CN112826792A - Sodium cantharidate vitamin B6 injection and preparation method thereof - Google Patents
Sodium cantharidate vitamin B6 injection and preparation method thereof Download PDFInfo
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- LXNHXLLTXMVWPM-UHFFFAOYSA-N pyridoxine Chemical compound CC1=NC=C(CO)C(CO)=C1O LXNHXLLTXMVWPM-UHFFFAOYSA-N 0.000 title claims abstract description 94
- 239000011734 sodium Substances 0.000 title claims abstract description 61
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 title claims abstract description 60
- 229910052708 sodium Inorganic materials 0.000 title claims abstract description 60
- 238000002360 preparation method Methods 0.000 title claims abstract description 55
- RADKZDMFGJYCBB-UHFFFAOYSA-N pyridoxal hydrochloride Natural products CC1=NC=C(CO)C(C=O)=C1O RADKZDMFGJYCBB-UHFFFAOYSA-N 0.000 title claims abstract description 47
- 239000011726 vitamin B6 Substances 0.000 title claims abstract description 47
- 235000019158 vitamin B6 Nutrition 0.000 title claims abstract description 47
- 229940011671 vitamin b6 Drugs 0.000 title claims abstract description 47
- 238000002347 injection Methods 0.000 title claims abstract description 43
- 239000007924 injection Substances 0.000 title claims abstract description 43
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 39
- 239000008215 water for injection Substances 0.000 claims abstract description 39
- 229930003270 Vitamin B Natural products 0.000 claims abstract description 8
- 235000019156 vitamin B Nutrition 0.000 claims abstract description 8
- 239000011720 vitamin B Substances 0.000 claims abstract description 8
- 239000000243 solution Substances 0.000 claims description 47
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims description 36
- 238000003756 stirring Methods 0.000 claims description 25
- 239000007788 liquid Substances 0.000 claims description 24
- 238000004140 cleaning Methods 0.000 claims description 18
- 238000000034 method Methods 0.000 claims description 14
- 230000001954 sterilising effect Effects 0.000 claims description 12
- 230000008569 process Effects 0.000 claims description 11
- 239000003814 drug Substances 0.000 claims description 7
- 239000002994 raw material Substances 0.000 claims description 7
- 238000001914 filtration Methods 0.000 claims description 4
- 238000002156 mixing Methods 0.000 claims description 4
- 239000003153 chemical reaction reagent Substances 0.000 claims description 3
- 238000007865 diluting Methods 0.000 claims description 3
- 238000004090 dissolution Methods 0.000 claims description 3
- 238000005070 sampling Methods 0.000 claims description 3
- 238000012546 transfer Methods 0.000 claims description 3
- 238000005303 weighing Methods 0.000 claims description 3
- 239000003708 ampul Substances 0.000 claims description 2
- 238000011049 filling Methods 0.000 claims description 2
- 238000007789 sealing Methods 0.000 claims description 2
- 239000000126 substance Substances 0.000 abstract description 6
- 239000000463 material Substances 0.000 abstract description 4
- 239000012467 final product Substances 0.000 abstract 1
- 238000012360 testing method Methods 0.000 description 9
- 238000004659 sterilization and disinfection Methods 0.000 description 7
- 230000008859 change Effects 0.000 description 6
- 206010028980 Neoplasm Diseases 0.000 description 5
- 201000011510 cancer Diseases 0.000 description 5
- 210000004027 cell Anatomy 0.000 description 5
- 239000000843 powder Substances 0.000 description 4
- 230000015572 biosynthetic process Effects 0.000 description 3
- 239000000203 mixture Substances 0.000 description 3
- 229930008399 cantharidic acid Natural products 0.000 description 2
- 150000001875 compounds Chemical class 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 230000001965 increasing effect Effects 0.000 description 2
- 210000000265 leukocyte Anatomy 0.000 description 2
- ZZDBMDNRQQDSKG-UHFFFAOYSA-N methyl 5-bromo-1-benzofuran-2-carboxylate Chemical compound BrC1=CC=C2OC(C(=O)OC)=CC2=C1 ZZDBMDNRQQDSKG-UHFFFAOYSA-N 0.000 description 2
- 239000011148 porous material Substances 0.000 description 2
- 238000003786 synthesis reaction Methods 0.000 description 2
- 210000004881 tumor cell Anatomy 0.000 description 2
