Cassia twig and poria cocos granules for preparing cassia twig and poria cocos capsules and preparation method of cassia twig and poria cocos granules

The Poria fine powder after wet sterilization and the Guizhi Poria granules prepared by the one-time drying method solve the problems of excessive microbial load and high production cost of Poria fine powder in the prior art, and achieve the uniformity of product quality and production efficiency improvement.

CN119970852APending Publication Date: 2025-05-13WEIHAI SHENWEI PHARM CO LTD
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Patent Information

Application Number
CN202510245811.6
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2025-03-04
Publication Date
2025-05-13

AI Technical Summary

Technical Problem

In the preparation of Guizhi Fuling Capsules, the microbial load of Poria fine powder exceeds the standard, the increase in production costs and time after two dryings, uneven product quality and ethanol residues.

Method used

The wet sterilized Poria cocos fine powder is used and the Guizhi Poria cocos granules are prepared by drying one-time method to reduce the use of ethanol in the mixing method of calcium crystals and particles to ensure the uniform distribution of calcium crystals.

Benefits of technology

It reduces the microbial load of Poria fine powder, reduces production time and cost, improves the uniformity of product quality, and avoids the problem of ethanol residue.

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Abstract

The invention discloses a cassia twig and poria cocos granule for preparing a cassia twig and poria cocos capsule and a preparation method of the cassia twig and poria cocos granule. The granule weight of 10,000 cassia twig and poria cocos capsules is taken as the total amount (3.1 kg) of a prescription; the cassia twig and poria cocos granules comprise the following raw materials: 1.5-2.5 kg of a cassia twig and poria cocos alcohol extraction concentrated solution (equivalent to the amount of 10,000 cassia twig and poria cocos capsules), 1.5-2.5 kg of a cassia twig and poria cocos water extraction concentrated solution (equivalent to the amount of 10,000 cassia twig and poria cocos capsules), 1.92 kg of poria cocos fine powder, 0.0325-0.065 g of paeonol crystals (equivalent to the amount of 10,000 cassia twig and poria cocos capsules) and 0.062-0.248 kg of an auxiliary filler (2%-8% of the total amount of a prescription). The preparation method comprises the following steps: uniformly mixing by adopting a trough type mixer, drying, coarsely crushing, adding paeonol by adopting an equivalent multiplication method, crystallizing, premixing, sieving by a 80-mesh sieve, crushing, granulating by adopting a mixed dry method, and forming by only one-time drying. And performing dry granulation, performing primary drying to prepare powder particles, and filling the powder particles into capsules.
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Description

Technical Field

[0001] The invention relates to a cinnamon twig fuling granule and a preparation method thereof, in particular to a cinnamon twig fuling granule for preparing a cinnamon twig fuling capsule and a preparation method thereof, belonging to the technical field of traditional Chinese medicine preparations. Background Art

[0002] Guizhi Fuling Capsule has the following functions and indications: promoting blood circulation, removing blood stasis, and eliminating symptoms. It is used for women with symptoms of blood stasis blocking the collaterals, amenorrhea, dysmenorrhea, and postpartum lochia; uterine fibroids, chronic pelvic inflammatory masses, dysmenorrhea, endometriosis, and ovarian cysts with the above symptoms; it can also be used for women with cystic breast hyperplasia, which is a syndrome of blood stasis blocking the collaterals, with symptoms of breast pain, breast lumps, and chest and flank distension; or for prostate hyperplasia, which is a syndrome of blood stasis blocking the bladder, with symptoms of uncomfortable urination, thin urine like a thread, or dripping urine, and lower abdominal distension and pain. Its public preparation method can be found in Figure 3 , Figure 4 The specific process is as follows:

[0003]

Prescription

[0004] [Preparation method] Take 192g of Poria cocos from the above five ingredients and grind it into fine powder; steam distill the peony bark, collect the distillate, and separate the volatile components for later use; extract the residue, cinnamon twig, white peony root, peach kernel and the remaining Poria cocos twice with 90% ethanol, combine the extracts, recover the ethanol until there is no alcohol taste, and concentrate to an appropriate amount under reduced pressure; add water to the residue and boil it twice, filter, combine the filtrate, and concentrate to an appropriate amount under reduced pressure. Mix the above two concentrated solutions with the Poria cocos fine powder, dry, grind, add an appropriate amount of dextrin, make granules, dry, add the volatile components of the peony bark, mix, put into capsules, and make 1000 capsules.

