RU2012134269A - Сухая стекловидная композиция, содержащая биологически активный материал - Google Patents
Сухая стекловидная композиция, содержащая биологически активный материал Download PDFInfo
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- RU2012134269A RU2012134269A RU2012134269/10A RU2012134269A RU2012134269A RU 2012134269 A RU2012134269 A RU 2012134269A RU 2012134269/10 A RU2012134269/10 A RU 2012134269/10A RU 2012134269 A RU2012134269 A RU 2012134269A RU 2012134269 A RU2012134269 A RU 2012134269A
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Abstract
1. Композиция, содержащая биологически активный материал, по меньшей мере один агент, формирующий матрицу, и по меньшей мере два стеклообразующих агента.2. Композиция по п.1, представляющая собой сухую стекловидную композицию, содержащую биологически активный материал.3. Композиция по п.1 с общим содержанием твердых веществ в пределах от примерно 30 массовых процентов до примерно 70 массовых процентов.4. Композиция по п.1, где биологически активный материал включает клетку, микроб, вирус, культуру клеток, бактерию, пробиотическую бактерию, растительную и почвенную пробиотическую бактерию, дрожжи, белок, рекомбинантный белок, фермент, пептид, гормон, вакцину, лекарственное средство, антибиотик, витамин, каротеноид, минерал, микробиоцид, фунгицид, гербицид, инсектицид или спермицид.5. Композиция по п.1, где агент, формирующий матрицу, представляет собой полисахарид, выбранный из группы, состоящей из ацетофталата целлюлозы (САР), карбоксиметилцеллюлозы, пектина, альгината натрия, солей альгиновой кислоты, гидроксипропилметилцеллюлозы (НРМС), метилцеллюлозы, каррагинана, гуаровой камеди, аравийской камеди, ксантановой камеди, камеди из плодов рожкового дерева, хитозана и производных хитозана, крахмалов и модифицированных крахмалов, циклодекстринов, инулина, мальтодекстринов, декстранов и их комбинаций.6. Композиция по п.1, где агент, формирующий матрицу, присутствует в количестве в пределах от примерно 1 массового процента до примерно 20 массовых процентов.7. Композиция по п.1, где стеклообразующие агенты легко растворяются в растворе и не сгущаются или не полимеризуются при контакте с водой и не образуют кристаллы в проце�
Claims (20)
1. Композиция, содержащая биологически активный материал, по меньшей мере один агент, формирующий матрицу, и по меньшей мере два стеклообразующих агента.
2. Композиция по п.1, представляющая собой сухую стекловидную композицию, содержащую биологически активный материал.
3. Композиция по п.1 с общим содержанием твердых веществ в пределах от примерно 30 массовых процентов до примерно 70 массовых процентов.
4. Композиция по п.1, где биологически активный материал включает клетку, микроб, вирус, культуру клеток, бактерию, пробиотическую бактерию, растительную и почвенную пробиотическую бактерию, дрожжи, белок, рекомбинантный белок, фермент, пептид, гормон, вакцину, лекарственное средство, антибиотик, витамин, каротеноид, минерал, микробиоцид, фунгицид, гербицид, инсектицид или спермицид.
5. Композиция по п.1, где агент, формирующий матрицу, представляет собой полисахарид, выбранный из группы, состоящей из ацетофталата целлюлозы (САР), карбоксиметилцеллюлозы, пектина, альгината натрия, солей альгиновой кислоты, гидроксипропилметилцеллюлозы (НРМС), метилцеллюлозы, каррагинана, гуаровой камеди, аравийской камеди, ксантановой камеди, камеди из плодов рожкового дерева, хитозана и производных хитозана, крахмалов и модифицированных крахмалов, циклодекстринов, инулина, мальтодекстринов, декстранов и их комбинаций.
6. Композиция по п.1, где агент, формирующий матрицу, присутствует в количестве в пределах от примерно 1 массового процента до примерно 20 массовых процентов.
7. Композиция по п.1, где стеклообразующие агенты легко растворяются в растворе и не сгущаются или не полимеризуются при контакте с водой и не образуют кристаллы в процессе сушки.
8. Композиция по п.1, где стеклообразующие агенты представляют собой белки, такие как бычий сывоточный альбумин и сывороточный альбумин человека, яичный альбумин, желатин, иммуноглобулины, выделенный соевый белок, пшеничный белок, сухое обезжиренное молоко, казеинат, белок молочной сыворотки, гороховый белок и любые белковые гидролизаты; углеводы, включая моносахариды (галактозу, D-маннозу, сорбозу и т.д.), дисахариды, включая лактозу, трегалозу, сахарозу и т.д.; аминокислоту, такую как лизин, глутамат натрия, глицин, аланин, аргинин или гистидин, а также гидрофобные аминокислоты (триптофан, тирозин, лейцин, фенилаланин и т.д.); метиламин, такой как бетаин; полиол, такой как трехатомные спирты или сахарные спирты высшей атомности, например глицерин, эритрит, глицерол, арабит, ксилит, сорбит, маннит и изомальт; пропиленгликоль; полиэтиленгликоль; поверхностно-активные вещества, такие как сложные эфиры жирных кислот и Сахаров, и фосфолипиды, такие как лецитин; и их комбинации.
