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The titer of heparin sodium will be affected by what factors in the production process
Heparin sodium titer is a very important factor in evaluating the quality of heparin sodium. Everyone knows that the titer unit of heparin sodium refers to the titer amount contained in each milligram of heparin sodium. It is assumed that the value of heparin sodium is 160IU/MG. This means that each milligram of heparin sodium has a titer of 160 IU. Assuming that a 5 ml blood collection tube requires 100 IU of heparin sodium for anticoagulation, the higher the titer, the more heparin sodium is added. However, the sales of heparin sodium are calculated according to the price per gram, which means that the higher the titer, the more expensive the price. Then in the production process, what factors will directly affect the titer of heparin sodium?
First of all, we need to know that the fine heparin sodium is extracted from crude heparin sodium. The crude heparin sodium is salt hydrolyzed by a certain concentration of sodium chloride solution; heated in a water bath at 50 ℃, stirred until all is dissolved, the solution is adjusted to pH 8.0, and added A certain amount of hydrogen peroxide is oxidized and kept at 20°C for several hours. Finally, filter with suction, adjust the pH of the filtrate to 6.5 with hydrochloric acid or sodium hydroxide, add 1 times the volume of the filtrate with 95% ethanol, and perform precipitation at room temperature. Take the precipitate and vacuum dry at 50°C for more than 3 hours to obtain heparin sodium fine product.
As shown in Figure 1, when the concentration of heparin sodium is 2%, the titer of heparin sodium is highest, and when the mass fraction of salt hydrolysis increases or decreases, the titer of heparin sodium decreases. The reason may be that the amount of sodium chloride has a certain effect on the salting-out of heparin or protein. When the concentration is low, the salting-out of heparin sodium is not complete, which makes the titer of heparin sodium low. When the concentration is high, most of the protein is also salted out. The titre of the sodium chloride will be reduced accordingly, so the concentration of sodium chloride cannot be too low or too high.
As shown in Figure 2, when the amount of hydrogen peroxide is 3% of the filtrate integral, the product has the highest potency; when the amount of hydrogen peroxide is 2% of the filtrate integral, the color of the product is slightly yellow and cannot reach the heparin sodium Product quality requirements: The volume fraction is 4%. The hydrogen peroxide titer is low. The reason for the low hydrogen peroxide may be that too much hydrogen peroxide is used, which may damage the structure of heparin sodium, causing partial loss of heparin sodium, resulting in lower potency. Therefore, the best choice for the amount of hydrogen peroxide is 3% by volume.
As shown in Figure 3, the longer the oxidation time, the higher the potency and the better the color of the product. However, if the time is too long, the oxidation will no longer proceed due to the exhaustion of the oxidant, which will lead to a decrease in the titer of heparin sodium, and the process is too time-consuming and the production is uneconomical. If the oxidation time is too short, not only the potency is low, but the color of the product is not ideal. Therefore, the optimal oxidation time is 12 hours, which can not only make the product quality meet the requirements, but also save time and make the process simple.
To sum up, the best conditions for the purification process of heparin sodium are: sodium chloride concentration 2%, oxidant dosage volume fraction 3%, oxidation time 12 h. Desheng is a manufacturer specializing in the production and development of heparin sodium. Generally between 150IU-180IU, all major manufacturers are welcome to consult and purchase.