[0005] However, according to this preparation method, there are the following problems: (1) the microbial load of the prepared Poria cocos powder often exceeds the standard and is unqualified; (2) the prepared Guizhi Fuling granules need to be dried twice before they can be formed. The alcohol extract concentrate, the water extract concentrate and the Poria cocos powder are first mixed evenly, vacuum dried into a dry paste, and then crushed into a dry paste powder. The dry paste powder is then added with auxiliary material dextrin, granulated by wet method, and dried. These two steps are required to form, which not only increases production cost and production time, but also has a less impact on the efficacy of the main drug than drying once; (3) the two-step method does not The granules prepared by the wet granulation method are then mixed with the volatile components of the peony bark (i.e., paeonol crystals). Since the granules prepared by the wet granulation method have a larger particle size (more than 80% are larger than 80 mesh), it is difficult to mix them evenly with the paeonol crystals (small particle size and small amount), which will cause uneven product quality. (4) Some people dissolve the paeonol crystals in ethanol and evenly spray them on the granules to mix them. However, it is difficult to completely evaporate a large amount of ethanol, and some ethanol will remain in the product, which will increase the production cost and the unsafe factor of a large amount of ethanol in the air. Summary of the invention

[0006] In order to solve the shortcomings of the above technology, the present invention provides a Guizhi Fuling granule for preparing Guizhi Fuling capsule and a preparation method thereof.

[0007] In order to solve the above technical problems, the technical solution adopted by the present invention is: a Guizhi Fuling granule for preparing Guizhi Fuling capsule, with the granule weight of 10,000 Guizhi Fuling capsules being 3.1 kg as the total amount of one prescription, and the raw materials thereof include:

[0008] Guizhi Fuling alcohol extract concentrate is equivalent to 10,000 Guizhi Fuling capsules;

[0009] Guizhi Fuling water extract concentrate is equivalent to 10,000 Guizhi Fuling capsules;

[0010] Poria cocos powder 1.92kg;

[0011] Paeonol crystals are equivalent to the amount of 10,000 Guizhi Fuling capsules;

[0012] Excipients: 2%-8% of the total amount of prescription dextrin.

[0013] Preferably, the total amount of a prescription is taken as the weight of 10,000 Guizhi Fuling Capsules, the Guizhi Fuling alcohol extract concentrate is 1.5kg-2.5kg, the Guizhi Fuling water extract concentrate is 1.5kg-2.5kg, the Poria powder is 1.92kg, the paeonol crystals are 0.0325g-0.065g, and the auxiliary material dextrin is 0.062kg-0.248kg.

[0014] A method for preparing Guizhi Fuling granules for preparing Guizhi Fuling capsules comprises the following steps:

[0015] Step S1, preparing raw materials: cinnamon twig tuckahoe alcohol extract concentrate, cinnamon tuckahoe water extract concentrate, tuckahoe powder, paeonol crystals, and auxiliary material dextrin;

[0016] Step S2, putting the Poria cocos powder and dextrin into a trough mixer for pre-mixing, i.e., dry mixing for 2-4 minutes, then adding the cinnamon twig Poria cocos alcohol extract concentrate and the cinnamon twig Poria cocos water extract concentrate for mixing, i.e., wet mixing for 2-4 minutes, placing the mixed material in a vacuum dryer for reduced pressure drying, discharging the material, and crushing to obtain a dry paste coarse powder for standby use;

[0017] Step S3, pre-mixing the dry paste coarse powder and paeonol crystals by equal amount doubling method, pulverizing after mixing evenly, and then mixing evenly to obtain powdery particles for preparing Guizhi Fuling Capsule, which are set aside.

