CN1644047A - Preparation for biological amnion with constant temperature reservation - Google Patents
Preparation for biological amnion with constant temperature reservation Download PDFInfo
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- CN1644047A CN1644047A CN 200410075361 CN200410075361A CN1644047A CN 1644047 A CN1644047 A CN 1644047A CN 200410075361 CN200410075361 CN 200410075361 CN 200410075361 A CN200410075361 A CN 200410075361A CN 1644047 A CN1644047 A CN 1644047A
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- amnion
- bioamnion
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Abstract
A process for preparing the amniotic membrane able to be stored at ordinary temp from placenta includes such steps as washing the raw amniotic membrane taken from placenta, treating it by 0.1-30% glycerin, prefreezing at 0- -56 deg.C for 1-10 hr, vacuum freeze drying at -10- -56 deg.C, packing and sterilizing.
Description
Technical field
But the present invention relates to a kind of preparation method of medicine equipment dressing bioamnion of normal temperature preservation.
Background technology
Amnion is because self exclusive characteristic receives the Chinese scholars concern, amnion is meant human placenta's basement membrane layer, it is the collagen tissue layer of no blood vessel, no cell structure, be rich in IV, collagen type v, basic fibroblast growth factor (BFGF), stem cell factor (HGF), the differentiation, the propagation that epithelial cell are divided a word with a hyphen at the end of a line grow into, promote epithelium play an important role in the epithelium wound healing.Amnion contains various albumen inhibiting factors, brings into play antiinflammatory action by suppressing the corresponding protein enzyme.Also contain simultaneously and suppress cytokine-expressing and regulate Apoptosis composition TGF-β
1, can avoid the collagenous fibres hyperplasia, the prevention adhesion.As a kind of new biomaterial, be widely used in the supplemental treatment of burn wound and ophthalmology disease in recent years both at home and abroad clinically, its curative effect highly significant.From domestic and foreign literature data report, used clinically amnion is fresh amnion, or the amnion that adopts profound hypothermia (80 ℃) to preserve.Fresh amnion often can not guarantee urgent clinical needs, and the amnion holding time that profound hypothermia is preserved is shorter, and transportation is inconvenient.
Summary of the invention
The objective of the invention is to:, but provide the easy normal temperature preservation of a kind of processing method, long shelf-life, convenient transportation, the preparation method of the bioamnion that can meet clinical needs at the problems referred to above.
But the preparation method of the bioamnion that normal temperature of the present invention is preserved is: with the amnion and the chorion blunt separation of placenta, clean, the amniotic epithelial cells layer that obtains is last, with the holder of nitrocellulose filter paper below, make the amnion water content ranges 1%～20% through vacuum drying, promptly get the bioamnion that suits in the normal temperature preservation.
But the preparation method of the bioamnion that normal temperature of the present invention is preserved can carry out freezing processing before vacuum drying.
But the preparation method of the bioamnion that normal temperature of the present invention is preserved is: the amnion of cleaning is handled through the glycerine with 0.1%～30%, put 0 ℃～-56 ℃ pre-freezes in freeze drier operating room 1～10 hour, unlatching condensation chamber refrigeration, make condenser temperature reach-10 ℃～-56 ℃, open vavuum pump, vacuum cooling drying makes the amnion water content reach 1%～20%, pack again, sterilize, get final product.
But the preparation method of the bioamnion that normal temperature of the present invention is preserved, freeze drier operating room optimum temperature range: 0 ℃～-30 ℃, best pre-freeze time range: 1～2 hour, the cold-trap optimum temperature range :-30 ℃～-45 ℃, optimal vacuum pressure 1Pa～40Pa.
The preparation method of bioamnion of the present invention through after the vacuum drying, makes the holding time of amnion extend to 2～3 years amnion, and preservation condition is that normal temperature is preserved.Therefore, transportation easily can meet clinical needs at any time.The present invention adopts boulton process, makes fresh amnion after vacuum drying, at normal temperatures long preservation.Because store method is not subjected to the restriction of temperature, helps amnion dressing large-scale production, preservation, for the eye surface diseases patient provides enough amnion dressing, alleviates clinical pressure.