- 102000001707 3',5'-Cyclic-AMP Phosphodiesterases Human genes 0.000 description 1
- 108010054479 3',5'-Cyclic-AMP Phosphodiesterases Proteins 0.000 description 1
- 206010006187 Breast cancer Diseases 0.000 description 1
- 208000026310 Breast neoplasm Diseases 0.000 description 1
- 208000017897 Carcinoma of esophagus Diseases 0.000 description 1
- 102000016938 Catalase Human genes 0.000 description 1
- 108010053835 Catalase Proteins 0.000 description 1
- 206010019799 Hepatitis viral Diseases 0.000 description 1
- 206010058467 Lung neoplasm malignant Diseases 0.000 description 1
- 208000002454 Nasopharyngeal Carcinoma Diseases 0.000 description 1
- 206010061306 Nasopharyngeal cancer Diseases 0.000 description 1
- 206010030155 Oesophageal carcinoma Diseases 0.000 description 1
- 208000015634 Rectal Neoplasms Diseases 0.000 description 1
- 230000004075 alteration Effects 0.000 description 1
- 230000001093 anti-cancer Effects 0.000 description 1
- 239000003963 antioxidant agent Substances 0.000 description 1
- 230000003078 antioxidant effect Effects 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 210000002798 bone marrow cell Anatomy 0.000 description 1
- 239000000969 carrier Substances 0.000 description 1
- 238000006243 chemical reaction Methods 0.000 description 1
- 201000010989 colorectal carcinoma Diseases 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- 230000037149 energy metabolism Effects 0.000 description 1
- 230000002708 enhancing effect Effects 0.000 description 1
- 201000005619 esophageal carcinoma Diseases 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 230000036039 immunity Effects 0.000 description 1
- 230000008595 infiltration Effects 0.000 description 1
- 238000001764 infiltration Methods 0.000 description 1
- 238000001802 infusion Methods 0.000 description 1
- 230000002401 inhibitory effect Effects 0.000 description 1
- 201000007270 liver cancer Diseases 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 201000005202 lung cancer Diseases 0.000 description 1
- 208000020816 lung neoplasm Diseases 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 201000011216 nasopharynx carcinoma Diseases 0.000 description 1
- 102000039446 nucleic acids Human genes 0.000 description 1
- 108020004707 nucleic acids Proteins 0.000 description 1
- 150000007523 nucleic acids Chemical class 0.000 description 1
- -1 pH regulator Substances 0.000 description 1
- 239000000546 pharmaceutical excipient Substances 0.000 description 1
- 239000002243 precursor Substances 0.000 description 1
- 102000004169 proteins and genes Human genes 0.000 description 1
- 108090000623 proteins and genes Proteins 0.000 description 1
- 206010038038 rectal cancer Diseases 0.000 description 1
- 201000001275 rectum cancer Diseases 0.000 description 1
- 238000013112 stability test Methods 0.000 description 1
- 239000003381 stabilizer Substances 0.000 description 1
- 239000003053 toxin Substances 0.000 description 1
- 231100000765 toxin Toxicity 0.000 description 1
- 201000001862 viral hepatitis Diseases 0.000 description 1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/34—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/4415—Pyridoxine, i.e. Vitamin B6
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
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- A61P31/20—Antivirals for DNA viruses
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- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
- A61P37/04—Immunostimulants
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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Abstract
The invention discloses a sodium cantharidate vitamin B6 injection, which comprises 0.04-0.06mg of sodium cantharidate, 61.00-1.50 mg of vitamin B and the balance of water for injection in a volume of 5mL, wherein the PH value of the injection is 4.5-5.5. The sodium cantharidate vitamin B6 injection prepared by the invention has the advantages of simple prescription, high safety because the auxiliary materials are common auxiliary materials of the injection, and stable quality of the final product prepared by the invention, and the related substances and content indexes meet the requirements. The invention also provides a preparation method of the sodium cantharidate vitamin B6 injection.
