Vitamin C injection as well as preparation method and application thereof

Abstract

The invention provides a vitamin C injection as well as a preparation method and application thereof. The vitamin C injection comprises vitamin C, a composite antioxidant, a metal ion complexing agent, a pH regulator, activated carbon and a solvent, wherein the composite antioxidant is selected from one or more of sodium sulfite, sodium hydrogen sulfite, sodium pyrosulfite, sodium thiosulfate or L-cysteine. By the adoption of the vitamin C injection, the oxidation phenomenon of the vitamin C injection can be further reduced, the problem that the vitamin C injection is not uniform in color is solved, all the components in the vitamin C injection act synergistically, the stability of the vitamin C injection is improved, and the effect of the vitamin C injection is better.

Description

Technical Field

[0001] This application relates to the technical field of veterinary drug products, and particularly to a vitamin C injection, its preparation method and application. Background Art

[0002] Vitamin C injection has functions such as antioxidation, enhancing immunity, and scavenging free radicals. It is mainly used for vitamin C deficiency, fever, chronic consumptive diseases, etc. Firstly, vitamin C injection can combine with free radicals in the body, thereby protecting free radicals, reducing free radical peroxidation damage, and thus delaying cell aging to achieve the antioxidation effect; secondly, injectable vitamin C can enhance the body's stress resistance and immune ability to the external environment, thereby improving the body's resistance to the external environment and reducing the occurrence of diseases.

[0003] In the production of vitamin C injection, it is found that after the sterilization process, the phenomenon of inconsistent liquid medicine color is likely to occur, which does not meet its character requirements (this product should be a colorless to slightly yellowish clear liquid), so it can only be scrapped. The scrapping of unqualified products causes huge losses to the enterprise.

[0004] Based on this, in the face of the problem of inconsistent liquid medicine color in the existing vitamin C injection in the prior art, the present invention provides a vitamin C injection and its preparation method to improve the above problems. Summary of the Invention

[0005] The main object of the present invention is to provide a vitamin C injection, its preparation method and application to solve the problem of inconsistent liquid medicine color in the existing vitamin C injection in the prior art.

[0006] To achieve the above object, according to one aspect of the present invention, a vitamin C injection is provided. The vitamin C injection includes: vitamin C, a composite antioxidant, a metal ion chelating agent, a pH regulator, activated carbon and a solvent; wherein, the composite antioxidant is selected from one or more of sodium sulfite, sodium bisulfite, sodium metabisulfite, sodium thiosulfate or L-cysteine.

[0007] Furthermore, by weight percentage, the vitamin C injection includes: 9-11 wt% of vitamin C, 0.1-3.0 wt% of the composite antioxidant, 0.05-2.00 wt% of the metal ion chelating agent, 0.05-2.00 wt% of the pH regulator, 0.02-1.50 wt% of the activated carbon and 83-90 wt% of the solvent.

[0008] Further, by weight percentage, the vitamin C injection comprises: 9-11 wt% of vitamin C, 0.1-1.0 wt% of a compound antioxidant, 0.05-2.00 wt% of a metal ion chelating agent, 0.05-1.50 wt% of a pH regulator, 0.02-1.00 wt% of activated carbon, and 85-90 wt% of a solvent.

[0009] Further, the metal ion chelating agent is selected from one or more of ethylenediaminetetraacetic acid, disodium ethylenediaminetetraacetate or citric acid; preferably, the pH regulator is selected from one or more of sodium bicarbonate, hydrochloric acid, and sodium hydroxide; preferably, the solvent is water for injection.

[0010] To achieve the above object, according to one aspect of the present invention, a preparation method of a vitamin C injection is provided. The preparation method includes: Step S1, dissolving a compound antioxidant in a pretreated solvent to obtain a compound antioxidant solution; Step S2, sequentially adding vitamin C, a metal ion chelating agent, and a pH regulator to the compound antioxidant solution to obtain a mixed solution; Step S3, adding water for injection to the mixed solution to a full volume, and after passing the semi-finished product inspection, adding activated carbon and performing stirring, standing, filtering, and filling and sealing treatments in sequence to obtain the vitamin C injection.

