VC calcium granules and a method for preparing the same

By using a precise ratio of calcium VC to ethyl cellulose and a dry-wet granulation method, the degradation and discoloration problems of calcium VC particles during the preparation process were solved, thereby improving yield and efficiency.

CN116211809BActive Publication Date: 2025-12-09HUAZHONG PHARMA
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Patent Information

Application Number
CN202310176752.2
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2023-02-28
Publication Date
2025-12-09
Estimated Expiration
2043-02-28

AI Technical Summary

Technical Problem

Existing VC calcium particles are prone to degradation and discoloration during preparation, resulting in low yield and a cumbersome and inefficient preparation process.

Method used

By using excipients such as calcium VC and ethyl cellulose in precise proportions, and combining dry granulation and wet granulation methods, the preparation process parameters are strictly controlled to avoid degradation and improve yield.

Benefits of technology

This effectively avoids the degradation and discoloration of VC calcium particles during the preparation process, increasing the yield to 87.3%-92.7% and greatly improving the preparation efficiency.

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Abstract

The application discloses VC calcium particles and a preparation method thereof. The VC calcium particles are prepared by precisely proportioning VC calcium and auxiliary materials such as ethyl cellulose, and the process parameters of the preparation of the VC calcium particles are strictly controlled in the preparation process, so that the degradation and discoloration of the VC calcium particles in the production process are effectively avoided, the stability of the preparation process is ensured, the yield of the finally prepared VC calcium particles is maintained between 87.3% and 92.7%, the yield of the VC calcium particles is greatly improved, the VC calcium particles are prepared by the wet granulation method, and the preparation efficiency of the VC calcium particles in the preparation process is effectively improved.
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Description

TECHNICAL FIELD

[0001] The present application belongs to the field of preparation of VC calcium, and particularly relates to a VC calcium particle and a preparation method thereof. BACKGROUND

[0002] VC calcium is a neutral ascorbate. It has no irritation to the stomach, and can provide about 10% of very easy-to-absorb calcium while supplementing vitamin C. Vitamin C calcium has the functions of antioxidation, antiviral, antitoxin, antiallergic, and enhancing immunity, and is an important factor for synthesizing the most important supporting tissue collagen in the body, and its important roles in growth and development, maintaining health, and resisting diseases are increasingly recognized by more and more people.

[0003] Vitamin C calcium has the same pharmacological effects of vitamin C and calcium, can be used for treating vitamin C deficiency and preventing and treating calcium deficiency, and is more easily absorbed by the human body and has enhanced stability after being prepared into calcium salt. Vitamin C calcium has been widely used in the medical and food industries abroad. In the food industry, vitamin C calcium can be used as an antioxidant, a fortifier, and an additive of food. The product is a vitamin C supplement and has the following effects: 1. treating vitamin C deficiency; 2. providing high content of vitamin C required by the human immune system to reduce the duration and incidence of viral infection; 3. meeting the additional needs of the human body for vitamin C during pregnancy, lactation, postoperative period, antibiotic treatment period, and people with digestive and absorptive disorders, and frequent smokers. Vitamin C calcium participates in the metabolism of amino acids, the synthesis of neurotransmitters, collagen, and interstitial tissue. Supplementing an appropriate amount of vitamin C calcium can promote the metabolism of nutrients and energy production of the body, enhance the immune function, improve the vascular adaptability, improve the elasticity and tension of the skin, blood vessels and other tissues, and improve the response energy of the body to stress (such as infection). In the body, ascorbic acid and dehydroascorbic acid form a reversible oxidation-reduction system, which plays an important role in biological oxidation and reduction and cell respiration. However, the current VC calcium particles are mostly prepared by chemical methods, and the VC calcium particles are prone to degradation and discoloration during the preparation process, and the yield is only 86%, which is relatively low. In addition, the entire extraction and chemical reaction process is relatively long, which greatly increases the preparation time of the VC calcium particles and reduces the preparation efficiency of the VC calcium particles. SUMMARY

[0004] In view of the deficiencies in the prior art, the present application aims to provide a VC calcium granule and a preparation method thereof, wherein VC calcium and excipients such as ethyl cellulose are prepared into VC calcium granules according to precise proportions, and the process parameters for preparing the VC calcium granules are strictly controlled during the preparation process, which on the one hand effectively avoids the degradation and discoloration of the VC calcium granules during the production process, ensures the stability of the preparation process, and on the other hand maintains the yield of the finally prepared VC calcium granules at 87.3%-92.7%, greatly improving the yield of the VC calcium granules, and in addition, the VC calcium granules are prepared by dry mixing and wet mixing, which effectively avoids the complicated extraction process of the VC calcium granules during the preparation process, greatly improving the preparation efficiency of the VC calcium granules.

