Immunox - Names and Identifiers
Name | thymopentin
|
Synonyms | TP-5 Immunox Timunox Thyopentin THYMOPENTIN thymopentin Sintomodulina Thymopent njection thymopentin (TP-5) Thymopoietin 32-36 32-36-Thymopoietin Thymopoietin II-(32-36) ThyMopentin for Injection Thymopoietin pentapeptide L-Arg-L-Lys-L-Asp-L-Val-L-Tyr-OH Thymopoietin pentapeptide-Fluorescin-isothiocyanate N~5~-(diaminomethylidene)ornithyllysyl-alpha-aspartylvalyltyrosine N~5~-(diaminomethylidene)-L-ornithyl-L-lysyl-L-alpha-aspartyl-L-valyl-L-tyrosine
|
CAS | 69558-55-0
|
EINECS | 811-641-8 |
InChI | InChI=1/C30H49N9O9/c1-16(2)24(28(46)38-22(29(47)48)14-17-8-10-18(40)11-9-17)39-27(45)21(15-23(41)42)37-26(44)20(7-3-4-12-31)36-25(43)19(32)6-5-13-35-30(33)34/h8-11,16,19-22,24,40H,3-7,12-15,31-32H2,1-2H3,(H,36,43)(H,37,44)(H,38,46)(H,39,45)(H,41,42)(H,47,48)(H4,33,34,35)/t19-,20-,21-,22-,24-/m0/s1 |
Immunox - Physico-chemical Properties
Molecular Formula | C30H49N9O9
|
Molar Mass | 679.77 |
Density | 1.44±0.1 g/cm3(Predicted) |
Solubility | DMSO:100 mg/mL (147.1 mM); Water:100 mg/mL (147.1 mM); Insoluble in ethanol. |
Appearance | Powder |
Color | White |
pKa | 3.07±0.10(Predicted) |
Storage Condition | Keep in dark place,Inert atmosphere,Store in freezer, under -20°C |
Refractive Index | 1.635 |
MDL | MFCD00214200 |
Physical and Chemical Properties | TP is a polypeptide extracted from calf thymus and two similar types were found: thymopoietin-I (TP-I) and thymopoietin-II(TP-II). TP-II is 49 peptide, consisting of 13 amino acids. The structural difference between TP-I and TP-II was that TP-II of the peptide chains were changed from Silk 1 and Su 43 to TP-I gan 1 and Group 43. The pentapeptide of Jing 32-casein 36 showed TP-II T cell differentiation activity in vitro and in vivo. 49 amino acids in 5 have physiological activity, has been artificial synthesis of spermidine peptide 5, namely thymopentin (timopentin), and for clinical use. In addition, the splenin isolated from the bovine spleen is similar to TP-II, so it is called TP-III. TP-II of the synthetic 5 peptides are temporarily referred to as thymus (TPe), and TP-III of the synthetic 5 peptides are temporarily referred to as spleen (SPe). TP-II and TPe act on neuromuscular transmission, inducing the differentiation of T cell precursor cells in vitro, while inhibiting the differentiation of B cells. TP-III and SPe can induce the differentiation of T and B cell precursor cells. Ubiquitin is composed of 74 amino acid residues, which can induce the differentiation of T cells and B cells. It is widely found in animal tissues (including thymus) and plants and fungi cells, associated with immune function. |
Use | Non-inhibitory function enhancer for the treatment of primary or secondary immunodeficiency |
Immunox - Risk and Safety
Immunox - Nature
Open Data Verified Data
This product is a derivative of the synthesis of the Sural thymus polypeptide (thymopopoitin), which can cause selective T cell differentiation, so it is the reason for the cell binding immune response. Although it is only pentapeptide, it has the same properties for the immune system.
Last Update:2024-01-02 23:10:35
Immunox - Standard
Authoritative Data Verified Data
This line consists of five amino acids in a synthetic polypeptide, it is N-[N-[N-[N2-L-arginyl-L-lysyl] -L-a aspartyl] -L-ascoryl] -L-tyrosine. The thymopentin (C30H49N9O9) should be 97.0% ~ 103.0% as calculated by water-free, solvent-free and acetic acid-free materials.
Last Update:2024-01-02 23:10:35
Immunox - Trait
Authoritative Data Verified Data
- This product is white or off-white powder or loose block.
