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Quality control method of Shangke bone-knitting medicine

A quality control method and drug technology, which is applied in the direction of drug combinations, pharmaceutical formulas, medical preparations containing active ingredients, etc., can solve the problems of inappropriate qualitative identification of Panax notoginseng, different identification methods, and inability to guarantee the accuracy of content determination, etc.

Inactive Publication Date: 2008-10-08
大连美罗中药厂有限公司
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Problems solved by technology

But there are some deficiencies in this quality control method, as: (1) in the Panax notoginseng TLC identification, the sample sampling amount is large; Experiment according to the disclosed method, the result: in the chromatogram of the notoginseng negative control solution, there is interference at the position corresponding to ginsenoside Rg1; and in the sample chromatogram, at the position corresponding to notoginsenoside R1, there is unseparated There are multiple spots, and it is impossible to determine whether there are corresponding spots, so it is not suitable for qualitative identification of Panax notoginseng, see attached figure 2 (2) frankincense is an imported medicinal material, and the frankincense composition of different varieties is different, so the corresponding identification method is also different, so the identification method of this medicinal taste in the preparation should not be the same
According to the content disclosed in this public document, it is impossible to determine the type of frankincense used in the control medicinal material, so it is impossible to select the corresponding control medicinal material for identification test
In addition, the extraction of sample in this method is to adopt ether sonication for 20 minutes, the pollution is too large, can't operate (because of the low boiling point of ether is volatile); The amount of the reference substance taken is inappropriate, far exceeding the upper limit of the sample content established by it, which will increase the measurement error; after the sample pretreatment, the residue cannot be completely dissolved with the mobile phase, so it cannot be quantitatively transferred for content determination; (4) mercury sulfide in cinnabar The content determination method has defects such as low detection sensitivity, long inspection period, incomplete chemical reaction of the sample, and easy to cause inspection errors. For example, ① the sample sampling volume is 10g, and only 50ml of sulfuric acid is used. The traditional Chinese medicine powder has the characteristics of light weight and large volume. The sampling volume is too large and the infiltration is not complete, which will lead to low measurement results; ②The Kjeldahl flask is used as the container in this method, and it has not been transferred to other suitable containers from the beginning to the end. This container is not suitable for chemical titration operations; ③According to its inspection method "Add 50ml of sulfuric acid and 5g of potassium nitrate, heat to dissolve..." In fact, the above-mentioned dissolved state cannot be achieved, and it is not operable
Therefore, the accuracy of the content determination cannot be guaranteed

Method used

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  • Quality control method of Shangke bone-knitting medicine
  • Quality control method of Shangke bone-knitting medicine
  • Quality control method of Shangke bone-knitting medicine

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0100] Example 1 Quality Control Method of Traumatology Bone-synthetic Medicine

[0101] The weight proportion of each crude drug in the described traumatology osteosynthesis medicine:

[0102] 6 parts of safflower, 20 parts of ground beetle, 5 parts of cinnabar

[0103] Nyx powder 10 parts Sunburned myrrh 2 parts Panax notoginseng 40 parts

[0104] 20 parts of roasted starfish 20 parts of roasted chicken bone 1 part of icicles

[0105] 10 parts of calcined natural copper, 2 parts of roasted frankincense, 2 parts of melon seeds

[0106] Character identification: For tablets: the product core is taupe to tan; taste bitter, fishy; for capsules: the product content is light brown to brown; Brown; bitter, fishy.

[0107] Microscopic identification: Take the medicine of the present invention and observe under a microscope: the pollen grains are round or oval, with a diameter of 43-66 μm, with tooth-like protrusions on the outer wall and 3 germination holes; the resin canal frag...

Embodiment 2

[0118] Example 2 Quality Control Method of Traumatology Bone Set Medicine

[0119] In addition to the content described in the above-mentioned embodiment 1, the following content is also included:

[0120] Identification of Nuxseed Powder

[0121] Get 4.0g of the pharmaceutical powder of the present invention, add 10:1 chloroform-ethanol mixed solution 15ml and concentrated ammonia water test solution 1.5ml, close up, ultrasonic treatment 20 minutes (160w, 50kHz), filter, and filtrate is as need testing sample Solution; Get strychnine and strychnine reference substance in addition, add chloroform to make the mixed solution that each 1ml contains 2mg, as reference substance solution; According to thin layer chromatography (Chinese Pharmacopoeia 2005 edition one, appendix VI B) For the test, draw 15 μl of the above-mentioned test solution and 5 μl of the reference solution, and place them on the same silica gel G thin-layer plate with sodium carboxymethylcellulose as a binder, ...

Embodiment 3

[0124] Example 3 Quality Control Method of Traumatology Bone Set Medicine

[0125] Except the content described in embodiment 2, also comprise the identification of starfish, specifically as follows:

[0126] Extraction method: Take 2.0g of the drug powder of the present invention and 0.5g of the starfish reference medicinal material, add 6ml of hot water respectively, cover with plastic wrap, cook at 100°C for 30min, let cool and then centrifuge at 4000rpm for 20 minutes, take 10μl of the supernatant; according to electrophoresis Method (Chinese Pharmacopoeia 2005 edition three, appendix IV C) test, carry out SDS-polyacrylamide gel electrophoresis according to the following electrophoresis conditions, promptly obtain; The same protein band appears on the corresponding position of test sample and contrast medicinal material;

[0127] The electrophoresis conditions described therein are: separating gel: 12.5%; stacking gel: 5%; constant current: 30mA; voltage: 200V; electrophor...

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Abstract

The invention discloses a quality control method for orthopedics-traumatology coaptation. The method adopts TLC to carry out qualitative identification for notoginseng, borneol, safflower and Nux vomica powder and uses electrophoresis for carrying out qualitative identification for starfish. HPLC and GC are respectively adopted to carry out quantitative identification for strychnine and the borneol. Chemical titration is adopted to carry out quantitative identification for mercury sulfide. Therefore, the quality control scope of the orthopedics-traumatology coaptation is enlarged. The quality control method for orthopedics-traumatology coaptation is easy to be practiced and has strong specialization. In addition, the quantitative identification has high precision and good repeatability, thus ensuring that the quality of compound medicine is uniform, stable, effective and controllable.

Description

technical field [0001] The invention relates to a quality control method of traditional Chinese medicine preparations, in particular to a quality control method of traditional Chinese medicine for traumatology and osteosynthesis. Background technique [0002] Drugs should be safe, effective, stable and controllable. Perfect quality control standards can ensure the reliability and uniformity of drug quality. The medicine of the present invention is composed of safflower, ground beetle, cinnabar, nuxychnium powder, sunburned myrrh, panax notoginseng, starfish, chicken bone, borneol, calcined natural copper, frankincense, and melon seeds, and has the function of promoting blood circulation. Removing blood stasis, reducing swelling and relieving pain, relaxing tendons and strengthening bones. It is used for bruises, flashbacks, broken bones, blood stasis, swelling and pain, redness and swelling of injuries, etc. It has a good therapeutic effect. [0003] In the Chinese patent...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/56A61P19/08G01N30/26G01N30/90G01N27/447A61K31/045A61K33/26A61K33/28A61K35/32A61K35/56A61K35/64A61K35/57A61K35/616
Inventor 张成海罗国良周文波陈心李晓艳李延成姜伟
Owner 大连美罗中药厂有限公司
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