Preparation method and quality control method of heartleaf houttuynia herb injection

A technology of Houttuynia cordata injection and quality control method, which is applied in the field of medicine, and can solve problems such as failure to prepare, waste of Houttuynia cordata resources, and limited solubilization effect of Tween-80

Inactive Publication Date: 2012-02-01
HUNAN ZHENGQING PHARM GRP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In the current process, Tween-80 is added to prepare Houttuynia cordata injection. When the volatile oil content in Houttuynia cordata raw material is high, the volatile oil in the heavy distillate is also high, and the solubilization effect of Tween-80 is limited, so it is difficult to prepare a clear medicine There

Method used

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  • Preparation method and quality control method of heartleaf houttuynia herb injection
  • Preparation method and quality control method of heartleaf houttuynia herb injection
  • Preparation method and quality control method of heartleaf houttuynia herb injection

Examples

Experimental program
Comparison scheme
Effect test

experiment example 1

[0019] Experimental Example 1: Screening of the amount of hydroxypropyl-β-cyclodextrin used as a solubilizer for Houttuynia cordata injection and its effect on clarity

[0020] Take the fresh whole herb of Houttuynia cordata, wash it, put it in a still pot, add appropriate amount of water, carry out steam distillation, collect the initial distillate to 1 times the weight of the whole herb (g / ml), redistill again, and collect the double distillate To 1 / 2 of the weight of the whole herb, add 0.7% sodium chloride to the heavy distillate, stir to dissolve, add water for injection to the prepared amount, and set aside.

[0021] Take 400ml of the above heavy distillate of Houttuynia cordata, add different amounts of hydroxypropyl-β-cyclodextrin and Tween-80 in the following table, mix well, put it in a collector-type constant temperature magnetic stirrer, and keep the temperature at 70°C , and stirred for 1 hour. Cool to room temperature, filter with a 0.65 μm filter membrane, and ...

experiment example 2

[0029] Experimental example 2: Study on the stability of hydroxypropyl-β-cyclodextrin as a solubilizer for Houttuynia cordata injection

[0030] Houttuynia cordata injection containing hydroxypropyl-β-cyclodextrin and Houttuynia cordata injection containing Tween-80 were used for accelerated experiments at 50°C, 60°C, and 70°C. Take samples at 2 hours, 4 hours, 6 hours, 8 hours, and 10 hours, and measure the pH value and methyl nonanone content of Houttuynia cordata injection at each temperature and time (detected by gas chromatography). The experiment was repeated three times, and the results are shown in Table 3, Table 4, and Table 5.

[0031] Table 3 Experiment 1 (Constant Temperature Accelerated Stability Test Result Table)

[0032]

[0033] Table 4 Experiment 2 (Constant Temperature Accelerated Stability Test Result Table)

[0034]

[0035] Table 5 Experiment 3 (Constant Temperature Accelerated Stability Test Result Table)

[0036]

[0037] Statistically go up t...

experiment example 3

[0044] Experimental example 3: Experimental study on the effect of hydroxypropyl-β-cyclodextrin as a solubilizer for Houttuynia cordata injection on hemolysis

[0045] Take 10ml of rabbit blood, put it in a 20ml centrifuge tube, stir it with a cotton swab to remove the fiber, wash the plasma with normal saline until the supernatant is colorless, pour off the supernatant; take 2ml from it and put it in a 100ml volumetric flask, add normal saline to 100ml, Mix well and set aside.

[0046] Prepare different samples according to Table 7, put them in a 10ml centrifuge tube, mix well, put them in a culture incubator, place them at 37±1°C for 1 hour, take them out, and observe whether there is coagulation of the lower layer and hemolysis. Put the centrifuge tube in a centrifuge and centrifuge for 1 minute, take the supernatant, measure the absorbance with ultraviolet spectrophotometry (the maximum absorption wavelength is 550nm), compare the absorbance of the supernatant in each tube...

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Abstract

The invention discloses a preparation method and quality control method of heartleaf houttuynia herb injection. The preparation method of the injection comprises the following steps: distilling whole plant of fresh heartleaf houttuynia herb with steam; collecting initial distillate; re-distilling to collecting re-distillate; adding an osmotic pressure regulating agent and a beta-cyclodextrin derivative; regulating the pH value; filtering; encapsulating; and sterializing to prepare the injection. According to the preparation, preparation of the heartleaf houttuynia herb injection without tween-80 is realized for the first time, the prepared heartleaf houttuynia herb injection does not have haemolysis, has high concentration of effective components, can be used for intramuscular injection or intravenous drip, and is safer in use and better in stability. The quality control method comprises a method of identifying methylnnonylketone and decanoyl acetaldehyde and a method of detecting the content of the methylnnonylketone, so that the product quality can be effectively controlled.

Description

technical field [0001] The invention relates to a preparation method and a quality control method of an injection, in particular to a preparation method and a quality control method of a Houttuynia cordata injection containing a β-cyclodextrin derivative, which belongs to the field of medical technology. This application is Divisional application of Patent No. 200410037630.2. Background technique [0002] The current production method of Houttuynia cordata injection is to take fresh whole herb of Houttuynia cordata for steam distillation, collect the initial distillate, then redistill, collect the double distillate, add sodium chloride and Tween-80, mix well, It is obtained by adding water for injection to the prepared amount, filtering, potting, and sterilizing. It has antibacterial, antiviral, anti-inflammatory and other effects, can improve the immune function of the body, and belongs to the national medical insurance class A drug. [0003] Houttuynia cordata injection ...

Claims

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Application Information

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IPC IPC(8): A61K36/78A61K9/08A61K47/40G01N30/88A61P29/00A61P31/04A61P31/12A61P37/04
Inventor 徐乃焕何晓丽吴飞驰董绍象袁涛
Owner HUNAN ZHENGQING PHARM GRP CO LTD
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