An inosine oral solution and a production process thereof

Abstract

The application discloses an inosine oral solution and a production process thereof, relates to the technical field of oral solution production, and comprises the following steps: S1: dissolving sucrose in purified water to obtain a sucrose solution; S2: taking inosine, sodium benzoate and stevioside, dissolving the inosine, the sodium benzoate and the stevioside in water to obtain a mixed solution, then adding composite adsorption microspheres into the mixed solution, filtering, uniformly mixing the filtrate with the sucrose solution, continuously adding purified water, and simultaneously adjusting the pH value by using sodium hydroxide; filtering and filling; wherein, the preparation method of the composite adsorption microspheres is as follows: mixing activated carbon, vermiculite and magnesium lithium silicate, uniformly grinding the mixture to obtain pretreated raw materials, adding the pretreated raw materials into silica sol for granulation, then performing electrode treatment to obtain the composite adsorption microspheres. The application can effectively further remove impurities in inosine by adopting the specific composite adsorption microspheres to adsorb the mixed solution, so that the influence of the impurities on the stability of the inosine is reduced.

Description

Technical Field

[0001] This invention relates to the field of oral solution production technology, specifically to an inosine oral solution and its production process. Background Technology

[0002] Inosine can be used to treat heart disease, liver disease, leukopenia, thrombocytopenia, optic nerve atrophy, and central retinitis. It can prevent and relieve the side effects on the heart or liver caused by blood-protective drugs. In addition, it can be used as a raw material for synthesizing antiviral drugs and food flavorings.

[0003] Inosine preparations include oral inosine solution, inosine tablets, inosine injection, and inosine capsules. Oral inosine solution is popular among patients due to its palatability and ease of administration. However, it is unstable during storage and is prone to flocculent precipitation. Therefore, how to solve this problem is worth studying. Summary of the Invention

[0004] The purpose of this invention is to at least solve one of the technical problems existing in the prior art, and to provide an inosine oral solution and its production process.

[0005] The technical solution of the present invention is as follows:

[0006] A manufacturing process for an inosine oral solution includes the following steps:

[0007] S1: Dissolve sucrose in purified water to obtain a sucrose solution;

[0008] S2: Take inosine, sodium benzoate, and steviol glycosides, dissolve them in water to obtain a mixed solution, then add composite adsorption microspheres to the mixed solution, filter, mix the filtrate with sucrose solution evenly, continue to add purified water, and adjust the pH value with sodium hydroxide; filter and fill.

[0009] The method for preparing the composite adsorption microspheres is as follows:

[0010] Activated carbon, vermiculite, and lithium magnesium silicate are mixed and ground evenly to obtain pretreated raw materials. The pretreated raw materials are then added to silica sol for granulation, followed by electrode treatment to obtain the final product.

[0011] Further, in step S1, pure water is boiled, sucrose is added while stirring, and the mixture is boiled again and then filtered through a fine filter for 10-20 minutes.

[0012] Furthermore, the filter element of the precision filter has a pore size of 0.4-0.6 μm.

[0013] Furthermore, the mass ratio of activated carbon, vermiculite, and lithium magnesium silicate is 3-5:1:1.

[0014] Furthermore, the electrode treatment conditions are as follows: the applied voltage is 80-120V, the controlled temperature is 60-120℃, and the constant temperature control is 0.5-1.5h.

[0015] Furthermore, the mass ratio of the pretreated raw material to the silica sol is 1:1-2.

[0016] Furthermore, the composite adsorption microspheres account for 2-8% of the mass of the mixed solution.

[0017] Furthermore, the pH value is 13.5.

[0018] The present invention also discloses an inosine oral solution, which is obtained by any of the production processes described above.

[0019] Furthermore, the concentration of inosine is 2 g / 100 mL.

[0020] The beneficial effects of this invention are:

[0021] The main reason affecting the clarity of inosine oral solution is the precipitation of the impurity hypoxanthine, which mainly comes from the part that was not removed during the production of inosine and its degradation during storage.

