Method for preparing and extracting thymosin as well as product of thymosin medication safety
A technology of thymosin and thymus, applied in the field of polypeptide/protein, can solve the problems of complex composition of thymosin and large adverse reactions, and achieve the effects of increasing preparation time, less equipment, less modification, and improved safety.
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Embodiment 1
[0028] Embodiment 1, the preparation of thymosin of the present invention
[0029] The initial steps are prepared according to the method described in Chinese Patent No. 02117757. An exemplary preparation method is: take 1 kg of fresh thymus, add 2000 ml of 0.05M citric acid-sodium citrate buffer solution with pH 3.2, use ultrasonic disruption for 3 minutes at a temperature below 4°C x 3 times to check that there are no intact cells, extract thymosin and stir For 15 minutes, heat to 80°C with microwave (5 minutes), quickly cool with ice-salt water to below 10°C, refrigerate and centrifuge to obtain 2500ml of centrifugate, perform ultrafiltration with an ultrafiltration column with a molecular weight cut-off of 10,000, and then filter the filtrate through nanofiltration Concentrate to 300ml, which is the crude product of thymosin. The above batches of fresh thymus are thymus from different sources, including calf thymus and pig thymus from Northeast China, Shandong, and Inner ...
Embodiment 2
[0032] Embodiment two, the pharmacodynamic test of different products
[0033] According to the conventional method of hydrocortisone modeling, the influence of different batches of thymosin on the formation rate of mouse E rosette was detected, and the HPLC detection prepared according to Example 1 was performed regardless of whether there was peak 2 in the HPLC detection. The E rosette formation rate of the corresponding batch of thymosin crude product without peak 2 is 12.18 ± 0.31%, while the E rosette formation rate of the corresponding batch of thymosin crude product with peak 2 in the HPLC detection prepared according to Example 1 It is 12.05±0.37%, the effects of the two are basically the same, there is no significant difference. This shows that whether there is a component corresponding to peak 2 in thymosin has no effect on thymosin exerting its medicinal effect.
Embodiment 3
[0034] Example 3, the safety results of different products
[0035] The thymosin prepared according to Example 1, regardless of whether there is an ingredient corresponding to peak 2, its injection can pass the current safety test of CFDA.
[0036] However, according to the long-term feedback statistics of our company's sales staff to the user units (hospitals), during 2003 to 2011, adverse reactions (including nausea, vomiting, diarrhea) that occurred after using the injection of thymosin prepared in accordance with Example 1 , cyanosis of the lips and / or skin, pale complexion, shortness of breath, bone and / or muscle pain, herpes and / or rash, fever and headache), 39.2% of them used the corresponding batches without peak 2 detected by HPLC Of those, 60.8% were from the corresponding batch that had peak 2 detected by HPLC. Considering that the batches in which peak 2 appeared only accounted for 17.4% of the total batches, the possibility of adverse reactions caused by the corr...
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