A broken ganoderma lucidum spore powder freeze-dried tablet and a preparation method thereof
Patent Information
- Application Number
- CN202611471501.7
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2026-09-21
- Publication Date
- 2026-10-27
AI Technical Summary
[0005]本发明的目的在于提供一种破壁灵芝孢子粉冻干片及其制备方法，旨在解决现有传统的机械压片工艺制备破壁灵芝孢子粉片剂时，受破壁灵芝孢子粉粒径小、含油率高的物料特性制约，常规压片制备得到的破壁灵芝孢子粉片剂崩解时限过长，不利于活性成分快速溶出释放的技术问题
[0014]本发明的一种破壁灵芝孢子粉冻干片及其制备方法，将灵芝孢子粉、麦芽糖和纯化水进行以下步骤：将入厂检验合格的灵芝孢子粉在气流分选间进行分选，收集颗粒饱满的灵芝孢子粉，把干瘪不饱满粗粉作为废弃物剔除；将分选得到的高品质灵芝孢子粉通过设定4级传送带频率的二辊破壁机循环上料，加料结束后开始计时，破壁处理90min后再经灭菌，获得破壁灵芝孢子粉；将破壁灵芝孢子粉与麦芽糖投入混合机，依靠三维摆动实现原辅料充分混匀；将混匀后的物料转入槽型混合机内干混，混合后在运行过程中缓慢滴加纯化水，使固液充分接触；将湿混物料装填至硅胶模具，用刮板轻轻刮平，将刮平后的样品放置于冻干机内进行冷冻；将冻干完成后进行样品脱模，使用复合铝箔袋对冻干片独立真空包装，最后装盒得到成品；通过上述过程，实现能够显著缩短片剂崩解时限，利于活性成分快速溶出释放。
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Abstract
Description
Technical Field
[0001] This invention relates to the field of health food technology, and in particular to a freeze-dried tablet of broken-cell wall Ganoderma lucidum spore powder and its preparation method. Background Technology
[0002] Reishi mushroom is a collective term for the fruiting bodies of various fungi in the genus Ganoderma of the family Ganodermataceae. It is a precious medicinal and edible herb with effects such as strengthening the body's resistance, nourishing the heart, and calming the mind. Reishi spore powder is the dried, mature spore of Reishi mushroom, containing all active substances such as polysaccharides and triterpenoids. However, the spores have a hard chitinous outer shell, which needs to be broken down to allow the human body to better absorb its internal active ingredients. Therefore, broken-cell wall Reishi spore powder has become a mainstream raw material for health food products on the market.
[0003] Currently, common dosage forms of broken-cell wall Ganoderma lucidum spore powder include powder, granules, hard capsules, and tablets. Powders are highly hygroscopic and easily clump together; granules require brewing during use, which is cumbersome; capsules have the drawback of high production costs. Tablets are convenient to take, provide precise dosage, and are better suited to the needs of modern consumers, making them a more ideal dosage form choice.
[0004] However, when preparing Ganoderma lucidum spore powder tablets using traditional mechanical compression processes, the small particle size and high oil content of the Ganoderma lucidum spore powder result in excessively long disintegration times, which is not conducive to the rapid dissolution and release of active ingredients. Summary of the Invention
[0005] The purpose of this invention is to provide a freeze-dried tablet of broken-cell wall Ganoderma lucidum spore powder and its preparation method. It aims to solve the technical problem that when preparing broken-cell wall Ganoderma lucidum spore powder tablets by conventional mechanical compression process, the material characteristics of broken-cell wall Ganoderma lucidum spore powder, such as small particle size and high oil content, result in a long disintegration time of the tablets, which is not conducive to the rapid dissolution and release of active ingredients.
[0006] To achieve the above objectives, the present invention provides a freeze-dried tablet of broken-cell wall Ganoderma lucidum spore powder, which is prepared from the following raw materials: Ganoderma lucidum spore powder, maltose, and purified water.
