Rhizoma polygonati and saussurea involucrata bone marrow peptide tablet and preparation method thereof

Abstract

The invention discloses a rhizoma polygonati and saussurea involucrata bone marrow peptide tablet and a preparation method thereof, and relates to the technical field of pharmaceutical preparations, the rhizoma polygonati and saussurea involucrata bone marrow peptide tablet comprises the following raw materials by weight: 30%-41% of collagen peptide powder, 26%-28% of L-isoleucine, 16%-19% of a compound nutrition enhancer, 9%-15% of rhizoma polygonati, 3.67%-3.69% of sorbitol, 1%-3% of yak bone marrow peptide powder, 0.1% of emblic leafflower fruit, 0.1% of fructus alpiniae oxyphyllae, 0.1% of mulberry powder, 0.01%-0.03% of a saussurea involucrata culture, and 1% of magnesium stearate. Wherein the compound nutrition enhancer comprises calcium carbonate, maltodextrin and cholecalciferol. Through an innovative raw material pretreatment technology and an intelligent control means, the retention rate and the extraction rate of key components such as polygonatum sibiricum polysaccharide and saussurea involucrata flavone are remarkably improved, the variable coefficients of quality indexes such as hardness, friability and disintegration time limit of the tablet are reduced by 60% or above compared with those of a traditional process, and the product stability is remarkably enhanced.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of pharmaceutical preparations, in particular to a polygonatum rhizome and saussurea involucrata bone marrow peptide tablet and a preparation method thereof. BACKGROUND

[0002] At present, the health industry is booming. Functional products with natural plants and bioactive peptides as core components have attracted widespread attention from consumers due to their natural and efficient health benefits. Polygonatum rhizome is rich in polysaccharides, steroidal saponins and other active substances, and is widely used in traditional health care. Saussurea involucrata contains flavonoids, polysaccharides and other components, and has high medicinal value. Bone marrow peptides contain various small molecule active peptides, and the three components have potential significant health benefits when used together.

[0003] However, there are many technical bottlenecks in the current market for related polygonatum rhizome, saussurea involucrata and bone marrow peptide products, which seriously restrict the quality and application value of the products. 1. Severe loss of active ingredients: In traditional preparation processes, polygonatum rhizome is often dried at 65°C using hot air, which can easily cause the polysaccharide chains in polygonatum rhizome to break, resulting in an active loss rate of more than 40%. The extraction of saussurea involucrata relies on traditional water boiling or ethanol reflux methods, which not only have an extraction rate of less than 25% for heat-sensitive components such as flavonoids, but also can damage the structure of secondary metabolites in saussurea involucrata at high temperatures for a long time, significantly reducing the medicinal value of the raw materials.

[0004] 2. Extensive preparation process parameters, unstable product quality: In the preparation process, there is a lack of precise parameter control. The mixing process relies on a two-dimensional mixer and an empirical time setting (usually 15-30 minutes), resulting in poor material uniformity and a high mixing coefficient of variation CV of up to 12%. The granulation process uses wet granulation, resulting in a wide particle size distribution (50-500 μm) of the prepared granules, which causes a large fluctuation in the tablet disintegration time, ranging from 15 to 40 minutes. The tablet pressing process only uses a constant pressure, resulting in a tablet hardness variation coefficient of up to 8%, which seriously affects the stability and bioavailability of the product.

[0005] 3. Fuzzy application scenarios, lack of evidence-based basis: The instructions for similar products on the market are mainly general statements such as "enhancing immunity", and no special clinical research has been conducted for specific groups of people. This cannot meet the needs of consumers for precise health interventions and limits the application of the product in different health scenarios. SUMMARY

[0006] The present application relates to the technical field of pharmaceutical preparations, in particular to a polygonatum rhizome and saussurea involucrata bone marrow peptide tablet and a preparation method thereof.

[0007] To achieve the above object, the present application provides the following technical solutions: the raw materials of the Rhizoma Polygonati and Saussurea involucrata bone marrow peptide tablet include, by weight percentage: collagen peptide powder 30%-41%, L-isoleucine 26%-28%, compound nutritional fortifier 16%-19%, Rhizoma Polygonati 9%-15%, sorbitol 3.67%-3.69%, yak bone marrow peptide powder 1%-3%, Phyllanthus emblica 0.1%, Alpinia oxyphylla 0.1%, mulberry powder 0.1%, Saussurea involucrata culture 0.01%-0.03%, and magnesium stearate 1%. The compound nutritional fortifier contains calcium carbonate, maltodextrin, and cholecalciferol.