Embodiment
The present invention is described in detail below in conjunction with embodiment.
Embodiment 1:
Select for use health to cut open the placenta tissue that the puerpera is produced in the palace, antenatal Serological testing is carried out according to relevant national standard, gets rid of hepatitis B, third liver, syphilis and aids.Amnion and chorion blunt separation with placenta, clean, the amniotic epithelial cells layer that obtains with the holder of nitrocellulose filter paper below last, glycerine submergence with 8%, adopt freeze drier, material was put 0 ℃～-30 ℃ pre-freezes in operating room 1～2 hour, open the condensation chamber refrigeration, open vavuum pump when making condenser temperature reach-35 ℃～-45 ℃, vacuum cooling drying 3～8 hours makes vacuum reach 4Pa～20Pa, and dried amnion can be preserved at normal temperatures through vacuum-packed, sterilization.By with electron microscopic observation and SABC test contrast, on the amnion in 1 year of normal temperature preservation and its institutional framework of fresh amnion comparison significant change does not take place.Its biological safety of amnion in 1 year of normal temperature preservation and toughness etc. all can reach requirements for clinical application.
Embodiment 2:
Select for use health to cut open the placenta tissue that the puerpera is produced in the palace, antenatal Serological testing is carried out according to relevant national standard, gets rid of hepatitis B, third liver, syphilis and aids.Amnion and chorion blunt separation with placenta, clean, the amniotic epithelial cells layer that obtains with the holder of nitrocellulose filter paper below last, glycerine submergence with 10%, adopt freeze drier, material was put 0 ℃～-30 ℃ pre-freezes in operating room 1～2 hour, open the condensation chamber refrigeration, open vavuum pump when making condenser temperature reach-10 ℃～-56 ℃, vacuum cooling drying 8 hours makes vacuum reach 4Pa～30Pa, and dried amnion can be preserved at normal temperatures through vacuum-packed, sterilization.
Embodiment 3:
Select for use health to cut open the placenta tissue that the puerpera is produced in the palace, antenatal Serological testing is carried out according to relevant national standard, gets rid of hepatitis B, third liver, syphilis and aids.With the amnion and the chorion blunt separation of placenta, to clean, the amniotic epithelial cells layer that obtains is last, with the holder of nitrocellulose filter paper below, freeze drier is adopted in glycerine submergence with 0.1%, and material is put 0 ℃～-30 ℃ of operating rooms, pre-freeze 2 hours, unlatching condensation chamber refrigeration is opened vavuum pump, vacuum cooling drying 5 hours when making condenser temperature reach-35 ℃～-45 ℃, make vacuum reach 6～30Pa, dried amnion can be preserved at normal temperatures through vacuum-packed, sterilization.
Embodiment 4:
Select for use health to cut open the placenta tissue that the puerpera is produced in the palace, antenatal Serological testing is carried out according to relevant national standard, gets rid of hepatitis B, third liver, syphilis and aids.Amnion and chorion blunt separation with placenta, clean, the amniotic epithelial cells layer that obtains is last, with the holder of nitrocellulose filter paper below, glycerine submergence with 8% is adopted vacuum drier, with material vacuum drying at normal temperatures 5 hours, make vacuum reach 4～20Pa, dried amnion can be preserved at normal temperatures through vacuum-packed, sterilization.
Embodiment 5:
Select for use health to cut open the placenta tissue that the puerpera is produced in the palace, antenatal Serological testing is carried out according to relevant national standard, gets rid of hepatitis B, third liver, syphilis and aids.Amnion and chorion blunt separation with placenta, clean, the amniotic epithelial cells layer that obtains is last, with the holder of nitrocellulose filter paper below, glycerine submergence with 5% is adopted vacuum drier, with material vacuum drying at normal temperatures 10 hours, make vacuum reach 2～10Pa, dried amnion can be preserved at normal temperatures through vacuum-packed, sterilization.
Claims (7)
1. but the preparation method of the bioamnion preserved of a normal temperature, it is characterized in that: with the amnion and the chorion blunt separation of placenta, clean, the amniotic epithelial cells layer that obtains is last, make amnion moisture content content range 1%～20% through vacuum drying, promptly get the bioamnion that suits in the normal temperature preservation.