[0018] Preferably, in step S1, the preparation process of Poria cocos powder is as follows:

[0019] Moist heat sterilization: spread the Poria cocos slices on a tray with a thickness of 2-3 cm, and put them into a traditional Chinese medicine sterilizer for sterilization and drying. Set the sterilization temperature to 115°C, the sterilization time to 10 minutes, and the drying time to 6 minutes;

[0020] Grinding: After the sterilized and dried Poria cocos slices are cooled to room temperature, they are crushed using a grinder through a 100-mesh sieve to make Poria cocos fine powder for later use.

[0021] Preferably, in step S1, the preparation process of paeonol crystals is as follows:

[0022] Put 2.4 kg of peony bark slices into a sandwich extraction tank, add 8 times water for micro-boiling distillation for 4-6 hours, and collect the distilled aromatic water until the distilled aromatic water liquid is colorless or anhydrous;

[0023] The collected aromatic water is placed in a cold storage at 2-8°C for 3-4 days, during which the barrel is shaken once every 2-3 hours for 5-15 seconds each time. After the crystals are precipitated, they are filtered with a 400-mesh filter cloth to obtain paeonol crystals. The filtered paeonol crystals are dried under reduced pressure below 35°C or placed on filter paper to dry naturally to make solid paeonol crystals for later use.

[0024] Preferably, in step S1, the preparation process of the cinnamon twig tuckahoe alcohol extract concentrate is as follows:

[0025] Preparation of peach kernel granules: crush the peach kernel pieces by a 20B universal grinder without a screen, set the frequency to 38±2HZ, and crush once to make peach kernel granules;

[0026] Take 2.4kg of the residue after extracting the volatile components from peony bark slices, 2.4kg of cinnamon twig slices, 2.4kg of white peony slices, 2.4kg of peach kernel crushed particles and 0.48kg of Poria slices, put them into a sandwich decoction pot, add 90% ethanol and reflux extraction twice, the first time with 6 times the amount of reflux for 1h, the second time with 4 times the amount of reflux for 0.5h, filter each extract through 200 mesh, combine the filtrate, and concentrate under reduced pressure at a temperature not greater than 70°C to recover ethanol until there is no alcohol taste. When the alcohol-extracted concentrated solution reaches a temperature of 60°C, the ρ is 1.1-1.2, discharge the material, and obtain cinnamon twig and Poria alcohol-extracted concentrated solution for standby use.

[0027] Preferably, the preparation process of the concentrated cinnamon twig and tuckahoe water extract is as follows: the residue after alcohol extraction is decocted with water twice, decocted for 0.5h each time with 4 times the amount, the liquid is filtered, the filtrate is combined, the water liquid after the distillation of peony bark is added, and the concentrated cinnamon twig and tuckahoe water extract is concentrated under reduced pressure at a temperature not greater than 80°C to a temperature of 60°C when ρ is 1.1-1.2, and the material is discharged to obtain the concentrated cinnamon twig and tuckahoe water extract for standby use;

[0028] Take samples of Guizhi Fuling alcohol extract concentrate and Guizhi Fuling water extract concentrate respectively, test the solid content, and calculate the amount of auxiliary material dextrin added according to the test results. The amount of dextrin used = total prescription amount - solid amount of alcohol extract concentrate - solid amount of water extract concentrate - amount of Poria cocos powder - amount of paeonol crystals. Since the amount of paeonol crystals is very small, it is usually ignored.

[0029] Preferably, in step S2, the reduced pressure drying is carried out at a temperature below 85°C until the water content reaches 2.0%-3.0%, and the discharged material is coarsely crushed with a 24-mesh sieve using a 30B type universal grinder.

[0030] Preferably, in step S3, the premixed material is crushed with a 30B universal grinder through an 80-mesh sieve, and then mixed evenly with a three-dimensional mixer to obtain Guizhi Fuling granules.

[0031] A Guizhi Fuling capsule is prepared by using Guizhi Fuling granules for preparing Guizhi Fuling capsule, and the Guizhi Fuling granules are filled into capsules by a capsule filling machine at a rate of 0.31 g per granule.

