Catalog 1 Pinyin 2 English Reference 3 Pharmacopoeia Standard for Insulin Injection 3.1 Name 3.1.1 Chinese Name 3.1.2 Chinese Pinyin 3.1.3 English Name 3.2 Source (Name), Content (Potency) 3.3 Properties 3.4 Identification 3.5 Inspection 3.5.1 pH 3.5.2 Associated Proteins 3.5.3 Polymer Proteins 3.5.4 Zinc 3.5.5 Phenol 3.5.6 Visible Foreign Material 3.5.7 Bacterial Endotoxins 3.5.8 Others 3.6 Content Determination 3.7 Category 3.8 Specification 3.9 Storage 3.10 Used in the past .6 Visible Foreign Substances 3.5.7 Bacterial Endotoxins 3.5.8 Others 3.6 Content Determination 3.7 Category 3.8 Specifications 3.9 Storage 3.10 Previous Names 3.11 Version 4 Insulin Injection Specifications 4.1 Alias for Insulin Injection 4.2 Foreign Names 4.3 Molecular Formula Ingredients 4.4 Pharmacology and Toxicology 4.5 Pharmacokinetics 4.6 Indications for Insulin Injection 4.7 Dosage and Administration 4.8 Insulin Injection 4.8 Adverse Reactions of Insulin Injection 4.9 Interactions 4.10 Precautions 4.11 For Pregnant and Nursing Women 4.12 For Children 4.13 For Elderly Patients 4.14 Specifications 5 References Attachment: * Other versions of the drug inserts related to Insulin Injection 1 Pinyin

yí dǎo sù zhù shè yè

2 English Reference

regular iletin

1 Pinyin

regular iletin

2 English Reference

regular iletin

2 English Reference

regular iletin

3 Insulin Injection Pharmacopoeia Standard 3.1 Name 3.1.1 Chinese name

Insulin Injection

3.1.2 Chinese Pinyin

Yidaosu Zhusheye

3.1.3 English name

Insulin Injection[1]

3.2 Source (name), content (potency), and quality (content) of Insulin Injection. Source (name), content (potency)

This product is a sterile aqueous solution of insulin. Its potency should be 90.0% to 110.0% of the labeled amount.

Glycerol 1.4-1.8g, phenol 0.25g per 100ml.

3.3 Character

This product is a colorless or almost colorless clear liquid.

3.4 Identification

Take the product, according to the identification of insulin under the (1) test, show the same results.

3.5 Inspection 3.5.1 pH value

It should be 6.6-8.0 (2010 version of Pharmacopoeia II Appendix VI H).

3.5.2 Related proteins

Take the product, add 3μl of 9.6mol/L hydrochloric acid solution to each 1ml to acidify, mix well and use as the test solution, take the appropriate amount of test solution (equivalent to about 2 units of insulin), check according to the method under insulin, record the chromatograms, subtract the phenol peaks, and the peak of A21 deaminated insulin shall not be greater than 5.0% by the bee-area normalization method. The sum of the other relevant protein peaks shall not be greater than 6.0%.

3.5.3 Polymer proteins

Take the product, add 3μl of 9.6mol/L hydrochloric acid solution per 1ml to acidify, mix well and then used as the test crystal solution; take 100μl of the test solution, according to the method under insulin to check, subtracting the retention time is greater than the main peak of the insulin of the other peaks, according to the method of normalization of the peak area, the retention time of the peak area of all the peaks is less than the main peak of the insulin sum of the peak area shall not be greater than 2.0%.

3.5.4 Zinc

Appropriate amount of the product was taken in precision, and diluted with 0.01mol/L hydrochloric acid solution quantitatively to make a solution containing about 4 units per 1ml, as the test solution, and examined according to the method under insulin, and the zinc content of each 100 units should not be more than 40 μg.

