Tablet for improving sporoderm-broken ganoderma lucidum spore powder and preparation method thereof

Abstract

The preparation method comprises the following steps: S1, taking ganoderma lucidum spore powder as a raw material, and carrying out superfine grinding on the ganoderma lucidum spore powder and a filling agent (1) to obtain superfine powder; the filling agent (1) comprises beta-cyclodextrin; s2, diluting a filler (2) and an adhesive in a solvent, and uniformly mixing to obtain a mixture; the filling agent (2) comprises one or more of sorbitol, isomaltitol and mannitol; s3, mixing and granulating the superfine powder and the mixture to obtain a soft material; and S4, sieving, drying and tabletting the soft material to obtain the improved sporoderm-broken ganoderma lucidum spore powder tablets. The invention solves the problems of non-uniform color and oil overflow when the sporoderm-broken ganoderma lucidum spore powder is pressed into tablets due to rich oil, effectively improves the taking body feeling, retains the functional components such as total triterpenes, and has the advantages of stable quality, convenience in taking and convenience in carrying.

Description

Technical Field

[0001] The invention relates to the field of health care products, and in particular to an improved wall-broken ganoderma lucidum spore powder tablet and a preparation method thereof. Background Art

[0002] Ganoderma lucidum spore powder is the spores emitted by the fungus of the genus Ganoderma. Ganoderma is a medicinal fungus with a long history. It can be traced back to the record in Shennong's Herbal Classic: Ganoderma lucidum: It can treat chest knots, benefit the heart, replenish the middle, increase wisdom, and prevent forgetfulness. Relevant studies in the past 40 years have shown that Ganoderma lucidum spore powder has multiple effects such as enhancing immune regulation, anti-tumor, and protecting the liver. Ganoderma lucidum spores are the sexual reproductive cells of the fruiting body of Ganoderma lucidum. They have all the genetically active components of the fruiting body, and their main active ingredient content is 75 times higher than that of Ganoderma lucidum. However, since the spore wall of Ganoderma lucidum spore powder is composed of chitin cellulose, it has a hard texture and a stable structure, which affects the digestion and absorption of the substances in the spores. After the wall is broken, it is more suitable for direct absorption by the stomach and intestines.

[0003] Ganoderma lucidum spore powder has a high oil content and its particle size distribution is at the micron level, which makes it very easy for the tablets to have oil overflow, resulting in flaky spots, low hardness and slow disintegration, unstable quality of active ingredients, and oil odor, which increases the difficulty of pressing them into tablets. Therefore, the Ganoderma lucidum spore powder-related products on the market are mainly in the form of powders, granules, capsules and other dosage forms.

[0004] At the same time, due to the large difference in brown color between the added excipients and the Ganoderma lucidum spore powder, problems such as uneven color are likely to occur, affecting the appearance of the finished product. The low hardness, looseness, and oil deterioration and odor of the tablets are one of the important reasons why consumers have a poor experience when taking the tablets, which greatly affects consumers' acceptance of the tablets.

[0005] In view of the above problems, "A broken wall Ganoderma lucidum spore powder tablet and its preparation method (CN115918900A)" discloses a method of using a combination of sorbitol and silicon dioxide to solve the problem of high oil content and poor compressibility of broken wall Ganoderma lucidum spore powder. However, the above solution may use a large amount of silicon dioxide as a filler. Studies have shown that excessive use of silicon dioxide food additives may cause gastrointestinal discomfort; "A Ganoderma lucidum spore powder tablet and its preparation method (CN113017081A)" discloses a method of trying to use Ganoderma lucidum polysaccharide or Dendrobium officinale polysaccharide to make a tablet of Ganoderma lucidum spore powder. The composition of sugar, microcrystalline cellulose, lactose, white sugar, and maltodextrin is mixed in equal amounts, granulated, dried at 60-70°C, and granulated to obtain a tablet. "A Ganoderma lucidum spore powder tablet and its preparation method (CN112021555A)" discloses a Ganoderma lucidum spore powder tablet and preparation method, which adopts sequential mixing and wet granulation tableting process. The mixing process of the above two inventions is complicated and not convenient for large-scale production. The former has a high drying temperature, which inevitably causes great damage to the effective ingredients such as triterpenes and unsaturated fatty acids in Ganoderma lucidum spore oil. The latter is granulated with water and dried at 30-50°C to a moisture content of less than 5%, which inevitably leads to a long drying time. At 30-40°C, it is a suitable growth temperature for microorganisms. Long-term low-temperature drying makes the microbial control of the final product face great challenges and affects the product quality. Summary of the invention

