Quality control method for ribonucleic acid II for injection

A technology for ribonucleic acid and injection, applied in the field of detection of ribonucleic acid for injection II, which can solve the problems of low specificity and achieve the effects of improving technological content, reducing costs, and expanding production scale

Active Publication Date: 2014-08-20
JILIN AODONG PHARMACEUTICAL INDUSTRY GROUP YANJI CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The identification and content determination in the current quality standard of the drug are all aimed at the total ribonucleic acid, and the specificity is not high
Although the drug has occupied a certain market share, has a large production scale and good sales, the application and approval of the drug was completed in accordance with the requirements of biochemical drugs. Therefore, in terms of the material basis of efficacy and quality control of this drug, there are still some deficiencies and areas that need to be improved in accordance with the requirements of current chemical drugs, the requirements of modernization and internationalization, and the requirements of ensuring the safety and effectiveness of medication.

Method used

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  • Quality control method for ribonucleic acid II for injection
  • Quality control method for ribonucleic acid II for injection
  • Quality control method for ribonucleic acid II for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0052] Embodiment 1, the optimization of high performance liquid chromatography detection ribonucleic acid II conditions for injection

[0053] 1. Confirmation of common peaks in the characteristic spectrum of ribonucleic acid for injection II and identification of common chromatographic peaks

[0054] 1. Liquid chromatography

[0055] (1) Preparation of the test solution

[0056] Accurately weigh 10 batches of ribonucleic acid II powder for injection, 10 mg each, into a 5ml measuring bottle, add 2 mg of nuclease, dissolve in water and set the volume to the mark, hydrolyze in a water bath at 60°C for 1 hour, let cool, make up to the mark with water, and shake well , filtered (0.45μm), and the filtrate was taken to obtain 10 batches of ribonucleic acid II for injection test solution.

[0057] (2) Preparation of reference solution

[0058] Accurately weigh appropriate amounts of cytosine nucleotides, uracil nucleotides, guanosine nucleotides, guanosine, and adenosine, respect...

Embodiment 2

[0154] Embodiment 2, the investigation of the methodology of high performance liquid chromatography detection ribonucleic acid II for injection

[0155] In the present embodiment, the preparation of need testing solution, the preparation of reference substance solution and chromatographic conditions are as follows:

[0156] a) Preparation of the test solution

[0157] Precisely weigh 10mg of ribonucleic acid II powder for injection and place it in a 5ml measuring bottle, add 2mg of nuclease, add water to dissolve and set the volume to the mark, hydrolyze in a water bath at 60°C for 1 hour, let it cool, make up to the mark with water, shake well, and filter (0.45μm), take the continued filtrate, that is.

[0158] b) Preparation of reference solution

[0159] Accurately weigh an appropriate amount of the reference substance, respectively, add water to make a reference substance solution containing 1mg per 1ml, and obtain.

[0160] c) Chromatographic conditions

[0161] Ameri...

Embodiment 3

[0187] Embodiment 3, the application of high performance liquid chromatography detection ribonucleic acid II for injection

[0188] Based on the above-mentioned Example 1 and Example 2, in this example, high-performance liquid chromatography was used to detect 10 batches of ribonucleic acid II for injection, and guanine nucleotide was used as a reference (that is, peak 4 was the reference peak, denoted as S). Calculate the relative peak area and relative retention time of each common peak. In addition, the similarity of 10 batches of ribonucleic acid II for injection was calculated with the software "Similarity Evaluation System of Chromatographic Fingerprint of Traditional Chinese Medicine" (Chinese Medicine Chromatographic Fingerprint Similarity Evaluation System (version 2.0)).

[0189] Wherein, the preparation of need testing solution, the preparation of reference substance solution and chromatographic conditions are as follows:

[0190] a) Preparation of the test solutio...

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Abstract

The invention discloses a quality control method for ribonucleic acid II for injection. The method comprises the following steps that the nucleic acid enzyme hydrolysis solution of a substance to be measured is subjected to high-performance liquid chromatogram analysis, an adopted chromatographic column is an Agilent ZORBAX SB-AQC18 chromatographic column, and a flowing phase is a mixture of a formic acid solution and an acetonitrile solution; after the analysis, if the substance to be measured is determined to contain five substances as follows: cytidylate, uridine monophosphate, guanine nucleotide, guanosine and adenosine, the substance to be measured is the ribonucleic acid II for injection or is the ribonucleic acid II for injection as a candidate; and if not, the substance to be measured is not the ribonucleic acid II for injection or is not the ribonucleic acid II for injection as the candidate. A high-performance liquid chromatographic technique is utilized, and the strong-specificity quality control method for the ribonucleic acid II for injection is established. The method has important meanings on increasing the technological content of the medicine, increasing the safety and effectiveness, reducing the cost, enlarging the production scale, increasing the market occupancy, and going forward to the international market.

Description

technical field [0001] The invention belongs to the field of biotechnology and relates to a method for detecting ribonucleic acid II for injection. Background technique [0002] "Ribonucleic acid for injection II" (BP element) is independently developed by Jilin Aodong Pharmaceutical Group Yanji Co., Ltd. by applying modern bioengineering technology, and has independent intellectual property rights in the field of biopharmaceuticals in my country. In 2002, after review by experts from the State Food and Drug Administration, it exclusively obtained the approval number of "Ribonucleic Acid for Injection II". This product is an immunomodulatory drug extracted from healthy bovine pancreas by applying modern bioengineering technology. It is suitable for adjuvant therapy of pancreatic cancer, liver cancer, gastric cancer, lung cancer, breast cancer, soft tissue sarcoma and other cancers. The adjuvant treatment of hepatitis also has a good effect; it can also be used for various d...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02G01N30/36
Inventor 高其品徐多多高阳李秉安刁桂芳
Owner JILIN AODONG PHARMACEUTICAL INDUSTRY GROUP YANJI CO LTD
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