CN110251461B - Vitamin B complex injection and preparation method thereof - Google Patents
Vitamin B complex injection and preparation method thereof Download PDFInfo
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- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
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Abstract
Every 1000mL of the vitamin B complex injection comprises the following components: 9.8-10.02 g vitamin B10.98-1.02 g of vitamin B20.98-1.02 g of vitamin B614.7-15.3 g of nicotinamide, 0.49-0.51 g of D-sodium pantothenate, 0.05-0.15 g of EDTA-2Na, 20-40 mL of triethanolamine and the balance of water for injection. Specifically, triethanolamine is added into 60% of prescription dose of water for injection, and vitamin B is added2Obtaining a first solution; sequentially adding vitamin B1Vitamin B6Adding nicotinamide and sodium D-pantothenate into 20% of the prescription amount of water for injection to obtain a solution II; mixing the solution II and the solution I, adjusting the pH value to 3.8-5.2, and adding the rest of water for injection; filtering, bottling, and sterilizing. The compound vitamin B injection prepared by the invention has low raw material cost, high efficiency and stable quality and meets the quality standard of veterinary drugs.
Description
Technical Field
The invention belongs to the technical field of veterinary medicines, and particularly relates to a compound vitamin B injection and a preparation method thereof.
Background
At present, in the preparation process of the vitamin B complex injection, Tween-80 is usually used as a cosolvent and the process is complex, for example, Chinese patent (publication No. CN1879626A) discloses a vitamin B complex injection and a preparation method thereof: (1) mixing vitamin B1Adding into water for injection, and stirring to dissolve; (2) mixing vitamin B6Dissolving in water for injection, mixing with the solution obtained in step (1), adding bethanechol chloride, and dissolving; (3) dissolving nicotinamide in water for injection, and adding anhydrous vitamin B2-5' -sodium phosphate is dissolved with stirring; (4) dissolving the sodium D-pantothenate and the disodium ethylene diamine tetraacetate into the water for injection, uniformly mixing, and uniformly mixing with the solution prepared in the step (3); (5) dissolving Tween-80 in water for injection, mixing with the solutions obtained in steps (2) and (4), adjusting pH, and adding water to 1000 ml.
In addition, vitamin B is mostly used in the existing vitamin B complex injection2Sodium-5' -phosphate to provide vitamin B2Component (B) but vitamin2The cost and the feeding amount of the sodium-5' -phosphate are higher, and the raw material cost of a producer is increased.
Disclosure of Invention
Aims to solve the problems of complex process and vitamin B in the preparation process of the vitamin B complex injection2The invention relates to a problem of high production cost caused by-5' -sodium phosphate, and provides a compound vitamin B injection which is low in cost, high in efficiency, stable in quality and in line with the quality standard of veterinary drugs, and a preparation method thereof.
The invention adopts the following technical scheme:
the composition of the vitamin B complex injection per 1000mL is as follows: 9.8-10.02 g vitamin B10.98-1.02 g of vitamin B20.98-1.02 g of vitamin B614.7-15.3 g nicotinamide, 0.49-0.51 g D-sodium pantothenate, 0.05-0.15 g EDTA-2Na, 20-40 mL triethanolamineAnd the balance of water for injection.
Preferably, the composition per 1000mL of injection is: 10g vitamin B11g of vitamin B21g of vitamin B615g nicotinamide, 0.5g sodium pantothenate, 0.1g EDTA-2Na, 30mL triethanolamine, and the balance water for injection.
The preparation method of the vitamin B complex injection comprises the following steps:
step 1: adding triethanolamine into 60% of water for injection, wherein the pH value of the water for injection reaches 11.2-11.7, and adding vitamin B2Fully stirring the mixture until the mixture is dissolved to obtain a solution I;
step 2: sequentially mixing the prescribed amount of vitamin B1Vitamin B6Adding nicotinamide, sodium D-pantothenate and EDTA-2Na into 20% of the prescription amount of water for injection, and stirring until the mixture is dissolved to obtain a solution II;
and step 3: adding the solution II into the solution I to obtain a mixed solution, adjusting the pH value of the mixed solution to 3.8-5.2, and adding the rest of water for injection;
and 4, step 4: filtering, bottling, and sterilizing with high pressure steam for 20 min.
Preferably, the pH of the water for injection after the addition of triethanolamine in step 1 is 11.4.
Preferably, the pH of the mixed solution in step 3 is adjusted to 4.5.
The invention has the following beneficial effects:
1. realize vitamin B2Substitute for vitamin B2-5' -sodium phosphate. Although vitamin B is in water2The solubility of the sodium-5' -phosphate is higher than that of vitamin B2However, vitamin B2The cost and the feeding amount of the sodium-5' -phosphate are higher than those of the vitamin B2High. Vitamin B for use in the present invention2The raw materials replace vitamin B in the original prescription2The sodium-5' -phosphate saves the raw material cost.