Description
Technical Field
The invention relates to the technical field of medicine production, in particular to a sodium cantharidate vitamin B6 injection and a preparation method thereof.
Background
Sodium cantharidate (cantharidiatium) with molecular formula of C8H8O5Na2The structural formula is as follows:
sodium cantharidate (cantharidiaticum)2) It is suitable for treating primary liver cancer, and has the advantages of maintaining anticancer effect, increasing leukocyte, and enhancing immunity. The product can inhibit the synthesis of tumor cell protein and nucleic acid, and then influence the biosynthesis of RNA and DNA, and finally inhibit the generation and division of cancer cells; can reduce the cAMP phosphodiesterase activity of tumor cells, improve the catalase activity, improve the energy metabolism of the cells and reduce the cancer toxin level; can directly inhibit the synthesis of DNA and RNA in cancer cells and the infiltration of precursors, change the morphology and function of cancer cells, and directly kill cancer cells, and can be used for treating hepatocarcinoma, lung cancer, nasopharyngeal carcinoma, breast cancer, esophageal carcinoma, carcinoma of large intestine, and rectal cancer. Has no inhibiting effect on bone marrow cells, can increase leukocyte, and can be used for treating viral hepatitis.
Chinese patent with application number CN200310111267.X discloses a unit dosage form of compound cantharidic acid powder injection and a preparation method thereof, the compound cantharidic acid powder injection is prepared by adding various carriers such as excipient, pH regulator, antioxidant, stabilizer and the like into raw materials, and the powder injection is prepared, so that the components of the powder injection contain more other components, the infusion reaction probability causing great harm is greatly increased, and the life of a patient can be endangered seriously.
Disclosure of Invention
The invention provides a sodium cantharidate vitamin B6 injection and a preparation method thereof, aiming at solving the problems in the prior art.
In order to achieve the technical purpose, the invention mainly adopts the following technical scheme:
a sodium cantharidate vitamin B6 injection is characterized in that: calculated by 5mL of volume, the injection contains 0.04-0.06mg of sodium cantharidate, 61.00-1.50 mg of vitamin B and the balance of water for injection, and the PH value of the injection is 4.5-5.5.
Preferably, the injection contains 0.05mg of sodium cantharidate, 61.25mg of vitamin B and the balance of water for injection in a volume of 5mL, and the PH of the injection is 4.8-5.2.
The invention also provides a preparation method of the sodium cantharidate vitamin B6 injection, which comprises the following steps:
(1) dissolution and transfer of vitamin B6:
a. adding a proper amount of water for injection into a dissolving tank, opening a top cover of the dissolving tank, pouring the accurately weighed vitamin B6 into the dissolving tank, cleaning a bottle with a plug and weighed vitamin B6 with the water for injection for 3 times, pouring the bottles into the dissolving tank respectively, then covering the dissolving tank, stirring, and stirring for 5 minutes to completely dissolve the vitamin B;
b. delivering the dissolved vitamin B6 solution to a solution preparation tank by using compressed air, then respectively cleaning the dissolving tank for 3 times by using a proper amount of water for injection, and respectively delivering all cleaning solutions to the solution preparation tank by using the compressed air;
c. adding water for injection into the liquid preparation tank to 80% of the prepared batch, then starting a stirring device of the liquid preparation tank, and stopping stirring until the whole process of the preparation is finished;
(2) dissolving and transferring sodium cantharidate:
d. adding a proper amount of water for injection into the dissolving tank, opening the top cover of the dissolving tank, pouring the precisely weighed sodium cantharidate into the dissolving tank, cleaning a bottle with a plug for weighing the sodium cantharidate with the water for injection for 3 times, respectively pouring the sodium cantharidate into the dissolving tank, then covering the dissolving tank, stirring, and stirring for 5 minutes to completely dissolve the sodium cantharidate;
e. delivering the dissolved sodium cantharidate solution to a solution preparation tank by using compressed air, then respectively cleaning the dissolving tank for 3 times by using a proper amount of water for injection, and respectively delivering all cleaning solution to the solution preparation tank by using the compressed air;
f. adding water for injection into the liquid preparation tank to 95% of the prepared batch, then starting a stirring device of the liquid preparation tank, and stopping stirring until the whole process of the preparation is finished;
(3) adjusting the pH of the solution:
g. taking a clean 500ml reagent bottle, preparing weighed sodium hydroxide into a solution with the concentration of 10% by using water for injection, adding 90% of the prepared sodium hydroxide into a preparation tank, diluting the solution by using a proper amount of water for injection, and transferring the solution into the preparation tank by using compressed air;
(2) separately filling and sealing with 5ml ampoule bottle, and sterilizing.