[0005] The object of the present application is achieved by the following technical solutions:

[0006] A VC calcium granule is prepared from the following components by mass fraction: 250-350 parts of VC calcium, 4.5-5.8 parts of ethyl cellulose and 21.0-23.8 parts of ethanol.

[0007] Preferably, the VC calcium granule is prepared from the following components by mass fraction: 280-330 parts of VC calcium, 4.8-5.5 parts of ethyl cellulose and 21.0-23.8 parts of ethanol.

[0008] Preferably, the VC calcium granule is prepared from the following components by mass fraction: 290-320 parts of VC calcium, 5.0-5.3 parts of ethyl cellulose and 21.5-23.1 parts of ethanol.

[0009] The preparation method of the VC calcium granule comprises the following steps:

[0010] (1) mixing ethyl cellulose and ethanol to prepare an ethyl cellulose ethanol solution with a concentration of 3.0-4.0wt%;

[0011] (2) putting VC calcium and ethyl cellulose into a granulator for dry mixing and granulation; the total amount of the ethyl cellulose in step (2) and step (1) is 4.8-5.5 parts, and the amount of the ethanol in step (1) is 21.0-23.8 parts;

[0012] (3) after the dry mixing and granulation in step (2) is completed, adding the ethyl cellulose ethanol solution in step (1) and continuously stirring for mixing and granulation;

[0013] (4) after the mixing and granulation in step (3) is completed, drying and granulating to prepare the VC calcium granule.

[0014] Preferably, the dry mixing time in step (2) is 150s, and the granulation time is 300s.

[0015] Preferably, the mixing granulation in step (3) has the parameters: granulation time is 150s, bag shaking time is 30s / time, and air outlet temperature is less than 60℃. The uneven shaking of VC calcium particles during the granulation process can be effectively avoided, the uniform adhesion of the excipients is ensured, and the preparation quality of the VC calcium particles is greatly improved.

[0016] Preferably, the drying method in step (4) is to draw the sample into a boiling dryer for drying.

[0017] Preferably, the 1.5mm round hole stainless steel screen is used during the granulation in step (4). The particle size of the product can be accurately controlled, and the final production quality of the VC calcium particles is ensured.

[0018] Compared with the prior art, the beneficial effects of the present application include:

[0019] (1) The VC calcium particles prepared by the present application are prepared by accurately mixing VC calcium and excipients such as ethyl cellulose, and the process parameters of the VC calcium particles are strictly controlled during the preparation. On the one hand, the degradation and discoloration of the VC calcium particles during the production process are effectively avoided, the stability of the preparation process is ensured, and on the other hand, the yield of the finally prepared VC calcium particles is maintained between 87.3% and 92.7%, greatly improving the yield of the VC calcium particles.

[0020] (2) The VC calcium particles prepared by the present application are prepared by dry mixing and wet granulation, which effectively avoids the complicated extraction process of the VC calcium particles during the preparation process, and greatly improves the preparation efficiency of the VC calcium particles. DETAILED DESCRIPTION

[0021] In order to make the purpose, technical scheme and advantages of the present application clearer, the present application will be further described in detail below with examples. It should be understood that the specific examples described herein are only used to explain the present application, and are not used to limit the present application.

[0022] Example 1

[0023] A VC calcium particle is prepared from the following components: 300kg of VC calcium, 5.3kg of ethyl cellulose and 23.2kg of ethanol.

[0024] The preparation method of the VC calcium particle is as follows:

[0025] (1) Mix ethyl cellulose (0.812kg) with ethanol (23.2kg) to prepare an ethyl cellulose ethanol solution with a concentration of 3.5wt%;

[0026] (2) Put 300 kg of VC calcium and ethyl cellulose (5.3-0.812=4.488 kg) into the granulator, and perform dry mixing for 150 s and granulation for 300 s;

[0027] (3) After the dry mixing and granulation in step (2) are completed, add the ethyl cellulose ethanol solution in step (1) to the mixture, and continuously stir to perform mixing and granulation, with a granulation time of 150 s, a bag shaking time of 30 s / time, and an air outlet temperature less than 60°C;

[0028] (4) After the mixing and granulation in step (3) are completed, draw into a fluidized dryer for drying and granulation (through a 1.5 mm round hole stainless steel screen), to obtain the VC calcium granules.

[0029] Example 2

[0030] A VC calcium granule is prepared from the following components by mass: 300 kg of VC calcium, 5.3 kg of ethyl cellulose, and 21.2 kg of ethanol.