[0007] This invention also provides a method for preparing freeze-dried tablets of broken-cell wall Ganoderma lucidum spore powder, comprising the following steps: Ganoderma lucidum spore powder that has passed the incoming inspection is sorted in the airflow separation room. The plump Ganoderma lucidum spore powder is collected, while the dry and unplump coarse powder is discarded as waste. The high-quality Ganoderma lucidum spore powder obtained from sorting is fed into a two-roller wall-breaking machine with a set 4-level conveyor belt frequency. After feeding is completed, the timer is started. After 90 minutes of wall-breaking treatment, it is sterilized to obtain broken Ganoderma lucidum spore powder. The broken-cell wall Ganoderma lucidum spore powder and maltose are put into a mixer, and the raw and auxiliary materials are fully mixed by three-dimensional oscillation. The mixed materials are transferred into a trough mixer for dry mixing. After mixing, purified water is slowly added dropwise during operation to ensure full contact between solid and liquid. Fill the wet mixture into the silicone mold, gently scrape it flat with a scraper, and then place the flattened sample in a freeze dryer for freezing. After freeze-drying, the samples are demolded, and the freeze-dried tablets are individually vacuum-packed in composite aluminum foil bags. Finally, they are boxed to obtain the finished product.
[0008] In the process of sorting the qualified Ganoderma lucidum spore powder in the airflow separation room, collecting the plump Ganoderma lucidum spore powder and removing the shriveled and unplump coarse powder as waste: In the airflow separation room, turn on the main power supply of the separator control cabinet, open the compressed air valve, set the frequency of the classifier inverter to 30HZ, set the frequency of the feeder inverter to 40HZ, install the collection bags at the three-stage discharge port, tie the bag openings tightly, turn on the induced draft fan, add Ganoderma lucidum spore powder into the hopper, turn on discharge pump No. 1 and discharge pump No. 2, and start the separation. Every 30 minutes, turn on the scraper to collect the plump Ganoderma lucidum spore powder into the bag, and treat the unplump and shriveled coarse powder as unqualified products and waste.
[0009] In the process of circulating the sorted high-quality Ganoderma lucidum spore powder through a two-roller cell disruptor with a set 4-level conveyor belt frequency, starting the timer after feeding, and then sterilizing after 90 minutes of cell disruption to obtain broken Ganoderma lucidum spore powder: When feeding materials, turn on the four-stage conveyor belt and adjust the frequency of the inverter, with stage 1 at 35Hz, stage 2 at 25Hz, stage 3 at 25Hz, and stage 4 at 23Hz. The feeding time should be controlled within 30 minutes.
[0010] In the process of circulating the sorted high-quality Ganoderma lucidum spore powder through a two-roller cell disruptor with a set 4-level conveyor belt frequency, starting the timer after feeding, and then sterilizing after 90 minutes of cell disruption to obtain broken Ganoderma lucidum spore powder: The temperature of the Ganoderma lucidum spore powder after cell wall breaking is controlled at 121℃, and the sterilization time is 30 minutes.
[0011] In the step of adding broken-cell wall Ganoderma lucidum spore powder and maltose into a mixer and using three-dimensional oscillation to achieve thorough mixing of the raw and auxiliary materials: The mass ratio of broken-cell wall Ganoderma lucidum spore powder to maltose is 7:3, the mixing speed of the mixer is 10 rpm, and the mixing time is 30 min.
[0012] In the step of transferring the mixed materials into a trough mixer for dry mixing, and then slowly adding purified water dropwise during operation to ensure sufficient contact between the solid and liquid components: The dry mixing speed of the trough mixer is 16 rpm, and the dry mixing time is 9 min. When adding purified water, the speed of the trough mixer is 9 rpm, and the mass ratio of purified water to solid material is 1:1 to 1:2. After the addition is completed, wet mixing is performed for 7 min. After mixing is completed, the mixer is tilted and discharged at low speed.
[0013] In the steps of filling the wet-mixed material into the silicone mold, gently leveling it with a scraper, and then placing the leveled sample in a freeze dryer for freezing: The silicone mold dimensions are 2cm×2cm×1.2cm; the pre-freezing temperature is -30℃, and the pre-freezing holding time is 30min.