2. The amount of organic solvent is reduced. The tween-80 is frequently applied to the vitamin B complex injection as the solubilizing effect, and the vitamin B complex injection does not contain the tween-80, thereby reducing the dosage of organic solvent in the prescription and ensuring the stable quality of the product.
3. The process steps are reduced, and the process is simpler. Compared with the prior art, the preparation process is simpler.
4. The prepared vitamin B complex injection can relieve the pain of injection and reduce the stress reaction of animals. This is because the cosolvent triethanolamine not only enables vitamin B2Can be dissolved sufficiently, and can relieve pain caused by injection when the preparation is used.
Drawings
FIG. 1 is a graph showing the results of four prescriptions of compound vitamin B injection under the conditions of high temperature and light irradiation. The prescription 1(0d), the prescription 2(0d), the prescription 3(0d), the prescription 4 high temperature 5d, the prescription 4 high temperature 10d, the prescription 4 illumination 5d and the prescription 4 illumination 10d are arranged from left to right in sequence.
Detailed Description
The invention is further described below with reference to specific embodiments. It is to be understood that the examples are illustrative only and are not to be construed as limiting the scope of the invention in any way. It will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the spirit and scope of the invention, and that such changes and modifications may be within the scope of the invention.
Example 1
Every 1000mL of the vitamin B complex injection comprises the following components: 9.8g vitamin B10.98g of vitamin B20.98g of vitamin B614.7g of nicotinamide, 0.49g of sodium D-pantothenate, 0.05g of EDTA-2Na, 20mL of triethanolamine and the balance of water for injection.
The preparation of the vitamin B complex injection comprises the following steps:
step 1: adding cosolvent triethanolamine into 60% injectable water with pH of 11.2, and adding vitamin B2Fully stirring the mixture until the mixture is dissolved to obtain a solution I;
step 2: sequentially mixing the prescribed amount of vitamin B1Vitamin B6Nicotinamide, sodium D-pantothenate and EDTA-2Na are added to the prescription of 20%Stirring the mixture in water for injection until the mixture is dissolved to obtain a solution II;
and step 3: adding the solution II into the solution I, adding the rest of the water for injection to obtain a mixed solution, and adjusting the pH value of the mixed solution to 4.5;
and 4, step 4: filtering with 0.22 μm filter membrane, bottling, and sterilizing with high pressure steam for 20 min.
Example 2
Every 1000mL of the vitamin B complex injection comprises the following components: 10.02g vitamin B11.02g of vitamin B21.02g of vitamin B615.3g of nicotinamide, 0.51g of sodium D-pantothenate, 0.15g of EDTA-2Na, 40mL of triethanolamine and the balance of water for injection.
The preparation of the vitamin B complex injection comprises the following steps:
step 1: adding cosolvent triethanolamine into 60% injectable water with pH of 11.7, and adding vitamin B2Fully stirring the mixture until the mixture is dissolved to obtain a solution I;
step 2: sequentially mixing the prescribed amount of vitamin B1Vitamin B6Adding nicotinamide, sodium D-pantothenate and EDTA-2Na into 20% of the prescription amount of water for injection, and stirring until the mixture is dissolved to obtain a solution II;
and step 3: adding the solution II into the solution I, adding the rest of the water for injection to obtain a mixed solution, and adjusting the pH value of the mixed solution to 4.5;
and 4, step 4: filtering with 0.22 μm filter membrane, bottling, and sterilizing with high pressure steam for 20 min.
Example 3
Every 1000mL of the vitamin B complex injection comprises the following components: 10g vitamin B11g of vitamin B21g of vitamin B615g of nicotinamide, 0.5g of D-sodium pantothenate, 0.1g of EDTA-2Na, 30mL of triethanolamine and the balance of water for injection.
The preparation of the vitamin B complex injection comprises the following steps:
step 1: adding cosolvent triethanolamine into 60% injectable water with pH of 11.4, and adding vitamin B2Fully stirring the mixture until the mixture is dissolved to obtain a solution I;
step 2: sequentially mixing the prescribed amount of vitamin B1Vitamin B6Adding nicotinamide, sodium D-pantothenate and EDTA-2Na into 20% of the prescription amount of water for injection, and stirring until the mixture is dissolved to obtain a solution II;
and step 3: adding the solution II into the solution I, adding the rest of the water for injection to obtain a mixed solution, and adjusting the pH value of the mixed solution to 4.5;
and 4, step 4: filtering with 0.22 μm filter membrane, bottling, and sterilizing with high pressure steam for 20 min.
