Qi tonifying and pulse restoring preparation

A technology for replenishing qi and rejuvenating the pulse and preparations, which is applied to medical preparations containing active ingredients, powder transportation, and freeze-drying transportation. Improve product quality and reduce the risk of contamination

Active Publication Date: 2013-03-27
TIANJIN TASLY ZHIJIAO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0058] Yiqi Fumai freeze-dried preparation for injection,

[0059] The prescription is as follows:

[0060]

[0061] Step 1, red ginseng is extracted three times with 90% ethanol under reflux, and 90% ethanol is added to be 8, 6, and 6 times respectively; the first and second times are respectively 3 hours, and the third time is 2 hours, the extracts are combined, and the ethanol is recovered under reduced pressure Add water to about 500ml until there is no alcohol smell, put it in cold place, separate and remove the upper layer of oil, boil the water layer until it is close to boiling, add 0.5% activated carbon of the amount of red ginseng medicinal materials, boil for 5 minutes, filter while it is hot to remove charcoal, and set aside the filtrate;

[0062] Step 2, decoct Ophiopogon japonicus and Schisandra chinensis with water for three times respectively, the amount of water added to Ophiopogon japonicus and Schisandra chinensis is 5, 4, 4 times and 7, 6, 6 times respec...

Embodiment 2

[0067] Yiqi Fumai freeze-dried preparation for injection,

[0068] The prescription is as follows:

[0069]

[0070] Step 1, red ginseng is extracted twice with 86% ethanol under reflux, and 86% ethanol is added for 8, 6 times respectively; the first time and the second time are 2 hours respectively, the extracts are combined, the ethanol is recovered under reduced pressure until there is no alcohol smell, and water is added To about 500ml, cool, separate and remove the upper layer of oil, boil the water layer until nearly boiling, add 0.5% activated carbon of the amount of red ginseng medicinal materials, boil for 5 minutes, filter while hot to remove charcoal, and set aside the filtrate;

[0071] Step 2, add water to decoct Ophiopogon japonicus and Schisandra chinensis respectively for 2 times, add 5, 4, and 7, 6 times of water respectively; the first time is 1 hour, the second time is 45 minutes, and the respective extracts are combined , concentrated under reduced pres...

Embodiment 3

[0076] Yiqi Fumai freeze-dried preparation for injection,

[0077] The prescription is as follows:

[0078]

[0079] Step 1, red ginseng is extracted 4 times with 94% reflux, and 94% ethanol is added for 8, 6, 6, and 6 times respectively; the first and second times are respectively 3 hours, the third and fourth times are 2 hours, and the extracts are combined. Recover ethanol under reduced pressure until there is no alcohol smell, add water to about 500ml, cool, separate and remove the upper layer oil, boil the water layer until it is near boiling, add 0.5% activated carbon of the amount of red ginseng medicinal materials, boil for 5 minutes, filter while hot to remove charcoal, and the filtrate spare;

[0080]Step 2, decoct Ophiopogon japonicus and Schisandra chinensis with water for 4 times respectively, the amount of water added to Ophiopogon japonicus and Schisandra chinensis is 5, 4, 4, 4 times and 7, 6, 6, 6 times respectively; the first time is 1 hour, the second ti...

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Abstract

The invention relates to a traditional Chinese medicinal preparation, and especially relates to a qi tonifying and pulse restoring preparation. The preparation is prepared through an improved method. The method comprises the following steps: 1, extracting Radix Ginseng Rubra by ethanol; 2, extracting Radix Ophiopogonis and Chinese magnoliavine by water, and precipitating twice by ethanol; 3, mixing a Radix Ginseng Rubra extract liquid obtained in step 1, and a Radix Ophiopogonis extract liquid and a Chinese magnoliavine extract liquid obtained in step 2 to obtain a mixed liquid, allowing the mixed liquid to pass through a D392 resin column, receiving the eluant when glucose flows out, concentrating, and drying to obtain extract products; and 4, using the extract products as medicinal active components to prepare the medicinal 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...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/8968A61K9/19A61P9/00A61P9/10
Inventor 杨悦武叶正良兰舒玲周学谦周大铮孙建强
Owner TIANJIN TASLY ZHIJIAO PHARMA
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