Liver protection capsule and preparation method thereof

Abstract

The invention provides a liver protection capsule and a preparation method thereof, and belongs to the technical field of liver protection capsule preparation, and the preparation method comprises the following steps: S1, raw material pretreatment; s2, mixing: mixing the sieved glycine with selenium-enriched yeast according to an equivalent incremental method to obtain mixed powder; s3, granulating and drying: spraying purified water into the boiled mixed powder in the boiling granulator in the step S2 as a wetting agent, and granulating; s4, size stabilization and total mixing: sieving the dried particles, and size stabilization; s5, filling and polishing are conducted, specifically, the capsules with qualified filling are polished; s6, sub-packaging: sub-packaging the capsules in the step S5 into oral solid medicinal high-density polyethylene bottles; through a one-step granulation process, the processes of mixing, granulation, drying and the like are integrated in the same boiling granulator to be completed, the independent steps of soft material preparation, wet granulation and transfer in the traditional process are omitted, the production cycle is remarkably shortened, the material loss is reduced, and the production efficiency and the equipment utilization rate are improved.

Description

Technical Field

[0001] This invention belongs to the field of liver-protecting capsule preparation technology, specifically a liver-protecting capsule and its preparation method. Background Technology

[0002] In the industrial production of existing liver-protecting health foods, wet granulation is commonly used. This typical process usually involves: pulverizing and sieving the raw materials, mixing them, adding high-concentration ethanol as a wetting agent to prepare a soft mass, then granulating using a swing granulator, drying, sizing, and mixing, finally filling into capsules. Although this traditional process can achieve the basic shaping of the product, it has defects and limitations in long-term application and safety assessment.

[0003] Liver protection products are designed to help protect against chemical liver damage, especially avoiding the effects of liver-damaging factors such as alcohol. However, traditional processes use high-concentration ethanol as a granulation solvent, which may leave trace amounts in the product. This potential risk of alcohol residue in liver protection products weakens their safety. Furthermore, ethanol is a flammable and explosive hazardous chemical, and its use requires explosion-proof conditions in the production area, resulting in high daily safety management costs and certain safety hazards. In addition, traditional swing granulation is a multi-unit step-by-step operation, and frequent material exposure and transfer not only lead to low production efficiency but also introduce risks of foreign matter contamination, cross-contamination, and microbial growth at multiple stages, affecting the uniformity and stability of the product.

[0004] In view of the above problems, this invention proposes a liver-protecting capsule and its preparation method. Through a one-step granulation process, mixing, granulation, and drying are integrated into a single fluidized bed granulator, eliminating the separate soft material preparation, wet granulation, and transfer steps required in traditional processes. This significantly shortens the production cycle, reduces material loss, and improves production efficiency and equipment utilization. By using purified water as a wetting agent to completely replace traditional ethanol, the risk of ethanol residue in the finished product is fundamentally eliminated. This method is particularly suitable for people with liver damage, ensuring that the product provides liver protection while maintaining higher safety during consumption. Furthermore, no explosion-proof facilities are required during production, greatly reducing production safety risks. Summary of the Invention

[0005] The purpose of this invention is to address the aforementioned problems in existing technologies by proposing a liver-protecting capsule and its preparation method.

[0006] The objective of this invention can be achieved through the following technical solutions:

[0007] A liver-protecting capsule and its preparation method, comprising the following steps:

[0008] S1: Raw material pretreatment, sieving kudzu root extract, Japanese raisin tree fruit extract, turmeric extract, selenium-enriched yeast and glycine separately;

[0009] S2: Mixing. The sieved glycine and selenium-enriched yeast are mixed in equal increments, and then mixed with the sieved kudzu root extract, Japanese raisin tree fruit extract and turmeric extract in a fluidized bed granulator to obtain a mixed powder.

[0010] S3: Granulation and drying: Purified water is sprayed into the boiling mixed powder in the fluidized bed granulator described in step S2 as a wetting agent for granulation, and then dried in the same equipment.

[0011] S4: Granulation and Mixing: The dried granules are sieved, granulated, and the resulting dry granules are mixed to obtain the total mixture A.

[0012] S5: Filling and polishing: Fill the hollow capsules with the total mixture A from step S4, and polish the capsules that have been filled to a satisfactory condition.

[0013] S6: Dispensing: Dispense the capsules described in step S5 into oral solid pharmaceutical high-density polyethylene bottles.

