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CN-122005482-A - Phyllanthus emblica and semen zizizizyphi spinosae tablet for improving sleep and tranquilizing by nourishing heart and preparation method thereof

CN122005482ACN 122005482 ACN122005482 ACN 122005482ACN-122005482-A

Abstract

The invention relates to the technical field of traditional Chinese medicine preparations, and discloses an emblic leafflower fruit and semen ziziziphi spinosae tablet for improving sleep and nourishing heart to calm the mind and a preparation method thereof. The preparation method comprises the steps of spraying a reserved polyethylene glycol and sorbitol forming a granulating matrix solution on the surface of a polysaccharide backing material, spraying phyllanthus emblica powder at high pressure in a high-viscosity critical period of a fluidized bed for crosslinking, carrying out instant cold air quenching to generate phase change, and tabletting and then carrying out water-based film coating. According to the invention, an amorphous glassy network structure formed by crosslinking the polyethylene glycol macromolecular chain segments and the tannin polyphenol in the phyllanthus emblica powder is utilized, so that the mechanical heat softening resistance of the polysaccharide powder in the continuous tabletting process is improved, the water absorption swelling risk in a damp-heat operation environment is reduced, and the retention rate of the active ingredients of the tablet core and the integrity of the coating film are ensured.

Inventors

  • ZHANG KESHENG

Assignees

  • 山东益仁堂药业有限公司

Dates

Publication Date
20260512
Application Date
20260324

Claims (10)

  1. 1. The phyllanthus emblica and wild jujube seed tablet for improving sleep and tranquilizing by nourishing the heart is characterized by being prepared from the following components in parts by weight: 20.0-35.0 parts of wild jujube seed powder, 10.0-20.0 parts of lily powder, 10.0-20.0 parts of longan pulp powder, 5.0-15.0 parts of lucid ganoderma powder, 5.0-15.0 parts of maltodextrin, 10.0-25.0 parts of sorbitol, 3.0-8.0 parts of emblic leafflower fruit powder, 0.5-1.5 parts of magnesium stearate and 2.0-6.0 parts of compound coating agent.
  2. 2. The emblic leafflower fruit and wild jujube seed tablet for improving sleep, nourishing the heart and soothing the nerves as claimed in claim 1 is characterized by being prepared from the following components in parts by weight: 27.5 parts of wild jujube seed powder, 15.0 parts of lily powder, 15.0 parts of longan pulp powder, 10.0 parts of lucid ganoderma powder, 10.0 parts of maltodextrin, 17.5 parts of sorbitol, 5.5 parts of emblic leafflower fruit powder, 1.0 part of magnesium stearate and 4.0 parts of compound film agent.
  3. 3. The emblic leafflower fruit and wild jujube seed tablet for improving sleep and nourishing heart to calm the mind according to claim 1, wherein the compound film coating agent is a pre-compounded hydroxypropyl methylcellulose and polyethylene glycol composition, and the number average molecular weight of the polyethylene glycol is 4000 or 6000.
  4. 4. The emblic leafflower fruit and wild jujube seed tablet for improving sleep and nourishing heart to calm the mind, according to claim 1, wherein 30.0% -40.0% of the total mass of the compound film coating agent is polyethylene glycol, the polyethylene glycol is distributed in the tablet core of the emblic leafflower fruit and wild jujube seed tablet as a granulating auxiliary matrix to provide a cross-linked network, and the rest of the compound film coating agent is distributed outside the tablet as a film coating layer.
  5. 5. A method for preparing the emblic leafflower fruit and wild jujube seed tablet for improving sleep, nourishing heart and soothing nerves as claimed in any one of claims 1 to 4, which is characterized by comprising the following steps: (1) Weighing and preprocessing materials, namely weighing raw material components according to parts by weight, extracting polyethylene glycol in the compound film coating agent, and reserving the polyethylene glycol for subsequent granulating steps, wherein the rest part of the compound film coating agent is used as coating powder for standby; (2) Dry powder premixing, namely dry mixing the wild jujube seed powder, the lily powder, the longan pulp powder, the lucid ganoderma powder and the maltodextrin to obtain a granulating base material; (3) Preparing a granulating matrix solution, namely adding sorbitol and polyethylene glycol reserved in the step (1) into an ethanol water solution, heating, preserving heat and dissolving to form a uniform dispersion; (4) Spraying granulating matrix solution onto the granulating base material in a fluidized bed, then raising the air inlet temperature to perform constant-temperature fluidization drying, and rapidly spraying phyllanthus emblica powder into a boiling material bed layer of the fluidized bed through high-pressure air flow under the condition of no shutdown and no cooling when the air outlet temperature reaches a preset value, and maintaining the hot air temperature to continuously perform strong fluidization mixing; (5) Quenching and freezing phase change, namely after mixing is completed, instantaneously cutting off a heating source and switching to a cold air system to perform fluidized bed cold air quenching until the integral temperature of a material bed layer is reduced below a target temperature, and stopping fluidization discharging to obtain dry particles; (6) Tabletting and coating, namely uniformly mixing the dry particles with magnesium stearate, continuously tabletting to obtain a tablet core of the plain tablet, preparing coating liquid from the coating powder remained in the step (1), and carrying out water-based spray coating and drying on the tablet core of the plain tablet to obtain the finished product.
  6. 6. The preparation method of the aqueous ethanol solution is characterized in that in the step (2), dry-mixing is carried out for 15-20 min at normal temperature under the condition of 15-25 rpm, in the step (3), the volume fraction of the aqueous ethanol solution is 85%, the solvent is heated to enable the temperature to be stable at 55-65 ℃, and the solvent is dissolved for 30-45 min under the condition of 100-200 rpm.
  7. 7. The preparation method according to claim 5, wherein in the step (4), the initial air inlet temperature of the fluidized bed is set to 45-55 ℃, the spraying flow rate of the granulating matrix solution is 15-30 mL/min, and the atomization air pressure is set to 0.15-0.25 MPa; And after spraying, immediately raising the air inlet temperature of the fluidized bed and keeping the temperature constant at 60-65 ℃ to continuously fluidize and dry.
  8. 8. The preparation method according to claim 5, wherein in the step (4), when the exhaust temperature reaches 48-52 ℃, a high-pressure airflow powder feeding device is started, phyllanthus emblica powder is rapidly sprayed into a fluidized bed within 1-2 min under the conveying air pressure of 0.2-0.4 MPa, and after the spraying is finished, the hot air temperature of 60-65 ℃ is maintained for continuous strong fluidization and mixing for 3-6 min.
  9. 9. The preparation method according to claim 5, wherein in the step (5), the inlet air temperature is suddenly reduced to 15-20 ℃ within 2-4 min for fluidized bed cold air quenching until the whole temperature of the material bed is reduced to below 25 ℃.
  10. 10. The method according to claim 5, wherein in the step (6), continuous tabletting is performed under parameters of main pressure of 10-20 kn and rotation speed of 20-40 rpm; Preparing coating powder into coating purified water solution with the mass fraction of 6.0% -10.0%, spraying and coating at the temperature of 38-42 ℃ and the atomization pressure of 0.20-0.30 MPa, stopping spraying liquid when the weight gain of the coating reaches 2.0% -2.5%, and performing original machine drying.

