Nysfungin tablet and preparation method thereof
The problem of stability and quality consistency of mycin tablets is solved by mixing and wet-drying and wet-drying methylphenol tablets with starch or low-substituted hydroxypropyl cellulose by dry-wet mixing and tableting process by placing dyspropyl cellulose. , achieving the effect of the stability and quality of nymycin tablets in compliance with national standards.
Patent Information
- Application Number
- CN202411379118.X
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2024-09-30
- Publication Date
- 2024-12-17
AI Technical Summary
The chemical properties of nymycin raw materials are unstable, which leads to the easy decomposition of active ingredients in unfavorable environments such as light and high temperature, affecting the production quality of nymycin tablets and making it difficult to meet the national drug quality standards.
Myphilin is prepared by dry mixing, wet mixing, drying, whole pelleting and tableting using a mixture of mycoplasmin, microcrystalline cellulose, magnesium stearate and starch or low-substituted hydroxypropyl cellulose as binders. Tablets ensure product stability and quality in compliance with the Ministry’s standards and the requirements of the Chinese Pharmacopoeia.
The prepared nymycin tablets remained stable in quality within 24 months, complying with the content and disintegration time limit indicators of the Ministry and the Chinese Pharmacopoeia, ensuring the consistency and effectiveness of the product.
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Abstract
Description
Technical Field
[0001] The invention belongs to the field of pharmaceutical engineering, and in particular relates to a nystatin tablet and a preparation method thereof. Background Art
[0002] As a polyene antifungal antibiotic, nystatin has a long history of application in my country's medical field. It is widely used in clinical practice, mainly for oral administration to treat various fungal infections in the digestive tract. In particular, nystatin has shown significant efficacy in combating gastroenteritis caused by mold or Candida, providing an effective treatment option for many patients.
[0003] However, it is worth noting that the chemical properties of nystatin API itself are not stable. This instability is mainly reflected in the fact that when nystatin is exposed to light, high temperature and other adverse environmental conditions, its active ingredients are prone to decomposition. This characteristic poses a considerable challenge to the production of nystatin tablets. Due to the unstable activity of the API, it is difficult to ensure that each batch of products can maintain a consistent quality level even in a strict production process. This not only affects the effect of the drug, but may also cause the final product to fail to meet the national drug quality standards, such as the specific requirements for drug purity, efficacy, etc. in the ministerial standards and the Chinese Pharmacopoeia. Summary of the invention
[0004] In view of the shortcomings of the prior art, the present invention aims to provide a nystatin tablet and a preparation method thereof. The nystatin tablet prepared by the present invention meets the requirements of the ministerial standards and the Chinese Pharmacopoeia in terms of content, disintegration time and other indicators, and the product quality is stable.
[0005] The purpose of the present invention is achieved through the following technical solutions: A nystatin tablet comprises nystatin, microcrystalline cellulose, magnesium stearate and a binder.
[0006] Preferably, the binder is a mixture of starch and low-substituted hydroxypropyl cellulose.
[0007] Preferably, the starch is corn starch.
[0008] Preferably, the above-mentioned nystatin tablets, calculated as 1,000 tablets, require 500 million units of nystatin, 15-25 g of microcrystalline cellulose, 5-10 g of magnesium stearate and 20-30 g of a binder.
[0009] Preferably, the above-mentioned nystatin tablets, calculated as 1000 tablets, require 500 million units of nystatin, 15-25 g of microcrystalline cellulose, 5-10 g of magnesium stearate, 15-20 g of starch and 5-10 g of low-substituted hydroxypropyl cellulose.
[0010] Preferably, the mesh size of corn starch is 120 mesh; the mesh size of magnesium stearate is 60 mesh, and the mesh size of nystatin is 100 mesh.
[0011] The preparation method of the above-mentioned nystatin tablets comprises the following steps: according to the component ratio, nystatin, microcrystalline cellulose and magnesium stearate are added into a granulator for dry mixing, and then a binder is added for wet mixing; after the wet mixing is completed, drying, granulation, total mixing and tableting are carried out in sequence to obtain nystatin tablets.