[0006] The present invention uses sugar alcohols such as sorbitol and beta-cyclodextrin in a specific ratio to encapsulate and adsorb the oily substances in the broken wall Ganoderma lucidum spore powder, effectively solving the problem of variegated spots on the surface and core of the tablets caused by oil seepage during the pressing process due to the high oil content of the broken wall Ganoderma lucidum spore powder. The tablets prepared by the present invention have a smooth surface, no obvious variegated spots and oil overflow, fast disintegration and stable quality, and the preparation process product has a high yield and excellent compressibility. The purpose of the present invention is to provide a method for preparing an improved broken wall Ganoderma lucidum spore powder tablet with uniform color, stable quality, no odor, and easy to carry and take.

[0007] In order to solve the above technical problems, the present invention adopts the following technical solutions:

[0008] An improved broken-wall ganoderma lucidum spore powder tablet and a preparation method thereof, comprising the following steps:

[0009] S1, taking Ganoderma lucidum spore powder as a raw material, mixing it with a filler ①, and superfine grinding them together to obtain superfine powder; the filler ① includes β-cyclodextrin;

[0010] S2, diluting the filler ② and the binder in a solvent, mixing them evenly, to obtain a mixture; the filler ② includes one or more of sorbitol, isomalt, and mannitol;

[0011] S3, mixing the ultrafine powder with the mixed material and granulating them to obtain a soft material;

[0012] S4, screening, drying and tableting the soft material to obtain improved wall-broken Ganoderma lucidum spore powder tablets.

[0013] Preferably, the mass ratio of the filler ① to the filler ② is 1 to 6:1.

[0014] Preferably, in step S1, the mass ratio of the Ganoderma lucidum spore powder to the filler ① is 1 to 4:1; in step S2, the mass ratio of the filler ② to the adhesive is 2 to 12:1.

[0015] Preferably, step S4 comprises:

[0016] S4-1: sieving the soft material to obtain wet granules;

[0017] S4-2: drying and sieving the wet granules to obtain dry granules;

[0018] S4-3: mixing the dry granules with a lubricant and a glidant to obtain a total mixed powder;

[0019] S4-4: Compress the total mixed powder into tablets to obtain the improved wall-broken Ganoderma lucidum spore powder tablets.

[0020] Preferably, step S4-4 includes:

[0021] S4-4-1: tableting the total mixed powder to obtain plain tablets;

[0022] S4-4-2: preparing the coating agent into a coating solution;

[0023] S4-4-3: Coating the plain tablets with the coating liquid to obtain the improved wall-broken Ganoderma lucidum spore powder tablets.

[0024] Preferably, in step S1, the ultrafine grinding conditions include: low temperature treatment for 10 to 20 minutes, working amplitude of 0 to 5 mm, and passing through a 150 to 250 mesh sieve; in step S3, the mixed granulation method includes stirring shear granulation; in step S4-1, the soft material screening includes passing through a 14 to 30 mesh sieve; in step S4-2, the drying method includes boiling drying, and the moisture content of the dry particles is ≤5%.

[0025] Preferably, in step S1, the ultrafine grinding conditions include: treatment at -15°C to 5°C for 10 to 20 minutes, working amplitude 0 to 5 mm, and passing through a 200-mesh sieve; the wall breaking rate of the ultrafine powder is greater than 95%; in step S4-2, the boiling drying temperature includes 45 to 55°C.

[0026] The low temperature control in the crushing stage is mainly to keep the spore powder as low as possible throughout the preparation process to prevent high-temperature oxidation of oils and fats. In the drying stage, boiling drying is used at a temperature of 50±5℃. The time for drying a batch of materials is about 0.5 to 2 hours. The materials are evenly heated during the drying process, which can simultaneously avoid high-temperature oxidation of oils and fats and the growth of microorganisms. If it is conventional hot air drying, because hot air drying first contacts the hot air from the surface of the material, the temperature at the air inlet is high, the temperature at the air outlet rises slowly, and the heating is uneven. Even if the drying temperature is controlled at 50±5℃, the time required is about more than 5 hours, and the local material at the air inlet is prone to long-term exposure to high temperature and oxidation, while the temperature of the local material at the air outlet is around 30℃~40℃, which is easy to cause microbial growth. If the temperature of hot air drying is controlled at 30℃~40℃ as a whole, the time consumed will inevitably be extended, and it is more likely to cause microbial growth.