[0022] The impurity gradually precipitates out due to the decrease in solubility caused by the hydrolysis of its hydrophilic sugar moiety. This precipitation accelerates the flocculation of hypoxanthine and inosine in the system, resulting in turbidity and precipitation.

[0023] Therefore, by performing adsorption treatment on the mixed solution and using composite adsorption microspheres with a specific composition, the present invention can effectively remove impurities in inosine, thereby reducing the impact of impurities on its stability. In addition, the 2% inosine solution provided by the present invention is stable below 60°C. Detailed Implementation

[0024] The embodiments of the present invention are described in detail below. These embodiments are exemplary and are only used to explain the present invention, and should not be construed as limiting the invention. Where specific techniques or conditions are not specified in the embodiments, they are performed according to the techniques or conditions described in the literature in the art or according to the product instructions. Reagents or instruments used, unless otherwise specified, are all commercially available conventional products.

[0025] Example 1

[0026] Take 100L of purified water and place it in a dissolving tank. Boil the water and add 40kg of sucrose while stirring. Continue boiling for 20 minutes. Filter the solution through a precision filter (0.45μm pore size) for 15 minutes to obtain a sucrose solution. Cool the solution to below 50℃ with cooling water and set aside. Take 10kg of inosine, 1.5kg of sodium benzoate, and 0.1kg of steviol glycosides. Dissolve them in water to obtain a mixed solution. Add 2% (by mass) of composite adsorption microspheres to the mixed solution. Filter the solution and mix the filtrate with the sucrose solution. Add purified water to a final volume of 500L and add 0.2kg of sodium hydroxide (pH 13.5). Stir for 20 minutes to ensure a homogeneous mixture. Filter and bottle the solution.

[0027] The method for preparing the composite adsorption microspheres is as follows:

[0028] Activated carbon, vermiculite, and lithium magnesium silicate were mixed in a mass ratio of 3:1:1 and ground evenly to obtain a pretreated raw material. The pretreated raw material was then added to silica sol for granulation and followed by electrode treatment to obtain the final product.

[0029] The electrode treatment conditions are as follows: the applied voltage is 120V, the temperature is controlled at 120℃, and the temperature is controlled for 1 hour.

[0030] The mass ratio of the pretreated raw material to the silica sol is 1:2.

[0031] Example 2

[0032] Take 100L of purified water and place it in a dissolving tank. Boil the water and add 40kg of sucrose while stirring. Continue boiling for 20 minutes. Filter the solution through a precision filter (0.45μm pore size) for 15 minutes to obtain a sucrose solution. Cool the solution to below 50℃ with cooling water and set aside. Take 10kg of inosine, 1.5kg of sodium benzoate, and 0.1kg of steviol glycosides. Dissolve them in water to obtain a mixed solution. Add 2% (by mass) of composite adsorption microspheres to the mixed solution. Filter the solution and mix the filtrate with the sucrose solution. Add purified water to a final volume of 500L and add 0.2kg of sodium hydroxide (pH 13.5). Stir for 20 minutes to ensure a homogeneous mixture. Filter and bottle the solution.

[0033] The method for preparing the composite adsorption microspheres is as follows:

[0034] Activated carbon, vermiculite, and lithium magnesium silicate were mixed in a mass ratio of 4:1:1 and ground evenly to obtain a pretreated raw material. The pretreated raw material was then added to silica sol for granulation and followed by electrode treatment to obtain the final product.

[0035] The electrode treatment conditions are as follows: the applied voltage is 120V, the temperature is controlled at 120℃, and the temperature is controlled for 1 hour.

[0036] The mass ratio of the pretreated raw material to the silica sol is 1:2.