[0012] Preferably, the dry mixing time is 100-150 s; the wet mixing time is 30-60 s.
[0013] Preferably, the drying method is: drying the product to 45-50°C, with a moisture content of ≤3.0%.
[0014] Preferably, the total mixing time is 15 min.
[0015] Preferably, the mesh size of the sieve of the granulation finishing machine is 20 meshes.
[0016] Preferably, the tablets are pressed using a rotary tablet press with a 8.0 m / m die.
[0017] Compared with the prior art, the beneficial effects of the present invention include: The nystatin tablets prepared by the present invention meet the requirements of the ministerial standards and the Chinese Pharmacopoeia in terms of identification, content, disintegration time and other inspection indicators. After 24 months of product stability inspection, its quality still meets the requirements, proving that the product quality is stable. DETAILED DESCRIPTION
[0018] In order to make the purpose, technical solution and advantages of the present invention more clearly understood, the present invention is further described in detail below in conjunction with the embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not used to limit the present invention.
[0019] The starch described in the examples and comparative examples is corn starch.
[0020] Example 1 A nystatin tablet is prepared from the following components: 500 million units of nystatin, 20 g of microcrystalline cellulose, 8 g of magnesium stearate, 18 g of starch and 8 g of a paste binder made of low-substituted hydroxypropyl cellulose are required for 1000 tablets.
[0021] The preparation method of the above-mentioned nystatin tablets comprises the following steps: According to the above-mentioned component ratio, nystatin, microcrystalline cellulose and magnesium stearate are first weighed and then added to a granulator for dry mixing for 120 seconds. Next, a paste adhesive made of starch and low-substituted hydroxypropyl cellulose is added to the mixture, and wet mixing is continued for 45 seconds. After wet mixing, the material is dried at 48°C using a boiling dryer until the moisture content of the granules does not exceed 3.0%. Finally, a granulator is used for granulation, a mixer is used for total mixing for 15 minutes, and finally a rotary tablet press (using an 8.0m / m middle die) is used for tableting to prepare the nystatin tablets.
[0022] Example 2 A nystatin tablet is prepared from the following components: 500 million units of nystatin, 25 g of microcrystalline cellulose, 5 g of magnesium stearate, 15 g of starch and 10 g of a paste binder made of low-substituted hydroxypropyl cellulose are required for 1000 tablets.
[0023] The preparation method of the above-mentioned nystatin tablets comprises the following steps: According to the above-mentioned component ratio, nystatin, microcrystalline cellulose and magnesium stearate are first weighed and then added to a granulator for dry mixing for 120 seconds. Next, a paste adhesive made of starch and low-substituted hydroxypropyl cellulose is added to the mixture, and wet mixing is continued for 45 seconds. After wet mixing, the material is dried at 50°C using a boiling dryer until the moisture content of the granules does not exceed 3.0%. Finally, a granulator is used for granulation, a mixer is used for total mixing for 15 minutes, and finally a rotary tablet press (using an 8.0m / m middle die) is used for tableting to prepare the nystatin tablets.
[0024] Example 3 A nystatin tablet is prepared from the following components: 500 million units of nystatin, 15 g of microcrystalline cellulose, 10 g of magnesium stearate, 20 g of starch and 5 g of a paste binder made of low-substituted hydroxypropyl cellulose are required for 1000 tablets.
[0025] The preparation method of the above-mentioned nystatin tablets comprises the following steps: According to the above-mentioned component ratio, nystatin, microcrystalline cellulose and magnesium stearate are first weighed and then added to a granulator for dry mixing for 150 seconds. Next, a paste adhesive made of starch and low-substituted hydroxypropyl cellulose is added to the mixture, and wet mixing is continued for 45 seconds. After wet mixing, the material is dried at 50°C using a boiling dryer until the moisture content of the granules does not exceed 3.0%. Finally, a granulator is used for granulation, a mixer is used for total mixing for 15 minutes, and finally a rotary tablet press (using an 8.0m / m middle die) is used for tableting to prepare the nystatin tablets.