[0027] An improved broken-wall Ganoderma lucidum spore powder tablet obtained by the preparation method of the improved broken-wall Ganoderma lucidum spore powder tablet.

[0028] Preferably, the composition comprises the following components in the following mass ratios: 40-60% of broken wall-cracked Ganoderma lucidum spore powder, 30-60% of a filler, 1-5% of a binder, 0.5-2% of a lubricant, and 1-3% of a coating agent.

[0029] Preferably, the filler includes the filler ① and the filler ②; the binder includes one or more of hydroxypropyl methylcellulose and povidone K30.

[0030] Compared with the prior art, the present invention has the following beneficial effects:

[0031] The present invention solves the problems of uneven color and oil overflow when the broken wall ganoderma lucidum spore powder is pressed into tablets in the current functional food field. The present invention uses β-cyclodextrin and sorbitol in the broken wall ganoderma lucidum spore powder tablets, so that the oil of the broken wall ganoderma lucidum spore powder is wrapped and adsorbed on the β-cyclodextrin, thereby reducing the generation of oil overflow. Tablets with uniform color are obtained, the problem of variegated spots on the surface of the tablet core is solved, and the physical feeling of taking is effectively improved.

[0032] In particular, low-temperature ultrafine grinding and boiling drying processes are used to prevent the oil in the Ganoderma lucidum spore powder from being exposed to high humidity and high heat environment for a long time, effectively retaining the effective ingredients such as Ganoderma lucidum total triterpenes and ergosterol.

[0033] The surface of the broken wall ganoderma lucidum spore powder tablet prepared by the present invention is smooth and complete, and the hardness and friability indexes are qualified. The film coating is adopted to further reduce the influence of air oxidation on the product and enhance the product stability. The coating agent is selected to have a natural color similar to the spore powder, so that consumers are more likely to accept the product. Through the above measures, the problem of physical sensation when taking is effectively improved, and the tablet has the advantages of stable quality, convenient taking and convenient carrying. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] Figure 1 The effect diagram of the tablets obtained in Examples 1-6 of the present invention.

[0035] Figure 2 The tablet effect diagram obtained by comparative examples 1-5 of the present invention. DETAILED DESCRIPTION

[0036] In order to make the objectives, technical solutions and advantages of the present invention more clear, the present invention will be further described in detail below with reference to the accompanying drawings.

[0037] Example 1

[0038] The components of the broken wall ganoderma lucidum spore powder tablet include 360 ​​parts of broken wall ganoderma lucidum spore powder, 50 parts of sorbitol, 154 parts of β-cyclodextrin, 15 parts of povidone K30, 3 parts of magnesium stearate, and 18 parts of film coating premix, and are specifically prepared by the following method:

[0039] A. Weigh the broken spore powder of Ganoderma lucidum and β-cyclodextrin, ultrafine grind for 15 minutes, pass through a 200-mesh sieve, and set aside to obtain ultrafine powder;

[0040] B. Weigh sorbitol, povidone K30, magnesium stearate, and film coating agent;

[0041] C. Mix sorbitol and povidone K30, and dilute evenly with water to obtain a mixture;

[0042] D. Add the mixed material to the ultrafine powder, stir and shear to granulate to obtain soft material; the soft material is sieved through a 24-mesh sieve to obtain wet granules;

[0043] E. Boil and dry the wet granules at 50°C until the moisture content is below 5%, and pass through a 24-mesh sieve to obtain dry granules;

[0044] F. mixing the dry granules with magnesium stearate to obtain a total mixed powder;

[0045] G. Tableting the total mixed powder to obtain plain tablets to be coated, and then coating the plain tablets with a coating liquid prepared with a film coating material to obtain the improved wall-broken Ganoderma lucidum spore powder tablets.