[0011] Further, the pretreated solvent includes: 70% of the solvent by preparation amount, and filtering CO2 is introduced into it until it reaches a saturated state to obtain the pretreated solvent.

[0012] Further, in Step S1, the compound antioxidant solution is placed in a preparation tank for carrying out.

[0013] Further, in Step S2, a pH regulator is added to adjust the pH value of the mixed solution to 5.5-6.2; preferably, in Step S3, the stirring speed is 40-80 rpm, the stirring time is 15-45 min; preferably, the standing time is 5-15 min, and the standing temperature is 25-40 °C.

[0014] Further, in Step S3, the filtering operation includes: taking the material after standing and sequentially filtering it with a 0.45 μm filter element and a 0.22 μm filter element; preferably, the filling and sealing treatment is carried out in an atmosphere filled with an inert gas to complete the filling and sealing treatment; preferably, after the filling and sealing treatment, the material after filling and sealing needs to be sterilized, lamp inspected, printed, and packaged in sequence to obtain the vitamin C injection; preferably, the temperature of the sterilization treatment is 100-121 °C, and the treatment time is 15-30 min.

[0015] According to another aspect of the present invention, an application of a vitamin C injection, or a vitamin C injection obtained by the above preparation method of the vitamin C injection, in the field of animal medicine is provided.

[0016] Applying the technical solution of the present invention can further reduce the oxidation phenomenon of vitamin C injection, solve the problem of inconsistent colors, and the components in the vitamin C injection of the present invention act synergistically to improve the stability of the vitamin C injection and make its effect better. Detailed implementation manners

[0017] To make the objectives, technical solutions, and advantages of the embodiments of the present application clearer, the technical solutions in the embodiments of the present application will be clearly and completely described below. Apparently, the described embodiments are some but not all of the embodiments of the present application. All other embodiments obtained by those of ordinary skill in the art based on the embodiments in the present application without creative efforts shall fall within the scope of protection of the present application.

[0018] As described in the background art part of the present invention, there is a problem of inconsistent colors of the liquid medicine in the existing vitamin C injection. The present invention provides a vitamin C injection, which includes: vitamin C, a compound antioxidant, a metal ion chelating agent, a pH regulator, activated carbon, and a solvent; wherein, the compound antioxidant is selected from one or more of sodium sulfite, sodium bisulfite, sodium metabisulfite, sodium thiosulfate, or L-cysteine.

[0019] The vitamin C injection provided by the present invention, especially adding a compound antioxidant, which is selected from one or more of sodium sulfite, sodium bisulfite, sodium metabisulfite, sodium thiosulfate, or L-cysteine, can further reduce the oxidation phenomenon of the vitamin C injection, solve the problem of inconsistent colors, and the vitamin C, compound antioxidant, metal ion chelating agent, activated carbon, and pH regulator in the present invention act synergistically to improve the stability of the vitamin C injection and make its use effect better.

[0020] In a preferred embodiment, by weight percentage, the vitamin C injection includes: 9-11 wt% of vitamin C, 0.1-3.0 wt% of the compound antioxidant, 0.05-2.00 wt% of the metal ion chelating agent, 0.05-2.00 wt% of the pH regulator, 0.02-1.50 wt% of the activated carbon, and 83-90 wt% of the solvent to further improve the stability of the vitamin C injection; further preferably, by weight percentage, the vitamin C injection includes: 9-11 wt% of vitamin C, 0.1-1.0 wt% of the compound antioxidant, 0.05-2.00 wt% of the metal ion chelating agent, 0.05-1.50 wt% of the pH regulator, 0.02-1.00 wt% of the activated carbon, and 85-90 wt% of the solvent.

[0021] In order to further make the pH value of the vitamin C injection moderate and suitable for its scope of use, preferably, the metal ion chelating agent is selected from one or more of ethylenediaminetetraacetic acid, disodium ethylenediaminetetraacetate or citric acid; the pH regulator is selected from one or more of sodium bicarbonate, hydrochloric acid, sodium hydroxide; the solvent is water for injection, so as to further improve the stability of the vitamin C injection.