And (3) sampling and detecting the pH value of the solution in the step (3) in the process of mixing the sodium hydroxide solution with the liquid medicine in the liquid preparation tank, and if the pH value is lower than 4.5, continuously adding the sodium hydroxide solution until the pH value is in the range of 4.5-5.5.
Wherein, the water for injection is continuously added into the liquid preparation tank to the prepared batch, and the mixture is continuously stirred for 20 minutes and uniformly mixed.
Further, the uniformly mixed liquid medicine is filtered by a first-stage precision filter.
Preferably, the pore diameter of the filtering element of the primary precision filter is 0.22 μm.
In the invention, the feeding amount of the sodium cantharidate is 5.00/X1Percent, the dosage of the vitamin B6 is 125.0/X2%, wherein, X1% represents the percentage content of the sodium cantharidate raw material; x2% represents the percentage of the raw material of the vitamin B6.
Compared with the prior art, the invention has the following beneficial effects:
(1) the prescription is simple, and the auxiliary materials used in the prescription are all common auxiliary materials of injection, so that the safety does not need to worry;
(2) the sodium cantharidate vitamin B6 injection prepared by the invention has stable quality, and related substances and content indexes meet the requirements.
Detailed Description
The invention is described in further detail in the following examples and examples, but is not limited thereto, and any equivalent alterations in the field made in accordance with the present disclosure are intended to fall within the scope of the invention.
Example 1 preparation of sodium cantharidate vitamin B6 injection
The prescription of sodium cantharidate vitamin B6 injection is shown in the following table 1:
| prescription 1 | Prescription 2 | Prescription 3 | |
| Sodium cantharidate (Zengchun) | 0.04mg | 0.05mg | 0.06mg |
| Vitamin B6 (pure) | 1mg | 1.25mg | 1.5mg |
| Water for injection | 5ml | 5ml | 5ml |
| pH value | 5 | 5 | 5 |
(1) Dissolution and transfer of vitamin B6:
a. adding a proper amount of water for injection into a dissolving tank, opening a top cover of the dissolving tank, pouring the accurately weighed vitamin B6 into the dissolving tank, cleaning a bottle with a plug and weighed vitamin B6 with the water for injection for 3 times, pouring the bottles into the dissolving tank respectively, then covering the dissolving tank, stirring, and stirring for 5 minutes to completely dissolve the vitamin B;
b. delivering the dissolved vitamin B6 solution to a solution preparation tank by using compressed air, then respectively cleaning the dissolving tank for 3 times by using a proper amount of water for injection, and respectively delivering all cleaning solutions to the solution preparation tank by using the compressed air;
c. adding water for injection into the liquid preparation tank to 80% of the prepared batch, then starting a stirring device of the liquid preparation tank, and stopping stirring until the whole process of the preparation is finished;
(2) dissolving and transferring sodium cantharidate:
d. adding a proper amount of water for injection into the dissolving tank, opening the top cover of the dissolving tank, pouring the precisely weighed sodium cantharidate into the dissolving tank, cleaning a bottle with a plug for weighing the sodium cantharidate with the water for injection for 3 times, respectively pouring the sodium cantharidate into the dissolving tank, then covering the dissolving tank, stirring, and stirring for 5 minutes to completely dissolve the sodium cantharidate;
e. delivering the dissolved sodium cantharidate solution to a solution preparation tank by using compressed air, then respectively cleaning the dissolving tank for 3 times by using a proper amount of water for injection, and respectively delivering all cleaning solution to the solution preparation tank by using the compressed air;
f. adding water for injection into the liquid preparation tank to 95% of the prepared batch, then starting a stirring device of the liquid preparation tank, and stopping stirring until the whole process of the preparation is finished;
(3) adjusting the pH of the solution:
g. taking a clean 500ml reagent bottle, preparing weighed sodium hydroxide into a solution with the concentration of 10% by using water for injection, adding 90% of the prepared sodium hydroxide into a preparation tank, diluting the solution by using a proper amount of water for injection, and transferring the solution into the preparation tank by using compressed air;
(3) and (5) encapsulating and sterilizing.