- This product is very soluble in water, slightly soluble in ethanol, insoluble in ethyl acetate, ether or petroleum ether.
specific rotation
take this product, precision weighing, add water to dissolve and quantitative dilution to make a solution containing 20mg per lml, according to the law (General 0621), with no water, calculated without solvent and without acetic acid, the specific rotation is from one 14.0 ° to one 22.0 °.
Last Update:2022-01-01 15:37:33
Immunox - Introduction
This product is a two-way immune regulator. It has the function of inducing and promoting the differentiation, maturation and activation of T lymphocytes and their subsets, regulating the proportion of T lymphocytes, so that CD4 /CD8 tends to be normal; regulating and enhancing the immune function of human cells, which can promote the maturation of T lymphocytes in the peripheral blood after mitogen activation, and increase the activation of T cells in various antigens or mitogen after various lymphokines (such: A, gamma interferon, interleukin 2 and interleukin 3) secretion, increase the level of lymphokine receptor on T cells. It also enhances lymphocyte response by activating T helper cells. In addition, this product may affect the chemotaxis of NK precursor cells, which become more cytotoxic after exposure to interferon.
Last Update:2022-10-16 17:28:00
Immunox - Use
Open Data Verified Data
- the usage and dosage were the same as Thymosin as the immunopotentiator. For primary immunodeficiency disease, daily intramuscular or subcutaneous injection of 0.5~1 mg/kg, continuous administration for 2 weeks. The maintenance amount was changed to 2-3 times per week. For secondary immunodeficiency diseases, 50mg is injected subcutaneously 3 times a week for 3 to 6 weeks.
- Specifications: 10 mg/vial, 50mg/vial.
Last Update:2022-01-01 11:11:53
Immunox - Differential diagnosis
Authoritative Data Verified Data
- take 1 mg of this product, add 1 ml of water to dissolve, add Biuret test solution (take copper sulfate 0.15g, add potassium sodium tartrate 0.6g, add 50ml of water, add 30ml of 10% sodium hydroxide solution with stirring, add water to 100ml, then obtain) lml, that is blue-purple or purple-red.
- in the chromatogram recorded under the content determination item, the retention time of the main peak of the test solution should be consistent with the retention time of the main peak of the reference solution.
- The infrared absorption spectrum of this product should be consistent with that of the reference product (General rule 0402).
Last Update:2022-01-01 15:37:34
Immunox - Safety
Open Data Verified Data
occasional skin itching, rash, periorbital edema and other skin allergic reactions and medication local pain, erythema damage, local bleeding, infiltration, etc. Serious adverse reactions for leukopenia, medication should be regular check if see neutropenia, medication should be stopped.
Last Update:2022-01-01 11:11:54
Immunox - Exam
Authoritative Data Verified Data
amino acid ratio
take an appropriate amount of this product, add hydrochloric acid solution (1-2 ) , and hydrolyze it at 110 ° C. For 24 hours, then determine it according to the appropriate amino acid analysis method. The relative ratio of each amino acid was calculated by dividing the sum of the moles of arginine, aspartic acid, lysine, tyrosine and valine by 5 as 1, valine should be 0.8 to 1.2.
alkalinity
take 5mg of this product, add water 5ml to dissolve, according to the law (General 0631),pH value should be 7.0~9.0.
clarity and color of solution
take 5mg of this product, add 5ml of water to dissolve, check according to law (General rule 0901 and general rule 0902 first method), the solution should be clear and colorless.
acetic acid
take an appropriate amount of this product, weigh it accurately, add diluent [mobile phase A (General 0872)-methanol (95:5)] A solution containing 10 mg per 1 ml was prepared by dissolution and quantitative dilution as a test solution. The content of acetic acid should not exceed 0872 as determined by the acetic acid assay in synthetic polypeptides (General rule 0.5%).
Related substances
take an appropriate amount of this product, add the mobile phase to dissolve and dilute to make a solution containing 5mg per lml, as a test solution; Take a sample solution of lml with precision, set in a 100ml measuring flask, dilute to the scale with the mobile phase, and shake to serve as a control solution. According to the chromatographic conditions under the content determination item, 20 u1 of the test solution and the control solution are respectively injected into the liquid chromatograph, and the chromatogram is recorded to 2. Times of the retention time of the main peak. If there are impurity peaks in the chromatogram of the test solution, the area of a single impurity peak shall not be greater than the area of the main peak of the control solution (1.0% ), and the sum of the areas of each impurity peak shall not be greater than 2 times the area of the main peak of the control solution (2.0%).