[0014] Preferably, the sieving in step S1 is through an 80-mesh sieve; the mixing time in step S3 is 20-40 minutes, the temperature of the mixing environment is 18-26℃, and the relative humidity is 45%-65%.

[0015] Preferably, in step S3, when the purified water is sprayed at the beginning, the temperature of the mixed powder is 45-55℃; the drying temperature is about 50℃, and the drying endpoint is when the particle moisture content is ≤4%.

[0016] Preferably, in step S4, the granulation is performed by passing the pellets through a 16-20 mesh sieve; the total mixing time is 3-10 minutes.

[0017] Preferably, in step S5, the capsule filling specification is 0.45g granules / capsule; the dispensing specification is 60 capsules / bottle.

[0018] Preferably, steps S1 to S6 are all carried out in an environment with an air cleanliness level of 100,000, with the ambient temperature controlled at 18-26℃ and the relative humidity controlled at 45%-65%.

[0019] A liver-protecting capsule, wherein each 100g of capsule contents contains: puerarin not less than 1.0g, glycine not less than 10.0g, selenium 1.78mg~3.7mg, and turmeric not less than 0.6g; the moisture content of the capsule contents is ≤4.0%.

[0020] Compared with existing technologies, the medium-frequency heat treatment process for this support roller has the following advantages:

[0021] 1. The present invention provides a liver-protecting capsule and its preparation method, which integrates mixing, granulation and drying processes into the same fluidized bed granulator through a one-step granulation process, eliminating the separate soft material preparation, wet granulation and transfer steps in the traditional process, significantly shortening the production cycle, reducing material loss and improving production efficiency and equipment utilization.

[0022] 2. The present invention provides a liver-protecting capsule and its preparation method, which completely replaces traditional ethanol by using purified water as a wetting agent, fundamentally eliminating the risk of ethanol residue in the finished product. It is especially suitable for people with liver damage, ensuring that the product has higher safety while exerting liver protection function. At the same time, no explosion-proof facilities are required in the production process, which greatly reduces the production safety risk.

[0023] 3. The liver-protecting capsule and its preparation method provided by the present invention ensure stable product quality, uniform particle size and good flowability of each batch by limiting key process parameters, thereby improving the consistency of capsule filling volume differences and reducing the impact of process fluctuations on product quality.

[0024] 4. The liver-protecting capsule and its preparation method provided by the present invention are carried out in a 100,000-level clean area throughout the entire process, combined with a one-step granulation closed operation, which effectively reduces the risk of microbial, foreign matter contamination and cross-contamination during the production process, and ensures that the product meets high standards of hygiene requirements.

[0025] 5. The liver-protecting capsule and its preparation method provided by the present invention, by adopting a low-temperature and rapid drying method, helps to protect the stability of active ingredients in heat-sensitive raw materials such as kudzu root extract and turmeric extract, and improves the level of assurance of product efficacy.

[0026] In summary, this invention provides a liver-protecting capsule and its preparation method. Through innovations in process integration, solvent harmlessness, parameter refinement, environmental purification, and standardization, it achieves a comprehensive improvement in safety, production efficiency, quality control level, and economic benefits while ensuring the stability of the active ingredients and controllable quality of the liver-protecting capsule. Detailed Implementation

[0027] The following are specific embodiments of the present invention, which further describe the technical solution of the present invention, but the present invention is not limited to these embodiments.

[0028] Example 1:

[0029] A method for preparing a liver-protecting capsule includes the following steps:

[0030] S1: Raw material pretreatment. After verifying the material code, product name, specifications, and number, kudzu root extract, Japanese raisin tree extract, turmeric extract, selenium-enriched yeast, and glycine are passed through an 80-mesh sieve.

[0031] S2: Mixing. The sieved glycine and selenium-enriched yeast are mixed in equal increments. Then, the mixture is mixed with the sieved kudzu root extract, Japanese raisin tree fruit extract and turmeric extract in a fluidized bed granulator. The mixture is kept at 22°C and 50% humidity for 30 minutes to obtain a mixed powder.

[0032] S3: Granulation and drying. The mixture from step S2 is continuously boiled and mixed. When the material temperature rises to 50°C, purified water (wetting agent) is sprayed in to granulate. After granulation, the mixture is dried at 50°C in the same equipment until the moisture content is 3.5%.