3.5.5 Phenol

Appropriate amount of phenol (purity ≥99.5%) was weighed in precision, and diluted with 0.01mol/L hydrochloric acid solution quantitatively to make a solution containing about 4 units per 1ml, as the test solution, and examined according to the method under insulin, and the zinc content of each 100 units should not be more than 40 μg. Dissolve and quantitatively dilute with 0.01mol/L hydrochloric acid solution to make a solution containing about 0.25mg of phenol per 1ml as phenol control solution; take appropriate amount of this product, quantitatively dilute with 0.01mol/L hydrochloric acid solution to make a solution containing about 0.25mg of phenol per 1ml as test solution; according to the chromatographic conditions under the determination of the content, with the detection wavelength of 270nm. Appropriate amount of insulin control, with phenol control solution to make a solution containing about 1 mg of insulin per 1 ml, take 20 μl injected into the liquid chromatograph, the separation of phenol bees and the main peak of insulin should be in accordance with the requirements. Take 20μl of each phenol control solution and test solution, inject them into liquid chromatograph, record the chromatogram, and calculate the peak area according to the external standard method. Each 1ml of this product should contain 2.2-2.8mg of phenol.

3.5.6 Visible foreign matter

Take this product, according to the law (2010 version of the Pharmacopoeia II Appendix IX H), shall not be detected metal shavings, glass shavings, color, length or maximum particle size of more than 2mm fibers and lumps and other obvious visible foreign matter. If the detection of fine visible foreign matter or smoke-like particles column, should take another 20 (bottle) with the method of retesting, the initial, retesting of the test article, the detection of fine visible foreign matter or smoke-like particles column of the test article shall not exceed 5 (bottle). [1]

3.5.7 Bacterial endotoxin

Take the product, according to the law check (2010 version of the Pharmacopoeia II Appendix Ⅺ E), the amount of endotoxin contained in each 1 unit of insulin should be less than 0.8EU.

3.5.8 Other

It should be in line with the relevant provisions under the injectable (2010 version of the Pharmacopoeia II Appendix I B).

3.6 Determination of content

Take the appropriate amount of the product, add 3ul of 9.6mol/L hydrochloric acid solution per 1ml to acidify[1], and quantitatively dilute it with 0.01mol/L hydrochloric acid solution to make a solution containing 40 units per 1ml (freshly prepared for clinical use, stored at 2~4℃, and used within 48 hours), and then determine it by the method under the item of insulin. According to the external standard method to insulin peak and A21 demineralized insulin peak area sum, that is obtained.

3.7 Category

Hypoglycemic drugs.

3.8 Specifications

(1) 3ml: 300 units? (2) 10ml: 400 units? (3) 10ml: 800 units

3.9 Storage

Airtight, stored in a cold place, avoid freezing.

3.10 Previous name

Neutral Insulin Injection[1]

3.11 Version

Chinese Pharmacopoeia of the People's Republic of China 2010 Edition

4 Insulin Injection Instruction Manual 4.1 Alias of Insulin Injection

Novolin

4.2 Foreign name

Insulin Injection

4.3 Molecular formula composition

Sterilized aqueous solution of insulin (porcine or bovine). Each 100ml can contain glycerol 1.4~1.8g with phenol 0.25g.

4.4 Pharmacology and toxicology

This product is a hypoglycemic drug. The main efficacy of insulin is to lower blood glucose, and at the same time affect the protein and fat metabolism, including the following effects: 1. Inhibit hepatic glycogenolysis and glycogen isomerization, reduce the hepatic output of glucose; 2. Promote the hepatic uptake of glucose and hepatic glycogen synthesis; 3. Promote the uptake of glucose and amino acids by the muscle and adipose tissues, and promote the synthesis and storage of proteins and fats; 4. Promote the hepatic production of very low density lipoprotein and activate lipoprotein lipase. Lipoprotein and activate lipoprotein lipase, promote the decomposition of very low density lipoprotein; 5. Inhibit fat and muscle fat and protein decomposition, inhibit the production of ketone bodies and promote the use of ketone bodies in the surrounding tissues.

