Description

ABSTRACT

The invention discloses a reduced-type glutathione freeze dried injection and making technique, which is characterized by the following: loading 95.0%-105.0% reduced-type glutathione (C10H17N306S) to display white block and powder; testing nitroso ferric sodium cyanide to display red; keeping the consistent reserving time of main peak of sample solution as comparison sample solution with pH value at 5.0-6.5; making dried weight not over 5.0% and the content of relative material not more than 4%; limiting the content of bacterial endotoxin less than 0.125EU; making other items satisfy the standard.

DESCRIPTION

Reduced glutathione (GSH) is a synthetic naturally peptide species in human cell’s matter, is made up of glutamic acid, cysteine and glycine, contains sulfhydryl and (SH), is distributed widely in each organ of body, plays an important role for keeping the cell biological function.

Reduced glutathione is mainly used in patients undergoing chemotherapy, radiation therapy subject clinically; Various hypoxemia: as acute anemia, adult respiratory distress syndrome, septicemia etc.; Hepatic disease comprises the liver injury that viral, drug toxicity, ethanol toxicity and other chemical substance toxicity cause; Also can be used for the auxiliary treatment that organophosphorus, amido or nitro compound are poisoned. Lyophilized powder injection of glutathione agent of the present invention should be average loading amount calculating in the unit container, contains reduced glutathione (C 10H 17N 30 65) should be 95.0%~~105.0% of labelled amount, be the white bulk; Differentiating under the item: the sodium nitroprusside test shows peony, and the retention time of need testing solution main peak should be consistent with the retention time of reduced glutathione reference substance solution main peak;

Checking under the item: pH value should be 5.0-6.5, loss on drying must not surpass 5.0%, and the content of related substance must not be greater than 4%, and bacteria endotoxin content should be less than 0.125EU, aseptically also should meet standards of pharmacopoeia, other should meet every regulation relevant under the injection item; Lyophilized powder injection of glutathione agent of the present invention is further elected as again by the average loading amount of unit container and is calculated, and contains reduced glutathione (C 10H 17N 30 6S) should be 95.0% ~105.0% of labelled amount; Character is white block and powder

The preparation technology of lyophilized powder injection of glutathione agent of the present invention can adopt the preparation technology of this area routine to be prepared, but answer the requirement to this product according to the invention, wherein the present invention is preferably: the reduced glutathione of getting recipe quantity adds an amount of water for injection, stir evenly, add an amount of lyophilizing proppant and or antioxidant, regulate pH value, filter, sterile filling, lyophilization gets product.

Glutathione freeze-dried powder injection of the present invention, specification are that 0.3g/ props up, 0.6g/ props up, 1.2g/ props up, 1.8g/ props up or 2.4g/ props up, and can also be prepared into other specification according to the needs of clinical use, are not limited to the cited scope of the present invention.

Glutathione freeze-dried powder injection more stable quality of the present invention, controlled has further improved the quality of product, has promoted patient’s drug safety.

Glutathione Injection Instructions

Please read the Instructions carefully and use it under the guidance of physician.

It is prohibited for those who have allergic reaction to this product.

Precautions

1. If rash, pale complexion, drop in blood pressure, or pulse rash occurs during medication. If symptoms such as abnormal pulse occur, the medication should be stopped immediately.

2. The bubbles after L-Cysteinyl Glycine is dissolved are used immediately, and the remaining liquid cannot be used again.

3. Intramuscular injection should only be used when this route of administration is required, and repeated injection at the same site should be avoided.

CH ≥ SH CO-NH-CH

CONHCH2COOH

– Adjuvant treatment of therapeutic damage caused by ionizing rays caused by poisoning caused by anti-tumor drugs, anti-tuberculosis drugs, analgesics and other chemical substances.

4. The drug can cause anaphylactic shock. Doctors should ask Patients about their drug allergy history and closely monitor them during medication. If symptoms and such as asthma, shortness of breath, difficulty breathing, palpitations, profuse sweating, and drop in blood pressure occur, the medication should be discontinued. immediately and treated promptly.

5. Patients with a history of asthma attacks should use it with caution.[Medicine for pregnant and lactating women] There is a lack of relevant information, and it is unclear.

Medication for children

Neonates, Premature infants, and children should use medications with caution, especially intramuscular.

Medication for the elderly

Elderly patients should appropriately reduce the dosage of medication. And monitor closely during medication.

MEDICINE INTERACTIONS

Avoid mixing this product with the following drugs: vitamin K3, Vitamin B12, calcium pantothenate, orotic acid, antihistamines, long-acting sulfonamides and Cyclin.

Drug overdose

There are no data overdose of this product, if overdose of this product occurs, symptomatic treatment should be provided.

Doxorubicin, daunorubicin, and benzoate do not affect the damage caused by chemotherapy. The first dose is 1500 mg 6GS, intravenously infused with 15 minutes. g daily. The maximum dose of cyclophosphamide treatment or light chemotherapy to the urinary system should not exceed 35mg/mg Ill. Can be used for auxiliary treatment of alcohol, viruses, and injuries. For days; severe hepatitis, 1200-2 cirrhosis, 1200mg.qd, iv,30 days: alcoholic hepatitis, raw hepatitis,1200-1800mg medication administration after irradiation ,treatment of hypoxemia, administration of saline, intravenous administration, later products 300-600mg are clear and colorless when injected ,IM/IV slow injection after meals, intravenous drip.

Pharmacology and Toxicology

Glutathione is a tripeptide compound containing a sulfhydryl group (SH).It has important physiological activities such as activating the redox system, activating SH enzymes, and detoxification in the human body. This product participates in the tricarboxylic acid cycle and sugar metabolism in the body, promotes the production of high energy in the bod y, and acts as a coenzyme. It is the glyoxylic acid and sugar phosphate dehydrogenase .This product can activate SH enzymes in the body, promote the metabolism of carbohydrates, fats and proteins ,and regulate the metabolic process of cell membranes, This product participates in the combination of various exogenous and endogenous toxic substances to from attenuated substances(Pharmacokinetics).

After 15 minutes of IV infusion of glutathione at a dose of 2g/m² , the average peak plasma concentration at the end of the infusion was 444 mmol/L the average basal concentration was 6.9mmol/L and the average volume of distribution was 15L.The elimination half -life is 10 minutes and the clearance rate is 850ml/min/m². It is excreted in the urine 90 minutes after infusion mainly as unchanged from and cysteine.

Storage / Packaging Store airtight.

Reactions / events include : Itching, Increased Sweating, Nettles, Shortness of Breath, Cough, Asthma, High Fever, Allergic Reaction.

Injection site phlebitis; Glass vial injection bottle 15ml (10 x 1 box)