Description

Phyllanthus emblica and semen zizizizyphi spinosae tablet for improving sleep and tranquilizing by nourishing heart and preparation method thereof Technical Field The invention relates to the technical field of traditional Chinese medicine preparations, in particular to an emblic leafflower fruit and wild jujube seed tablet for improving sleep, nourishing heart and soothing nerves and a preparation method thereof. Background The problems of sleep disorder such as insomnia and palpitation are increasingly common, and compound conditioning by adopting medicinal and edible traditional Chinese medicinal materials such as spina date seed, lily, ganoderma lucidum and the like is a common intervention means at present. The traditional Chinese medicine compound raw materials or extracts usually contain rich plant polysaccharide components. In the actual production operation of solid preparations, the polysaccharide-rich material itself has a strong hygroscopicity and a low glass transition temperature. In order to improve taste or formability, polyol adjuvants are often introduced into the formulation, which further exacerbates the thermal sensitivity and hygroscopic tendency of the material. In the continuous tabletting process, mechanical friction heat generated by equipment operation easily causes polysaccharide and polyol matrix to cross the glass transition temperature, so that phase softening and viscous rheology occur, obvious viscous flushing phenomenon is caused, and the continuity and molding quality of preparation production are affected. In addition, in the subsequent film coating process, particularly in the hot and humid environment of the aqueous film coating, the polysaccharide tablet cores are extremely liable to absorb moisture in the coating liquid and undergo local swelling. The expansion of the internal volume of the tablet core not only can rupture the film just formed to cause the surface of the coating to crack, but also can promote external moisture to penetrate into the tablet core to initiate a microenvironment hydration reaction. The invasion of water can cause degradation and loss of easily-hydrolyzed or thermosensitive medicinal components such as the wild jujube saponins, so that the retention rate of the effective components is reduced, and the batch quality stability of the final product is difficult to ensure. Conventional physical mixing or conventional granulation processes have had difficulty building up a micro-physical structure with sufficient mechanical rigidity and moisture retarding capabilities inside the tablet core that is not effective in addressing the process compatibility issues described above. Disclosure of Invention The invention solves the technical problems that the traditional Chinese medicine polysaccharide powder and the polyalcohol auxiliary materials are easy to soften, adhere and wash due to mechanical heating in the preparation processing process, and are easy to absorb moisture and swell in a damp-heat environment, thereby causing degradation of active ingredients and cracking of coating. In order to solve the problems, the invention provides the following technical scheme: The invention provides an emblic leafflower fruit and wild jujube seed tablet for improving sleep and nourishing heart to calm the mind, which is prepared from the following components, by weight, 20.0-35.0 parts of wild jujube seed powder, 10.0-20.0 parts of lily powder, 10.0-20.0 parts of longan pulp powder, 5.0-15.0 parts of ganoderma lucidum powder, 5.0-15.0 parts of maltodextrin, 10.0-25.0 parts of sorbitol, 3.0-8.0 parts of emblic leafflower fruit powder, 0.5-1.5 parts of magnesium stearate and 2.0-6.0 parts of compound film agent. By adopting the technical scheme, the invention utilizes the specific interaction of each component on the microscopic phase to construct the amorphous solid dispersion network with high glass transition temperature, thereby improving the thermodynamic stability of the prescription powder in the mechanical processing and damp-heat environment. The specific action mechanism is as follows: 1) Providing a hydrogen bond donor-acceptor basis, introducing polysaccharide extract and sorbitol into the system as matrixes, and performing structural intervention by adding a compound film coating agent and phyllanthus emblica powder in a specific proportion. The compound film coating agent contains polyethylene glycol macromolecular chain segments, and the phyllanthus emblica powder contains tannin polyphenols. 2) The surface of tannin molecule has high density phenolic hydroxyl groups, which are used as strong hydrogen bond donors and widely non-covalent cross-linked with aliphatic hydroxyl groups of sorbitol and ether bond oxygen atoms on polyethylene glycol skeleton. The ether bond oxygen atom of polyethylene glycol provides a lone pair electron and participates in the construction of external hydrogen bonds in a large number. 3) The multi-point anchoring act