4.5 Pharmacokinetics

Orally, it is easily destroyed by digestive enzymes in the gastrointestinal tract. Subcutaneous administration is rapidly absorbed, with an onset of action 0.51 hours after subcutaneous injection, a peak effect at 24 hours, and a maintenance time of 57 hours; intravenous injection has an onset of action in 1030 minutes, a peak at 1530 minutes, and a duration of 0.51 hours. The half-life of insulin in the circulation is 510 minutes for sedated insulin and 2 hours after subcutaneous injection. Absorption is very irregular after subcutaneous injection, and the absorption of insulin can be different at different injection sites, with the fastest absorption in the abdominal wall and faster absorption in the lateral aspect of the upper arm than in the lateral aspect of the anterior femoral aspect; the absorption varies greatly from patient to patient, and even in the same patient, it may be different at different times. After insulin is absorbed into the blood circulation, only 5% of it is bound to plasma proteins, but it can be combined with insulin antibody, which prolongs the action time of insulin. It is metabolized mainly in the kidneys and liver, with a small amount excreted in the urine.

4.6 Indications

All types of diabetes .

Clinically used for: 1. Type I diabetes mellitus; 2. Type II diabetes mellitus with severe infections, trauma, major surgery and other serious stress *** conditions, as well as the combination of cardiovascular and cerebrovascular complications, renal or retinopathy, etc.; 3. Diabetic ketoacidosis, hyperglycemic non-ketotic hyperosmolar coma; 4. Long-term diabetes type II diabetes mellitus plasma insulin level is really low, after reasonable diet, physical activity and Type II diabetes mellitus with contraindications to oral hypoglycemic drugs, such as pregnancy, breastfeeding, etc.; 5. Adult or elderly diabetes mellitus patients with acute onset, significant weight loss with marked emaciation; 6. Gestational diabetes mellitus; 7. Diabetes mellitus secondary to severe pancreatic disease; 8. Intravenous dextrose and low dose insulin can be used in the early stages of severe malnutrition, emaciation, intractable gestational vomiting, and hepatic rigidity, to promote tissue growth and improve blood circulation. insulin to promote tissue utilization of glucose.

4.7 Usage and dosage of insulin injection

Subcutaneous injection is usually given three times a day, 1530 minutes before meals, and a small dose is added before bedtime if necessary. The dosage is adjusted gradually according to the condition, blood glucose and urine glucose starting from a small dose (24 units each time depending on weight and other factors).The total amount of daily insulin required by patients with type 1 diabetes mellitus is mostly between 0.51 units per kilogram of body weight, which is adjusted according to the results of glucose monitoring.The total amount of daily insulin required by patients with type 2 diabetes mellitus is more variable, and in the case of patients with no acute complications, the sensitive ones only need 510 units per day, and about 20 units in general, which is the most common in patients with type 2 diabetes mellitus. Those who are obese and less sensitive to insulin may require significantly more. In the case of acute complications (infection, trauma, surgery, etc.), patients with type 1 and type 2 diabetes should be injected every 46 hours, and the dose should be adjusted according to changes in the condition and the results of blood glucose monitoring.

Intravenous injection is mainly used in the treatment of diabetic ketoacidosis, hyperglycemic hyperosmolar coma. Can be intravenous continuous drip hourly adult 46 units, pediatric according to the hour body weight 0.1 units / kg, according to blood glucose changes to adjust the dose; can also be the first static injection of 10 units plus intramuscular injection of 46 units, according to blood glucose changes to adjust. In severe cases, 10 units can be injected intravenously first, followed by intravenous drip. When the blood glucose drops below 13.9mmol/L (250mg/ml), the insulin dose and the frequency of injection will be reduced accordingly. At the same time of using insulin, it should also be rehydrated to correct electrolyte disorders and acidosis and pay attention to the body's need for calories. Patients with diabetes who are unable to eat should be given an insulin drip along with an intravenous glucose infusion.

4.8 Adverse reactions

Allergic reactions, injection site erythema, pruritus, measles, angioneurotic edema.

1. Hypoglycemic reactions, sweating, palpitations, weakness, and in severe cases, impaired consciousness, ****tachycardia, tachycardia and even coma.

2. Insulin resistance, the daily dose needs to be more than 200 units or more.

3. Fat atrophy and lipoatrophy at the injection site.

4. Ocular refractive disorders.

4.9 Interactions

1. Glucocorticosteroids, adrenocorticotropic hormones, glucagon, estrogens, oral contraceptives, epinephrine, phenytoin sodium, thiazide diuretics, thyroxine, etc., can elevate blood glucose concentrations to varying degrees, and the dosage of these drugs or insulin should be adjusted when used together.