[0032] Compared with the prior art, the present invention has the following beneficial effects:

[0033] (1) The present invention sterilizes the Poria cocos slices by wet method and then grinds them into Poria cocos powder, so that the microbial load of the Poria cocos powder is greatly reduced, and other internal quality indicators of Poria cocos meet the standard requirements, ensuring the quality requirements of Poria cocos powder for direct use as medicine;

[0034] (2) The volatile components distilled from the peony bark slices are placed in a cold storage for crystal growth, and shaken from time to time during the process to make it easier for paeonol to crystallize, shorten the crystal growth time, and increase the crystal yield;

[0035] (3) A 20B universal grinder is used to crush the peach kernels (without a screen). This crushing method is simple and easy, and the peach kernel crumbs are used to prepare Guizhi Fuling granules. The transfer rate of the amygdalin content of the peach kernel is high, and the Guizhi Fuling granules are not sticky.

[0036] (4) The alcohol extract concentrate of Guizhi Fuling, the water extract concentrate of Guizhi Fuling, and the fine powder of Fuling are directly added to the auxiliary materials for mixing, drying, and crushing. Drying is only done once, which not only saves energy consumption and production time, but also avoids the risk of "downgrading" of quality and efficacy caused by two high-temperature drying of the drug, thereby improving the efficacy;

[0037] (5) The volatile components of the peony bark are added in the form of solid crystalline paeonol, and are gradually mixed by the equal amount doubling method, and are pre-mixed before pulverization, which is conducive to the uniform distribution of paeonol crystals in the Guizhi Fuling granules, so that the granules have uniform content and uniform quality; in addition, the paeonol is not added in the form of an ethanol solution, which avoids ethanol residue in the Guizhi Fuling granules and avoids the unsafe factor of a large amount of ethanol in the air, thereby reducing the production cost and ensuring production safety;

[0038] (6) The Guizhi Fuling granules prepared by this method for preparing Guizhi Fuling capsules do not stick to the capsules, the material is not astringent, and the filling amount is stable when the granules are filled into the capsules.

[0039] Compared with the granule preparation method of Guizhi Fuling Capsule in Volume 1 of the Chinese Pharmacopoeia 2020 (twice drying and molding), the granule preparation method of Guizhi Fuling Capsule of the present invention saves production time cost, reduces energy consumption, and avoids twice drying of the drug, thereby reducing production cost and quality risk and improving drug efficacy. BRIEF DESCRIPTION OF THE DRAWINGS

[0040] Figure 1 The present invention is a process flow chart of Guizhi Fuling Capsule extraction;

[0041] Figure 2 The process flow chart of the Guizhi Fuling Capsule preparation of the present invention is as follows;

[0042] Figure 3 It is a process flow chart of extracting Guizhi Fuling Capsule in the prior art;

[0043] Figure 4 It is a process flow chart of Guizhi Fuling Capsule preparation in the prior art;

[0044] Figure 5 Schematic diagram of sampling points for uniformity of particle content prepared in the present invention. DETAILED DESCRIPTION

[0045] The present invention will be further described in detail below in conjunction with the accompanying drawings and specific embodiments.

[0046] Example 1

[0047] The total prescription amount is 5.58kg (equivalent to the prescription amount of 18,000 Guizhi Fuling Capsules).

[0048] A cinnamon twig and fuling granule comprises 3.67 kg of cinnamon twig and fuling alcohol extract concentrate, 4.41 kg of cinnamon twig and fuling water extract concentrate, 3.456 kg of fuling fine powder, 0.0684 kg of paeonol crystals, and 0.144 kg of auxiliary material dextrin (2.58% of the total amount of the prescription).

[0049] Guizhi Fuling granules are prepared by the following method:

[0050] S1. Spread the Poria cocos slices on a tray with a thickness of about 1 cm, put them into a Chinese medicine sterilizer, set the sterilization temperature to 115°C, the sterilization time to 10 min, and the drying time to 6 min, and sterilize and dry them. After the material is cooled to room temperature, it is crushed with a pulverizer through a 100-mesh sieve to obtain Poria cocos fine powder, and 3.456 kg of Poria cocos fine powder is weighed for standby use.