And (3) sampling and detecting the pH value of the solution in the step (3) in the process of mixing the sodium hydroxide solution with the liquid medicine in the liquid preparation tank, and if the pH value is lower than 4.8, continuously adding the sodium hydroxide solution until the pH value is within the range of 4.5-5.5.
Wherein, the water for injection is continuously added into the liquid preparation tank to the prepared batch, and the mixture is continuously stirred for 20 minutes and uniformly mixed.
Further, the uniformly mixed liquid medicine is filtered by a first-stage precision filter.
Preferably, the pore diameter of the filtering element of the primary precision filter is 0.22 μm.
In the invention, the feeding amount of the sodium cantharidate is 5.00/X1Percent, the dosage of the vitamin B6 is 125.0/X2%, wherein, X1% represents the percentage content of the sodium cantharidate raw material; x2% represents the percentage of the raw material of the vitamin B6.
Test example 2 examination results before and after sterilization of solutions of different formulations
Respectively taking 200 sodium cantharidate vitamin B6 injections prepared and produced by the above prescriptions 1-3, and respectively sterilizing (by wet heat sterilization method, temperature is 115.5 ℃, sterilization time is 35 minutes, F)0Value ≧ 8), and the results thereof are shown in Table 2 below:
example 3 examination of solution stability test at different pH
In order to examine the change of pH value of the sodium cantharidate vitamin B6 injection before and after sterilization, the following formula is prepared for examination, and the specific formula is shown in Table 3:
respectively taking 200 sodium cantharidate vitamin B6 injections prepared and produced by the above prescriptions 2, 4-9, and sterilizing respectively (adopting moist heat sterilization method, temperature is 115.5 deg.C, sterilization time is 35 minutes, F)0Value ≧ 8), and the results thereof are shown in Table 4 below:
as can be seen from the above list, when the pH values were between 4.2 and 5.8, the amount of change in pH values was large before and after sterilization; the amount of change in pH is small when the pH is 4.5 to 5.5, and the change in pH is minimal especially when the pH is 4.8 to 5.2, so the sodium cantharidinate vitamin B6 injection is optimally selected to have a pH between 4.8 and 5.2, and is optimally prescribed 2.
Example 4 influencing factor test
20 samples of the prescription 1, the prescription 2 and the prescription 3 are respectively taken, the samples are respectively placed for 10 days under the conditions of high temperature of 60 ℃ and strong light of 4500lx +/-500 lx, samples are taken on the 5 th day and the 10 th day, and items such as properties, pH values, visible foreign matters, related substances, contents and the like are examined, and the test results are shown in a table 5.
As can be seen from the results in Table 5, the samples of the formulas 1, 2 and 3 of the product are placed at 60 ℃ under strong light 4500lx +/-500 lx for 10 days, and compared with 0 day, the indexes of the product have no obvious change, which indicates that the product is stable under the conditions of high temperature and strong light.