[0033] S4: Granulation and total mixing: The dried granules are passed through an 18-mesh sieve, granulated, and mixed for 5 minutes. The resulting dry granules are then mixed again to obtain total mixture A.

[0034] S5: Filling and Polishing. Take the empty capsules from the total mixture A in step S4, fill them with an automatic capsule filling machine, with a specification of 0.45g / capsule. Place the qualified capsules in a capsule polishing machine for polishing to remove surface powder. After polishing, send the capsules for inspection. If they pass the inspection, proceed to the next process.

[0035] S6: Dispensing. The capsules described in step S5 are dispensed into oral solid pharmaceutical high-density polyethylene bottles, with each capsule filled at 0.45g / capsule, and 60 capsules per bottle.

[0036] The air cleanliness requirements for production environments such as sieving, mixing, granulation, drying, sizing, total mixing, filling, polishing, and packaging are Class 100,000, which meets the requirements of GB 17405.

[0037] Example 2:

[0038] A method for preparing a liver-protecting capsule includes the following steps:

[0039] S1: Raw material pretreatment. After verifying the material code, product name, specifications, and number, kudzu root extract, Japanese raisin tree extract, turmeric extract, selenium-enriched yeast, and glycine are passed through an 80-mesh sieve.

[0040] S2: Mixing. The sieved glycine and selenium-enriched yeast are mixed in equal increments. Then, the mixture is mixed with the sieved kudzu root extract, Japanese raisin tree fruit extract and turmeric extract in a fluidized bed granulator. The mixture is mixed for 25 minutes at 20°C and 55% humidity to obtain a mixed powder.

[0041] S3: Granulation and drying. The mixture from step S2 is continuously boiled and mixed. When the material temperature rises to 50°C, purified water is sprayed in for granulation. After granulation, the mixture is dried at 48°C in the same equipment until the moisture content is 4.0%.

[0042] S4: Granulation and total mixing: The dried granules are passed through a 20-mesh sieve, granulated, and mixed for 5 minutes. The resulting dry granules are then mixed again to obtain total mixture A.

[0043] S5: Filling and Polishing. Take the empty capsules from the total mixture A in step S4, fill them with an automatic capsule filling machine, with a specification of 0.45g / capsule. Place the qualified capsules in a capsule polishing machine for polishing to remove surface powder. After polishing, send the capsules for inspection. If they pass the inspection, proceed to the next process.

[0044] S6: Dispensing. The capsules described in step S5 are dispensed into oral solid pharmaceutical high-density polyethylene bottles, with each capsule filled at 0.45g / capsule, and 60 capsules per bottle.

[0045] The air cleanliness requirements for production environments such as sieving, mixing, granulation, drying, sizing, total mixing, filling, polishing, and packaging are Class 100,000, which meets the requirements of GB 17405.

[0046] Example 3

[0047] A method for preparing a liver-protecting capsule includes the following steps:

[0048] S1: Raw material pretreatment. After verifying the material code, product name, specifications, and number, kudzu root extract, Japanese raisin tree extract, turmeric extract, selenium-enriched yeast, and glycine are passed through an 80-mesh sieve.

[0049] S2: Mixing. The sieved glycine and selenium-enriched yeast are mixed in equal increments. Then, the mixture is mixed with the sieved kudzu root extract, Japanese raisin tree fruit extract and turmeric extract in a fluidized bed granulator. The mixture is kept at 24°C and 60% humidity for 30 minutes to obtain a mixed powder.

[0050] S3: Granulation and drying. The mixture from step S2 is continuously boiled and mixed. When the material temperature rises to 52°C, purified water is sprayed in for granulation. After granulation, the mixture is dried at 50°C in the same equipment until the moisture content is 3.5%. The ambient temperature is controlled at 24°C and the relative humidity is controlled at 60%.

[0051] S4: Granulation and mixing: After drying, the granules are sieved through an 18-mesh sieve, granulated, and mixed for 5 minutes. The resulting dry granules are then mixed again to obtain total mixture A. The ambient temperature is controlled at 24℃ and the relative humidity is controlled at 60%.

[0052] S5: Filling and Polishing. Take the empty capsules from the total mixture A in step S4, fill them with an automatic capsule filling machine, with a specification of 0.45g / capsule. Place the qualified capsules in a capsule polishing machine for polishing to remove surface powder. After polishing, send the capsules for inspection. If they pass the inspection, proceed to the next process.