[0046] Example 2

[0047] The components of the broken wall ganoderma lucidum spore powder tablet include 300 parts of broken wall ganoderma lucidum spore powder, 100 parts of sorbitol, 169 parts of beta-cyclodextrin, 10 parts of hydroxypropyl methylcellulose, 3 parts of magnesium stearate, and 18 parts of film coating premix, and are specifically prepared by the following method:

[0048] A. Weigh the broken spore powder of Ganoderma lucidum and β-cyclodextrin, ultrafine grind for 15 minutes, pass through a 200-mesh sieve, and set aside to obtain ultrafine powder;

[0049] B. Weigh sorbitol, hydroxypropyl methylcellulose, magnesium stearate, and film coating agent;

[0050] C. Mix sorbitol and hydroxypropyl methylcellulose, and dilute evenly with water to obtain a mixture;

[0051] D. Add the mixed material to the ultrafine powder, stir and shear to granulate to obtain soft material; the soft material is sieved through a 24-mesh sieve to obtain wet granules;

[0052] E. Boil and dry the wet granules at 50°C until the moisture content is below 5%, and pass through a 24-mesh sieve to obtain dry granules;

[0053] F. mixing the dry granules with magnesium stearate to obtain a total mixed powder;

[0054] G. Tableting the total mixed powder to obtain plain tablets to be coated, and then coating the plain tablets with a coating liquid prepared with a film coating material to obtain the improved wall-broken Ganoderma lucidum spore powder tablets.

[0055] Example 3

[0056] The components of the broken wall ganoderma lucidum spore powder tablet include 240 parts of broken wall ganoderma lucidum spore powder, 120 parts of sorbitol, 209 parts of beta-cyclodextrin, 10 parts of hydroxypropyl methylcellulose, 3 parts of magnesium stearate, and 18 parts of film coating premix, and are specifically prepared by the following method:

[0057] A. Weigh the broken spore powder of Ganoderma lucidum and β-cyclodextrin, ultrafine grind for 15 minutes, pass through a 200-mesh sieve, and set aside to obtain ultrafine powder;

[0058] B. Weigh sorbitol, hydroxypropyl methylcellulose, magnesium stearate, and film coating agent;

[0059] C. Mix sorbitol and hydroxypropyl methylcellulose, and dilute evenly with water to obtain a mixture;

[0060] D. Add the mixed material to the ultrafine powder, stir and shear to granulate to obtain soft material; the soft material is sieved through a 24-mesh sieve to obtain wet granules;

[0061] E. Boil and dry the wet granules at 50°C until the moisture content is below 5%, and pass through a 24-mesh sieve to obtain dry granules;

[0062] F. mixing the dry granules with magnesium stearate to obtain a total mixed powder;

[0063] G. Tableting the total mixed powder to obtain plain tablets to be coated, and then coating the plain tablets with a coating liquid prepared with a film coating material to obtain the improved wall-broken Ganoderma lucidum spore powder tablets.

[0064] Example 4

[0065] The components of the broken wall ganoderma lucidum spore powder tablet include 360 ​​parts of broken wall ganoderma lucidum spore powder, 50 parts of isomalt, 154 parts of β-cyclodextrin, 15 parts of povidone K30, 3 parts of magnesium stearate, and 18 parts of film coating premix, and are specifically prepared by the following method:

[0066] A. Weigh the broken spore powder of Ganoderma lucidum and β-cyclodextrin, ultrafine grind for 15 minutes, pass through a 200-mesh sieve, and set aside to obtain ultrafine powder;

[0067] B. Weigh isomalt, povidone K30, magnesium stearate, and film coating agent;

[0068] C. Mix isomalt and povidone K30, and dilute evenly with water to obtain a mixture;

[0069] D. Add the mixed material to the ultrafine powder, stir and shear to granulate to obtain soft material; the soft material is sieved through a 24-mesh sieve to obtain wet granules;

[0070] E. Boil and dry the wet granules at 50°C until the moisture content is below 5%, and pass through a 24-mesh sieve to obtain dry granules;

[0071] F. mixing the dry granules with magnesium stearate to obtain a total mixed powder;

[0072] G. Tableting the total mixed powder to obtain plain tablets to be coated, and then coating the plain tablets with a coating liquid prepared with a film coating material to obtain the improved wall-broken Ganoderma lucidum spore powder tablets.

