A kind of Qi Fumai preparation

Abstract

The invention relates to a traditional Chinese medicine preparation, in particular to a preparation for nourishing qi and restoring pulse. The preparation is prepared by an improved method, the method is as follows: extract red ginseng with ethanol; times; the extracts are combined and passed through the D392 resin column until sugar flows out, the effluent is received, concentrated and dried to obtain the extract; the extract is used as the active ingredient of the medicine and prepared into a pharmaceutical preparation.

Description

technical field [0001] The invention relates to a traditional Chinese medicine preparation, in particular to a traditional Chinese medicine injection for treating cardiovascular diseases. Background technique [0002] Yiqi Fumai (freeze-dried) powder injection for injection is a powder injection for injection made from red ginseng, Ophiopogon japonicus and Schisandra chinensis. Chest obstruction and heartache, palpitation, shortness of breath, slight spontaneous sweating pulse. It is clinically used for the prevention and treatment of coronary heart disease, angina pectoris and combined cardiac insufficiency or cardiogenic shock. Obtained the national new drug production approval on December 30, 2006, with the approval number 2006B03342. [0003] After obtaining the production approval document, relevant technical personnel in the company organized technical personnel to carry out trial production according to the declared process. After passing the GMP certification organ...

AI Technical Summary

Problems solved by technology

[0005] 2. Since red ginseng medicinal materials are processed and highly saccharified to form a dense surface, direct extraction with 95% ethanol may cause the saccharified surface to shrink, and only a small amount of ginsenosides in red ginseng can be extracted, even after soaking for 16 hours The post-extraction is also difficult to achieve the purpose, resulting in a decrease in solvent penetration, which is not conducive to extraction

[0006] 3. Due to the traditional process of water extraction or alcohol extraction-alcohol precipitation or water precipitation combined with pH adjustment and impurity removal, it is difficult to completely remove pigments, proteins, tannins and other substances in Chinese herbal medicines. Therefore, it is produced according to the current process. The color of the extract is relatively dark. Due to the lengthy process and the difficulty of process control, it is difficult to ensure the clarity of the extract after water dissolution, which makes the follow-up operation difficult for the preparation and will inevitably increase the difficulty of the preparation process. For Finished products pose a quality risk

[0007] 4. There are many pigments in the extract, which leads to a decrease in the freezing point and increases the difficulty of freeze-drying the preparation

However, the increase of excipients will adversely affect the rapid solubility of freeze-dried preparations, which is not conducive to clinical use

[0008] 5. Meglumine is added to the current preparation process. According to the process analysis, the pH value of the solution will reach about 9.5 after adding meglumine, and it will drop to about 6.5 after boiling for 1 hour. The pH of the preparation liquid will drop significantly, resulting in a significant color of the solution. deepen

[0009] 6. The preparation period is longer

The current extraction process obtains three extracts, which are respectively dissolved-filtered-or carbon-treated and filtered, combined with boiling-refrigerated filtration. The construction period is nearly 2 days, and the workshop temperature is controlled at 18-22°C, which is suitable for the reproduction of bacteria. The lengthy construction period increases the process. The difficulty of control brings quality risks to the finished preparation

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