[0014] This invention discloses a freeze-dried tablet of broken-cell wall Ganoderma lucidum spore powder and its preparation method. The method involves the following steps: Ganoderma lucidum spore powder that has passed factory inspection is sorted in an airflow separation room, collecting plump spores and discarding shriveled and coarse powder as waste; the high-quality Ganoderma lucidum spore powder obtained from the sorting is circulated through a two-roller cell disruptor with a 4-stage conveyor belt frequency; timing begins after feeding, and the cell disruption process lasts 90 minutes before sterilization to obtain broken-cell wall Ganoderma lucidum spore powder; the broken-cell wall Ganoderma lucidum spore powder is then mixed with maltose... The raw materials are fed into a mixer, where three-dimensional oscillation ensures thorough mixing. The mixed material is then transferred to a trough mixer for dry mixing, during which purified water is slowly added dropwise to ensure full contact between the solid and liquid components. The wet-mixed material is then filled into a silicone mold and gently leveled with a scraper. The leveled sample is then placed in a freeze dryer for freezing. After freeze-drying, the sample is demolded, and the freeze-dried tablets are individually vacuum-packed in composite aluminum foil bags. Finally, the tablets are boxed to obtain the finished product. Through the above process, the disintegration time of the tablets can be significantly shortened, facilitating the rapid dissolution and release of the active ingredients. Attached Figure Description
[0015] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.
[0016] Figure 1 This is a flowchart of the preparation method of the freeze-dried Ganoderma lucidum spore powder tablets of the present invention. Detailed Implementation
[0017] Exemplary embodiments will now be described in detail, examples of which are illustrated in the accompanying drawings. When the following description relates to the drawings, unless otherwise indicated, the same numbers in different drawings represent the same or similar elements. The embodiments described in the following exemplary embodiments do not represent all embodiments consistent with this application.
[0018] The terminology used in this application is for the purpose of describing particular embodiments only and is not intended to be limiting of the application. The singular forms “a,” “the,” and “the” used in this application and the appended claims are also intended to include the plural forms unless the context clearly indicates otherwise. It should also be understood that the term “and / or” as used herein refers to and includes any or all possible combinations of one or more of the associated listed items.
[0019] It should be understood that although the terms first, second, third, etc., may be used in this application to describe various information, such information should not be limited to these terms. These terms are only used to distinguish information of the same type from one another. For example, without departing from the scope of this application, first information may also be referred to as second information, and similarly, second information may also be referred to as first information. Depending on the context, the word "if" as used herein may be interpreted as "when," "when," or "in response to determination."
[0020] This invention provides a freeze-dried tablet of broken-cell wall Ganoderma lucidum spore powder, which is prepared from the following raw materials: Ganoderma lucidum spore powder, maltose, and purified water.
[0021] Please see Figure 1 This invention provides a method for preparing freeze-dried tablets of broken-cell wall Ganoderma lucidum spore powder, comprising the following steps: S100: The Ganoderma lucidum spore powder that has passed the factory inspection is sorted in the air classifier room. The classifier frequency is set to 30HZ and the feeder frequency is set to 40HZ. The collection bag is loaded and the blower and unloading pump are turned on for sorting. The scraper is started every 30 minutes to collect the plump spore powder and remove the dry and unplump coarse powder waste. S200: The high-quality Ganoderma lucidum spore powder obtained from sorting is fed into a two-roller wall-breaking machine with a set 4-stage conveyor belt frequency. During feeding, the 4-stage conveyor belt is turned on and the frequency of the frequency converter is adjusted, with stage 1 at 35HZ, stage 2 at 25HZ, stage 3 at 25HZ, and stage 4 at 23HZ. The feeding time is controlled within 30 minutes. The timing starts after the feeding is completed. After 90 minutes of wall-breaking treatment, it is sterilized at 121℃ for 30 minutes to obtain broken Ganoderma lucidum spore powder. S300: Add broken-cell wall Ganoderma lucidum spore powder and maltose into the mixer. The mass ratio of broken-cell wall Ganoderma lucidum spore powder to maltose is 7:3. The mixing speed of the mixer is 10 rpm and the mixing time is 30 min. The raw and auxiliary materials are fully mixed by relying on three-dimensional oscillation. S400: Transfer the mixed material into the trough mixer for dry mixing. The dry mixing speed is 16 rpm and the dry mixing time is 9 min. When adding purified water, the speed of the trough mixer is 9 rpm. The mass ratio of purified water to solid material is 1:1 to 1:2. After the addition is completed, wet mix for 7 min. After mixing is finished, reverse the speed and tilt the mixer to discharge the material. S500: Fill the wet mixture into the silicone mold, gently scrape it flat with a scraper, and place the flattened sample in a freeze dryer for freezing. The pre-freezing temperature is -30℃ and the pre-freezing time is 30min. The silicone mold size is 2cm×2cm×1.2cm. S600: After freeze-drying, demold the sample, vacuum-pack the freeze-dried tablets individually in composite aluminum foil bags, and finally box them to obtain the finished product.
