Freeze-dried vaccine protective agent, freeze-dried varicella attenuated live vaccine and preparation methods of freeze-dried vaccine protective agent and freeze-dried varicella attenuated live vaccine
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A technology of freeze-dried protective agent and live attenuated vaccine, which is applied in the field of vaccine production and preparation technology, can solve the problems of hidden safety hazards in vaccine administration, and achieve the effects of low bovine serum albumin residue, stable virus titer, and less allergic reaction
Active Publication Date: 2015-01-07
陈安明
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Problems solved by technology
[0005] In order to solve the problem that the existing varicella vaccine lyoprotectant contains gelatin, or contains dextran although the gelatin has been removed, and some formulas still contain human albumin, so that there are still potential hidden dangers in the
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Embodiment 1
[0026] Example 1 Preparation of vaccine lyoprotectant
[0027]According to the proportion of trehalose 75g / l, sodium glutamate 10g / l, urea 5g / l, L-arginine 2g / l, 199 culture medium 9.9g / l, weigh each material, fully dissolve in appropriate amount of sterile injection After watering, dilute to volume, use 1N hydrochloric acid to adjust the pH value to 7.3, sterilize and filter to get ready; store at 2-8°C for later use, and the validity period is 12 months.
Embodiment 2
[0028] Example 2 Preparation of vaccine lyoprotectant
[0029] According to the ratio of trehalose 50g / l, sodium glutamate 15g / l, urea 8g / l, L-arginine 2g / l, 199 culture medium 9.9g / l, weigh each material, fully dissolve in appropriate amount of sterile injection After watering, dilute to volume, use 1N hydrochloric acid to adjust the pH value to 7.2, sterilize and filter to get ready; store at 2-8°C for later use, and the validity period is 12 months.
Embodiment 3
[0030] Example 3 Preparation of Vaccine Lyoprotectant
[0031] According to the proportion of trehalose 100g / l, sodium glutamate 5g / l, urea 2g / l, L-arginine 2g / l, 199 culture medium 9.9g / l, weigh each material, fully dissolve in appropriate amount of sterile injection After watering, dilute to volume, use 1N hydrochloric acid to adjust the pH value to 7.4, sterilize and filter to get ready; store at 2-8°C for later use, and the validity period is 12 months.
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Abstract
The invention discloses a freeze-dried vaccine protective agent, a freeze-dried varicella attenuated live vaccine and preparation methods of the freeze-dried vaccine protective agent and the freeze-dried varicella attenuated live vaccine, belongs to the field of vaccine production and preparation processes, and solves the problem that an existing freeze-dried vaccine protective agent of a varicella vaccine contains gelatin, or contains dextranum and still contains human serum albumin even if the gelatin is removed, so that a potential hazard still exists in the safety of medication of the vaccine. The freeze-dried vaccine protective agent contains mycose, sodium glutamate, urea, L-arginine and a 199 culture medium, and does not contain macromolecular allergen ingredients such as gelatin, dextranum and human serum albumin; the bacterial endotoxin content is low; the varicella vaccine prepared by using the protective agent is low in endotoxin content and residual content of bovine serum albumin and antibiotics, good in stability, safe and effective; the main point is direct infection after passage; the cells are cleaned in the next day after infection, and are replaced with a serum-free maintenance fluid; the operation is simple; the cost is low; regular and uniform formation of cytopathy is facilitated; and the residual content of the bovine serum albumin can be greatly lowered.
Description
technical field [0001] The invention belongs to the technical field of vaccine production and preparation technology, and in particular relates to a vaccine freeze-drying protectant, a freeze-dried live attenuated varicella vaccine and a preparation method thereof. Background technique [0002] Varicella (chickenpox) is a common highly contagious disease in childhood, which is mainly transmitted through air droplets and contact. After recovery from the initial infection, latent infection is common, and reactivation of the latent virus can cause herpes zoster. The clinical features of chickenpox are rashes on the skin and mucous membranes of the whole body in batches, and maculopapular rashes, papules, herpes and scabs exist at the same time. 96% of the cases have obvious clinical symptoms, and only 4% are subclinical infections. In the temperate regions of the northern hemisphere, it is easy to The secondary infection rate of close family contact of infected persons is close...
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