[0051] S2, put 4.32kg of peony bark slices into a sandwich extraction tank, add 8 times of water for micro-boiling distillation for 4-6h, collect the distilled aromatic water until the water is colorless or anhydrous liquid is distilled. Store the aromatic water in a cold storage for 3-4 days, shake the barrel once every 2-3 hours during this period, and shake for about 15 seconds each time. After crystallization, filter with a 400-mesh double-layer filter cloth (with a layer of medium-speed filter paper in the middle), take paeonol crystals, dry under reduced pressure below 35°C or place on filter paper to evaporate naturally, and obtain 0.0684kg of paeonol crystals for standby use.

[0052] S3. The peach kernel slices are crushed by a grinder (without a screen) at a frequency of 38±2HZ. The pieces are crushed once to produce peach kernel pieces for later use.

[0053] S4, take 4.32kg of peony bark residue, 4.32kg of cinnamon twig slices, 4.32kg of white peony slices, 4.32kg of peach kernel slices, and 0.864kg of Poria slices, put them into the decoction pot before the interlayer, add 90% ethanol and reflux extraction twice, the first time 6 times the amount of reflux for 1h, the second time 4 times the amount of reflux for 0.5h, each extract is filtered through 200 mesh, the filtrate is combined, and the ethanol is recovered under reduced pressure (≤70℃) until there is no alcohol taste, and the alcohol extract concentrate is extracted to ρ of 1.1-1.2, 60℃, and the material is discharged to obtain 3.67kg of cinnamon twig and Poria alcohol extract concentrate for standby use.

[0054] S5. After the alcohol extraction, the residue was decocted with water for 2 more times, each time with 4 times the amount for 0.5h. The drug solution was filtered, the filtrate was combined, and the water solution after the distillation of Paeonia suffruticosa was added. The mixture was concentrated under reduced pressure to ρ of 1.1-1.2 at 60°C. The material was discharged to obtain 4.41kg of Cassia Twig and Poria water extract concentrate for standby use.

[0055] S6. Sampling 3.67kg of Cinnamomum cassiae and Poria cocos alcohol extract concentrate and 4.41kg of Cinnamomum cassiae and Poria cocos water extract concentrate were conducted to detect the solid contents, which were 1.65kg and 0.33kg, respectively.

[0056] S7. According to the test results, the amount of auxiliary material dextrin is calculated. Dextrin amount = total amount of prescription - solid amount of alcohol extract concentrate - solid amount of water extract concentrate - amount of Poria cocos powder - amount of paeonol crystals. The amount of dextrin used in this embodiment is 0.144 kg. Considering the loss of materials in subsequent operations, the amount of paeonol crystals is small, so the amount of dextrin used is not actually subtracted from the amount of paeonol, and the weight of paeonol crystals is negligible.

[0057] S8. Take 3.67 kg of cinnamon twig and tuckahoe alcohol extract concentrate, 4.41 kg of cinnamon tuckahoe water extract concentrate, and 3.456 kg of tuckahoe fine powder, add 0.144 kg of auxiliary material dextrin, use a trough mixer to mix, dry under vacuum reduced pressure below 85°C to a moisture content of 2.0-3.0%, and use a 30B universal grinder to coarsely grind through a 24-mesh sieve to obtain 5.26 kg of cinnamon twig and tuckahoe dry paste coarse powder, and set aside.

[0058] S9. Use the equal amount doubling method to premix 0.0684 kg of paeonol crystals with 5.26 kg of cinnamon twig fuling dry paste coarse powder, then use a 30B universal grinder to grind through an 80-mesh sieve, mix evenly, and make 4.54 kg of powdered particles to obtain the cinnamon twig fuling granules for preparing cinnamon twig fuling capsules, which are set aside.

[0059] S10. Use a capsule filling machine to fill each capsule with 0.31 g of Guizhi Fuling granules.