[0073] Example 5

[0074] The components of the broken wall ganoderma lucidum spore powder tablet include 360 ​​parts of broken wall ganoderma lucidum spore powder, 50 parts of mannitol, 154 parts of β-cyclodextrin, 15 parts of povidone K30, 3 parts of magnesium stearate, and 18 parts of film coating premix, and are specifically prepared by the following method:

[0075] A. Weigh the broken spore powder of Ganoderma lucidum and β-cyclodextrin, ultrafine grind for 15 minutes, pass through a 200-mesh sieve, and set aside to obtain ultrafine powder;

[0076] B. Weigh mannitol, povidone K30, magnesium stearate, and film coating agent;

[0077] C. Mix isomalt and povidone K30, and dilute evenly with water to obtain a mixture;

[0078] D. Add the mixed material to the ultrafine powder, stir and shear to granulate to obtain soft material; the soft material is sieved through a 24-mesh sieve to obtain wet granules;

[0079] E. Boil and dry the wet granules at 50°C until the moisture content is below 5%, and pass through a 24-mesh sieve to obtain dry granules;

[0080] F. mixing the dry granules with magnesium stearate to obtain a total mixed powder;

[0081] G. Tableting the total mixed powder to obtain plain tablets to be coated, and then coating the plain tablets with a coating liquid prepared with a film coating material to obtain the improved wall-broken Ganoderma lucidum spore powder tablets.

[0082] Example 6

[0083] The components of the broken wall ganoderma lucidum spore powder tablet include 360 ​​parts of broken wall ganoderma lucidum spore powder, 41 parts of isomalt, 41 parts of mannitol, 122 parts of β-cyclodextrin, 15 parts of povidone K30, 3 parts of magnesium stearate, and 18 parts of film coating premix, and are specifically prepared by the following method:

[0084] A. Weigh the broken spore powder of Ganoderma lucidum and β-cyclodextrin, ultrafine grind for 15 minutes, pass through a 200-mesh sieve, and set aside to obtain ultrafine powder;

[0085] B. Weigh isomalt, mannitol, povidone K30, magnesium stearate, and film coating agent;

[0086] C. Mix isomalt, mannitol and povidone K30, and dilute evenly with water to obtain a mixture;

[0087] D. Add the mixed material to the ultrafine powder, stir and shear to granulate to obtain soft material; the soft material is sieved through a 24-mesh sieve to obtain wet granules;

[0088] E. Boil and dry the wet granules at 50°C until the moisture content is below 5%, and pass through a 24-mesh sieve to obtain dry granules;

[0089] F. mixing the dry granules with magnesium stearate to obtain a total mixed powder;

[0090] G. Tableting the total mixed powder to obtain plain tablets to be coated, and then coating the plain tablets with a coating liquid prepared with a film coating material to obtain the improved wall-broken Ganoderma lucidum spore powder tablets.

[0091] Comparative Example 1

[0092] The components of the broken wall ganoderma lucidum spore powder tablet include 300 parts of broken wall ganoderma lucidum spore powder, 269 parts of sorbitol, 10 parts of hydroxypropyl methylcellulose, 3 parts of magnesium stearate, and 18 parts of film coating premix, and are specifically prepared by the following method:

[0093] A. Weigh the broken spore powder of Ganoderma lucidum, ultrafine grind for 15 minutes, pass through a 200-mesh sieve, and set aside to obtain ultrafine powder;

[0094] B. Weigh sorbitol, hydroxypropyl methylcellulose, magnesium stearate, and film coating agent;

[0095] C. dilute hydroxypropyl methylcellulose evenly with water to obtain an adhesive solution;

[0096] D. Add the binder solution and sorbitol to the ultrafine powder, stir and shear to granulate to obtain a soft material; the soft material is sieved through a 24-mesh sieve to obtain wet granules;

[0097] E. Boil and dry the wet granules at 50°C until the moisture content is below 5%, and pass through a 24-mesh sieve to obtain dry granules;

[0098] F. mixing the dry granules with magnesium stearate to obtain a total mixed powder;

[0099] G. Tableting the total mixed powder to obtain plain tablets to be coated, and then coating the plain tablets with a coating liquid prepared with a film coating material to obtain the improved wall-broken Ganoderma lucidum spore powder tablets.

