CN114129679A - Calcium tablet special for children and preparation method thereof - Google Patents

Calcium tablet special for children and preparation method thereof Download PDF

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Publication number
CN114129679A
CN114129679A CN202010918027.4A CN202010918027A CN114129679A CN 114129679 A CN114129679 A CN 114129679A CN 202010918027 A CN202010918027 A CN 202010918027A CN 114129679 A CN114129679 A CN 114129679A
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calcium
parts
children
tablet
special
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华子昂
刘宝全
朱美瑛
孙宁
竹添
王姣
万君兴
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/75Rutaceae (Rue family)
    • A61K36/752Citrus, e.g. lime, orange or lemon
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/06Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
    • A61K33/10Carbonates; Bicarbonates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/14Alkali metal chlorides; Alkaline earth metal chlorides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/42Phosphorus; Compounds thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/48Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/62Nymphaeaceae (Water-lily family)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/88Liliopsida (monocotyledons)
    • A61K36/894Dioscoreaceae (Yam family)
    • A61K36/8945Dioscorea, e.g. yam, Chinese yam or water yam
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/88Liliopsida (monocotyledons)
    • A61K36/896Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
    • A61K36/8969Polygonatum (Solomon's seal)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/88Liliopsida (monocotyledons)
    • A61K36/906Zingiberaceae (Ginger family)
    • A61K36/9062Alpinia, e.g. red ginger or galangal
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/02Nutrients, e.g. vitamins, minerals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/10Preparation or pretreatment of starting material
    • A61K2236/15Preparation or pretreatment of starting material involving mechanical treatment, e.g. chopping up, cutting or grinding
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30Extraction of the material
    • A61K2236/33Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/333Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH

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  • Health & Medical Sciences (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
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  • Animal Behavior & Ethology (AREA)
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  • Microbiology (AREA)
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  • Inorganic Chemistry (AREA)
  • Diabetes (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nutrition Science (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Coloring Foods And Improving Nutritive Qualities (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

Aiming at the current situation of calcium deficiency of children, the life big data is utilized to determine the core gene target point of calcium deficiency of children, and then the network pharmacology big data is utilized to screen and obtain the medicine-food homologous plant formula for supplementing calcium to children, and the medicine-food homologous plant formula is prepared from the following raw materials in parts by weight: 5-30 parts of dried orange peel, 5-30 parts of Chinese yam, 5-40 parts of white hyacinth bean, 3-20 parts of sharpleaf galangal fruit, 5-35 parts of gordon euryale seed and 6-25 parts of rhizoma polygonati, and is prepared by matching with food raw materials containing 800mg of calcium in 400-plus materials according to the following method: s1 micronizing pericarpium Citri Reticulatae, rhizoma Dioscoreae, semen lablab album, fructus Alpinae Oxyphyllae, semen euryales, and rhizoma Polygonati, breaking cell wall, and extracting functional components; centrifuging the S2 extract to obtain supernatant; s3, concentrating the supernatant, and mixing with the calcium raw material superfine powder; s4 granulating, performing aseptic treatment, and preparing the calcium tablet special for children according to the standard tablet process. The calcium tablet is designed according to life big data, is prepared from medicinal and edible plant raw materials, and has simple preparation method.