[0053] S6: Dispensing. The capsules described in step S5 are dispensed into oral solid pharmaceutical high-density polyethylene bottles, with each capsule filled at 0.45g / capsule, and 60 capsules per bottle.

[0054] The air cleanliness requirements for production environments such as sieving, mixing, granulation, drying, sizing, total mixing, filling, polishing, and packaging are Class 100,000, which meets the requirements of GB 17405.

[0055] Example 4

[0056] A method for preparing a liver-protecting capsule includes the following steps:

[0057] S1: Raw material pretreatment. After verifying the material code, product name, specifications, and number, kudzu root extract, Japanese raisin tree extract, turmeric extract, selenium-enriched yeast, and glycine are passed through an 80-mesh sieve.

[0058] S2: Mixing. The sieved glycine and selenium-enriched yeast are mixed in equal increments, and then mixed with the sieved kudzu root extract, Japanese raisin tree fruit extract and turmeric extract in a fluidized bed granulator. The mixture is mixed for 30 minutes at 22°C and 50% humidity to obtain a mixed powder. The settling bacteria of the operating environment and materials are tested at fixed intervals.

[0059] S3: Granulation and drying. The mixture from step S2 is continuously boiled and mixed. When the material temperature rises to 50°C, purified water is sprayed in for granulation. After granulation, the mixture is dried at 50°C in the same equipment until the moisture content is 3.5%. Settling bacteria are tested on the operating environment and materials at fixed intervals.

[0060] S4: Granulation and total mixing: The dried granules are passed through an 18-mesh sieve, granulated, and mixed for 5 minutes. The resulting dry granules are then mixed again to obtain total mixture A.

[0061] S5: Filling and Polishing. Take the empty capsules from the total mixture A in step S4, fill them with an automatic capsule filling machine, with a specification of 0.45g / capsule. Place the qualified capsules in a capsule polishing machine for polishing to remove surface powder. After polishing, send the capsules for inspection. If they pass the inspection, proceed to the next process.

[0062] S6: Dispensing. The capsules described in step S5 are dispensed into oral solid pharmaceutical high-density polyethylene bottles, with each capsule filled at 0.45g / capsule, and 60 capsules per bottle.

[0063] The air cleanliness requirements for production environments such as sieving, mixing, granulation, drying, sizing, total mixing, filling, polishing, and packaging are Class 100,000, which meets the requirements of GB 17405.

[0064] Comparative Example 1

[0065] A method for preparing a liver-protecting capsule includes the following steps:

[0066] S1: Raw material pretreatment. After verifying the material code, product name, specifications, and number, kudzu root extract, Japanese raisin tree extract, turmeric extract, selenium-enriched yeast, and glycine are passed through an 80-mesh sieve.

[0067] S2: Mixing. The sieved glycine and selenium-enriched yeast are mixed in equal increments. Then, the mixture is mixed with the sieved kudzu root extract, Japanese raisin tree fruit extract and turmeric extract in a fluidized bed granulator. The mixture is kept at 24°C and 50% humidity for 30 minutes to obtain a mixed powder.

[0068] S3: Granulation and drying. The mixture from step S2 is continuously boiled and mixed. While the material is boiling and mixing, heating is turned on. After mixing for 30 minutes, when the material temperature rises to 50°C, 95% ethanol is sprayed in to granulate. After granulation, the material is dried at 50°C in the same equipment until the moisture content is 3.5%.

[0069] S4: Granulation and total mixing: The dried granules are passed through an 18-mesh sieve, granulated, and mixed for 5 minutes. The resulting dry granules are then mixed again to obtain total mixture A.

[0070] S5: Filling and Polishing. Take the empty capsules from the total mixture A in step S4, fill them with an automatic capsule filling machine, with a specification of 0.45g / capsule. Place the qualified capsules in a capsule polishing machine for polishing to remove surface powder. After polishing, send the capsules for inspection. If they pass the inspection, proceed to the next process.

[0071] S6: Dispensing. The capsules described in step S5 are dispensed into oral solid pharmaceutical high-density polyethylene bottles, with each capsule filled at 0.45g / capsule, and 60 capsules per bottle.

[0072] The air cleanliness requirements for production environments such as sieving, mixing, granulation, drying, sizing, total mixing, filling, polishing, and packaging are Class 300,000, which meets the requirements of GB 17405.