[0100] Comparative Example 2

[0101] The components of the broken wall Ganoderma lucidum spore powder tablet include 300 parts of broken wall Ganoderma lucidum spore powder, 269 parts of β-cyclodextrin, 10 parts of hydroxypropyl methylcellulose, 3 parts of magnesium stearate, and 18 parts of film coating premix, and are specifically prepared by the following method:

[0102] A. Weigh the broken spore powder of Ganoderma lucidum and β-cyclodextrin, ultrafine grind for 15 minutes, pass through a 200-mesh sieve, and set aside to obtain ultrafine powder;

[0103] B. Weigh hydroxypropyl methylcellulose, magnesium stearate, and film coating agent;

[0104] C. dilute hydroxypropyl methylcellulose evenly with water to obtain an adhesive solution;

[0105] D. Add the binder solution to the ultrafine powder, stir and shear to granulate to obtain a soft material; the soft material is sieved through a 24-mesh sieve to obtain wet granules;

[0106] E. Boil and dry the wet granules at 50°C until the moisture content is below 5%, and pass through a 24-mesh sieve to obtain dry granules;

[0107] F. mixing the dry granules with magnesium stearate to obtain a total mixed powder;

[0108] G. Tableting the total mixed powder to obtain plain tablets to be coated, and then coating the plain tablets with a coating liquid prepared with a film coating material to obtain the improved wall-broken Ganoderma lucidum spore powder tablets.

[0109] Comparative Example 3

[0110] The components of the broken wall ganoderma lucidum spore powder tablet include 300 parts of broken wall ganoderma lucidum spore powder, 269 parts of isomalt, 10 parts of hydroxypropyl methylcellulose, 3 parts of magnesium stearate, and 18 parts of film coating premix, and are specifically prepared by the following method:

[0111] A. Weigh the broken spore powder of Ganoderma lucidum, ultrafine grind for 15 minutes, pass through a 200-mesh sieve, and set aside to obtain ultrafine powder;

[0112] B. Weigh isomalt, hydroxypropyl methylcellulose, magnesium stearate, and film coating agent;

[0113] C. dilute hydroxypropyl methylcellulose evenly with water to obtain an adhesive solution;

[0114] D. Add the binder solution and isomalt to the ultrafine powder, stir and shear to granulate to obtain a soft material; the soft material is sieved through a 24-mesh sieve to obtain wet granules;

[0115] E. Boil and dry the wet granules at 50°C until the moisture content is below 5%, and pass through a 24-mesh sieve to obtain dry granules;

[0116] F. mixing the dry granules with magnesium stearate to obtain a total mixed powder;

[0117] G. Tableting the total mixed powder to obtain plain tablets to be coated, and then coating the plain tablets with a coating liquid prepared with a film coating material to obtain the improved wall-broken Ganoderma lucidum spore powder tablets.

[0118] Comparative Example 4

[0119] The components of the broken wall ganoderma lucidum spore powder tablet include 300 parts of broken wall ganoderma lucidum spore powder, 239 parts of beta-cyclodextrin, 30 parts of sorbitol, 10 parts of hydroxypropyl methylcellulose, 3 parts of magnesium stearate, and 18 parts of film coating premix, and are specifically prepared by the following method:

[0120] A. Weigh the broken wall Ganoderma lucidum spore powder and β-cyclodextrin and grind them into ultrafine powder for 15 minutes, pass through a 200-mesh sieve, and set aside to obtain ultrafine powder;

[0121] B. Weigh sorbitol, hydroxypropyl methylcellulose, magnesium stearate, and film coating agent;

[0122] C. Mix sorbitol and hydroxypropyl methylcellulose, and dilute evenly with water to obtain a mixture;

[0123] D. Add the mixed material to the ultrafine powder, stir and shear to granulate to obtain soft material; the soft material is sieved through a 24-mesh sieve to obtain wet granules;

[0124] E. Boil and dry the wet granules at 50°C until the moisture content is below 5%, and pass through a 24-mesh sieve to obtain dry granules;

[0125] F. mixing the dry granules with magnesium stearate to obtain a total mixed powder;

[0126] G. Tableting the total mixed powder to obtain plain tablets to be coated, and then coating the plain tablets with a coating liquid prepared with a film coating material to obtain the improved wall-broken Ganoderma lucidum spore powder tablets.