Description

Calcium tablet special for children and preparation method thereof
Technical Field
The invention relates to a calcium tablet special for children and a preparation method thereof.
Background
The children are in the stage of rapid growth of bodies, and need a large amount of calcium for building bones and muscles, so the demand of calcium is very large, and the viscera of the children are delicate and tender in the development stage, the qi of the body is not filled, the healthy viscera function is not formed, the deficiency of the kidney, the spleen and the lung qi often appears, and the characteristics of delicate and tender lung, frequent insufficiency of the spleen and frequent deficiency of the kidney are shown. The absorption and utilization of calcium are limited, and calcium deficiency easily occurs.
At present, the most common method for supplementing calcium for children is to take calcium supplementing products. However, the existing calcium supplement products are only added with exogenous calcium (or added with vitamin D), which is to supplement calcium, and the exogenous calcium is only added under the condition that the absorption and transformation mechanism of calcium and the special physiological characteristics of children are not completely understood, and other necessary conditions of calcium absorption are neglected, so that the absorption amount of calcium is far less than the daily requirement of calcium, and the situation that only calcium is not absorbed is caused. And the expert committee of vitamin D discipline group of the calcium deficiency committee of the chinese college of senior citizens pointed out: "the following dosing method has proven ineffective, or ineffective and the risk of poisoning increases, and therefore the use of active vitamin D formulations" is not recommended [ china journal of calcium deficiency 2014, volume 20, phase 9.
Chinese patent CN201210422523.6 discloses a calcium preparation, its preparation method and application, the formulation is composed of calcium salt, vitamin D, vitamin K, mannitol and glucose. Chinese patent CN200910082672.0 discloses a micro-emulsion calcium preparation, a preparation method and application thereof, wherein a micro-emulsion structure is used as a carrier of a calcium source, and vitamins, lecithin and sorbitol are used in a matching manner. The calcium supplement products are only designed from the calcium absorption angle, and do not supplement calcium according to the physiological characteristics and molecular mechanism of children, so that the problem of calcium deficiency of children cannot be fundamentally solved. The most suitable medicine formula is not screened from a molecular mechanism causing calcium deficiency of children, and the scientificity and the effectiveness are lacked.
In addition, the addition amount of calcium in the beverage specified in national food safety standard of food nutrition enhancer use (GB 14880-2012) is 160-1350 mg/kg, the daily consumption of the domestic calcium preparation related liquid food is about 100mL at present, the maximum addition amount of calcium limited by laws and regulations is only 135 mg, the requirement that the daily calcium intake of children is 1200 and 1500 mg/day is far less, the calcium supplementing effect on children is very little, and other types of foods have the problem.
Disclosure of Invention
Aiming at the defects, the invention starts with a cause mechanism aiming at the calcium deficiency of children, utilizes a life big data technology to excavate a key gene target point of the calcium deficiency of the children, finds a key compound for regulating and controlling the key gene target point through a network pharmacological system tool, and screens a medicine-food homologous traditional Chinese medicine to form a traditional Chinese medicine formula for promoting the calcium supplement of the children, wherein the traditional Chinese medicine formula is prepared from the following raw materials in parts by weight: 5-30 parts of dried orange peel, 5-30 parts of Chinese yam, 5-40 parts of white hyacinth bean, 3-20 parts of sharpleaf galangal fruit, 5-35 parts of gordon euryale seed and 6-25 parts of rhizoma polygonati, and the food raw materials containing 400-800mg of calcium are matched for use, and the preparation method comprises the following steps: s1 mixing pericarpium Citri Reticulatae, rhizoma Dioscoreae, semen lablab album, fructus Alpinae Oxyphyllae, semen euryales, and rhizoma Polygonati in proportion, micronizing, breaking cell wall, and extracting functional components; centrifuging the S2 extract to obtain supernatant; s3, concentrating the supernatant, and mixing with the calcium raw material superfine powder; s4 granulating, performing aseptic treatment, and preparing the calcium tablet special for children according to the standard tablet process.
Preferably, the agitation leaching parameters are: the liquid-material ratio is 5-12, the extraction temperature is 90-boiling, the extraction time is 0.5-2 hours, and the extraction times are 1-2 times.
Preferably, the extracting solution is phosphate solution, so that the pH value of the extracting system is maintained to be stable, and the calcium-phosphorus ratio can be adjusted to improve the calcium absorption efficiency.
Preferably, the supernatant is obtained using a continuous centrifugation technique, preferably a tube centrifuge.
Preferably, the calcium is a calcium-containing material prescribed in food safety laws, such as calcium carbonate, calcium chloride, calcium phosphate, and the like.
Detailed Description
The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the embodiments of the present invention. It is to be understood that the described embodiments are merely exemplary of the invention, and not restrictive of the full scope of the invention. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
Example 1
