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Trehalsoe in Pharmaceutical

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Trehalose is a non-reducing disaccharide consisting of two glucose molecules linked by an a, a–1,1 bond.

Trehalose is widely used in pharmaceuticals 

Application of trehalose in the pharmaceutical industry:

(1) in medicine has been applied successfully trehalose alternative as blood products, plasma protein vaccine, lymphocyte, tissue bioactive substances such as stabilizing agent. Can not only under the condition of room temperature dry storage, more important is can prevent blood source pollution caused by the spread of deadly diseases such as hepatitis b, AIDS, attaches great importance to the world health organization.

(2) the Cambridge Quadrant research foundation will polio vaccine mixed with trehalose after lyophilization, found its stability when 45 ? in dry state without becoming dry and liquid when 4 ? storage condition. This project is successful, vaccine will greatly simplify the processing, storage and transportation costs, reduce vaccine and to ensure the long distance transport vaccine still can keep high activity, which will greatly help the world health organization to eliminate polio within the scope of the biggest target.

(3) the United States at the university of California, John? Claudius and his colleagues to mix, trehalose and manufacturing of platelet cells after drying dehydration dry the cell, the lyophilization may be retained for a long time at room temperature. Practice has proved that adding trehalose and after long time preservation of platelets in hydration still has 85% survival, survival rate than most blood bank short-term preservation of platelets.

(4) Trehalsoe in pharmaceutical: the trehalose can be applied to study the preservation of biological reagents, such as various tool enzyme, cell membrane, organelle, antibody, antigen and viruses, etc., makes the life science research is more convenient and effective, the British university Camilo. C and other detailed study of the trehalose of DNA restriction enzyme DNA ligase and DNA polymerase of protection, the results showed that all join trehalose dry enzyme sample, keep 35 days or in 37 ? 70 ? save nine months later, its vitality and no damage, still can accurate DNA truncation. Institute of microbiology of Chinese academy of sciences in China application of trehalose dry preparation, used for determination of serum cholesterol three diagnostic tool enzyme, after long-term storage at room temperature, active rate is over 90%, has been successfully entered in clinical application. This is other kinds of protective agent can't reach the effect, use of trehalose as a diagnostic tool enzyme biological reagents such as stabilizing agent and protective agent, can be at room temperature under the condition of dry and save, not only simplify the preparation process of biological reagents, also gives our country is vast rural areas bring convenience of diagnosis and treatment of the patient's disease.

Bifidobacterium (5) is used to improve the human body in the intestinal microecological balance of bacteria, the bacteria live bifidobacterium preparation as powerful weapon of disease cure, popular in Europe and the United States, Japan and other developed countries. In our country, bacteria live bifidobacterium preparation has gradually become a force of the pharmaceutical industry. Because of bifidobacterium is a kind of living conditions is very demanding of anaerobic bacteria, a slight change of the external environment is easy to cause the death of the bacteria, therefore, how to improve the survival rate of bifidobacteria, the shelf life of products, has always been a technical problem of living bacteria preparation industry. Over the past 2012 years is generally use skim milk as a freeze, but the effect is not very ideal, in the process of storage, the survival rate of bacteria decreased rapidly. 2012 results showed that the trehalose as a protective agent, the survival rate of bifidobacteria than skim milk more than double, is particularly exciting, trehalose can make freeze-dried bifidobacteria remain active for a long time, at room temperature significantly extend the shelf life of living bacteria preparation. In order to solve the living bacteria preparation industry facing the product storage performance is poor, the problem of short shelf life.

(6) applications

1), the preparation of solid from liquid products products

500 g to 500 grams of anhydrous trehalose, made by the above methods 290 g egg yolk powder, skimmed milk powder, 4.4 g of calcium chloride, 1.85 g, 0.01 g sulfur ammonia with potassium element, 0.1 grams of ascorbic acid sodium acetic acid vitamin, 0.6 g and 0.6 g mixes nicotinic acid amine, each take 25 grams into the waterproof aluminum foil bag, heat sealing is good, which made the solid products. Water content, less air bag the product without refrigeration, long-term stability can be stored at room temperature. It has good water solubility and dispersion, just put the 1 small bag before using the solid product soluble in about 150-300 ml of water into liquid food, breathe into the nasal cavity, stomach or intestinal.

