A kind of breast patch and its preparation and application method
A technology of patch and breast, applied in the field of breast patch
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Embodiment 1
[0044] The present embodiment breast patch is prepared as follows:
[0045] (1) Tissue pre-treatment: take the small intestinal submucosa tissue material and divide it into specified sizes, remove the lymphoid tissue, rinse with tap water for 3 times, and then rinse with purified water until the surface is free of stains, place the washed small intestinal submucosa tissue material in Put it on a water filter device such as a strainer, let it stand for more than 5 minutes, and drain the water.
[0046] (2) virus inactivation: adopt peracetic acid-ethanol solution to soak small intestinal submucosa tissue material, this process can be carried out in stainless steel barrel, peracetic acid concentration (volume percentage) adopts 0.1%, ethanol concentration (volume percentage) adopts 5 %, the inactivation time is 2 hours, the ratio (volume ratio) of the solution to the small intestinal submucosa tissue material is 8:1, and the temperature range is 20°C; times, the volume ratio of...
Embodiment 2
[0056] Carry out performance test to sample in embodiment 1, test item and result are as follows:
[0057] 1) DNA residue: According to the fourth part of the biological agent residual DNA detection method "Chinese Pharmacopoeia" 2015 edition, the fluorescence staining method was used to detect the DNA residue of the sample provided in Example 1, and the result: the DNA residue of the sample provided in Example 1 The amount is less than 3.64±0.96ng / mg.
[0058] 2) Clearance rate of galactosidase (α-Gal): Take 2mg each of animal-derived biological material Gal positive reference substance and Gal antigen negative reference substance, add 1ml of lysate, lyse for 30-90min, and prepare 20, 10, 5 , 2.5, 1.25, and 0.625 μg of Gal standard curve samples, take 50 mg of each test product before and after immunogen removal, add 2 ml of lysate, and lyse for 30-90 min; take the supernatant after the lysate reacts with M86 antibody, add 96 Orifice plate, add secondary antibody, add color ...
Embodiment 3
[0071] Biocompatibility experiments were carried out on the samples in Example 1, and the detection items included: pyrogen, cytotoxicity, delayed hypersensitivity reaction, intradermal reaction, acute systemic toxicity, Ames test, mouse lymphoma cell mutation test, chromosomal aberration , implantation, subchronic toxicity.
[0072] 1) Pyrogen
[0073] The test solution was prepared according to the ratio of extraction medium at a mass ratio of 1:5, 37±1°C, 72±2hr, extraction medium: normal saline. According to the method specified in GB / T 14233.2-2005, the product has no pyrogen reaction.
[0074] 2) Cytotoxicity
[0075] Prepare the test solution according to the ratio of extraction medium with a mass ratio of 1:5, 37±1°C, 24±2hr, extraction medium: MEM medium containing serum. Take the test solution and carry out the test according to the test method specified in GB / T16886.5-2003, and the result is that the cytotoxic reaction of the product is not greater than grade 1. ...
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