EXAMPLE 4 preparation of vitamin B complex injections of different formulations
The injection is divided into four prescriptions according to different cosolvent, and the raw material composition of each prescription per 1000mL of injection is shown in Table 1.
TABLE 1 kinds and amounts of raw materials in different prescriptions
4.1 preparation of vitamin B complex injection
The four formulations of vitamin B complex injection were prepared according to the preparation method of example 3.
4.2 quality assessment of vitamin B Complex injections
(1) Traits
The vitamin B complex injection prepared by the four prescriptions is yellow clear or almost clear liquid with green fluorescence.
(2) pH value
The pH value of the vitamin B complex injection prepared by the four formulas is within 3.8-5.2 through the measurement of a pH meter.
(3) Determination of content of active ingredient
(ii) vitamin B1
Precisely measuring appropriate amount of the obtained injection (equivalent to vitamin B)150mg) of the mixture is diluted to 50mL by water, 2mL of hydrochloric acid is added, boiling is carried out, 4mL of silicotungstic acid test solution is immediately dropped, boiling is continued for 2 minutes, and the temperature is increased by 80 DEG CFiltering with constant weight sintered glass crucible, washing the precipitate with boiling hydrochloric acid solution (1 → 20)20mL for several times, washing with water 10mL for one time, washing with acetone twice (5 mL each time), drying at 80 deg.C to constant weight, precisely weighing, and multiplying the weight of the precipitate with 0.1939 to obtain product containing C12H17ClN4Weight of OS & HCl.
② vitamin B2
And (4) avoiding light. Precisely measuring appropriate amount of the obtained injection (equivalent to vitamin B)210mg) of the crude product, placing the crude product in a 1000mL brown volumetric flask, adding 2mL of 10% acetic acid solution and 7mL of 14% sodium acetate solution, adding water to dilute the crude product to a scale, shaking the crude product uniformly, measuring absorbance at a wavelength of 444nm by an ultraviolet-visible spectrophotometry, and measuring the absorbance according to C17H20N4O6Absorption coefficient (E) of1％ 1cm) 323, calculating to obtain the product.
(4) Investigation of influence factors
The purpose is as follows: examining the rationality, production process and packaging condition of the preparation
The investigation content is as follows: appearance, pH value, and effective component content.
The samples prepared according to the recipe were placed at high temperature (60 ℃) and under intense light irradiation (illumination 4500Lx) for 10d, and samples were taken at time points 0, 5, and 10d, respectively. The results of the four compound vitamin B injection prescriptions under the influence of high temperature and illumination are shown in Table 2. From the contents in Table 2, it can be seen that the vitamin B in the injection is improved2The dissolution effect of (A) is of utmost importance, wherein sodium hydroxide and ammonia solutions are not suitable as vitamin B2Co-solvent (see fig. 1); vitamin B production using disodium hydrogen phosphate2The dosage is large when dissolving pH value, and the appearance character is that no precipitation appears in a short time, but vitamin B1Content measurement, when the crucible is washed by water, the effective components cannot be retained in the crucible, so that the content measurement is inaccurate; triethanolamine is used as a cosolvent in the formula IV, the color of the injection is deepened after the injection is irradiated by strong light of 5d 4500Lx and 10d4500Lx (shown in figure 1), the relative marked amount is slightly reduced, but not less than 94.0%, and the formula IV accords with the relevant regulation of pharmacopoeia, which shows that the formula IV is stable under the closed and light-proof conditions. Due to the fact thatTriethanolamine is preferably used as vitamin B in the invention2Co-solvent (b) of (a).
TABLE 2 examination of the products of different prescriptions
Example 5 clinical applications
5.1 test drugs
The vitamin B complex injection prepared in example 3 and a commercially available vitamin B complex injection (Henan Prowang bioengineering Co., Ltd., standard: 10mL) were prepared.
5.2 test animals
About 10kg of nursery pigs 33 with symptoms of dyspepsia, anorexia and rough hair were randomly selected.
5.3 test methods
33 nursery pigs were randomly divided into 3 groups of 11 pigs each. Group 1 and 2 the vitamin B complex injection prepared by the fourth prescription in example 1 and the commercially available vitamin B complex injection were injected into the pig muscle, respectively, and the injection amounts: 2 mL/head; group 3 was a blank control, and was given saline at the same volume. Each group was treated 2 times daily for 2 consecutive days.
5.4 Observation index
Clinical symptoms: the clinical symptoms of diet, feces, mental and the like of each group were observed and recorded every day.
5.5 therapeutic efficacy assessment criteria
And (4) invalidation: consistent with pre-treatment symptoms
The method has the following advantages: poor mental state, no love for exercise and improved appetite.