[0022] In this embodiment, the Ganoderma lucidum spore powder that has passed the incoming inspection is first sorted in the air classifier room. The classifier frequency is set to 30 Hz and the feeder frequency to 40 Hz. The collection bags are loaded and the blower and unloading pump are turned on for sorting. The scraper is started every 30 minutes to collect the plump spore powder and remove the dry and unplump coarse powder waste. Then, the high-quality Ganoderma lucidum spore powder obtained from the sorting is circulated through a two-roll mill with a 4-stage conveyor belt frequency. The 4-stage conveyor belt is turned on during feeding. The conveyor belt is used to adjust the frequency of the frequency converter, with levels 1 at 35Hz, 25Hz, 25Hz, and 23Hz respectively. The feeding time is controlled within 30 minutes. Timing begins after feeding is complete. The cell wall breaking process lasts 90 minutes, followed by sterilization at 121℃ for 30 minutes to obtain broken-cell wall Ganoderma lucidum spore powder. The broken-cell wall Ganoderma lucidum spore powder and maltose are then added to a mixer at a mass ratio of 7:3. The mixer speed is 10 rpm, and the mixing time is 3 minutes. The raw materials and excipients are thoroughly mixed using a three-dimensional oscillation process. The mixed materials are then transferred to a trough mixer for dry mixing at 16 rpm for 9 minutes. When adding purified water, the trough mixer rotates at 9 rpm, with a water-to-solid material mass ratio of 1:1 to 1:2. After addition, wet mixing continues for 7 minutes. At the end of the mixing process, the mixture is discharged at a low speed by reversing the direction of rotation. The wet-mixed material is then filled into a silicone mold and gently leveled with a scraper. The leveled sample is then placed in a freeze dryer for freezing at -30°C for 30 minutes. The silicone mold dimensions are 2cm × 2cm × 1.2cm. Finally, after freeze-drying, the sample is demolded, and the freeze-dried tablets are individually vacuum-packed in composite aluminum foil bags. The finished product is then boxed. This process significantly shortens the tablet disintegration time, facilitating rapid dissolution and release of active ingredients, while effectively preserving the total triterpenoid active ingredients of the broken-cell wall Ganoderma lucidum spore powder, ensuring stable product quality.
[0023] Furthermore, in the step of sorting the qualified Ganoderma lucidum spore powder in the air classifier, collecting the plump Ganoderma lucidum spore powder and discarding the shriveled and unplump coarse powder as waste: In the airflow separation room, turn on the main power supply of the separator control cabinet, open the compressed air valve, set the frequency of the classifier inverter to 30HZ, set the frequency of the feeder inverter to 40HZ, install the collection bags at the three-stage discharge port, tie the bag openings tightly, turn on the induced draft fan, add Ganoderma lucidum spore powder into the hopper, turn on discharge pump No. 1 and discharge pump No. 2, and start the separation. Every 30 minutes, turn on the scraper to collect the plump Ganoderma lucidum spore powder into the bag, and treat the unplump and shriveled coarse powder as unqualified products and waste.
