Quality control method for leech and preparation containing leech

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

Active Publication Date: 2011-01-12
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: the preparation of need testing solution

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

[0050] Sink the extract with 95% ethanol alcohol until the alcohol content is 80%, leave it overnight, filter with filter paper, adjust the pH value of the filtrate to 7.0 with NaOH aqueous solution, put it in the refrigerator overnight, and filter with filter paper to obtain succinic acid 10.56 grams of crude crystals from the sodium extract were recrystallized with 95% et...

Embodiment 2

[0052] Embodiment 2: the preparation of need testing solution

[0053] Take 1 kg of dried leech medicinal material, cut into small pieces, extract twice with 70% ethanol, add alcohol for the first time to 7 kg, add alcohol for the second time to 6 kg, reflux each time for 1.5 hours, and combine twice The alcohol extract is filtered with a 200-mesh filter cloth, and the ethanol is recovered under reduced pressure at 0.06 to 0.08 atmospheres, and the extract is concentrated to 1.2 kg (that is, the weight ratio of the extract to the medicinal material is 1.2: 1), and the extract is obtained. use.

[0054] Sink the extract with 95% ethanol alcohol to 80% alcohol content, leave it overnight, filter with filter paper, recover ethanol, add water to 2.5 kg, sink in water, leave it overnight, filter with filter paper, adjust the pH value of the filtrate with hydrochloric acid to 1.5, extracted 5 times with ethyl acetate, combined the extracts, recovered ethyl acetate, prepared liquid ...

Embodiment 3

[0056] Embodiment 3: the preparation of need testing solution

[0057] Take 1 kg of dried leech medicinal material, cut into small pieces, extract twice with 70% ethanol, add alcohol for the first time to 7 kg, add alcohol for the second time to 6 kg, reflux each time for 1.5 hours, and combine twice The alcohol extract is filtered with a 200-mesh filter cloth, and the 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, stand overnight, filter to obtain a water-sinking liquid, and set aside.

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

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PUM

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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 containingthe 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 invention relates to the field of traditional Chinese medicine, in particular, the invention relates to a method for quality control of Chinese medicinal material leeches and pharmaceutical preparations containing leeches, or leech extracts, or effective parts of leeches, or groups of effective parts of leeches. Background technique [0002] Leeches are the dried whole body of leech Whitmania pigra Whitman, Hirudonipponica Whitman or willow-leaf leech Whitmania acronulata Whitman, which are caught in summer and autumn, scalded to death with boiling water, and dried in the sun or at low temperature. It tastes salty, bitter, flat in nature, returns to the liver meridian, has little toxicity, has the effects of breaking blood, removing blood stasis, and dredging menstruation. It is used for lumps in the abdomen, blood stasis, amenorrhea, and injury from falls; Abdominal pain, blood accumulation, injury and blood stasis pain, carbuncle and erysipelas e...

Claims

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Application Information

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