[0073] Comparative Example 2

[0074] A method for preparing a liver-protecting capsule includes the following steps:

[0075] S1: Raw material pretreatment. After verifying the material code, product name, specifications, and number, kudzu root extract, Japanese raisin tree extract, turmeric extract, selenium-enriched yeast, and glycine are passed through an 80-mesh sieve.

[0076] S2: Mixing. The sieved glycine and selenium-enriched yeast are mixed in equal increments. Then, the mixture is mixed with the sieved kudzu root extract, Japanese raisin tree fruit extract and turmeric extract in a fluidized bed granulator. The mixture is kept at 24°C and 50% humidity for 30 minutes to obtain a mixed powder.

[0077] S3: Granulation and drying. The mixture from step S2 is continuously boiled and mixed. When the material temperature rises to 50°C, a 30% ethanol aqueous solution is sprayed in to granulate. After granulation, the mixture is dried at 50°C in the same equipment until the moisture content is 3.5%.

[0078] S4: Granulation and total mixing: The dried granules are passed through an 18-mesh sieve, granulated, and mixed for 5 minutes. The resulting dry granules are then mixed again to obtain total mixture A.

[0079] S5: Filling and Polishing. Take the empty capsules from the total mixture A in step S4, fill them with an automatic capsule filling machine, with a specification of 0.45g / capsule. Place the qualified capsules in a capsule polishing machine for polishing to remove surface powder. After polishing, send the capsules for inspection. If they pass the inspection, proceed to the next process.

[0080] S6: Dispensing. The capsules described in step S5 are dispensed into oral solid pharmaceutical high-density polyethylene bottles, with each capsule filled at 0.45g / capsule, and 60 capsules per bottle.

[0081] The air cleanliness requirements for production environments such as sieving, mixing, granulation, drying, sizing, total mixing, filling, polishing, and packaging are Class 300,000, which meets the requirements of GB 17405.

[0082] Comparative Example 3

[0083] A method for preparing a liver-protecting capsule includes the following steps:

[0084] S1: Raw material pretreatment. After verifying the material code, product name, specifications, and number, kudzu root extract, Japanese raisin tree extract, turmeric extract, selenium-enriched yeast, and glycine are passed through an 80-mesh sieve.

[0085] S2: Mixing. The sieved glycine and selenium-enriched yeast are mixed in equal increments. Then, the mixture is mixed with the sieved kudzu root extract, Japanese raisin tree fruit extract and turmeric extract in a fluidized bed granulator. The mixture is mixed for 30 minutes at 22°C and 50% humidity to obtain a mixed powder.

[0086] S3: Granulation and drying. The mixture from step S2 is continuously boiled and mixed. When the material temperature reaches 50°C, a 2% hydroxypropyl methylcellulose (HPMC) aqueous solution is sprayed in to granulate. After granulation, the mixture is dried at 50°C in the same equipment until the moisture content is 3.5%.

[0087] S4: Granulation and total mixing: The dried granules are passed through an 18-mesh sieve, granulated, and mixed for 5 minutes. The resulting dry granules are then mixed again to obtain total mixture A.

[0088] S5: Filling and Polishing. Take the empty capsules from the total mixture A in step S4, fill them with an automatic capsule filling machine, with a specification of 0.45g / capsule. Place the qualified capsules in a capsule polishing machine for polishing to remove surface powder. After polishing, send the capsules for inspection. If they pass the inspection, proceed to the next process.

[0089] S6: Dispensing. The capsules described in step S5 are dispensed into oral solid pharmaceutical high-density polyethylene bottles, with each capsule filled at 0.45g / capsule, and 60 capsules per bottle.

[0090] The air cleanliness requirements for production environments such as sieving, mixing, granulation, drying, sizing, total mixing, filling, polishing, and packaging are Class 100,000, which meets the requirements of GB 17405.

[0091] Comparative Example 4

[0092] S1: Raw material pretreatment. After verifying the material code, product name, specifications, and number, kudzu root extract, Japanese raisin tree extract, turmeric extract, selenium-enriched yeast, and glycine are passed through an 80-mesh sieve.

[0093] S2: Mixing. The sieved glycine and selenium-enriched yeast are mixed in equal increments. Then, the mixture is mixed with the sieved kudzu root extract, Japanese raisin tree fruit extract and turmeric extract in a fluidized bed granulator. The mixture is kept at 24°C and 50% humidity for 30 minutes to obtain a mixed powder.