[0024] Furthermore, in the step of filling the wet-mixed material into the silicone mold, gently smoothing it with a scraper, and then placing the smoothed sample in a freeze dryer for freezing, the pre-freezing temperature is -30℃ and the pre-freezing holding time is 30 minutes, wherein the silicone mold size is 2cm×2cm×1.2cm: After freezing, freeze-dry according to the following formula, see Table 1 (Freeze-drying formula for broken-cell wall Ganoderma lucidum spore powder):
[0025] Table 1 Further, the experimental process and results of freeze-dried Ganoderma lucidum spore powder tablets: Disintegration time comparison: The basket of the lifting disintegrator is suspended from the support by the stainless steel shaft at the top and immersed in a 1000 mL beaker. The position of the basket is adjusted so that when it is lowered to the lowest point, the screen is 25 mm away from the bottom of the beaker. The beaker contains water at a temperature of 37 ℃±1 ℃. The water level is adjusted so that when the basket is raised to the highest point, the screen is 15 mm below the water surface. The top of the basket should not be submerged in the solution.
[0026] Take 6 freeze-dried tablets of broken-cell wall Ganoderma lucidum spore powder and 6 conventionally compressed tablets of broken-cell wall Ganoderma lucidum spore powder. Place one tablet in each clean glass tube in a hanging basket, add a baffle, turn on the instrument, record the time, and observe the disintegration.
[0027] The experimental results are summarized in Table 2:
[0028] Table 2 Friability Comparison: According to the 2025 edition of the Pharmacopoeia of the People's Republic of China, Section IV, General Chapter 0101, Tablets, orally disintegrating tablets prepared by freeze-drying are exempt from friability testing. Therefore, no friability comparison experiment was conducted on the freeze-dried tablets of broken-cell wall Ganoderma lucidum spore powder.
[0029] Stability test comparison: The total triterpenoid content of the raw material for the freeze-dried Ganoderma lucidum spore powder tablets before tableting—a mixture of broken-cell wall Ganoderma lucidum spore powder and maltose—was determined, and the result was 3.0 g / 100 g. 100g each of freeze-dried Ganoderma lucidum spore powder tablets (batch numbers: 20260422, 20260423, and 20260424) were placed in an accelerated stability test chamber at a storage temperature of 40℃±2℃ and a storage humidity of 75%RH±5%. At 0, 1, 2, and 3 months, each batch of product was tested for appearance, disintegration time, total triterpenoid content, total bacterial count, coliform bacteria, mold, and yeast count. All test results were then compiled.
[0030] Summary table of stability results: 1. Experimental data for month 0, see Table 3:
[0031] Table 3 II: Experimental data for the first month, see Table 4:
[0032] Table 4 3. Experimental data for the second month, see Table 5:
[0033] Table 5 IV: Experimental data for the third month, see Table 6:
[0034] Table 6 By comparing the total triterpenoid content of the mixture before tableting with the total triterpenoid data in the stability test of the finished product of Ganoderma lucidum spore powder freeze-dried tablets, it can be seen that the freeze-drying process does not destroy the active ingredient—total triterpenoids—in Ganoderma lucidum spore powder, and the content of total triterpenoids will not decrease during the freeze-drying process.
[0035] Other embodiments of this application will readily occur to those skilled in the art upon consideration of the specification and practice of the disclosure herein. This application is intended to cover any variations, uses, or adaptations of this application that follow the general principles of this application and include common knowledge or customary techniques in the art not disclosed herein.
[0036] It should be understood that this application is not limited to the precise structure described above and shown in the accompanying drawings, and various modifications and changes can be made without departing from its scope.
Claims
1. A freeze-dried tablet of broken-cell wall Ganoderma lucidum spore powder, characterized in that, It is prepared from the following raw materials: Ganoderma lucidum spore powder, maltose, and purified water.
2. A method for preparing freeze-dried tablets of broken-cell wall Ganoderma lucidum spore powder, as described in claim 2, characterized in that, Includes the following steps: Ganoderma lucidum spore powder that has passed the incoming inspection is sorted in the airflow separation room. The plump Ganoderma lucidum spore powder is collected, while the dry and unplump coarse powder is discarded as waste. The high-quality Ganoderma lucidum spore powder obtained from sorting is fed through a two-roller wall-breaking machine with a set 4-level conveyor belt frequency. After feeding is completed, the timer is started. After 90 minutes of wall-breaking treatment, it is sterilized to obtain broken Ganoderma lucidum spore powder. The broken-cell wall Ganoderma lucidum spore powder and maltose are put into a mixer, and the raw and auxiliary materials are fully mixed by three-dimensional oscillation. The mixed materials are transferred into a trough mixer for dry mixing. After mixing, purified water is slowly added dropwise during operation to ensure full contact between solid and liquid. Fill the wet mixture into the silicone mold, gently scrape it flat with a scraper, and then place the flattened sample in a freeze dryer for freezing. After freeze-drying, the samples are demolded, and the freeze-dried tablets are individually vacuum-packed in composite aluminum foil bags. Finally, they are boxed to obtain the finished product.