Example 5 accelerated test
The samples of the formula 1, the formula 2 and the formula 3 are taken, placed for 6 months under the conditions of the temperature of 40 ℃ plus or minus 2 ℃ and the relative humidity of 75 percent plus or minus 5 percent, sampled once at the end of the 1 st month, 2 nd month, 3 rd month and 6 th month in the test period, and the items of properties, pH value, visible foreign matters, related substances, content and the like are examined, and the results are shown in a table 6.
The test result shows that: the samples of the formula 1, the formula 2 and the formula 3 are placed for 6 months at the temperature of 40 +/-2 ℃ and the RH of 75 +/-5 percent, and compared with 0 month, the indexes of the samples are not obviously changed, which shows that the sodium cantharidate vitamin B6 injection prepared by the formula and the process of the invention is placed for 6 months at the temperature of 40 +/-2 ℃ and the RH of 75 +/-5 percent, and the quality is stable.
EXAMPLE 6 Long term test
Samples of the prescription 1, the prescription 2 and the prescription 3 are taken and placed for 6 months under the conditions of the temperature of 25 +/-2 ℃ and the relative humidity of 60 +/-10%. Samples were taken at the end of each of 0, 3 and 6 months, and items such as properties, pH values, visible foreign substances, related substances and contents were examined, and the test results are shown in Table 7.
The test result shows that: the samples of the formula 1, the formula 2 and the formula 3 are placed for 6 months at the temperature of 25 +/-2 ℃ and the RH of 60 +/-10 percent, and compared with the sample of 0 month, the indexes of the samples are not obviously changed, which indicates that the sodium cantharidate vitamin B6 injection prepared by the formula and the process of the invention is stable in quality when placed for 6 months at the temperature of 25 +/-2 ℃ and the RH of 60 +/-10 percent.
The sodium cantharidinate vitamin B6 injection provided by the invention has a simple prescription and guaranteed safety, and the sodium cantharidinate vitamin B6 injection prepared by the invention has better stability.
The embodiments of the present invention have been described in detail, but the description is only for the preferred embodiments of the present invention and should not be construed as limiting the scope of the present invention. All equivalent changes and modifications made within the scope of the present invention should be covered by the present patent.
Claims (8)
1. A sodium cantharidate vitamin B6 injection is characterized in that: calculated by 5mL of volume, the injection contains 0.04-0.06mg of sodium cantharidate, 61.00-1.50 mg of vitamin B and the balance of water for injection, and the PH value of the injection is 4.5-5.5.
2. The sodium cantharidate vitamin B6 injection according to claim 1, which is characterized in that: calculated by 5mL volume, the injection contains 0.05mg of sodium cantharidate, 61.25mg of vitamin B and the balance of water for injection, and the PH value of the injection is 4.8-5.2.