[0022] Another aspect of the present invention provides a preparation method of a vitamin C injection. The preparation method of the vitamin C injection includes: Step S1, dissolving a compound antioxidant in a pretreated solvent to obtain a compound antioxidant solution; Step S2, sequentially adding vitamin C, a metal ion chelating agent and a pH regulator to the compound antioxidant solution to obtain a mixed solution; Step S3, adding water for injection to the mixed solution to make up the total volume, and after passing the semi-finished product inspection, adding activated carbon and then performing stirring, standing, filtering and filling-sealing treatments in sequence to obtain the vitamin C injection.

[0023] Those skilled in the art first place the compound antioxidant in a pretreated solvent for dissolution to obtain a compound antioxidant solution; then sequentially add vitamin C, a metal ion chelating agent and a pH regulator to the compound antioxidant solution to obtain a mixed solution; finally, add water for injection to the mixed solution to make up the total volume, and after passing the semi-finished product inspection, add activated carbon and then perform stirring, standing, filtering and filling-sealing treatments in sequence to obtain the vitamin C injection. The vitamin C injection prepared in this way has better stability, is not prone to the phenomenon of inconsistent colors, and the above preparation method is simple and easy to operate, and has broad industrial application prospects.

[0024] In a preferred embodiment, the pretreated solvent includes: 70% of the solvent by preparation amount, and filtered CO2 is introduced into it until it is in a saturated state to obtain the pretreated solvent, so as to further reduce the phenomenon of inconsistent colors of the vitamin C injection and improve its stability.

[0025] In order to further avoid the phenomenon of inconsistent colors of the vitamin C injection and improve its stability, preferably, in Step S1, the compound antioxidant solution is placed in a preparation tank to enhance the stability of the compound antioxidant solution.

[0026] In order to further prepare the vitamin C injection to obtain a suitable pH value, preferably, in Step S2, a pH regulator is added to adjust the pH value of the mixed solution to 5.5 - 6.2; in Step S3, the stirring speed is 40 - 80 rpm, and the stirring time is 15 - 45 min; further preferably, the standing time is 5 - 15 min, and the standing temperature is 25 - 40 °C, so that the vitamin C injection is uniform and stable, and the problem of inconsistent colors is reduced.

[0027] In a preferred embodiment, in step S3, the filtration operation includes: taking the prepared material and successively filtering it through a 0.45 μm filter element and a 0.22 μm filter element; to remove impurities therein, improve the product cleanliness, and avoid the influence of impurities on the product performance; preferably, the potting treatment is carried out in an atmosphere filled with an inert gas to complete the potting treatment; thereby improving the product stability. Further preferably, after the potting treatment, the potted material needs to be successively sterilized, lamp inspected, printed, and packaged to obtain vitamin C injection; more preferably, the temperature of the sterilization treatment is 100-121 °C, and the treatment time is 15-30 min.

[0028] Another aspect of the present invention also provides an application of the above vitamin C injection, or a vitamin C injection obtained by the preparation method of the above vitamin C injection, in the field of animal medicine.

[0029] The following further describes the present application in detail with specific embodiments, and these embodiments should not be construed as limiting the scope claimed by the present application.

[0030] Example 1

[0031] First, add 70% of the injection water in the preparation amount (1000 mL), introduce filtered CO2 until it reaches a saturated state, then use sodium thiosulfate and L-cysteine as the compound antioxidant, and its total dosage accounts for 0.1% of the preparation amount. After dissolving it with an appropriate amount of injection water, add it to the preparation tank; then successively add vitamin C, ethylenediaminetetraacetic acid disodium as the metal ion complexing agent, and sodium bicarbonate as the pH regulator, adjust the pH value to 5.8, and add injection water to the full volume to obtain a semi-finished product. After the semi-finished product passes the inspection, add activated carbon, and its dosage accounts for 0.1% of the preparation amount, stir for 5 minutes, the stirring speed is 60 rpm, stand still at 30 °C for 10 minutes and then filter (first through a 0.45 μm filter element and then through a 0.22 μm filter element), and perform potting, and an inert gas is also filled during the potting treatment; finally, successively perform sterilization (sterilization conditions are 121 °C, 15 minutes), lamp inspection, printing, and packaging to obtain vitamin C injection, and store it in the warehouse after passing the full inspection. By weight percentage, the vitamin C injection includes: 10 wt% of vitamin C, 0.2 wt% of the compound antioxidant, 0.15 wt% of the metal ion complexing agent, 0.1 wt% of the pH regulator, 0.2 wt% of activated carbon, and 89.35 wt% of the solvent.