And (3) healing: good mental state, bright and lively hair, and normal respiration and appetite recovery.
5.6 results
TABLE 3 therapeutic results of vitamin B complex injections from different sources
The results showed that there was no significant difference in clinical effects between the vitamin B complex injection prepared in example 3 and the commercially available vitamin B complex injection in the two treatment groups (P)>0.05), there was a significant difference (P) between the two treatment groups and the blank control group<0.05), the results show that vitamin B2And vitamin B2The sodium-5' -phosphate as the main raw material of the vitamin B complex injection has no significant difference in clinical effect, but the former has more advantages than the latter in cost performance.
The above-mentioned embodiments are merely preferred embodiments of the present invention, which are merely illustrative and not restrictive, and it should be understood that other embodiments may be easily implemented by those skilled in the art by means of replacement or modification according to the technical contents disclosed in the specification, and therefore, all changes and modifications that come within the spirit and technical conditions of the present invention should be included in the claims of the present invention.
Claims (5)
1. The vitamin B complex injection is characterized in that each 1000mL of the injection comprises the following components: 9.8-10.02 g vitamin B10.98-1.02 g of vitamin B20.98-1.02 g of vitamin B614.7-15.3 g of nicotinamide, 0.49-0.51 g of D-sodium pantothenate, 0.05-0.15 g of EDTA-2Na, 20-40 mL of triethanolamine and the balance of water for injection.
2. The vitamin B complex injection according to claim 1, wherein the composition per 1000mL of the injection is: 10g vitamin B11g of vitamin B21g of vitamin B615g of nicotinamide, 0.5g of D-sodium pantothenate, 0.1g of EDTA-2Na, 30mL of triethanolamine and the balance of water for injection.
3. The method for preparing vitamin B complex injection of claim 1 or 2, comprising the steps of:
step 1: adding triethanolamine into 60% of the prescription amount of water for injection, wherein the pH value of the water for injection reaches 11.2-11.7, adding vitamin B2Fully stirring the mixture until the mixture is dissolved to obtain a solution I;
step 2: sequentially mixing the prescribed amount of vitamin B1Vitamin B6Adding nicotinamide, sodium D-pantothenate and EDTA-2Na into 20% of the prescription amount of water for injection, and stirring until the mixture is dissolved to obtain a solution II;
and step 3: adding the solution II into the solution I to obtain a mixed solution, adjusting the pH value of the mixed solution to 3.8-5.2, and adding the rest of water for injection;
and 4, step 4: filtering, bottling, and sterilizing with high pressure steam for 20 min.
4. The method of claim 3, wherein the pH of the water for injection after the addition of triethanolamine in step 1 is 11.4.
5. The method for preparing vitamin B complex injection according to claim 3, wherein the pH of the mixed solution in step 3 is adjusted to 4.5.
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2003022208A3 (en) * | 2001-09-07 | 2003-09-25 | Nobex Corp | Pharmaceutical compositions of insulin drug-oligomer conjugates and methods of treating diseases therewith |
| CN1879626A (en) * | 2006-05-18 | 2006-12-20 | 天津生机集团有限公司 | Compound Vitamin B injection and preparation method thereof |
| CN101966184A (en) * | 2010-07-26 | 2011-02-09 | 天津生机集团股份有限公司 | Vitamin B complex injection for treating porcine indigestion and preparation method |
| CN107115354A (en) * | 2017-07-03 | 2017-09-01 | 山东中牧兽药有限公司 | A kind of vitamin B complex injection and preparation method |
| CN107898805A (en) * | 2017-10-10 | 2018-04-13 | 济南康和医药科技有限公司 | A kind of 12 kinds of vitamin freeze-dried preparations of injection and preparation method thereof |
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Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2003022208A3 (en) * | 2001-09-07 | 2003-09-25 | Nobex Corp | Pharmaceutical compositions of insulin drug-oligomer conjugates and methods of treating diseases therewith |
| CN1879626A (en) * | 2006-05-18 | 2006-12-20 | 天津生机集团有限公司 | Compound Vitamin B injection and preparation method thereof |
| CN101966184A (en) * | 2010-07-26 | 2011-02-09 | 天津生机集团股份有限公司 | Vitamin B complex injection for treating porcine indigestion and preparation method |
| CN107115354A (en) * | 2017-07-03 | 2017-09-01 | 山东中牧兽药有限公司 | A kind of vitamin B complex injection and preparation method |
| CN107898805A (en) * | 2017-10-10 | 2018-04-13 | 济南康和医药科技有限公司 | A kind of 12 kinds of vitamin freeze-dried preparations of injection and preparation method thereof |
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