[0008] Preparation method of Rhizoma Polygonati and Saussurea involucrata bone marrow peptide tablet The preparation method includes the following steps: Deep pretreatment of raw materials Pretreatment of Rhizoma Polygonati: the Rhizoma Polygonati slices are first pretreated in a microwave power of 300W and a vacuum degree of-0.08MPa for 5 minutes, and then dried in a vacuum freeze-drying equipment at-45℃ for 16 hours. After drying, the Rhizoma Polygonati is ground and passed through a 120-mesh sieve. This process can increase the retention rate of Rhizoma Polygonati polysaccharide to 92%.

[0009] Pretreatment of Saussurea involucrata: the innovative "aqueous two-phase extraction-supercritical CO2 refining" process is adopted. First, the Saussurea involucrata is extracted with a polyethylene glycol / potassium phosphate aqueous two-phase system, and then the extraction product is refined by supercritical CO2. The pressure in the refining process is controlled at 25MPa, the temperature is controlled at 40℃, and the extraction time is controlled at 120 minutes. Through this process, the extraction rate of effective components of Saussurea involucrata is increased by 35% compared with traditional methods.

[0010] Pretreatment of bone marrow peptide: the yak bone marrow peptide raw material is subjected to nanomembrane filtration treatment, and the nanomembrane has a molecular weight cut-off of 500Da to remove macromolecular impurities. After filtration, it is passed through a 100-mesh sieve for use.

[0011] Weighing: according to the weight percentage of the above-mentioned raw material composition, accurately weigh all the pretreated materials and the raw materials such as collagen peptide powder, L-isoleucine, compound nutritional fortifier, sorbitol, Phyllanthus emblica, Alpinia oxyphylla, mulberry powder, and magnesium stearate, and reserve them for use.

[0012] Intelligent mixing: introduce a near-infrared spectrum online monitoring system, add the weighed materials except magnesium stearate into a three-dimensional mixer, mix at a speed of 25-35 revolutions per minute for 25 minutes, and monitor the uniformity of the material composition in real time through the near-infrared spectrum online monitoring system during the mixing process to ensure that the coefficient of variation CV is ≤3%.

[0013] Spray granulation: The intelligently mixed material is fed into a spray granulation equipment for granulation. During the granulation process, the inlet air temperature is controlled at 110-120℃ and the atomization pressure is controlled at 0.3MPa, resulting in uniform particles with a particle size distribution of 100-300μm.

[0014] Total Mixing: The granules obtained by spray granulation are granulated, and then magnesium stearate is added. The granulated material and magnesium stearate are mixed evenly to obtain the total mixture.

[0015] Tableting: Using pressure pulsation control technology, a pulsating pressure of ±0.5kN is superimposed on the main pressure of 8-12kN to compress the total mixture into tablets with a weight of 0.5g / tablet, a hardness of 4.5±0.3kg, and a friability of ≤0.5%.

[0016] Packaging and Inspection: The qualified tablets are packaged according to the process specifications. After packaging, the finished products are inspected according to relevant standards. The qualified products are the finished Huangjing Xuelian bone marrow peptide tablets.

[0017] Compared with the prior art, the beneficial effects of the present invention are: 1. This application utilizes innovative raw material pretreatment technologies (dynamic microwave-assisted vacuum freeze-drying technology, aqueous two-phase extraction-supercritical CO2 refining process, and nanomembrane filtration technology) and intelligent control methods (online monitoring of the mixing process using near-infrared spectroscopy and pressure pulsation control of the tableting process) to significantly improve the retention and extraction rates of key components such as Polygonatum polysaccharides and Saussurea flavonoids. The coefficient of variation of quality indicators such as tablet hardness, friability, and disintegration time is reduced by more than 60% compared with traditional processes, and the product stability is significantly enhanced.