residual solvent
take about 0.lg of this product, precision weighing, put it in 20ml headspace bottle, Precision Add internal standard solution (take appropriate amount of N-propanol, precision weighing, water was added to dissolve and quantitatively diluted to prepare 0.lmg solution) lml to dissolve, seal, as a test solution; Respectively, precision weighing methanol, ethanol, ether, acetonitrile, dichloromethane, Tetrahydrofuran, pyridine, N, add an appropriate amount of N-dimethylformamide into a 100ml volumetric flask, Add 10ml of dimethyl sulfoxide to dissolve, dilute with water to the scale, shake well, and use it as a reference stock solution. Take 1ml in a precise volume and put it into a 10ml volumetric flask, dilute to the scale with internal standard solution and shake well (each lm l contains 300 of methanol, 500 of ethanol, 500 of ether, 41 tons of acetonitrile, 60 tons of dichloromethane, 72% of tetrahydrofuran, pyridine (20 μg), JV,iV-dimethylformamide (88ug), 1ml was accurately measured, placed in a 20ml headspace bottle, sealed, and used as a reference solution. According to the determination method of residual solvent (General Principle 0861 second method), the capillary column with 6% cyanopropyl phenyl-94% dimethyl polysiloxane (or similar polar) as the stationary liquid is the column, 0.32mm x 30m; the initial temperature is 40°C, maintained for 4 minutes, heated to 140°C at a rate of 10°C per minute, maintained for 1 minute, and then heated to 220°C at a rate of 20°C per minute for 3 minutes; the detector temperature was 250°C; The inlet temperature was 230°C; The headspace bottle equilibrium temperature was 90°C and the equilibrium time was 30 minutes. The reference solution was injected in Headspace, and the peaks were obtained in the order of methanol, ethanol, diethyl ether, acetonitrile, dichloromethane, Tetrahydrofuran, pyridine and N,N-dimethylformamide, the degree of separation between peaks shall meet the requirements. Respectively take the test solution and the reference solution into the headspace, record the chromatogram, according to the internal standard method to calculate the peak area, Methanol, ethanol, ether, acetonitrile, dichloromethane, Tetrahydrofuran, pyridine, N,N-dimethylformamide residues shall be in accordance with the provisions.
moisture
take this product, according to the determination of moisture (General 0832 first method), the water content shall not exceed 5.0%.
Last Update:2022-01-01 15:37:35
Immunox - Content determination
Authoritative Data Verified Data
- measured by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica gel as filler; Phosphate buffer (pH 7.0 )-methanol (90:10) as mobile phase; The detection wavelength was 275nm. The number of theoretical plates shall not be less than 1200 based on the peak of thymopentin.
- the appropriate amount of this product is accurately weighed, and the mobile phase is added to dissolve and quantitatively dilute to make a solution containing 0.5mg per 1 ml as a test solution, 20ul of the sample solution was accurately measured, injected into the liquid chromatograph, and the chromatogram was recorded. An appropriate amount of thymopentin reference substance was taken and determined by the same method, and the peak area was calculated according to the external standard method.
Last Update:2022-01-01 15:37:35
Immunox - Category
Authoritative Data Verified Data
Last Update:2022-01-01 15:37:36
Immunox - Storage
Authoritative Data Verified Data
sealed, stored in the cool dark.
Last Update:2022-01-01 15:37:36
Immunox - Thymopentin injection
Authoritative Data Verified Data
This product is thymopentin sterilized aqueous solution, containing thymopentin (C30H49N909) should be labeled amount of 90.0% ~ 110.0%.
trait
This product is a clear colorless liquid.
identification
- take 1 branch of this product, add 2 drops of Biuret test solution under the item of thymopentin, which is blue-purple or purple-red.
- in the chromatogram recorded under the content determination item, the retention time of the main peak of the test solution should be consistent with the retention time of the main peak of the reference solution.
examination
- the pH value should be 6.0 to 8.0 (General 0631).
- appropriate amount of related substances should be taken and diluted with mobile phase to prepare a solution containing 1 mg per 1ml as a test solution, dilute to the scale with the mobile phase, shake, and serve as a control solution. According to the chromatographic conditions under the content determination item, each L01 of the test solution and the control solution is accurately measured and injected into the liquid chromatograph respectively, and the chromatogram is recorded to 2.5 times of the retention time of the main peak. If there are impurity peaks in the chromatogram of the test solution, the area of a single impurity peak shall not be greater than the area of the main peak of the control solution (1.0% ), and the sum of the areas of each impurity peak shall not be greater than 2 times the area of the main peak of the control solution (2.0%).