9. Композиция по п.1, где стеклообразующие агенты присутствуют в композиции в количестве в пределах от примерно 1 массового процента до примерно 80 массовых процентов.
10. Способ получения композиции по п.1 в форме стабильного сухого порошка, включающий объединение биологически активного материала, агента, формирующего матрицу, и двух стеклообразующих агентов в водном растворителе с образованием вязкой суспензии; быстрое замораживание суспензии в жидком азоте с образованием твердых замороженных гранул, капельных частиц или нитей; продувка твердых замороженных частиц под вакуумом и при температуре ниже точки замерзания композиции; стадию первичной жидкостной сушки композиции путем выпаривания под вакуумом при температуре композиции выше ее температуры замерзания; вторичную сушку композиции при полном вакууме и при температуре 20°С или выше в течение периода времени, достаточного для снижения активности воды композиции до Aw 0,3 или ниже.
11. Способ получения композиции по п.1, включающий приготовление вязкой суспензии, содержащей биологически активный материал, по меньшей мере один агент, формирующий матрицу, и по меньшей мере два стеклообразующих агента; быстрое замораживание суспензии в жидком азоте с образованием аморфной структуры замороженных частиц в форме нитей, капельных частиц, гранул или микрогранул; снижение давления на замороженные частицы до значения ниже 2000 мторр (266,6 Па) в течение менее 30 минут; подъем давления до значения более 2000 мторр и нагревание от 20°С до 70°С для ускорения дегидратации композиции.
12. Способ по п.11, где перед сушкой композицию быстро замораживают до температуры ниже ее температуры замерзания.
13. Способ по п.11, где первичную сушку осуществляют путем выпаривания.
14. Способ по п.11, где первичную сушку осуществляют путем лиофилизации.
15. Способ по п.11, где стадию вторичной сушки ускоряют путем увеличения температуры и/или вакуумметрического давления.
16. Способ по п.11, где композицию сушат в течение периода времени, достаточного для снижения активности воды композиции до Aw 0,3 или менее.
17. Способ по п.11, где высушенную композицию режут, дробят, измельчают или соответствующим образом распыляют в сыпучий порошок.
18. Способ по п.17, где размер частиц высушенной композиции составляет менее чем примерно 1000 мкм.
19. Способ по п.11, дополнительно включающий введение композиции животным и растениям в виде в виде восстановленной жидкости или в виде измельченного порошка и в качестве пищевого или кормового продукта.
20. Способ по п.11, дополнительно включающий смешивание композиции с компонентом, выбранным из группы, состоящей из детской молочной смеси, энергетических напитков и корма для домашних животных; и введение младенцам человека, взрослым людям, животным или растениям.
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CN102725393B (zh) | 2015-12-02 |
AR125029A2 (es) | 2023-05-31 |
RU2535869C2 (ru) | 2014-12-20 |
PL2529004T3 (pl) | 2017-12-29 |
JP2013517801A (ja) | 2013-05-20 |
DK2529004T3 (en) | 2017-09-25 |
BR112012018839A2 (pt) | 2015-09-15 |
US8834951B2 (en) | 2014-09-16 |
US20150031544A1 (en) | 2015-01-29 |
MX2012008795A (es) | 2012-08-17 |
US20120322663A1 (en) | 2012-12-20 |
EP2529004A2 (en) | 2012-12-05 |
ES2639397T3 (es) | 2017-10-26 |
SG182317A1 (en) | 2012-08-30 |
JP5886763B2 (ja) | 2016-03-16 |
CN102725393A (zh) | 2012-10-10 |
BR112012018839B1 (pt) | 2020-04-14 |
CA2785815C (en) | 2018-04-24 |
WO2011094469A2 (en) | 2011-08-04 |
MX336076B (es) | 2016-01-07 |
AR080073A1 (es) | 2012-03-14 |
CA2785815A1 (en) | 2011-08-04 |
WO2011094469A3 (en) | 2011-12-29 |
EP2529004B1 (en) | 2017-06-07 |
US9731020B2 (en) | 2017-08-15 |
EP2529004A4 (en) | 2013-10-23 |
NZ601017A (en) | 2014-07-25 |
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