3. The method for preparing freeze-dried Ganoderma lucidum spore powder tablets as described in claim 1, characterized in that, In the process of sorting the Ganoderma lucidum spore powder that has passed the incoming inspection in the airflow separation room, collecting the plump Ganoderma lucidum spore powder and removing the shriveled and unplump coarse powder as waste: In the airflow separation room, turn on the main power supply of the separator control cabinet, open the compressed air valve, set the frequency of the classifier inverter to 30HZ, set the frequency of the feeder inverter to 40HZ, install the collection bags at the three-stage discharge port, tie the bag openings tightly, turn on the induced draft fan, add Ganoderma lucidum spore powder into the hopper, turn on discharge pump No. 1 and discharge pump No. 2, and start the separation. Every 30 minutes, turn on the scraper to collect the plump Ganoderma lucidum spore powder into the bag, and treat the unplump and shriveled coarse powder as unqualified products and waste.
4. The method for preparing freeze-dried Ganoderma lucidum spore powder tablets as described in claim 1, characterized in that, In the process of circulating the high-quality Ganoderma lucidum spore powder obtained from sorting through a two-roller cell disruptor with a set 4-level conveyor belt frequency, timing is started after the feeding is completed, and the cell disruption process lasts for 90 minutes before sterilization to obtain cell-wall broken Ganoderma lucidum spore powder: When feeding materials, turn on the four-stage conveyor belt and adjust the frequency of the inverter, with stage 1 at 35Hz, stage 2 at 25Hz, stage 3 at 25Hz, and stage 4 at 23Hz. The feeding time should be controlled within 30 minutes.
5. The method for preparing freeze-dried Ganoderma lucidum spore powder tablets as described in claim 4, characterized in that, In the process of circulating the high-quality Ganoderma lucidum spore powder obtained from sorting through a two-roller cell disruptor with a set 4-level conveyor belt frequency, timing is started after the feeding is completed, and the cell disruption process lasts for 90 minutes before sterilization to obtain cell-wall broken Ganoderma lucidum spore powder: The temperature of the Ganoderma lucidum spore powder after cell wall breaking is controlled at 121℃, and the sterilization time is 30 minutes.
6. The method for preparing freeze-dried Ganoderma lucidum spore powder tablets as described in claim 1, characterized in that, In the step of adding broken-cell wall Ganoderma lucidum spore powder and maltose into a mixer, and relying on three-dimensional oscillation to achieve thorough mixing of the raw and auxiliary materials: The mass ratio of broken-cell wall Ganoderma lucidum spore powder to maltose is 7:3, the mixing speed of the mixer is 10 rpm, and the mixing time is 30 min.
7. The method for preparing freeze-dried Ganoderma lucidum spore powder tablets as described in claim 1, characterized in that, In the process of transferring the mixed materials into a trough mixer for dry mixing, and then slowly adding purified water during operation to ensure sufficient contact between the solid and liquid components: The dry mixing speed of the trough mixer is 16 rpm, and the dry mixing time is 9 min. When adding purified water, the speed of the trough mixer is 9 rpm, and the mass ratio of purified water to solid material is 1:1 to 1:
2. After the addition is completed, wet mixing is performed for 7 min. After mixing is completed, the mixer is tilted and discharged at low speed.
8. The method for preparing freeze-dried Ganoderma lucidum spore powder tablets as described in claim 1, characterized in that, In the steps of filling the wet mixture into the silicone mold, gently leveling it with a scraper, and then placing the leveled sample in a freeze dryer for freezing: The silicone mold dimensions are 2cm×2cm×1.2cm; the pre-freezing temperature is -30℃, and the pre-freezing holding time is 30min.