- sterile take this product, inspection according to law (General 1101), should comply with the provisions.
- bacterial endotoxin this product, according to the law to check (General 1143), per 1 mg thymopentin containing endotoxin should be less than 5. 0EU.
- others should comply with the relevant provisions under injection (General 0102).
Content determination
- measured by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica gel as filler; Phosphate buffer (pH 7.0)-methanol (90:10) as mobile phase; The detection wavelength was 275nm. The number of theoretical plates shall not be less than 1200 based on the peak of thymopentin.
- The determination method is to take 5 pieces of this product, after mixing evenly, take an appropriate amount of precision, and quantitatively dilute with mobile phase to prepare a solution containing 0.5mg per 1 ml as a test solution, 20 u1 was accurately measured, injected into the liquid chromatograph, and the chromatogram was recorded. An appropriate amount of thymopentin reference substance was also taken, which was determined by the same method and calculated by peak area according to external standard method.
category
Same as thymopentin.
specification
(l) lml:lmg (2 )lml:1Omg
storage
sealed and stored at 2-8°C.
Last Update:2022-01-01 15:37:37
Immunox - Thymopetin for Injection
Authoritative Data Verified Data
This product is thymopentin with the right amount of mannitol and other excipients by freezing, drying made of sterile lyophilized product. Thymopentin (C30H49N909) should be 90.0% to 110.0% of the labeled amount.
trait
This product is a white freeze-dried loose mass or powder.
identification
- take this product, add water to dissolve and dilute to make a solution containing 1 mg per 1ml, take 1ml of the above solution, and add 1ml of Biuret test solution under thymopentin, that is, blue-purple or purple-red.
- in the chromatogram recorded under the content determination item, the retention time of the main peak of the test solution should be consistent with the retention time of the main peak of the reference solution.
examination
- the pH value of this product shall be measured according to law (General rule 0631) after each bottle is dissolved with 5ml of water. The pH value shall be 6.0~8.0.
- the clarity and color of the solution shall be obtained by adding 1 ml of water to dissolve each one, which shall be checked according to law (General rules 0902 and 0901 respectively). The solution shall be clear and colorless; If it is turbid, compared with No. 1 turbidity standard solution, should not be more concentrated.
- the moisture content of this product shall not exceed 0832 as determined by the method for determination of moisture (General rule 5.0% first method).
The content uniformity of - shall be calculated based on the content of each bottle measured under the content determination item, and shall comply with the regulations (General rule 0941).
- appropriate amount of related substances should be taken, dissolved and diluted with mobile phase to make a solution containing 5mg per 1ml, which should be used as a test solution; 1ml should be accurately measured and placed in a 100ml measuring flask, dilute to the scale with the mobile phase, shake, and serve as a control solution. According to the chromatographic conditions under the content determination item, 20 u1 of the test solution and the control solution are respectively injected into the liquid chromatograph, and the chromatogram is recorded to 2.5 times of the retention time of the main peak. If there are impurity peaks in the chromatogram of the test solution, the area of a single impurity peak shall not be greater than the area of the main peak of the control solution (1.0%), and the sum of the areas of each impurity peak shall not be greater than 2 times the area of the main peak of the control solution (2.0%).
- sterile take this product, dissolve with appropriate solvent, according to the law inspection (General 1101 ) , should comply with the provisions.
- bacterial endotoxin take this product, according to the law to check (General 1143), per 1 mg thymopentin containing endotoxin should be less than 5.0 EU.
- others should comply with the relevant provisions under injection (General 0102).
Content determination
- measured by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica gel as filler; Phosphate buffer (pH 7.0)-methanol (90:10) as mobile phase; The detection wavelength was 275nm. The number of theoretical plates shall not be less than 1200 based on the peak of thymopentin.
- determination of 10 bottles of this product, each bottle plus mobile phase dissolved and quantitatively diluted to make a solution containing about 0.5mg per 1 ml, as a test solution, the sample solution 20 u1 was accurately measured, and the human liquid chromatograph was injected to record the chromatogram. An appropriate amount of thymopentin reference substance was taken and determined by the same method, and the peak area was calculated according to the external standard method.
category
Same as thymopentin.
specification
(l)lmg ( 2 ) 10mg
storage
sealed and kept in a cool dark place.
Last Update:2022-01-01 15:37:38