[0031] A preparation method of the VC calcium granule, steps of which are as follows:

[0032] (1) Mix ethyl cellulose (0.741 kg) with ethanol (21.2 kg) to prepare an ethyl cellulose ethanol solution with a concentration of 3.5 wt%;

[0033] (2) Put 300 kg of VC calcium and ethyl cellulose (5.3-0.741=4.559 kg) into the granulator, and perform dry mixing for 150 s and granulation for 300 s;

[0034] (3) After the dry mixing and granulation in step (2) are completed, add the ethyl cellulose ethanol solution in step (1) to the mixture, and continuously stir to perform mixing and granulation, with a granulation time of 150 s, a bag shaking time of 30 s / time, and an air outlet temperature less than 60°C;

[0035] (4) After the mixing and granulation in step (3) are completed, draw into a fluidized dryer for drying and granulation (through a 1.5 mm round hole stainless steel screen), to obtain the VC calcium granules.

[0036] Example 3

[0037] A VC calcium granule is prepared from the following components by mass: 300 kg of VC calcium, 5.3 kg of ethyl cellulose, and 22.2 kg of ethanol.

[0038] A preparation method of the VC calcium granule, steps of which are as follows:

[0039] (1) ethyl cellulose (0.777 kg) is mixed with ethanol (22.2 kg) to prepare an ethyl cellulose ethanol solution with a concentration of 3.5 wt%;

[0040] (2) 300 kg of VC calcium and ethyl cellulose (5.3-0.777=4.523 kg) are put into a granulator for dry mixing for 150 s and granulation for 300 s;

[0041] (3) after the dry mixing and granulation of step (2) is completed, the ethyl cellulose ethanol solution of step (1) is added thereto, and mixing and granulation is carried out with constant stirring, the granulation time is 150 s, the shaking bag time is 30 s / time, and the air outlet temperature is less than 60℃;

[0042] (4) after the mixing and granulation of step (3) is completed, the granules are dried in a fluidized bed dryer and sieved (through a 1.5 mm round hole stainless steel screen), thereby preparing the VC calcium granules.

[0043] The yield of the VC calcium granules prepared in Examples 1-3 is counted, and the results are shown in Table 1.

[0044] Table 1: Yield statistics of Examples 1-3 and prior art

[0045] Sample Example 1 Example 2 Example 3 Prior art Yield 92.7% 87.3% 89.0% 86%

[0046] As can be seen from Table 1, the yield of the VC calcium prepared by the preparation method of the present application is as high as 87.3-92.7%, which is an improvement over the prior art of 86%.

[0047] The specific embodiments of the present application described above do not constitute a limitation on the scope of protection of the present application. Any various other corresponding changes and modifications made in accordance with the technical concept of the present application should be included in the scope of protection of the claims of the present application.

Claims

1. A type of VC calcium granules, characterized in that, It was prepared from the following components in parts by weight: 300 parts calcium VC, 5.3 parts ethyl cellulose and 23.2 parts ethanol; The preparation of the VC calcium particles also includes the following steps: (1) Ethyl cellulose is mixed with ethanol to prepare an ethyl cellulose ethanol solution with a concentration of 3.0~4.0wt%; (2) Add calcium VC and ethyl cellulose into a granulator and perform dry mixing and granulation. (3) After the dry mixing granulation in step (2) is completed, add the ethyl cellulose ethanol solution in step (1) and stir continuously to carry out the mixing granulation operation.

2. The method for preparing the VC calcium particles according to claim 1, characterized in that, Includes the following steps: (1) Ethyl cellulose is mixed with ethanol to prepare an ethyl cellulose ethanol solution with a concentration of 3.0~4.0wt%; (2) Add calcium VC and ethyl cellulose into a granulator and perform dry mixing and granulation. (3) After the dry mixing granulation in step (2) is completed, add the ethyl cellulose ethanol solution in step (1) and stir continuously to carry out the mixing granulation operation; (4) After the mixing and granulation in step (3) is completed, the mixture is dried and granulated to obtain the VC calcium granules.

3. The method for preparing VC calcium particles according to claim 2, characterized in that, The parameters for mixing and granulation in step (3) are: granulation time is 150s, bag shaking time is 30s / time, and air outlet temperature is less than 60℃.

4. The method for preparing VC calcium particles according to claim 2 or 3, characterized in that, The dry mixing time in step (2) is 150s.

5. The method for preparing VC calcium particles according to claim 4, characterized in that, The granulation time in step (2) is 300s.

6. The method for preparing VC calcium particles according to claim 2, characterized in that, The drying method described in step (4) is to draw the sample into a boiling dryer for drying.

7. The method for preparing VC calcium particles according to claim 2, characterized in that, In step (4), the granules are passed through a stainless steel sieve with 1.5mm round holes.

Citation Information

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