[0060] In Examples 2 to 9, the total amount of the prescription is 5.58 kg, which is equivalent to the prescription amount of 18,000 Guizhi Fuling Capsules;

[0061] Example 2-Example 9, Guizhi Fuling Granules include 2.77-4.74kg of Guizhi Fuling alcohol extract concentrate, 3.05-5.01kg of Guizhi Fuling water extract concentrate, 3.456kg of Poria powder, 0.0492-0.0712kg of paeonol crystals, and 0.124-0.344kg of auxiliary material dextrin, and the amount of dextrin used is 2.22%-6.16% of the total prescription.

[0062] In Example 2-Example 9, the preparation method and steps of Guizhi Fuling Granules are consistent with those in Example 1, and the amount of each material added is the same, which are: 4.32kg of Moutan Bark Slices, 4.32kg of White Peony Slices, 4.32kg of Guizhi Slices, 4.32kg of Peach Kernel Slices Crushed Granules, 0.864kg of Poria Slices, and 3.456kg of Poria Fine Powder.

[0063] In Examples 10 to 12, the total prescription amount is 77.5 kg, which is equivalent to the prescription amount of 250,000 Guizhi Fuling Capsules.

[0064] Example 10-Example 12, Guizhi Fuling granules include Guizhi Fuling alcohol extract concentrate (37.93kg, 39.52kg, 37.10kg, Guizhi Fuling water extract concentrate (37.56kg, 35.52kg, 39.28kg), Poria powder (48kg), Paeonol crystals (0.832kg, 0.961kg, 0.854kg), and auxiliary material dextrin (4.11kg, 3.48kg, 4.93kg). The auxiliary material dextrin is used in an amount of 5.3%, 4.49%, and 6.36% of the total prescription amount, respectively.

[0065] Example 10-Example 12, the preparation method and steps of Guizhi Fuling Granules are consistent with Example 1, and the amount of each material is 13.889 times that of Example 1, namely: 60kg of Moutan Cortex Slices, 60kg of White Peony Root Slices, 60kg of Guizhi Slices, 60kg of Peach Kernel Slices Crushed Granules, 12kg of Poria Slices, and 48kg of Poria Fine Powder.

[0066] In Example 1 to Example 12, the amount of auxiliary material dextrin in Guizhi Fuling Granules is 2%-8% of the total prescription.

[0067] During the implementation of Example 1 to Example 12, the input amount and output amount of each material are detailed in Table 1.

[0068] The contents of the ingredients in the finished Guizhi Fuling Capsules produced in Examples 1 to 12 are shown in Table 2.

[0069] The contents of each component of Guizhi Fuling Capsule prepared by the present invention are compared with those of the known original method. The contents of paeonol and paeoniflorin are basically in the same range, but the content of amygdalin in the capsules prepared by the present invention is significantly higher than that of the original method, as shown in Table 2. In Examples 1-12, the content of amygdalin in each capsule is 2.89-5.66 mg, 3.89 mg / capsule on average, while the content of amygdalin in each capsule prepared by the original method is 2.45-3.71 mg, 2.88 mg / capsule on average. The capsules prepared by the present invention have a high content of amygdalin, indicating that the present invention fully extracts the effective ingredient amygdalin kernel in peach kernel and gives full play to the drug effect. The high content of amygdalin further indicates the advancement and scientificity of the peach kernel crushing method in the present invention.

[0070] The Guizhi Fuling granules prepared in Examples 10-12 were put into polyethylene bags and stored for 35 days. A hygroscopicity test was conducted during the storage period. Samples were taken at 0d, 10d, 20d, 30d and 35d to detect moisture. As shown in Table 3, the experimental results show that the Guizhi granules prepared by the method of the present invention have an increase in moisture of only 0.20%-0.37% after storage for 35 days. The moisture content of the granules is relatively stable, not easy to become damp, and has good hygroscopicity. Therefore, the granules are not easy to stick to the capsules when filling them, which facilitates the filling operation and ensures stable product quality.