2. Oral hypoglycemic drugs and insulin have synergistic hypoglycemic effect.

3. Anticoagulants, salicylates, sulfonamides, and antitumor drugs such as methotrexate can compete with insulin and plasma protein binding, thus increasing the level of free insulin in the blood. Non-steroidal anti-inflammatory analgesics can enhance the hypoglycemic effect of insulin.

4. β-blockers such as propranolol can prevent the adrenaline response to elevate blood glucose, interfere with the function of blood glucose regulation of the muscle, and insulin can increase the risk of hypoglycemia, but also mask the symptoms of hypoglycemia, prolonging the time of hypoglycemia. It can mask the symptoms of hypoglycemia and prolong the duration of hypoglycemia. When used together, the dose of insulin should be adjusted.

5. Moderate to large amounts of alcohol can enhance the effect of insulin-induced hypoglycemia, which can cause severe and persistent hypoglycemia, and it is more likely to occur in fasting or when liver glycogen stores are low.

6. Chloroquine, quinidine, quinine, etc. can slow down the degradation of insulin, insulin concentration in the blood to increase and thus enhance its hypoglycemic effect.

7. Glycemic drugs such as certain calcium channel blockers, colistin, danazol, diazepam, growth hormone, heparin, H2 receptor antagonists, marijuana, morphine, nicotine, sulfinpyrazone, etc. can change glucose metabolism, so that blood glucose, so insulin and the combination of the above drugs should be increased appropriately.

8. Angiotensinase inhibitors, bromocriptine, clofibrate, ketoconazole, lithium, mebendazole, pyridoxine, theophylline, etc. can directly or indirectly reduce blood glucose in different ways.

9. Octreotide can inhibit the secretion of growth hormone, glucagon and insulin, and cause delayed gastric emptying and gastrointestinal peristalsis, resulting in delayed absorption of food, which reduces postprandial hyperglycemia, and the amount of insulin should be appropriately reduced at the beginning of the use of octreotide, and then adjusted according to blood glucose.

10. Smoking: It can antagonize the hypoglycemic effect of insulin by releasing catecholamines, and smoking can also reduce the absorption of insulin from the skin. Therefore, when smokers who are on insulin therapy suddenly quit smoking, they should observe the changes in blood glucose, and consider whether it is necessary to appropriately reduce the dosage of insulin.

4.10 Precautions

Prohibited in patients with insulin allergy.

1. Hypoglycemic reaction, severe hypoglycemic coma, in patients with severe hepatic and renal lesions, etc. should closely observe blood glucose.

2. Patients with the following conditions, insulin needs to be reduced: abnormal liver function, hypothyroidism, nausea and vomiting, abnormal renal function, glomerular filtration rate of 1050 ml per minute, the dose of insulin is reduced to 9575%; glomerular filtration rate is reduced to less than 10 ml per minute, the dose of insulin is reduced to 50%.

3. Insulin requirement is increased when the patient is accompanied by the following conditions: hyperthermia, hyperthyroidism, acromegaly, diabetic ketoacidosis, severe infection or trauma, major surgery, and so on.

4. Blood glucose, urine routine, liver and kidney function, vision, fundus retinal vessels, blood pressure and electrocardiogram should be checked regularly during the medication period to understand the condition and diabetic complications.

4.11 Drugs for pregnant and lactating women

The insulin requirement of pregnant women with diabetes mellitus increases during pregnancy and decreases after delivery; if the diabetes mellitus detected in pregnancy is gestational diabetes mellitus, insulin treatment should be terminated after delivery; follow up their blood glucose, and then decide the treatment according to the presence or absence of diabetes mellitus.

4.12 Children's medication

Children are prone to hypoglycemia, blood glucose fluctuations are large, adjust the dose should be 0.51 units, gradually increase or decrease; pubertal adolescents to increase the dose appropriately, and then gradually reduced after puberty.

4.13 Elderly patients

Elderly people are prone to hypoglycemia, need to pay special attention to diet, physical activity in moderation.

4.14 Specification