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Quality control method for leech and preparation containing leech

A quality control method and leech technology, applied in the preparation of test samples, measuring devices, medical raw materials derived from leeches/worms, etc., can solve the problems of poor specificity, lack of qualitative identification and content determination, insufficient research on chemical components, etc. problems, to achieve the effect of ensuring the stability of the curative effect, ensuring the uniformity and improving the level of quality control

Active Publication Date: 2010-05-12
LUNAN PHARMA GROUP CORPORATION
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, due to insufficient research on the chemical components of leeches, most of the quality control methods for leeches or leech extracts in existing drug standards are inspection of leaching substances, thin-layer identification of leech reference medicinal materials, etc., for example, "People's Republic of China In Pharmacopoeia 2005 Edition Part One, leeches are used as reference medicines for thin-layer identification in the Chinese Pharmacopoeia 2005, and the content determination is only a rough record of the volume of thrombin consumed by leech extracts. The amount of antithrombin that neutralizes one unit of antithrombin is regarded as an anticoagulant. Blood enzyme activity unit, which stipulates that the antithrombin activity per 1 gram of leech medicinal materials should not be less than 16.0U (where U is the unit of thrombin activity per 1 gram, U / g)
This method for identifying or measuring leech medicinal materials lacks qualitative identification and content determination of effective chemical components in leeches, has poor specificity, and cannot effectively control the quality of leeches and pharmaceutical preparations containing leeches

Method used

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  • Quality control method for leech and preparation containing leech
  • Quality control method for leech and preparation containing leech
  • Quality control method for leech and preparation containing leech

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0048] Embodiment 1: Preparation of test solution

[0049] Take 1 kg of dried leech medicinal materials, cut them into small pieces, and extract twice with 70% ethanol. The amount of alcohol added for the first time is 7 kg, and the amount of alcohol added for the second time is 6 kg. Each reflux extraction is 1.5 hours, and the two alcohols are combined. The extract is filtered with a 200-mesh filter cloth, and ethanol is recovered under reduced pressure at 0.06 to 0.08 atmospheres, and the extract is concentrated to 1 kilogram (that is, the weight ratio of the extract to the medicinal material is 1:1) to obtain the extract, stand-by.

[0050] Precipitate the extract with 95% ethanol to an alcohol content of 80%, leave it overnight, filter it with filter paper, adjust the pH of the filtrate to 7.0 with NaOH aqueous solution, place it in a refrigerator overnight, and filter it with filter paper to obtain succinic acid. 10.56 g of crude crystals of the sodium extract were recr...

Embodiment 2

[0052] Embodiment 2: Preparation of test solution

[0053] Take 1 kg of dried leeches, cut them into small pieces, extract twice with 70% ethanol, add 7 kg of alcohol for the first time, and add 6 kg of alcohol for the second time. The alcohol extract was filtered with a 200-mesh filter cloth, and the ethanol was recovered under reduced pressure at 0.06 to 0.08 atmospheres, and the extract was concentrated to 1.2 kg (that is, the weight ratio of the extract to the medicinal material was 1.2:1) to obtain the extract, which was to be use.

[0054] Precipitate the extract with 95% ethanol to an alcohol content of 80%, leave it overnight, filter it with filter paper, recover ethanol, add water to 2.5 kg, precipitate with water, leave it overnight, filter with filter paper, and adjust the pH of the filtrate with hydrochloric acid. To 1.5, extract 5 times with ethyl acetate, combine the extracts, recover ethyl acetate, prepare liquid phase (Varian brand 218 type, Varian UV-vis, Det...

Embodiment 3

[0056] Embodiment 3: Preparation of test solution

[0057] Take 1 kg of dried leeches, cut them into small pieces, extract twice with 70% ethanol, add 7 kg of alcohol for the first time, and add 6 kg of alcohol for the second time. The alcohol extract is filtered with a 200-mesh filter cloth, and ethanol is recovered under reduced pressure at 0.06 to 0.08 atmospheres, and the extract is concentrated to 1.0 kg (that is, the weight ratio of the extract to the medicinal material is 1: 1) to obtain the extract, add water to 2.5 kg, sink in water, place overnight, filter to obtain a water precipitation liquid, which is ready for use.

[0058] Take 1.5 kg of the treated macroporous resin (HPD-100 type), pack the column by wet method, load the sample, elute with 3.6 kg of water, and the flow rate is 20 ml / min. The water in the water eluate was recovered under reduced pressure under atmospheric pressure, concentrated to 1.0 kg, and set aside.

[0059] The concentrated solution was a...

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Abstract

The invention relates to a quality control method for a leech and a preparation containing the leech. The method takes succinic acid or sodium succinate as an index component, and carries out quality control on the leech and the preparation containing the leech through the qualitative and / or quantitative determination of the index component. The quality of the leech and the preparation containing the leech can be accurately controlled by the quality control method which can more reliably and more accurately evaluate the leech and the preparation containing the leech so as to improve the quality control level of medicaments and ensure the quality uniformity and the curative effect stability of the preparation.

Description

technical field [0001] The present invention relates to the field of traditional Chinese medicine, in particular, the present invention relates to the quality control method of Chinese medicinal material leech and a pharmaceutical preparation containing leech, or leech extract, or leech effective part, or leech effective part group. Background technique [0002] The leech is the dry whole of the leech Whitmania pigra Whitman, the leech Hirudonipponica Whitman or the willow leech Whitmania acranulata Whitman, caught in summer and autumn, scalded to death with boiling water, sun-dried or dried at low temperature. Its taste is salty, bitter, neutral in nature, returns to the liver meridian, has a small poison, has the effect of breaking blood, removing blood stasis, and clearing the meridian. Abdominal pain, blood accumulation, pain caused by injury and blood stasis, carbuncle and erysipelas embolism. [0003] As a classic medicine for breaking blood and removing blood stasis,...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K35/62A61P7/02A61P9/10G01N1/28G01N30/36G01N30/90
Inventor 赵志全
Owner LUNAN PHARMA GROUP CORPORATION
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