[0071] Table 1 Material summary of Examples 1-12

[0072]

[0073] Table 2 Comparison of the particle content of Examples 1-12 and the original method content

[0074]

[0075] Table 3 Hygroscopicity test of Guizhi Fuling granules prepared in Examples 10-12

[0076]

[0077] During the preparation process of Example 10-12, the particles were finally mixed in a SYH-200L three-dimensional mixer, and the paeonol content was detected by sampling at 9 points (top, middle and bottom) (sampling points are as follows: Figure 5 As shown), it was checked and confirmed that a very small amount of paeonol material could be mixed evenly, ensuring that the uniformity of the paeonol content in the particles met the requirements, as shown in Table 4. As can be seen from Table 4, the paeonol content at each point in Examples 10-12 is basically consistent, with a small deviation, and the RSD% is 0.433%, 0.488%, and 0.394%, respectively, and the content is very uniform.

[0078]

[0079] The Guizhi Fuling granule filler provided by the embodiment of the present invention has a small amount of auxiliary materials, a high uniformity of paeonol content, and a high content of amygdalin, which can reduce production costs and quality risks. One-time drying of the drug can effectively improve the efficacy of the product.

[0080] The above implementation modes are not limitations of the present invention, and the present invention is not limited to the above examples. Changes, modifications, additions or substitutions made by technicians in this technical field within the scope of the technical solution of the present invention also belong to the protection scope of the present invention.

Claims

1. A Guizhi Fuling granule for preparing Guizhi Fuling capsule, characterized in that: The total amount of a prescription is 10,000 Guizhi Fuling Capsules, and the raw materials include: Guizhi Fuling alcohol extract concentrate is equivalent to 10,000 Guizhi Fuling capsules; Guizhi Fuling water extract concentrate is equivalent to 10,000 Guizhi Fuling capsules; Poria cocos powder 1.92kg; Paeonol crystals are equivalent to the amount of 10,000 Guizhi Fuling capsules; Excipients: 2%-8% of the total amount of prescription dextrin.

2. The Guizhi Fuling granules for preparing Guizhi Fuling capsules according to claim 1, characterized in that: The total weight of a prescription of 10,000 Guizhi Fuling Capsules is 3.1kg, the Guizhi Fuling alcohol extract concentrate is 1.5kg-2.5kg, the Guizhi Fuling water extract concentrate is 1.5kg-2.5kg, the Poria powder is 1.92kg, the paeonol crystals are 0.0325g-0.065g, and the auxiliary material dextrin is 0.062kg-0.248kg.

3. A method for preparing Guizhi Fuling granules for preparing Guizhi Fuling capsules according to any one of claims 1 to 2, characterized in that: The steps include: Step S1, preparing raw materials: cinnamon twig tuckahoe alcohol extract concentrate, cinnamon tuckahoe water extract concentrate, tuckahoe powder, paeonol crystals, and auxiliary material dextrin, dextrin amount = 3.1 - tuckahoe powder 1.92 - solid content of cinnamon tuckahoe alcohol extract concentrate - solid content of cinnamon tuckahoe water extract concentrate - paeonol crystals; Step S2, first put 1.92 kg of Poria cocos powder and dextrin into a trough mixer for pre-mixing, i.e., dry mixing for 2-4 minutes, then add cinnamon twig Poria cocos alcohol extract concentrate and cinnamon twig Poria cocos water extract concentrate for mixing, i.e., wet mixing for 2-4 minutes, put the mixed material into a vacuum dryer for reduced pressure drying, then discharge the material, grind it to obtain a dry paste coarse powder, and set it aside; Step S3, pre-mixing the coarse powder of the dry paste with the paeonol crystals by the equal amount doubling method, crushing them into 80 mesh after mixing them evenly, and then mixing them evenly to obtain powdery particles for preparing Guizhi Fuling Capsules, which are set aside.

4. The method for preparing Guizhi Fuling granules for preparing Guizhi Fuling capsules according to claim 3, characterized in that: In step S1, the preparation process of Poria cocos powder is as follows: Moist heat sterilization: spread the Poria cocos slices on a tray with a thickness of 2-3 cm, and put them into a traditional Chinese medicine sterilizer for sterilization and drying. Set the sterilization temperature to 115°C, the sterilization time to 10 minutes, and the drying time to 6 minutes; Grinding: After the sterilized and dried Poria cocos slices are cooled to room temperature, they are crushed using a grinder through a 100-mesh sieve to make Poria cocos fine powder for later use.