[0094] S3: Granulation and drying. The mixture from step S2 is continuously boiled and mixed. While the material is boiling and mixing, heating is turned on. After mixing for 30 minutes, when the material temperature rises to 50°C, purified water is sprayed in to granulate. After granulation, the material is dried at 50°C in the same equipment until the moisture content is 3.5%.

[0095] S4: Granulation and total mixing: The dried granules are passed through an 18-mesh sieve, granulated, and mixed for 5 minutes. The resulting dry granules are then mixed again to obtain total mixture A.

[0096] S5: Filling and Polishing. Take the empty capsules from the total mixture A in step S4, fill them with an automatic capsule filling machine, with a specification of 0.45g / capsule. Place the qualified capsules in a capsule polishing machine for polishing to remove surface powder. After polishing, send the capsules for inspection. If they pass the inspection, proceed to the next process.

[0097] S6: Dispensing. The capsules described in step S5 are dispensed into oral solid pharmaceutical high-density polyethylene bottles, with each capsule filled at 0.45g / capsule, and 60 capsules per bottle.

[0098] The air cleanliness requirements for production environments such as sieving, mixing, granulation, drying, sizing, total mixing, filling, polishing, and packaging are Class 300,000, which meets the requirements of GB 17405.

[0099] Table 1. Comparative analysis of accelerated test results after sampling at 0 months.

[0100]

[0101]

[0102]

[0103] Table 2. Comparative analysis of accelerated test results after 1 month of sampling.

[0104]

[0105]

[0106]

[0107]

[0108]

[0109]

[0110] Samples from batches 211001, 211002, 211003, 211004, 211005, and 211006 of the Sunflower Brand Kudzu Root, Hovenia dulcis, and Curcuma longa Capsules were subjected to accelerated testing at 37℃±2℃ and 75%±5% humidity. Samples were taken in 0 months, 1 month, 2 months, and 3 months, and tested according to the relevant methods in the product's enterprise standard. At 0 months, batches 211001, 211002, and 211003 only underwent factory inspection and met factory requirements; batches 211004, 211005, and 211006 underwent full inspection. The testing in January, February, and March was accelerated. Samples in batches 211001, 211002, and 211003 were tested for all items except glycine, hexachlorocyclohexane (HCH), and DDT. Samples in batches 211004, 211005, and 211006 underwent full-item testing.

[0111] Tables 1-5 show the results of the quality analysis of different batches of products from the examples and comparative examples. The results indicate that the content of puerarin in all batches of the examples and comparative examples remained stable at 2.1-2.3 g / 100g within 0 months and 3 months of accelerated testing, far exceeding the lower limit of the standard (≥1.0 g / 100g), with no significant difference. The selenium content in all batches remained stable within the standard range (1.78-3.7 mg / 100g) during the accelerated testing period. The values ​​of the example batches (e.g., 2.12 mg / 100g) and the comparative example batches (e.g., 2.04 mg / 100g) were close, showing a consistent fluctuation trend. In the example batches, the content of turmeric met the standard (≥0.6 g / 100g) at 0 months (0.70-0.74 g / 100g) and remained stable during the accelerated testing period (0.85-0.94 g / 100g), comparable to the results of the comparative example batches. The glycine content of the example batches (17.1-17.5 g / 100g) met the standard (≥10 g / 100g) and remained stable. The comparative batches did not include this item in their factory inspection, but the data in the examples show that the process did not negatively affect the glycine content.

[0112] Results of testing for moisture, ash, and disintegration time showed that all batches met the company's standards at each time point and remained stable during accelerated testing, with no deterioration trend before and after the change.

[0113] Heavy metals (lead, arsenic, mercury, chromium): All batch test results were far below the national standard limits, with some items showing "not detected". The example process (purified water granulation) did not introduce any new heavy metal contamination risks.

[0114] Pesticide residues (HCH, DDT): The test results for all batches after the change were "not detected", which meets the standards.

[0115] Microbial limits (total bacterial count, molds and yeasts, coliforms, etc.): All batches met the requirements for microbial indicators at all stages of accelerated testing, and the microbial levels of the modified batches at some time points were comparable to or slightly better than those before the modification, indicating that the Class 100,000 clean environment (example) effectively ensured and may have improved the hygienic quality of the product. Pathogenic bacteria (Salmonella, Staphylococcus aureus): All batches were "not detected".

[0116] All batches meet the requirements in terms of appearance, color, odor, taste, and impurities, and their appearance and sensory quality are stable.