[0032] Comparative Example 1

[0033] The difference from Example 1 is that the compound antioxidant is not added.

[0034] Performance test:

[0035] 1) Color uniformity

[0036] Dilute the sample with water to prepare a solution containing 50 mg of vitamin C per 1 mL, and measure it using an ultraviolet-visible spectrophotometer. Measure the absorbance at a wavelength of 420 nm. If the absorbance does not exceed 0.06, the color is qualified.

[0037] 2) Stability

[0038] Conduct tests under high temperature and light. If it can be maintained for 12 months, the stability is relatively good; if it can be maintained for 18 months under freezing conditions, the stability is relatively good; if it is stored in a sealed manner in a cool and dark place and can be maintained for 36 months, the stability is relatively good.

[0039] Perform the above performance tests on the products of the above examples and comparative examples, and the test results are as follows.

[0040] Table 1: Results table of color uniformity inspection for the products of examples and comparative examples.

[0041] Table 2: Results of the destructive experiment for the product of Example 1.

[0042] Table 3: Results of the long-term stability experiment for the product of Example 1.

[0043] Table 1

[0044]

[0045] Table 2

[0046]

[0047] Note: If the product color is colorless, the stability is relatively good; if the product color is yellow, the stability is relatively poor.

[0048] Table 3

[0049]

[0050] Note: If the product color is colorless, the stability is relatively good.

[0051] From the above description, it can be seen that the above examples of the present invention achieve the following technical effects:

[0052] Using the vitamin C injection provided by the present invention, especially adding a composite antioxidant, which is selected from one or more of sodium sulfite, sodium bisulfite, sodium metabisulfite, sodium thiosulfate or L-cysteine, can further reduce the oxidation phenomenon of the vitamin C injection and solve the problem of uneven color. Moreover, the vitamin C, composite antioxidant, metal ion chelating agent, activated carbon and pH regulator in the present invention act synergistically to improve the stability of the vitamin C injection and make its use effect relatively good.

[0053] Although this specification contains many specific implementation details, these should not be construed as limiting the scope of any invention or the scope of what is claimed, but rather as mainly describing the features of specific embodiments of a particular invention. Certain features described in multiple embodiments in this specification may also be implemented in combination in a single embodiment. On the other hand, the various features described in a single embodiment may also be implemented separately in multiple embodiments or in any suitable sub-combination. Additionally, although features may operate in certain combinations as described above and even were initially claimed as such, one or more features from a claimed combination may in some cases be removed from that combination, and the claimed combination may be directed to a sub-combination or a variation of a sub-combination.

[0054] Similarly, although operations are depicted in a particular order, this should not be construed as requiring that those operations be performed in the particular order shown or sequentially, or that all illustrated operations be performed, to achieve the desired result. In some cases, multitasking and parallel processing may be advantageous. Additionally, the separation of various system modules and components in the above embodiments should not be construed as requiring such separation in all embodiments, and it should be understood that the described program components and systems can generally be integrated together in a single software product or packaged into multiple software products.

[0055] Thus, specific embodiments of the subject matter have been described. Other embodiments are within the scope of the appended claims. In some cases, the acts recited in the claims may be performed in a different order and still achieve the desired result. Additionally, the depicted processing is not necessarily in the particular order or sequential order shown to achieve the desired result. In some implementations, multitasking and parallel processing may be advantageous.

[0056] It should be noted that, in this context, relational terms such as "first" and "second" are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any actual relationship or order between these entities or operations. Moreover, the term "comprising", "including" or any other variation thereof is intended to cover non-exclusive inclusion, such that a process, method, article or device comprising a series of elements includes not only those elements but also other elements not expressly listed, or elements that are inherent to such process, method, article or device. Without further limitation, an element defined by the statement "comprising a..." does not exclude the presence of additional identical elements in the process, method, article or device comprising the element.

