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Quality control method of cordate houttuynia eye drop

A quality control method and technology of eye drops, applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems of ineffective control of the quality of Houttuynia cordata eye drops, affecting product production and quality assurance, and complex active ingredients. Achieve uniform and stable quality, easy operation, high precision and sensitivity

Inactive Publication Date: 2015-12-16
SICHUAN SUNNYHOPE PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, since the main component of Houttuynia cordata eye drops is the extract of Houttuynia cordata, and the active ingredients in the extract are complicated, only methyl nonanone is identified and determined, and the detection method is too simple. Compared with the current drug quality There is a large gap in the requirements of control
Therefore existing quality control method can't effectively control the quality of Houttuynia cordata eye drops, thereby influences the production of product and guarantees quality

Method used

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  • Quality control method of cordate houttuynia eye drop
  • Quality control method of cordate houttuynia eye drop
  • Quality control method of cordate houttuynia eye drop

Examples

Experimental program
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Effect test

Embodiment 1

[0034] The preparation method of Houttuynia cordata eye drops is: take 2000g of fresh Houttuynia cordata, carry out steam distillation, collect 2000ml of the initial distillate, and then carry out redistillation, collect 1000ml of redistillate, add the same amount of water for injection, and then carry out redistillation, Collect 900ml of rectified liquid, add 7g of sodium chloride, 805g of polysorbate and 0.3g of ethylparaben, mix well, add water for injection to make 1000ml, filter, pot, and obtain.

Embodiment 2

[0036] The quality control method of the Houttuynia cordata eye drops of above-mentioned embodiment 1, it may further comprise the steps:

[0037] S1. TLC identification of methyl nonanone

[0038] Take the methyl nonanone reference substance, add absolute ethanol to make a solution containing 0.5 mg per 1 ml, and use it as the reference substance solution; according to the thin-layer chromatography test, absorb 10 μl of the reference substance solution and 20 μl of the test solution, and place them on On the same silica gel G thin-layer plate, dots into streaks, using cyclohexane-ethyl acetate as the developing solvent, the volume ratio of cyclohexane and ethyl acetate in cyclohexane-ethyl acetate is 9:1, develop and take out , dried, sprayed with dinitrophenylhydrazine test solution, in the chromatogram of the test product, on the position corresponding to the chromatogram of the reference substance, spots of the same color appear;

[0039] S2. Determination of the content ...

Embodiment 3

[0051] Embodiment 3: the thin layer identification of methyl nonanone

[0052] The preparation method of the test solution of the original standard is to extract with chloroform after acidification, wherein the sampling volume of the sample is relatively large (100ml is taken each time), and the used extraction solvent (i.e. chloroform) is highly toxic, so it is now revised to take [content Determination] under the item solution as the test solution, the spots are obvious, easy to check, and save samples and solvents, the method is more convenient, time-saving, and environmentally friendly. In addition, the n-hexane in the developer was replaced by cyclohexane, which is less toxic.

[0053] The preparation method of the solution under [Content Determination] is: accurately measure 25ml of this product, and pass through the pretreated C 8 Solid phase extraction cartridge (100mg: 1ml), elute with a mixed solution of ethyl acetate-ethanol (7:3), collect about 1.8ml of the eluate...

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Abstract

The invention discloses a quality control method of a cordate houttuynia eye drop. The method comprises: thin-layer identification of methyl-nonyl-ketone, measurement of content of methyl-nonyl-ketone, and characteristic spectrum. In accordance with "Quality Standard of Traditional Chinese Medicine Guiding Principles for Validation of Analytical Methods" of Chinese Pharmacopoeia edited in 2010, validation of methods of each detection project of an original standard is performed, and projects with problems are improved. An injection of cordate houttuynia is taken as a research basis; identification of other component is added; and identification of terpineol and bornyl acetate by adopting a CC method is added. According to the requirement, and through research, a preparation method of a solution of a to-be-tested product in thin-layer identification of methyl-nonyl-ketone is changed. By referring to a research content of the injection of cordate houttuynia, identification of components of terpineol, bornyl acetate, terpineol, and the like by adopting a CC method is added, and check of the characteristic spectrum of the components is established to ensure uniform stable quality of the cordate houttuynia eye drop.

Description

technical field [0001] The invention relates to a quality control method, in particular to a quality control method of Houttuynia cordata eye drops. Background technique [0002] Houttuynia cordata is the rooted whole plant of the perennial herbaceous plant Houttuynia cordata Thunb. of the family Tribaceae. It is well-known as Pleurotus chinensis, Purple Houttuynia, Pig's Nostril, Jiujielian, etc. Its fresh plants have a pungent fishy smell after being broken, and are widely distributed. In my country's central, southeast and southwest provinces, especially in Hunan, Hubei, Sichuan, Jiangsu and other provinces. Houttuynia cordata has the effects of clearing heat and detoxifying, eliminating carbuncle and draining pus, diuresis and treating stranguria. Studies have shown that Houttuynia cordata contains volatile components, flavonoids, organic acids, sterols, alkaloids and other components. Houttuynia cordata is mainly eaten as a working vegetable with tender stems and leave...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/90G01N30/02
Inventor 黄莜萍王建波陈开军李涛程亮聂飞范世德胥勤
Owner SICHUAN SUNNYHOPE PHARM CO LTD
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