[0127] Comparative Example 5

[0128] The components of the broken wall ganoderma lucidum spore powder tablet include 300 parts of broken wall ganoderma lucidum spore powder, 30 parts of β-cyclodextrin, 239 parts of sorbitol, 10 parts of hydroxypropyl methylcellulose, 3 parts of magnesium stearate, and 18 parts of film coating premix, and are specifically prepared by the following method:

[0129] A. Weigh the broken wall Ganoderma lucidum spore powder and β-cyclodextrin and grind them into ultrafine powder for 15 minutes, pass through a 200-mesh sieve, and set aside to obtain ultrafine powder;

[0130] B. Weigh sorbitol, hydroxypropyl methylcellulose, magnesium stearate, and film coating agent;

[0131] C. Mix sorbitol and hydroxypropyl methylcellulose, and dilute evenly with water to obtain a mixture;

[0132] D. Add the mixed material to the ultrafine powder, stir and shear to granulate to obtain soft material; the soft material is sieved through a 24-mesh sieve to obtain wet granules;

[0133] E. Boil and dry the wet granules at 50°C until the moisture content is below 5%, and pass through a 24-mesh sieve to obtain dry granules;

[0134] F. mixing the dry granules with magnesium stearate to obtain a total mixed powder;

[0135] G. Tableting the total mixed powder to obtain plain tablets to be coated, and then coating the plain tablets with a coating liquid prepared with a film coating material to obtain the improved wall-broken Ganoderma lucidum spore powder tablets.

[0136] Effect Example 1

[0137] The differences of the Ganoderma lucidum spore powder tablets were evaluated by the appearance, hardness, tablet weight and friability of the prepared tablets. The evaluation results of Examples 1-6 and Comparative Examples 1-5 are shown in Table 1 and Table 2, respectively:

[0138] Tablet appearance: Use visual inspection to directly observe and evaluate the tablets. The tablet surface should be uniform in color and smooth.

[0139] Hardness: Take 5 tablets and measure them using a tablet hardness tester.

[0140] Tablet weight difference: Referring to the provisions of the "Chinese Pharmacopoeia", for tablets with an average weight exceeding 0.3g, the weight difference is ±5%; detection method: Take 20 tablets of the test sample, accurately weigh the total weight, calculate the average tablet weight, then accurately weigh the weight of each tablet separately, compare the weight of each tablet with the average tablet weight, according to the provisions in the table, no more than 2 tablets shall exceed the weight difference limit, and no single tablet shall exceed the limit by 1 times.

[0141] Friability: Refer to the provisions of the Chinese Pharmacopoeia, take a number of tablets so that the total weight is about 6.5g; use a hair dryer to blow away the powder that falls off the tablets, weigh accurately, put them in a cylinder, and rotate them 100 times. Take them out, remove the powder in the same way, weigh accurately, and the weight loss shall not exceed 1%, and no broken, cracked or crushed tablets shall be detected.

[0142] Disintegration time limit: refer to the provisions of the Chinese Pharmacopoeia, take 6 tablets of the test sample, and place them in the disintegration time limit tester that meets the requirements of the Pharmacopoeia. Each tablet should be completely disintegrated within 60 minutes. If one tablet cannot be completely disintegrated, another 6 tablets should be taken for retesting, and all should meet the requirements.

[0143] Table 1 Summary of the effects of the embodiments

[0144]

[0145] Table 2 Comparative Example Effect Summary

[0146]

[0147]

[0148] From the results of Table 1 and Table 2, the tablets prepared in Examples 1 to 6 of the present invention according to the formulation range of the claims have smooth tablet surfaces, meet the hardness and friability standards, and have no white spots on the tablet surfaces, which effectively improves the spot problem and oil overflow problem of the appearance of the high-content broken-wall Ganoderma lucidum spore powder tablets.

