Nuclear magnetic resonance quality control method for ginseng and astragalus strengthening injection
A quality control method, Shenqi Fuzheng technology, applied in the direction of nuclear magnetic resonance analysis, etc., can solve the problems of undetectable organic acids and sugar compounds, loss of large water-soluble components, cumbersome operation, etc. The method is simple and easy to implement , Strong specificity, high precision effect
Active Publication Date: 2014-06-25
LI MIN PHARM FAB OF LIVZON PHARM GRP +1
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Problems solved by technology
Although the method described in the patent application publication has many advantages, there are still deficiencies. The use of high performance liquid chromatography (HPLC) analysis method to study natural products requires pretreatments such as extraction and refining, and the operation is more loaded down with trivial details, and low efficiency
Moreover, during the separation process of the ODS chromatographic column, the loss of the relatively large water-soluble components is eliminated.
Therefore, the HPLC fingerprint technique cannot detect the amino acids, organic acids and carbohydrates in Shenqi Fuzheng Injection
Method used
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Embodiment 1
[0035] Embodiment 1: Shenqi Fuzheng Injection 1 Establishment of H-NMR Standard Fingerprint
[0036] 1.1 Instruments and reagents
[0037] BRUKER AVANCE III600 superconducting nuclear magnetic resonance spectrometer, proton excitation frequency 600.23MHz, equipped with BBFO normal phase observation broadband probe and BVT3200 digital temperature controller. American Wilmad WG-5000 NMR sample tube. D. 2 0 deuterium degree>99.8%, American Norell company. 3-(Trimethylsilyl)propionic acid-d4 sodium salt (TSP) deuteration degree>98%, Sigma-Aldrich company. Ten batches of Shenqi Fuzheng Injection (1109539, 1105304, 1104244, 1012733B, 1012732B, 0910522, 0910521, 0808002, 0808001, 0709299) were provided by Limin Pharmaceutical Factory of Livzon Group.
[0038] 1.2 Preparation of Shenqi Fuzheng Injection Test Sample Solution
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The invention provides a method of controlling the quality of amino acids, organic acids and sugars in a ginseng and astragalus strengthening injection by combining a proton nuclear magnetic resonance fingerprint with the content determination of a plurality of ingredients. A quality control method aiming at the amino acids, the organic acids and sugar compounds in the ginseng and astragalus strengthening injection is built by adopting a qualitative and quantitative nuclear magnetic resonance fingerprint technique, and can be combined with a high-performance liquid chromatography (HPLC) fingerprint in industrial production. Thus, total quantity control on the ginseng and astragalus strengthening injection product is achieved.
Description
technical field [0001] The invention relates to a quality control method of Shenqi Fuzheng Injection, in particular to controlling the quality of amino acids, organic acids and carbohydrates in Shenqi Fuzheng Injection by using proton nuclear magnetic resonance fingerprints combined with multi-component content determination. Background technique [0002] Shenqi Fuzheng Injection is Shenqi Fuzheng Injection, a new national second-class traditional Chinese medicine successfully developed by Limin Pharmaceutical Factory of Livzon Group. Official production approval. Shenqi Fuzheng Injection is a compound preparation composed of traditional qi-invigorating drugs Codonopsis pilosula and Astragalus membranaceus. It has the effect of nourishing qi and strengthening the body. It is used for fatigue, fatigue, lack of qi, lazy speech, spontaneous sweating and dizziness caused by deficiency of lung and qi. For lung cancer and gastric cancer, see the above Adjuvant therapy for symptom...
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IPC IPC(8): G01N24/08
Inventor 曹晖姜苗苗许磊黄文华刘东来谢海燕
Owner LI MIN PHARM FAB OF LIVZON PHARM GRP
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