Schisandra chinensis medicinal material and its Shengmai injection preparation using the construction method of hplc fingerprint
A technology of Shengmai injection and fingerprint spectrum, applied in the field of Schisandra chinensis medicinal materials and Shengmai injection preparations, can solve the problems that the quality of Schisandra chinensis cannot be fully reflected, the establishment, and the inability to fully reflect the quality of Shengmai injection.
Active Publication Date: 2020-07-07
YAAN THREE NINE PHARMA
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Problems solved by technology
Schisandra chinensis and Shengmai injection have been used clinically for many years. At present, the content of schisandrin A in Schisandra chinensis is only controlled in the "Chinese Pharmacopoeia", which cannot fully reflect the quality of Schisandra chinensis and Shengmai injection.
Although the establishment of fingerprints is of great significance for effectively controlling the quality of Schisandra chinensis and its preparations, there is no method for constructing fingerprints of Schisandra chinensis and its Shengmai injection preparations. Establishing fingerprints for intravenous injection preparations cannot achieve the purpose of comprehensive quality evaluation of Schisandra chinensis and its preparations
Method used
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Embodiment 1
[0053] Embodiment 1 provides a Schisandra chinensis medicinal material and its Shengmai injection preparation using the construction method of HPLC fingerprint, which is carried out according to the following process:
[0054] The first step, accurately weigh 2g Schisandra chinensis, add 100ml purified water, decoct for 2 hours, filter, collect the subsequent filtrate as the medicinal material test solution; produce according to the Shengmai injection process, and obtain the preparation test solution.
[0055] The second step is to weigh schisandrin A, add methanol and mix to obtain a reference substance solution, and the content of schisandrin A in the reference substance solution is 10 μg / ml.
[0056] The third step is beneficial to the HPLC determination of the chromatographic conditions of the test solution of the medicinal material or the solution of the preparation test solution: Waterssymmetry shield TM RP 18 Chromatographic column, 4.6mm×250mm, 5.0μm; detection wavel...
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The invention discloses a fructus schisandrae chinensis medicine and a pulse-activating injection preparation thereof adopting an HPLC fingerprint spectrum construction method and relates to the fieldof traditional Chinese medicines and preparations. According to the construction method, a fructus schisandrae chinensis medicine test solution or a pulse-activating injection preparation test solution is drawn and injected into a liquid chromatograph for HPLC analysis, and HPLC fingerprint spectrum of the fructus schisandrae chinensis medicine or HPLC fingerprint spectrum of the pulse-activatinginjection preparation is obtained. The analysis method of the fructus schisandrae chinensis medicine and the pulse-activating injection preparation thereof is established to evaluate correlation between the medicine and the preparation, and quality control from the medicine to the preparation is realized. Through establishment of the HPLC fingerprint spectrums of the fructus schisandrae chinensismedicine and the pulse-activating injection preparation thereof, the relative content of main components in the fructus schisandrae chinensis medicine and the preparation thereof is accurately analyzed and determined, the product quality can be effectively and reliably predicted according to the content, so that the quality of the medicine and the correlation between the medicine and the preparation can be evaluated comprehensively.
Description
technical field [0001] The invention relates to the field of detection of traditional Chinese medicines and preparations, and in particular to a Schisandra medicinal material and a Shengmai injection preparation using a method for constructing HPLC fingerprints. Background technique [0002] Schisandra chinensis (Turcz.) Baill. is the dried and mature fruit of Magnolia plant Schisandra chinensis (Turcz.) Baill. Shengmai injection is a traditional Chinese medicine preparation made from red ginseng, Ophiopogon japonicus and Schisandra chinensis. It can be administered by intramuscular injection or intravenous drip. Jue cold, sweating, sudden pulse, myocardial infarction, cardiogenic shock, septic shock, etc. have the above syndromes. Schisandra chinensis and Shengmai injection have been used clinically for many years. At present, the content of schisandrin A in Schisandra chinensis is only controlled in the "Chinese Pharmacopoeia", which cannot fully reflect the quality of Sc...
Claims
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IPC IPC(8): G01N30/88
CPCG01N30/88G01N2030/8809
Inventor 干建伟胡敏董礼韦婷吴建国
Owner YAAN THREE NINE PHARMA