[0018] 2. Through clinical / animal experiments targeting different populations, the efficacy of the Polygonatum and Snow Lotus Bone Marrow Peptide Tablets in various scenarios, such as sub-health conditioning (e.g., fatigue improvement, immunity enhancement), joint care (e.g., cartilage repair, inflammation suppression), and adjuvant disease treatment (e.g., adjuvant therapy for tumor radiotherapy and chemotherapy, intervention for postmenopausal osteoporosis), has been clarified. This fills the gap in application research of similar products and provides a scientific basis for precise market positioning and product function development. Attached Figure Description

[0019] Figure 1 This is a flowchart illustrating the preparation process of a Polygonatum and Saussurea bone marrow peptide tablet. Detailed Implementation

[0020] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0021] This invention provides a technical solution for Polygonatum sibiricum and snow lotus bone marrow peptide tablets and their preparation method.

[0022] Example 1

[0023] Raw material ratio: By weight percentage, collagen peptide powder 35%, L-isoleucine 28%, compound nutritional fortifier 16%, Polygonatum sibiricum 14%, sorbitol 3.68%, yak bone marrow peptide powder 2%, Phyllanthus emblica 0.1%, Alpinia oxyphylla 0.1%, mulberry powder 0.1%, Saussurea involucrata culture 0.02%, magnesium stearate 1%. Among them, the weight ratio of calcium carbonate, maltodextrin, and cholecalciferol in the compound nutritional fortifier is 1:2:0.5.

[0024] Preparation process Raw material pretreatment: Polygonatum, snow lotus, and yak bone marrow peptides were pretreated according to the above-mentioned deep pretreatment steps.

[0025] Weighing: Accurately weigh each raw material according to the above raw material ratio.

[0026] Intelligent mixing: Add all materials except magnesium stearate to the three-dimensional mixer and mix at 30 rpm for 25 minutes. Online monitoring via near-infrared spectroscopy ensures that the mixing coefficient of variation (CV) is 2.5%.

[0027] Spray granulation: During the spray granulation process, the inlet air temperature is controlled at 120℃ and the atomization pressure is controlled at 0.3MPa to obtain particles with a particle size distribution of 100-300μm.

[0028] Total mixing: After granulating, add magnesium stearate and mix well.

[0029] Tableting: Based on the main pressure of 10kN, an additional ±0.5kN pulsating pressure is added to compress the tablets into tablets with a weight of 0.5g / tablet, a hardness of 4.5±0.3kg, and a friability of 0.4%.

[0030] Packaging and Inspection: After packaging according to the process specifications, the product is inspected and qualified.

[0031] Application Effects: The Polygonatum and Snow Lotus Bone Marrow Peptide Tablets prepared in this embodiment are used for sub-healthy individuals. The tablets are taken twice daily, two tablets each time, for eight consecutive weeks. Clinical studies showed that the subjects' Fatigue Scale-14 (FS-14) scores decreased by 28%, and serum immunoglobulin IgG levels increased by 15%. For joint care, oral administration of these tablets to a rat model of osteoarthritis increased the expression of type II collagen in cartilage tissue by 40% and decreased the level of the inflammatory factor TNF-α by 32%.

[0032] Example 2

[0033] Raw material ratio: By weight percentage, collagen peptide powder 30%, L-isoleucine 28%, compound nutritional fortifier 19%, Polygonatum sibiricum 15%, sorbitol 3.67%, yak bone marrow peptide powder 3%, Phyllanthus emblica 0.1%, Alpinia oxyphylla 0.1%, mulberry powder 0.1%, Saussurea involucrata culture 0.03%, magnesium stearate 1%. The weight ratio of calcium carbonate, maltodextrin, and cholecalciferol in the compound nutritional fortifier is 1:2:0.5.

[0034] Preparation process: Except for reducing the inlet air temperature to 110°C during spray granulation to better protect the heat-sensitive components, the other preparation steps are the same as in Example 1.

[0035] Application effects: The Polygonatum and Snow Lotus Bone Marrow Peptide Tablets prepared in this embodiment were used by cancer patients during radiotherapy and chemotherapy. When patients took this product in conjunction with radiotherapy and chemotherapy, the incidence of neutropenia decreased by 22% and weight loss decreased by 18%. When used by postmenopausal women with osteoporosis, after 12 months of continuous use, the T-score of lumbar spine bone mineral density increased by 0.8 and the osteocalcin level increased by 25%.

[0036] Both of the above embodiments have been verified through pilot production, demonstrating good process repeatability, stable product quality, and achieving the expected application results.