5. The method for preparing Guizhi Fuling granules for preparing Guizhi Fuling capsules according to claim 3, characterized in that: In step S1, the preparation process of paeonol crystals is as follows: Put 2.4 kg of peony bark slices into a sandwich extraction tank, add 8 times water for micro-boiling distillation for 4-6 hours, and collect the distilled aromatic water until the distilled aromatic water liquid is colorless or anhydrous; The collected aromatic water is placed in a cold storage at 2-8°C for 3-4 days, during which the barrel is shaken once every 2-3 hours for 5-15 seconds each time. After the crystals are precipitated, they are filtered with a 400-mesh filter cloth to obtain paeonol crystals. The filtered paeonol crystals are dried under reduced pressure below 35°C or placed on filter paper to dry naturally to make solid paeonol crystals for later use.

6. The method for preparing Guizhi Fuling granules for preparing Guizhi Fuling capsules according to claim 3, characterized in that: In step S1, the preparation process of the cinnamon twig and tuckahoe alcohol extract concentrate is as follows: Preparation of peach kernel granules: crush the peach kernel pieces by a 20B universal grinder without a screen, set the frequency to 38±2HZ, and crush once to make peach kernel granules; Take 2.4kg of the residue after extracting the volatile components from peony bark slices, 2.4kg of cinnamon twig slices, 2.4kg of white peony slices, 2.4kg of peach kernel crushed particles and 0.48kg of Poria slices, put them into a sandwich decoction pot, add 90% ethanol and reflux extraction twice, the first time with 6 times the amount of reflux for 1h, the second time with 4 times the amount of reflux for 0.5h, filter each extract through 200 mesh, combine the filtrate, and concentrate under reduced pressure at a temperature not greater than 70°C to recover ethanol until there is no alcohol taste. When the alcohol-extracted concentrated solution reaches a temperature of 60°C, the ρ is 1.1-1.2, discharge the material, and obtain cinnamon twig and Poria alcohol-extracted concentrated solution for standby use.

7. The method for preparing Guizhi Fuling granules for preparing Guizhi Fuling capsules according to claim 3, characterized in that: The preparation process of the cinnamon twig tuckahoe water extract concentrate is as follows: add water to the drug residue after alcohol extraction and decoct twice, decocting for 0.5h each time with 4 times the amount, filter the drug solution through 200 mesh, combine the filtrate, add the water solution distilled from peony bark, and concentrate under reduced pressure at a temperature not greater than 80°C to ρ1.1-1.2 at a temperature of 60°C, discharge the material, and obtain the cinnamon tuckahoe water extract concentrate for standby use; Samples of Guizhi Fuling alcohol extract concentrate and Guizhi Fuling water extract concentrate were taken respectively to detect their solid content. According to the test results, the amount of auxiliary material dextrin added was calculated: dextrin dosage = total prescription amount - solid amount of alcohol extract concentrate - solid amount of water extract concentrate - amount of Poria cocos fine powder - amount of paeonol crystals.

8. The method for preparing Guizhi Fuling granules for preparing Guizhi Fuling capsules according to claim 3, characterized in that: In the step S2, the reduced pressure drying is carried out at a temperature below 85°C until the water content reaches 2.0%-3.0%, and the material is coarsely crushed through a 24-mesh sieve using a 30B universal grinder to obtain Guizhi Fuling dry paste.

9. The method for preparing Guizhi Fuling granules for preparing Guizhi Fuling capsules according to claim 3, characterized in that: In the step S3, the premixed materials are crushed by a 30B universal crusher through an 80-mesh sieve, and then mixed by a three-dimensional mixer.

10. A Guizhi Fuling capsule, characterized in that: The method is prepared by using the Guizhi Fuling granules for preparing Guizhi Fuling capsules as claimed in claim 1, and is filled into capsules by a capsule filling machine at a rate of 0.31 g per capsule.

Citation Information

Patent Citations

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