[0037] Example 3

[0038] Take 100L of purified water and place it in a dissolving tank. Boil the water and add 40kg of sucrose while stirring. Continue boiling for 20 minutes. Filter the solution through a precision filter (0.45μm pore size) for 15 minutes to obtain a sucrose solution. Cool the solution to below 50℃ with cooling water and set aside. Take 10kg of inosine, 1.5kg of sodium benzoate, and 0.1kg of steviol glycosides. Dissolve them in water to obtain a mixed solution. Add 2% (by mass) of composite adsorption microspheres to the mixed solution. Filter the solution and mix the filtrate with the sucrose solution. Add purified water to a final volume of 500L and add 0.2kg of sodium hydroxide (pH 13.5). Stir for 20 minutes to ensure a homogeneous mixture. Filter and bottle the solution.

[0039] The method for preparing the composite adsorption microspheres is as follows:

[0040] Activated carbon, vermiculite, and lithium magnesium silicate were mixed in a mass ratio of 5:1:1 and ground evenly to obtain a pretreated raw material. The pretreated raw material was then added to silica sol for granulation and followed by electrode treatment to obtain the final product.

[0041] The electrode treatment conditions are as follows: the applied voltage is 120V, the temperature is controlled at 120℃, and the temperature is controlled for 1 hour.

[0042] The mass ratio of the pretreated raw material to the silica sol is 1:2.

[0043] Example 4

[0044] Take 100L of purified water and place it in a dissolving tank. Boil the water and add 40kg of sucrose while stirring. Continue boiling for 20 minutes. Filter the solution through a precision filter (0.45μm pore size) for 15 minutes to obtain a sucrose solution. Cool the solution to below 50℃ with cooling water and set aside. Take 10kg of inosine, 1.5kg of sodium benzoate, and 0.1kg of steviol glycosides. Dissolve them in water to obtain a mixed solution. Add 2% (by mass) of composite adsorption microspheres to the mixed solution. Filter the solution and mix the filtrate with the sucrose solution. Add purified water to a final volume of 500L and add 0.2kg of sodium hydroxide (pH 13.5). Stir for 20 minutes to ensure a homogeneous mixture. Filter and bottle the solution.

[0045] The method for preparing the composite adsorption microspheres is as follows:

[0046] Activated carbon, vermiculite, and lithium magnesium silicate were mixed in a mass ratio of 4:1:1 and ground evenly to obtain a pretreated raw material. The pretreated raw material was then added to silica sol for granulation and followed by electrode treatment to obtain the final product.

[0047] The electrode treatment conditions are as follows: the applied voltage is 120V, the temperature is controlled at 120℃, and the temperature is controlled for 1 hour.

[0048] The mass ratio of the pretreated raw material to the silica sol is 1:1.5.

[0049] Example 5

[0050] Take 100L of purified water and place it in a dissolving tank. Boil the water and add 40kg of sucrose while stirring. Continue boiling for 20 minutes. Filter the solution through a precision filter (0.45μm pore size) for 15 minutes to obtain a sucrose solution. Cool the solution to below 50℃ with cooling water and set aside. Take 10kg of inosine, 1.5kg of sodium benzoate, and 0.1kg of steviol glycosides. Dissolve them in water to obtain a mixed solution. Add 2% (by mass) of composite adsorption microspheres to the mixed solution. Filter the solution and mix the filtrate with the sucrose solution. Add purified water to a final volume of 500L and add 0.2kg of sodium hydroxide (pH 13.5). Stir for 20 minutes to ensure a homogeneous mixture. Filter and bottle the solution.

[0051] The method for preparing the composite adsorption microspheres is as follows:

[0052] Activated carbon, vermiculite, and lithium magnesium silicate were mixed in a mass ratio of 4:1:1 and ground evenly to obtain a pretreated raw material. The pretreated raw material was then added to silica sol for granulation and followed by electrode treatment to obtain the final product.

[0053] The electrode treatment conditions are as follows: the applied voltage is 120V, the temperature is controlled at 120℃, and the temperature is controlled for 1 hour.