[0037] It will be apparent to those skilled in the art that the present invention is not limited to the details of the exemplary embodiments described above, and that the invention can be implemented in other specific forms without departing from its spirit or essential characteristics. Therefore, the embodiments should be considered in all respects as exemplary and non-limiting, and the scope of the invention is defined by the appended claims rather than the foregoing description. Thus, all variations falling within the meaning and scope of equivalents of the claims are intended to be included within the present invention. No reference numerals in the claims should be construed as limiting the scope of the claims.

Claims

1. A Polygonatum and Snow Lotus Bone Marrow Peptide Tablet, characterized in that: Its raw materials, by weight percentage, include: 30%-41% collagen peptide powder, 26%-28% L-isoleucine, 16%-19% compound nutritional fortifier, 9%-15% Polygonatum sibiricum, 3.67%-3.69% sorbitol, 1%-3% yak bone marrow peptide powder, 0.1% Phyllanthus emblica, 0.1% Alpinia oxyphylla, 0.1% mulberry powder, 0.01%-0.03% snow lotus culture, and 1% magnesium stearate. The compound nutritional fortifier includes calcium carbonate, maltodextrin, and cholecalciferol.

2. A method for preparing the Polygonatum and Saussurea involucrata bone marrow peptide tablets according to claim 1, characterized in that, Includes the following steps: S1. Deep pretreatment of raw materials Polygonatum pretreatment: Using the "dynamic microwave-assisted vacuum freeze-drying" technology, the Polygonatum slices were first placed in an environment with a microwave power of 300W and a vacuum degree of -0.08MPa for 5 minutes for pretreatment, and then transferred to a vacuum freeze-drying equipment at -45℃ for 16 hours for drying. After drying, the Polygonatum was pulverized and passed through a 120-mesh sieve. Snow lotus pretreatment: First, snow lotus was extracted using a polyethylene glycol / potassium phosphate aqueous two-phase system, and then the extract was purified by supercritical CO2. Pretreatment of bone marrow peptides: Yak bone marrow peptide raw materials are subjected to nano-membrane filtration. The molecular weight cutoff of the nano-membrane is 500 Da to remove large molecular impurities. After filtration, the raw materials are passed through a 100-mesh sieve for later use. S2. Weighing: Accurately weigh all pretreated materials, as well as collagen peptide powder, L-isoleucine, compound nutritional fortifier, sorbitol, amla, alpinia oxyphylla, mulberry powder, magnesium stearate, etc., according to the weight percentage of the above raw material composition, and set aside for later use. S3, Intelligent Mixing: Introducing a near-infrared spectroscopy online monitoring system, the weighed materials except magnesium stearate are added to the three-dimensional mixer and mixed at a speed of 25-35 rpm for 25 minutes; S4. Spray granulation: The intelligently mixed material is fed into the spray granulation equipment for granulation. S5. Total Mixing: The granules obtained by spray granulation are granulated, and then magnesium stearate is added. The granulated material and magnesium stearate are mixed evenly to obtain the total mixture. S6. Tableting: Using pressure pulsation control technology, a pulsating pressure of ±0.5kN is superimposed on the main pressure of 8-12kN to compress the total mixture into tablets with a weight of 0.5g / tablet, a hardness of 4.5±0.3kg, and a friability of ≤0.5%. S7. Packaging and Inspection: Pack the qualified tablets according to the process specifications. After packaging, inspect the finished product according to relevant standards. The qualified product is the finished product of Huangjing Xuelian Bone Marrow Peptide Tablets.

3. The method for preparing Polygonatum and Saussurea involucrata bone marrow peptide tablets according to claim 2, characterized in that: During the pretreatment of snow lotus in step S1, the pressure during the refining process is controlled at 25 MPa, the temperature at 40 °C, and the extraction time at 120 minutes.

4. The method for preparing Polygonatum and Saussurea involucrata bone marrow peptide tablets according to claim 2, characterized in that: During the mixing process in step S3, the uniformity of material composition is monitored in real time by a near-infrared spectroscopy online monitoring system to ensure that the mixing coefficient of variation (CV) is ≤3%.

5. The method for preparing Polygonatum and Saussurea involucrata bone marrow peptide tablets according to claim 2, characterized in that: In step S4, the inlet air temperature is controlled at 110-120℃ and the atomization pressure is controlled at 0.3MPa during the granulation process, so as to obtain uniform particles with a particle size distribution of 100-300μm.

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