A calcium tablet special for children and a preparation method thereof, the specific steps are as follows: s1 mixing the following raw materials: 5 parts of dried orange peel, 5 parts of Chinese yam, 5 parts of white hyacinth bean, 3 parts of sharpleaf galangal fruit, 5 parts of gordon euryale seed and 6 parts of rhizoma polygonati are subjected to superfine grinding and then are fully mixed; s2 stirring and leaching, wherein the specific parameters are as follows: 0.1M phosphate solution (pH7.0), liquid-material ratio of 5, extraction temperature of 90 deg.C, extraction time of 0.5 hr, extraction frequency of 2 times, and microwave-assisted extraction to accelerate dissolution, wherein the extraction adopts tubular centrifuge to obtain supernatant, and rotation speed of 16000 rpm takes supernatant; s3, after vacuum concentration, the supernatant is fully mixed with calcium carbonate micropowder containing 400mg of calcium; s4, granulating according to a standard granulation process, carrying out aseptic treatment, and preparing the calcium tablet special for children according to a tablet standard process.
Example 2
A calcium tablet special for children and a preparation method thereof, the specific steps are as follows: s1 mixing the following raw materials: 30 parts of dried orange peel, 30 parts of Chinese yam, 40 parts of white hyacinth bean, 20 parts of sharpleaf galangal fruit, 35 parts of gordon euryale seed and 25 parts of rhizoma polygonati are subjected to superfine grinding and then mixed; s2 stirring and leaching, wherein the specific parameters are as follows: 0.2M phosphate solution (pH7.0), liquid-material ratio of 12, boiling extraction at extraction temperature, extraction time of 2 hours, extraction times of 1 time, accelerated dissolution by using microwave-assisted extraction technology, obtaining supernatant by using a tubular centrifuge, and taking the supernatant at a rotation speed of 16000 rpm; s3, mixing the supernatant with calcium chloride micropowder containing 800mg of calcium after vacuum concentration; s4, granulating according to a standard granulation process, carrying out aseptic treatment, and preparing the calcium tablet special for children according to a tablet standard process.
Example 3
A calcium tablet special for children and a preparation method thereof, the specific steps are as follows: s1 mixing the following raw materials: 10 parts of dried orange peel, 10 parts of Chinese yam, 10 parts of white hyacinth bean, 10 parts of sharpleaf galangal fruit, 10 parts of gordon euryale seed and 10 parts of rhizoma polygonati are subjected to superfine grinding and then mixed; s2 stirring and leaching, wherein the specific parameters are as follows: extracting with pure water at a liquid-material ratio of 7, an extraction temperature of 90 deg.C, an extraction time of 1 hr, and an extraction frequency of 2 times, accelerating dissolution by using microwave-assisted extraction technology, obtaining supernatant by using a tubular centrifuge, and obtaining supernatant at a rotation speed of 16000 rpm; s3, after vacuum concentration, the supernatant is fully mixed with calcium carbonate containing 600mg of calcium and calcium phosphate micro powder containing 200mg of calcium; s4, granulating according to a standard granulation process, carrying out aseptic treatment, and preparing the calcium tablet special for children according to a tablet standard process.
Clinical validation
Example 1, example 2, and example 3 were all clinically validated according to the following methods:
method (A)
Inclusion criteria for 1 case
Children 1-5 years old; the patients were tested voluntarily, and the medicine was taken on time and the doctor was given a double-visit at regular intervals.
2 exclusion criteria
If the medicine is not taken according to the regulation, the curative effect can not be judged; insufficient data and the like affecting the judgment of curative effect or safety.
3 clinical verification
The calcium tablet taken alone by a child is taken as a control group, and the calcium tablet taken in the embodiment is taken as a verification group, wherein the calcium tablets are taken by 20 cases respectively. The taking method comprises the following steps: calcium tablet for children is taken 3 times a day according to the instruction; the calcium tablet of the embodiment of the invention is 2 tablets per time and 3 times a day; the administration is continued for 3 months.
Bone density measurement: the bone density of lumbar vertebrae L2-4 and left femoral neck Wards triangle of each group of patients is measured by a dual-energy X-ray bone density measuring instrument before and after taking (after 3 months).
The statistical method adopts SPSS 20.0 statistical software to perform data analysis, the measurement data is expressed by x +/-s, the comparison adopts t test, and the counting data comparison adopts x 2 test. P <0.05 indicates that the difference is statistically significant.
(II) verification result
Example 1 comparison of bone Density before and after administration (g/cm)3,Mean±SD)
Figure DEST_PATH_IMAGE002
Example 2 comparison of bone Density before and after administration (g/cm)3,Mean±SD)
Figure DEST_PATH_IMAGE004
Example 3 comparison of bone Density before and after administration (g/cm)3,Mean±SD)
Figure DEST_PATH_IMAGE006
The clinical verification result shows that: after the control group and the verification group are taken for 3 months, the bone density of lumbar vertebra and femoral neck is improved to different degrees. The calcium tablet of the invention has better effect on relieving osteoporosis in lactation than the calcium preparation of the control group, wherein the water average of the calcium tablet of the verification group of the example 2 for improving the bone density is higher than that of the examples 1 and 3, and the example 2 is a better formula proportion and a preparation process of the calcium tablet of the invention.
Any combination of the summary of the invention and the detailed description of the invention section above, including the description of the invention, is not intended to be limiting in any way and does not describe all aspects of the combination for the sake of brevity. Any modification, equivalent replacement, or improvement made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims (6)