[0117] Based on the data in Tables 1 to 5, capsules produced using the new process (one-step vertical fluidized bed granulation, purified water as wetting agent, Class 100,000 cleanroom) showed no statistically significant differences compared to capsules produced using the original process (shaking granulation, 95% ethanol as wetting agent, Class 300,000 cleanroom) in terms of the content of all key active ingredients, routine quality indicators, stability, and safety. All indicators continued to meet product standards, confirming that this process change did not reduce the product's intrinsic quality, health benefits, or stability.

[0118] Eliminating the potential risks of 95% ethanol residue makes the product safer for people needing liver protection, especially those who need to avoid alcohol intake. Simultaneously, it completely avoids the production safety hazards and corresponding explosion-proof facility requirements associated with ethanol as a flammable solvent. The cleanliness of the production environment has been upgraded from Class 300,000 to Class 100,000. Combined with a one-step granulation integrated process, it reduces material exposure and transfer points, significantly lowering the risks of confusion, errors, foreign matter introduction, and microbial contamination during production, thus improving product uniformity and quality assurance capabilities. One-step granulation integrates mixing, granulation, and drying steps, shortening the process cycle and improving production efficiency. Using purified water instead of ethanol reduces solvent costs and avoids the environmental burden of ethanol recycling or disposal.

[0119] Table 6 Quality Requirements of Raw Materials for Examples and Comparative Examples

[0120]

[0121] The specific embodiments described herein are merely illustrative of the spirit of the invention. Those skilled in the art to which this invention pertains may make various modifications or additions to the described specific embodiments or use similar methods to substitute them, without departing from the spirit of the invention or exceeding the scope defined by the appended claims.

Claims

1. A method for preparing a liver-protecting capsule, characterized in that, Includes the following steps: S1: Raw material pretreatment, sieving kudzu root extract, Japanese raisin tree fruit extract, turmeric extract, selenium-enriched yeast and glycine separately; S2: Mixing. The sieved glycine and selenium-enriched yeast are mixed in equal increments, and then mixed with the sieved kudzu root extract, Japanese raisin tree fruit extract and turmeric extract in a fluidized bed granulator to obtain a mixed powder. S3: Granulation and drying: Purified water is sprayed into the boiling mixed powder in the fluidized bed granulator described in step S2 as a wetting agent for granulation, and then dried in the same equipment. S4: Granulation and Mixing: The dried granules are sieved, granulated, and the resulting dry granules are mixed to obtain the total mixture A. S5: Filling and polishing: Fill the hollow capsules with the total mixture A from step S4, and polish the capsules that have been filled to a satisfactory condition. S6: Dispensing: Dispense the capsules described in step S5 into oral solid pharmaceutical high-density polyethylene bottles.

2. The method for preparing a liver-protecting capsule as described in claim 1, characterized in that, The sieving in step S1 is sieve 80 mesh; the mixing time in step S3 is 20-40 minutes, the temperature of the mixing environment is 18-26℃, and the relative humidity is 45%-65%.

3. The method for preparing a liver-protecting capsule as described in claim 2, characterized in that, In step S3, when the purified water is sprayed at the beginning, the temperature of the mixed powder is 45-55℃; the drying temperature is about 50℃, and the drying endpoint is when the moisture content of the particles is ≤4%.

4. The method for preparing a liver-protecting capsule as described in claim 3, characterized in that, In step S4, the granulation is carried out by passing the pellets through a 16-20 mesh sieve; the total mixing time is 3-10 minutes.

5. The method for preparing a liver-protecting capsule as described in claim 3, characterized in that, In step S5, the capsule filling specification is 0.45g granules / capsule; the dispensing specification is 60 capsules / bottle.

6. The method for preparing a liver-protecting capsule as described in claim 1, characterized in that, Steps S1 to S6 are all carried out in an environment with an air cleanliness level of 100,000, with the ambient temperature controlled at 18-26℃ and the relative humidity controlled at 45%-65%.

7. A liver-protecting capsule, characterized in that, It is prepared by the method described in any one of claims 1-6.

8. The liver-protecting capsule as described in claim 7, characterized in that, Each 100g capsule contains: puerarin not less than 1.0g, glycine not less than 10.0g, selenium 1.78mg~3.7mg, and turmeric not less than 0.6g; the moisture content of the capsule contents is ≤4.0%.

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