2. but the preparation method of the bioamnion that normal temperature according to claim 1 is preserved is characterized in that: carried out freezing processing before the amnion vacuum drying.
3. but the preparation method of the bioamnion that normal temperature according to claim 1 and 2 is preserved, it is characterized in that: the amnion of cleaning is handled through the glycerine with 0.1%～30%, put 0 ℃～-56 ℃ pre-freezes in freeze drier operating room 1～10 hour, unlatching condensation chamber refrigeration makes condenser temperature reach-10 ℃～-56 ℃, opens vavuum pump, vacuum cooling drying, make the amnion water content reach 1%～15%, pack again, sterilize, get final product.
4. but the preparation method of the bioamnion that normal temperature according to claim 3 is preserved, it is characterized in that: freeze drier operating room optimum temperature range: 0 ℃～-30 ℃, pre-freeze Best Times scope: 1-2 hour, cold-trap optimum temperature range :-30 ℃～-45 ℃, optimal vacuum pressure 2Pa～15Pa, vacuum cooling drying Best Times scope: 3～10 hours, amnion optimum moisture content scope: 5%～12%.
5. but the preparation method of the bioamnion of preserving according to the described normal temperature of claim 3 is characterized in that: 1～72 hour vacuum cooling drying time.
6. but the preparation method of the bioamnion of preserving according to the described normal temperature of claim 3 is characterized in that: during vacuum cooling drying, and vacuum ranges 1Pa～40Pa.
7. but the preparation method of the bioamnion of preserving according to the described normal temperature of claim 3 is characterized in that: packing, adopt vacuum-packed.
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200410075361 CN1644047A (en) | 2004-08-27 | 2004-08-27 | Preparation for biological amnion with constant temperature reservation |
| PCT/CN2004/001010 WO2005021014A1 (en) | 2003-09-03 | 2004-09-02 | Preparation of biological amnion preservable at room temperature |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200410075361 CN1644047A (en) | 2004-08-27 | 2004-08-27 | Preparation for biological amnion with constant temperature reservation |
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| CN1644047A true CN1644047A (en) | 2005-07-27 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN 200410075361 Pending CN1644047A (en) | 2003-09-03 | 2004-08-27 | Preparation for biological amnion with constant temperature reservation |
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101444202A (en) * | 2007-11-27 | 2009-06-03 | 天津市医药科学研究所 | Fresh amnion preservation fluid, fresh amnion preservation method and application thereof |
| CN101889569A (en) * | 2010-07-23 | 2010-11-24 | 马吉献 | Method for drying and storing biological amnion |
| CN102586175A (en) * | 2011-09-30 | 2012-07-18 | 上海交通大学附属第一人民医院 | Method for culturing human limbal stem cell graft |
| CN105833357A (en) * | 2016-05-09 | 2016-08-10 | 郭迎庆 | Preparation method of biological amniotic membrane easy to preserve |
| CN107296041A (en) * | 2017-07-02 | 2017-10-27 | 江西瑞济生物工程技术股份有限公司 | A kind of fresh amnion preserves liquid and fresh amnion store method and application |
-
2004
- 2004-08-27 CN CN 200410075361 patent/CN1644047A/en active Pending
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101444202A (en) * | 2007-11-27 | 2009-06-03 | 天津市医药科学研究所 | Fresh amnion preservation fluid, fresh amnion preservation method and application thereof |
| CN101889569A (en) * | 2010-07-23 | 2010-11-24 | 马吉献 | Method for drying and storing biological amnion |
| CN101889569B (en) * | 2010-07-23 | 2013-05-22 | 马吉献 | Method for drying and storing biological amnion |
| CN102586175A (en) * | 2011-09-30 | 2012-07-18 | 上海交通大学附属第一人民医院 | Method for culturing human limbal stem cell graft |
| CN105833357A (en) * | 2016-05-09 | 2016-08-10 | 郭迎庆 | Preparation method of biological amniotic membrane easy to preserve |
| CN107296041A (en) * | 2017-07-02 | 2017-10-27 | 江西瑞济生物工程技术股份有限公司 | A kind of fresh amnion preserves liquid and fresh amnion store method and application |
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