[0149] Comparing the results of Comparative Examples 1, 2, and 3, the tablets made with a single filler have poor molding effect and appearance compared with the examples. The formulation using β-cyclodextrin has poor molding properties, and the formulation using sorbitol and isomalt has rough tablets with obvious variegated spots. Comparing the results of Comparative Examples 4 and 5, the formulations exceeding the scope of the claims have obvious deficiencies in tablet molding properties, and it is impossible to obtain uniform, stable, and white spot-free tablet products.

[0150] The above disclosure is only the preferred embodiment of the present invention, which certainly cannot be used to limit the scope of the present invention. Therefore, equivalent changes made according to the claims of the present invention are still within the scope of the present invention.

Claims

1. An improved broken-wall Ganoderma lucidum spore powder tablet and a preparation method thereof, characterized in that: The steps include: S1, taking Ganoderma lucidum spore powder as a raw material, mixing it with a filler ①, and superfine grinding them together to obtain superfine powder; the filler ① includes β-cyclodextrin; S2, diluting the filler ② and the binder in a solvent, mixing them evenly, to obtain a mixture; the filler ② includes one or more of sorbitol, isomalt, and mannitol; S3, mixing the ultrafine powder with the mixed material and granulating them to obtain a soft material; S4, screening, drying and tableting the soft material to obtain improved wall-broken Ganoderma lucidum spore powder tablets.

2. The method for preparing the improved broken-wall Ganoderma lucidum spore powder tablet according to claim 1, characterized in that: The mass ratio of the filler ① to the filler ② is 1 to 6:

1.

3. The method for preparing the improved broken-wall Ganoderma lucidum spore powder tablet according to claim 1, characterized in that: In step S1, the mass ratio of the ganoderma lucidum spore powder to the filler ① is 1 to 4:1; in step S2, the mass ratio of the filler ② to the adhesive is 2 to 12:

1.

4. The method for preparing the improved broken-wall Ganoderma lucidum spore powder tablet according to claim 1, characterized in that: Step S4 includes: S4-1: sieving the soft material to obtain wet granules; S4-2: drying and sieving the wet granules to obtain dry granules; S4-3: mixing the dry granules with a lubricant and a glidant to obtain a total mixed powder; S4-4: Compress the total mixed powder into tablets to obtain the improved wall-broken Ganoderma lucidum spore powder tablets.

5. The method for preparing the improved broken-wall Ganoderma lucidum spore powder tablet according to claim 4, characterized in that: Step S4-4 includes: S4-4-1: tableting the total mixed powder to obtain plain tablets; S4-4-2: preparing the coating agent into a coating solution; S4-4-3: Coating the plain tablets with the coating liquid to obtain the improved wall-broken Ganoderma lucidum spore powder tablets.

6. The method for preparing the improved broken-wall Ganoderma lucidum spore powder tablet according to claim 4, characterized in that: In step S1, the ultrafine grinding conditions include: low temperature treatment for 10 to 20 minutes, working amplitude of 0 to 5 mm, and passing through a 150 to 250 mesh sieve; in step S3, the mixed granulation method includes stirring shear granulation; in step S4-1, the soft material screening includes passing through a 14 to 30 mesh sieve; in step S4-2, the drying method includes boiling drying, and the moisture content of the dry particles is ≤5%.

7. The method for preparing the improved broken-wall Ganoderma lucidum spore powder tablet according to claim 6, characterized in that: In step S1, the ultrafine grinding conditions include: treatment at -15°C to 5°C for 10 to 20 minutes, working amplitude 0 to 5 mm, and passing through a 200-mesh sieve; the wall breaking rate of the ultrafine powder is greater than 95%; in step S4-2, the boiling drying temperature includes 45 to 55°C.

8. An improved broken-wall Ganoderma lucidum spore powder tablet obtained by the preparation method of the improved broken-wall Ganoderma lucidum spore powder tablet as claimed in claim 1.

9. The improved broken-wall Ganoderma lucidum spore powder tablet according to claim 1, characterized in that: The invention comprises the following components in mass ratio: 40-60% of broken wall ganoderma spore powder, 30-60% of filler, 1-5% of adhesive, 0.5-2% of lubricant and 1-3% of coating agent.

10. The improved broken-wall Ganoderma lucidum spore powder tablet according to claim 1, characterized in that: The filler includes the filler ① and the filler ②; the binder includes one or more of hydroxypropyl methylcellulose and povidone K30; and the lubricant includes magnesium stearate.

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