[0026] Example 4 A nystatin tablet is prepared from the following components: 500 million units of nystatin, 15 g of microcrystalline cellulose, 10 g of magnesium stearate, 15 g of starch and 5 g of a paste binder made of low-substituted hydroxypropyl cellulose are required for 1000 tablets.
[0027] The preparation method of the above-mentioned nystatin tablets comprises the following steps: According to the above-mentioned component ratio, nystatin, microcrystalline cellulose and magnesium stearate are first weighed and then added to a granulator for dry mixing for 100 seconds. Next, a paste adhesive made of starch and low-substituted hydroxypropyl cellulose is added to the mixture, and wet mixing is continued for 45 seconds. After wet mixing, the material is dried at 45°C using a boiling dryer until the moisture content of the granules does not exceed 3.0%. Finally, a granulator is used for granulation, a mixer is used for total mixing for 15 minutes, and finally a rotary tablet press (using an 8.0m / m middle die) is used for tableting to prepare the nystatin tablets.
[0028] According to the content requirements of WS1-XG-056-2011 standard (nystatin should be 90.0% to 110.0% of the labeled amount), the stability of the nystatin tablets prepared in Examples 1 to 4 was investigated. The results are shown in Table 1.
[0029] Table 1 Results of product quality stability study of Nystatin Tablets (% of labeled amount)
[0030] It can be seen from Table 1 that the 24-month stability test results of the nystatin tablets prepared in Examples 1 to 4 of the present invention all meet the content requirements in the ministerial standard (WS1-XG-056-2011), and the product quality is stable.
[0031] According to the requirements on disintegration time limit in Appendix XA of Part II of the 2010 edition of the Chinese Pharmacopoeia (disintegration time should be ≤15 min), the stability of disintegration time of the nystatin tablets prepared in Examples 1 to 4 was investigated. The results are shown in Table 2.
[0032] Table 2 Disintegration time test results of nystatin tablets (min)
[0033] The specific implementation of the present invention described above does not constitute a limitation on the protection scope of the present invention. Any other corresponding changes and modifications made based on the technical concept of the present invention should be included in the protection scope of the claims of the present invention.
Claims
1. A nystatin tablet, characterized in that: Includes nystatin, microcrystalline cellulose, magnesium stearate, and binders.
2. The nystatin tablet according to claim 1, characterized in that: The adhesive is a mixture of starch and low-substituted hydroxypropyl cellulose; The starch is corn starch.
3. The nystatin tablet according to claim 1, characterized in that: For 1,000 tablets, 500 million units of nystatin, 15 to 25 g of microcrystalline cellulose, 5 to 10 g of magnesium stearate and 20 to 30 g of binder are required.
4. The nystatin tablet according to claim 2, characterized in that: Based on 1,000 tablets, 500 million units of nystatin, 15-25g of microcrystalline cellulose, 5-10g of magnesium stearate, 15-20g of starch and 5-10g of low-substituted hydroxypropyl cellulose are required.
5. The nystatin tablet according to claim 2, characterized in that: The mesh number of the corn starch is 120 meshes; the mesh number of the magnesium stearate is 60 meshes, and the mesh number of the nystatin is 100 meshes.
6. The method for preparing the nystatin tablets according to any one of claims 1 to 5, characterized in that: The method comprises the following steps: according to the component ratio, adding nystatin, microcrystalline cellulose and magnesium stearate into a granulator for dry mixing, and then adding a binder for wet mixing; after the wet mixing, drying, granulation, total mixing and tableting are sequentially performed to obtain nystatin tablets.
7. The method for preparing nystatin tablets according to claim 6, characterized in that: The dry mixing time is 100-150s; the wet mixing time is 30-60s.
8. The method for preparing nystatin tablets according to claim 6, characterized in that: The drying method is: drying the product to 45-50°C, with a moisture content of ≤3.0%.
9. The method for preparing nystatin tablets according to claim 6, characterized in that: The total mixing time is 15min; The mesh number of the sieve of the granulation finishing machine is 20 meshes.
10. The method for preparing nystatin tablets according to claim 6, characterized in that: The tablets are pressed using a rotary tablet press with an 8.0 m / m middle die.
Citation Information
Patent Citations
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CN116763751A
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GB8406101D0