[0057] The above are only specific embodiments of the present application, enabling those skilled in the art to understand or implement the present application. Various modifications to these embodiments will be obvious to those skilled in the art, and the general principles defined herein can be implemented in other embodiments without departing from the spirit or scope of the present application. Therefore, the present application will not be limited to these embodiments shown herein, but rather to the broadest scope consistent with the principles and novel features claimed herein.

Claims

1. A vitamin C injection, characterized in that, The vitamin C injection solution comprises: vitamin C, a composite antioxidant, a metal ion chelating agent, a pH regulator, activated carbon and a solvent; wherein, the composite antioxidant is selected from one or more of sodium sulfite, sodium bisulfite, sodium metabisulfite, sodium thiosulfate or L-cysteine.

2. The vitamin C injection according to claim 1, wherein, By weight percentage, the vitamin C injection solution comprises: 9-11 wt% of the vitamin C, 0.1-3.0 wt% of the composite antioxidant, 0.05-2.00 wt% of the metal ion chelating agent, 0.05-2.00 wt% of the pH regulator, 0.02-1.50 wt% of the activated carbon and 83-90 wt% of the solvent.

3. The vitamin C injection according to claim 1 or 2, characterized in that, By weight percentage, the vitamin C injection solution comprises: 9-11 wt% of the vitamin C, 0.1-1.0 wt% of the composite antioxidant, 0.05-2.00 wt% of the metal ion chelating agent, 0.05-1.50 wt% of the pH regulator, 0.02-1.00 wt% of the activated carbon and 85-90 wt% of the solvent.

4. The vitamin C injection according to any one of claims 1 to 3, characterized in that, The metal ion chelating agent is selected from one or more of ethylenediaminetetraacetic acid, disodium ethylenediaminetetraacetate or citric acid; Preferably, the pH regulator is selected from one or more of sodium bicarbonate, hydrochloric acid, sodium hydroxide; Preferably, the solvent is water for injection.

5. A method for preparing the vitamin C injection according to any one of claims 1 to 4, characterized in that, The preparation method comprises: Step S1, dissolving the composite antioxidant in the pretreated solvent to obtain a composite antioxidant solution; Step S2, sequentially adding vitamin C, the metal ion chelating agent and the pH regulator to the composite antioxidant solution to obtain a mixed solution; Step S3, adding water for injection to the mixed solution to the full volume, and after passing the semi-finished product inspection, adding activated carbon and then performing stirring, standing, filtration and filling and sealing treatments in sequence to obtain the vitamin C injection solution.

6. The preparation method of the vitamin C injection according to claim 5, wherein, The pretreated solvent comprises: 70% of the solvent by the preparation amount, and filtering the CO2 into it until it is in a saturated state to obtain the pretreated solvent.

7. The preparation method of the vitamin C injection according to claim 5 or 6, characterized in that, In the step S1, the composite antioxidant solution is placed in a preparation tank for carrying out.

8. The preparation method of the vitamin C injection according to any one of claims 5 to 7, characterized in that, In the step S2, adding the pH regulator to adjust the pH value of the mixed solution to 5.5-6.2; Preferably, in the step S3, the stirring speed is 40-80 rpm and the stirring time is 15-45 min; Preferably, the standing time is 5-15 min and the standing temperature is 25-40 °C.

9. The preparation method of the vitamin C injection according to any one of claims 5 to 8, characterized in that, In the step S3, the filtration operation comprises: taking the material after standing and performing the filtration treatment successively with a 0.45 μm filter element and a 0.22 μm filter element; Preferably, the filling and sealing treatment is carried out in an atmosphere filled with an inert gas to complete the filling and sealing treatment; Preferably, after the filling and sealing treatment, the material after filling and sealing also needs to be subjected to sterilization, lamp inspection, printing and packaging treatments in sequence to obtain the vitamin C injection solution; Preferably, the temperature of the sterilization treatment is 100-121 °C and the treatment time is 15-30 min.

10. Use of an injection of vitamin C according to any one of claims 1 to 4, or an injection of vitamin C obtained by the method for preparing an injection of vitamin C according to any one of claims 5 to 9, in the field of veterinary medicine.

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