1. The special calcium tablet for children and the preparation method thereof are characterized in that the raw materials are mixed according to the following parts by weight: the food raw material containing 400-plus 800mg calcium, 5-30 parts of dried orange peel, 5-30 parts of Chinese yam, 5-40 parts of white hyacinth bean, 3-20 parts of sharpleaf galangal fruit, 5-35 parts of gordon euryale seed and 6-25 parts of rhizoma polygonati are prepared according to the following method: s1 micronizing pericarpium Citri Reticulatae, rhizoma Dioscoreae, semen lablab album, fructus Alpinae Oxyphyllae, semen euryales, and rhizoma Polygonati, breaking cell wall, and extracting functional components; centrifuging the S2 extract to obtain supernatant; s3, concentrating the supernatant, and mixing with the calcium raw material superfine powder; s4 granulating, performing aseptic treatment, and preparing the calcium tablet special for children according to the standard tablet process.
2. The calcium tablet special for children as claimed in claim 1, wherein the stirring and leaching parameters are as follows: the liquid-material ratio is 5-12, the extraction temperature is 90-boiling, the extraction time is 0.5-2 hours, and the extraction times are 1-2 times.
3. The children calcium tablet and the preparation method thereof according to claim 1, wherein the extract is preferably phosphate solution, the pH value of the extraction system is stabilized, and the calcium-phosphorus ratio of the calcium tablet is adjusted to promote the calcium absorption and utilization efficiency.
4. The children specific calcium tablet and the preparation method thereof according to claim 1, wherein the supernatant is obtained by a continuous centrifugation technology, preferably a tube centrifuge.
5. The calcium tablet as claimed in claim 1, wherein the calcium is a calcium-containing material such as calcium carbonate, calcium chloride, calcium phosphate, etc. prescribed in food safety law.
6. Protecting the special calcium tablet for children prepared by the method and application in calcium supplement for children.
CN202010918027.4A 2020-09-03 2020-09-03 Calcium tablet special for children and preparation method thereof Pending CN114129679A (en)

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1209285A (en) * 1998-08-19 1999-03-03 韩国庆 Health-care food
CN104623478A (en) * 2015-01-23 2015-05-20 广州中医药大学 Medicine for regulating spleen-deficiency syndrome type intestinal bacilli illness and preparation method thereof
CN108938989A (en) * 2018-10-22 2018-12-07 河南中医药大学 It is a kind of treat osteoporosis cover fennel essence bone-building up powder

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1209285A (en) * 1998-08-19 1999-03-03 韩国庆 Health-care food
CN104623478A (en) * 2015-01-23 2015-05-20 广州中医药大学 Medicine for regulating spleen-deficiency syndrome type intestinal bacilli illness and preparation method thereof
CN108938989A (en) * 2018-10-22 2018-12-07 河南中医药大学 It is a kind of treat osteoporosis cover fennel essence bone-building up powder

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
"补钙之前打个问号", 中国矿业报, pages 1 *
辛兵: "妇儿疾病小偏方", vol. 1, 中国妇女出版社, pages: 228 *

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