3. A method for preparing sodium cantharidate vitamin B6 injection as claimed in claim 1, which comprises the following steps:
(1) dissolution and transfer of vitamin B6:
a. adding a proper amount of water for injection into a dissolving tank, opening a top cover of the dissolving tank, pouring the accurately weighed vitamin B6 into the dissolving tank, cleaning a bottle with a plug and weighed vitamin B6 with the water for injection for 3 times, pouring the bottles into the dissolving tank respectively, then covering the dissolving tank, stirring, and stirring for 5 minutes to completely dissolve the vitamin B;
b. delivering the dissolved vitamin B6 solution to a solution preparation tank by using compressed air, then respectively cleaning the dissolving tank for 3 times by using a proper amount of water for injection, and respectively delivering all cleaning solutions to the solution preparation tank by using the compressed air;
c. adding water for injection into the liquid preparation tank to 80% of the prepared batch, then starting a stirring device of the liquid preparation tank, and stopping stirring until the whole process of the preparation is finished;
(2) dissolving and transferring sodium cantharidate:
a. adding a proper amount of water for injection into the dissolving tank, opening the top cover of the dissolving tank, pouring the precisely weighed sodium cantharidate into the dissolving tank, cleaning a bottle with a plug for weighing the sodium cantharidate with the water for injection for 3 times, respectively pouring the sodium cantharidate into the dissolving tank, then covering the dissolving tank, stirring, and stirring for 5 minutes to completely dissolve the sodium cantharidate;
b. delivering the dissolved sodium cantharidate solution to a solution preparation tank by using compressed air, then respectively cleaning the dissolving tank for 3 times by using a proper amount of water for injection, and respectively delivering all cleaning solution to the solution preparation tank by using the compressed air;
c. adding water for injection into the liquid preparation tank to 95% of the prepared batch, then starting a stirring device of the liquid preparation tank, and stopping stirring until the whole process of the preparation is finished;
(3) adjusting the pH of the solution:
a. taking a clean 500ml reagent bottle, preparing weighed sodium hydroxide into a solution with the concentration of 10% by using water for injection, adding 90% of the prepared sodium hydroxide into a preparation tank, diluting the solution by using a proper amount of water for injection, and transferring the solution into the preparation tank by using compressed air;
(4) separately filling and sealing with 5ml ampoule bottle, and sterilizing.
4. The preparation method of sodium cantharidate vitamin B6 injection according to claim 3, which is characterized in that: and (3) sampling and detecting the pH value of the solution in the step (3) in the process of mixing the sodium hydroxide solution with the liquid medicine in the liquid preparation tank, and if the pH value is lower than 4.5, continuously adding the sodium hydroxide solution until the pH value is within the range of 4.5-5.5.
5. The preparation method of sodium cantharidate vitamin B6 injection according to claim 4, which is characterized in that: and (4) continuously adding water for injection into the liquid preparation tank to the prepared batch, continuously stirring for 20 minutes, and uniformly mixing.
6. The preparation method of sodium cantharidate vitamin B6 injection according to claim 5, which is characterized in that: filtering the uniformly mixed liquid medicine by using a first-stage precision filter.
7. The preparation method of sodium cantharidate vitamin B6 injection according to claim 6, which is characterized in that: the aperture of the filtering element of the first-stage precise filter is 0.22 mu m.
8. The preparation method of sodium cantharidate vitamin B6 injection according to claim 3, which is characterized in that: the feeding amount of the sodium cantharidate is 5.00/X1Percent, the dosage of the vitamin B6 is 125.0/X2%, wherein, X1% represents the percentage content of the sodium cantharidate raw material; x2% represents the percentage of the raw material of the vitamin B6.
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1537530A (en) * | 2003-10-22 | 2004-10-20 | 力 刘 | Unit dosage type compound cantharis acid powder-injection, and its prepn. method |
| CN301632133S (en) * | 2011-03-14 | 2011-08-03 | 贵州柏强制药有限公司 | Packing box (sodium cantharidinate and vitamin b6 injection) |
| CN104814959A (en) * | 2015-04-08 | 2015-08-05 | 贵州柏强制药有限公司 | Magnetic sodium cantharidinate vitamin B6 compound preparation and preparation method thereof |
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2021
- 2021-01-14 CN CN202110046733.9A patent/CN112826792A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1537530A (en) * | 2003-10-22 | 2004-10-20 | 力 刘 | Unit dosage type compound cantharis acid powder-injection, and its prepn. method |
| CN301632133S (en) * | 2011-03-14 | 2011-08-03 | 贵州柏强制药有限公司 | Packing box (sodium cantharidinate and vitamin b6 injection) |
| CN104814959A (en) * | 2015-04-08 | 2015-08-05 | 贵州柏强制药有限公司 | Magnetic sodium cantharidinate vitamin B6 compound preparation and preparation method thereof |
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| Title |
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| 范立娟: "斑蝥酸钠维生素B6联合5-氟尿嘧啶、亚叶酸钙治疗晚期大肠癌疗效观察", 《中国现代医药杂志》 * |
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