20ml of diethylamine aqueous solution with a volume ratio of 20%, transfer it to a separatory funnel, shake and extract with diethyl ether 4 times, 20ml each time , take the ether solution, evaporate to dryness in a water bath, dissolve the residue with 2ml of absolute ethanol, and then wave it to about 0.7ml as the test solution; take anothe...

Embodiment 3

[0321] Embodiment 3: the quality detection method of the present invention is:

[0322] traits:

[0323] Compound Coral Ginger Solution is a brownish-yellow to yellow clear solution, with a jasmine aroma, pungent after a long time smell, and volatile; urea miconazole ointment is light yellow ointment;

[0324] Identification:

[0325] (1) Take 5ml of this product, after sublimation, add vanillin sulfuric acid solution dropwise to the sublimated product, and the purple color will appear immediately;

[0326] (2) Take 10ml of this product, put it in an evaporating dish and evaporate it to dryness in a water bath, dissolve the residue with 10ml of diethylamine aqueous solution with a volume ratio of 20%, transfer it to a separatory funnel, shake and extract with diethyl ether three times, 10ml each time, Separate the ether solution, evaporate to dryness in a water bath, dissolve the residue with 1ml of absolute ethanol, and then wave it to about 0.5ml as the test solution; take...

technical field

[0001] The invention relates to a detection method of compound coral ginger solution urea miconazole ointment compound preparation, belonging to the technical field of traditional Chinese medicine quality detection. Background technique

[0002] Compound coral ginger solution urea miconazole ointment compound preparation is composed of compound coral ginger solution and urea miconazole ointment. It is mainly used to treat tinea manus, pedis and onychomycosis. book), standard number WS-10001-(HD-0360)-2002. The inventor finds through research that in the existing compound coral ginger solution urea miconazole ointment composite preparation quality standard, the determination of salicylic acid content is a titration analysis method, the sampling amount is small, and the amount of the sodium hydroxide amount titration solution consumed is relatively large. less, the error of the measurement results is large; and there is salicylic acid interference in the curre...

Examples

Embodiment 1

[0257] Embodiment 1: the quality detection method of the present invention is:

[0258] traits:

[0259] Compound Coral Ginger Solution is a brownish-yellow to yellow clear solution, with a jasmine aroma, pungent after a long time smell, and volatile; urea miconazole ointment is light yellow ointment;

[0260] Identification:

[0261] (1) Take 2ml of this product, after sublimation, add vanillin sulfuric acid solution dropwise to the sublimated product, and the purple color will appear immediately;

[0262] (2) Take 5ml of this product, put it in an evaporating dish and evaporate it to dryness in a water bath, dissolve the residue with 5ml of diethylamine aqueous solution with a volume ratio of 20%, transfer it to a separating funnel, and shake it with ether to extract twice, 5ml each time , Separate the ether solution, evaporate to dryness in a water bath, dissolve the residue with 0.5ml of absolute ethanol, and then wave it to about 0.2ml, as the test solution. In additio...

Embodiment 2

[0289] Embodiment 2: the quality detection method of the present invention is:

[0290] traits:

[0291] Compound Coral Ginger Solution is a brownish-yellow to yellow clear solution, with a jasmine aroma, pungent after a long time smell, and volatile; urea miconazole ointment is light yellow ointment;

[0292] Identification:

[0293] (1) Take 10ml of this product, after sublimation, add vanillin sulfuric acid solution dropwise to the sublimation product, and the purple color will appear immediately;

[0294] (2) Take 20ml of this product, put it in an evaporating dish and evaporate it to dryness in a water bath, dissolve the residue with 20ml of diethylamine aqueous solution with a volume ratio of 20%, transfer it to a separatory funnel, shake and extract with diethyl ether 4 times, 20ml each time , take the ether solution, evaporate to dryness in a water bath, dissolve the residue with 2ml of absolute ethanol, and then wave it to about 0.7ml as the test solution; take anothe...

Embodiment 3

[0321] Embodiment 3: the quality detection method of the present invention is:

[0322] traits:

[0323] Compound Coral Ginger Solution is a brownish-yellow to yellow clear solution, with a jasmine aroma, pungent after a long time smell, and volatile; urea miconazole ointment is light yellow ointment;

[0324] Identification:

[0325] (1) Take 5ml of this product, after sublimation, add vanillin sulfuric acid solution dropwise to the sublimated product, and the purple color will appear immediately;

[0326] (2) Take 10ml of this product, put it in an evaporating dish and evaporate it to dryness in a water bath, dissolve the residue with 10ml of diethylamine aqueous solution with a volume ratio of 20%, transfer it to a separatory funnel, shake and extract with diethyl ether three times, 10ml each time, Separate the ether solution, evaporate to dryness in a water bath, dissolve the residue with 1ml of absolute ethanol, and then wave it to about 0.5ml as the test solution; take...

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