2), Trehalsoe in pharmaceutical :the preparation of solid pharmaceuticals

In order to do the BALL - 1 cell subcutaneous transplantation, in has just given birth to injected rats with making immune serum in the traditional way, in order to reduce the immune response, according to the general method to feed 3 weeks, remove the voles subcutaneous tumor formation, cut it into small pieces, then put the small pieces scattered dissolve in normal saline. Dissolution of tumor cells in serum-free medium RPMI1640 (pH 7.2) after cleaning, it dissolves in the new configuration of the same kind of medium concentration dilution broth to contain 2 x 106 cells per milliliter, and kept under 35 ?.

Join 200 iu/ml in the suspension of cells of human body a - interferon, training about 2 hours later, to join 300 ha/ml HVJ, another 20 hours training, induction training body produce more of the human body a - interferon. The cell culture under the condition of 4 ?, 1000 x g centrifugal, remove the sediment, supernatant by membrane filtration, the filtrate to one with a proof - interferon antibody in the chromatography column, then add buffer to make components, which are not absorbed then absorbed by the pillars of the component elution and condensed into a concentration of about 0.01 w/v % of human interferon is a solution, the human body a - interferon than energy of about 2 x 108 iu/mg protein, around 4 ml per rats can be obtained a - interferon.

Will 6 g anhydrous trehalose in moisture-proof plastic bottles of 100 ml, injection to the water in the bottle of 0.2 ml contains about 4 x 106 iu interferon is a solution of the human body, with a rubber plug to sterile capping bottles, so it can be obtained solid pharmaceuticals. According to its preparation process, including human interferon is a solution and anhydrous trehalose contact, it is easy to dehydration, it does not need to freeze drying, will make the solid products of interferon is a stable and efficient.

This product is soluble in water, the human body a - interferon can be used as a sensitive resistance reagent (such as: antiviral reagents, antitumor reagent and anti rheumatism reagent, etc.), the drip or intramuscular injection into the body, effectively prevent or treat many diseases. The product is suitable for use in internal medicine, also can make oral reagents and diagnostic reagent.

3), the preparation of solid pharmaceuticals

Will is the result of human lymphatic element BALL - 1 cell inoculation to join Eagle foundation of 20% fetal bovine serum in the culture medium (PH 7.4), according to the conventional method in 37 ? suspension culture, cultivate cells in serum-free Eagle basal medium (PH 7.4) after cleaning, it poured into the new configuration of Eagle base medium containing 20% fetal bovine serum, and concentration to the concentration of 1 x 107 cells/ml. In solution to join the 1, 000 ha/ml HVJ, in 38 ? under constant temperature 24 hours training, make the HVJ induced into a - hTNF. Will contain a - hTNF cell suspension was in 4 ?, under centrifugal 1000 x g, the supernatant fluid in the 0.01 M phosphate buffer after dialysis 15 hours of physiological saline, using membrane filtration. For the purification of a - hTNF solution, adding the filtrate the pillars of an anti interferon antibody, pour not absorbed by the pillars of components into one with antitumor necrosis a - gene monoclonal antibody, has the affinity chromatography column, elution is absorbed by the chromatography column component, get a - hTNF solution concentration to 0.01 w/v %, among them a - hTNF than energy is about 2 x 106 jru/mg protein. Such a - hTNF yield of about 5 x 104 jru/L cell culture.

Will 10 g anhydrous trehalose in 100 ml bottle, then inject 0.5 ml solution containing 1 x 105 jru a - hTNF, sterile block with a rubber plug, can produce the product. To above method, medicines, powdered anhydrous trehalose water make a - hTNF solution dehydration, without freeze-dried, can make a - hTNF stable and efficient.

This product is soluble in water, a - hTNF can be used as a sensitive resistance reagent (such as: antiviral reagents, abdominal swelling agent resistance and immune disease resistant agent, etc.), the effective drip or intramuscular injection into the human body to prevent or treat many diseases. The product is suitable for use in medicine, but also can make oral reagents and diagnostic reagent.

It is also widely applied as a key component in cryopreservation / freeze media to stabilise cell membranes and improve the recovery and robustness of cells used for bioproduction and cell therapy.

The stabilising benefits of trehalose include but are not limited to:

Monoclonal antibodies (mAbs)

Fusion proteins

Antibody fragments (fAbs)

Peptides

Stem cells

Vaccines

Pfanstiehl Brand Trehalose is available as USP-NF (United States Pharmacopoeia -- National Formulary), EP (European Pharmacopoeia) and JP (Japanese Pharmacopoeia). Pfanstiehl also holds a US DMF for the Trehalose (T-104-4) product.

Available Package Sizes: 0.2kg,1kg, 5kg, 20kg


Payment: T/T or L/C at sight.

Store: in cool and dry places.Keep away from strong light.

Guarantee period: 30 months




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