[0054] The mass ratio of the pretreated raw material to the silica sol is 1:1.

[0055] Example 6

[0056] Unlike Example 4, composite adsorption microspheres were then added to the mixed solution at a ratio of 5% by mass of the mixed solution.

[0057] Example 7

[0058] Unlike Example 4, composite adsorption microspheres were then added to the mixed solution at a ratio of 8% by mass of the mixed solution.

[0059] Comparative Example 1

[0060] Unlike Example 6, no composite adsorption microspheres were added.

[0061] Comparative Example 2

[0062] Unlike Example 6, the composite adsorption microspheres are lithium magnesium silicate.

[0063] Comparative Example 3

[0064] Unlike Example 6, the composite adsorption microspheres are made of activated carbon.

[0065] Comparative Example 4

[0066] Unlike Example 6, the composite adsorption microspheres are vermiculite.

[0067] The stability of the samples from the above embodiments and comparative examples was investigated, and the results are shown in Table 1.

[0068] The examination method is as follows:

[0069] The samples were placed at 40℃ and 75% relative humidity for 6 months for accelerated testing. Samples were taken and observed at 3 months, 6 months and 12 months. The indicators were: appearance, clarity, pH and inosine content.

[0070] Table 1 Test results of the examples and comparative examples

[0071]

[0072]

[0073] As can be seen from Table 1, the stability of the embodiments is better than that of the comparative examples. The main reason may be that the present invention uses composite adsorption microspheres with a specific composition to adsorb the mixed solution, which can effectively remove impurities in inosine, thereby reducing the impact of impurities on its stability.

[0074] The embodiments described above are merely preferred embodiments of the present invention, and while the descriptions are specific and detailed, they should not be construed as limiting the scope of the present invention. It should be noted that those skilled in the art can make various other corresponding changes and modifications based on the technical solutions and concepts described above, and all such changes and modifications should fall within the protection scope of the claims of the present invention.

Claims

1. A production process for an inosine oral solution, characterized in that, Includes the following steps: S1: Dissolve sucrose in purified water to obtain a sucrose solution; S2: Take inosine, sodium benzoate and steviol glycosides, dissolve them in water to obtain a mixed solution, then add composite adsorption microspheres to the mixed solution, filter, mix the filtrate with sucrose solution evenly, continue to add purified water, and adjust the pH value with sodium hydroxide at the same time. Filtration, filling; The method for preparing the composite adsorption microspheres is as follows: Activated carbon, vermiculite, and lithium magnesium silicate are mixed and ground evenly to obtain pretreated raw materials. The pretreated raw materials are then added to silica sol for granulation, followed by electrode treatment to obtain the final product. The mass ratio of activated carbon, vermiculite, and lithium magnesium silicate is 3-5:1:1; the electrode treatment conditions are: applied voltage of 80-120V, controlled temperature of 60-120℃, and constant temperature control for 0.5-1.5h.

2. The production process of an inosine oral solution according to claim 1, characterized in that, In step S1, boil pure water, add sucrose while stirring, continue boiling, and then filter and circulate for 10-20 minutes.

3. The production process of an inosine oral solution according to claim 2, characterized in that, The filter element of the precision filter has a pore size of 0.4-0.6μm.

4. The production process of an inosine oral solution according to claim 1, characterized in that, The mass ratio of the pretreated raw material to the silica sol is 1:1-2.

5. The production process of an inosine oral solution according to claim 1, characterized in that, The composite adsorption microspheres account for 2-8% of the mass of the mixed solution.

6. The production process of an inosine oral solution according to claim 1, characterized in that, The pH value is 13.

5.

7. An oral solution of inosine, characterized in that, It is obtained by using the production process described in any one of claims 1-6.

8. An inosine oral solution as described in claim 7, characterized in that, The concentration of inosine is 2 g / 100 mL.

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