CN114129686A - 一种老年人专用钙片及其制备方法 - Google Patents
一种老年人专用钙片及其制备方法 Download PDFInfo
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- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 title claims abstract description 64
- 239000011575 calcium Substances 0.000 title claims abstract description 64
- 229910052791 calcium Inorganic materials 0.000 title claims abstract description 64
- 238000002360 preparation method Methods 0.000 title claims abstract description 14
- 238000000034 method Methods 0.000 claims abstract description 21
- 239000006228 supernatant Substances 0.000 claims abstract description 17
- 239000002994 raw material Substances 0.000 claims abstract description 11
- 244000163122 Curcuma domestica Species 0.000 claims abstract description 9
- 238000002156 mixing Methods 0.000 claims abstract description 9
- 230000008569 process Effects 0.000 claims abstract description 9
- 229940069978 calcium supplement Drugs 0.000 claims abstract description 8
- 235000013305 food Nutrition 0.000 claims abstract description 8
- 244000061520 Angelica archangelica Species 0.000 claims abstract description 6
- 235000003392 Curcuma domestica Nutrition 0.000 claims abstract description 6
- 235000001287 Guettarda speciosa Nutrition 0.000 claims abstract description 6
- 235000008599 Poria cocos Nutrition 0.000 claims abstract description 6
- 244000185386 Thladiantha grosvenorii Species 0.000 claims abstract description 6
- 235000011171 Thladiantha grosvenorii Nutrition 0.000 claims abstract description 6
- 235000003373 curcuma longa Nutrition 0.000 claims abstract description 6
- 235000013976 turmeric Nutrition 0.000 claims abstract description 6
- 235000017784 Mespilus germanica Nutrition 0.000 claims abstract description 5
- 244000182216 Mimusops elengi Species 0.000 claims abstract description 5
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- 235000007837 Vangueria infausta Nutrition 0.000 claims abstract description 5
- 239000000843 powder Substances 0.000 claims abstract description 5
- 244000241838 Lycium barbarum Species 0.000 claims abstract description 4
- 235000015459 Lycium barbarum Nutrition 0.000 claims abstract description 4
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- 208000001132 Osteoporosis Diseases 0.000 description 4
- 244000197580 Poria cocos Species 0.000 description 4
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- QYSXJUFSXHHAJI-XFEUOLMDSA-N Vitamin D3 Natural products C1(/[C@@H]2CC[C@@H]([C@]2(CCC1)C)[C@H](C)CCCC(C)C)=C/C=C1\C[C@@H](O)CCC1=C QYSXJUFSXHHAJI-XFEUOLMDSA-N 0.000 description 4
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- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 description 3
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- 206010003694 Atrophy Diseases 0.000 description 1
- UXVMQQNJUSDDNG-UHFFFAOYSA-L Calcium chloride Chemical compound [Cl-].[Cl-].[Ca+2] UXVMQQNJUSDDNG-UHFFFAOYSA-L 0.000 description 1
- 208000024172 Cardiovascular disease Diseases 0.000 description 1
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 description 1
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 description 1
- FBPFZTCFMRRESA-JGWLITMVSA-N D-glucitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-JGWLITMVSA-N 0.000 description 1
- 208000007530 Essential hypertension Diseases 0.000 description 1
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 description 1
- 208000001953 Hypotension Diseases 0.000 description 1
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- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 description 1
- 235000013361 beverage Nutrition 0.000 description 1
- 210000000988 bone and bone Anatomy 0.000 description 1
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- 229940067606 lecithin Drugs 0.000 description 1
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- SHUZOJHMOBOZST-UHFFFAOYSA-N phylloquinone Natural products CC(C)CCCCC(C)CCC(C)CCCC(=CCC1=C(C)C(=O)c2ccccc2C1=O)C SHUZOJHMOBOZST-UHFFFAOYSA-N 0.000 description 1
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- 239000000600 sorbitol Substances 0.000 description 1
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- 230000009466 transformation Effects 0.000 description 1
- QORWJWZARLRLPR-UHFFFAOYSA-H tricalcium bis(phosphate) Chemical compound [Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O QORWJWZARLRLPR-UHFFFAOYSA-H 0.000 description 1
- 238000010200 validation analysis Methods 0.000 description 1
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- 229940046010 vitamin k Drugs 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
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- A61K36/18—Magnoliophyta (angiosperms)
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- A61K36/81—Solanaceae (Potato family), e.g. tobacco, nightshade, tomato, belladonna, capsicum or jimsonweed
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/06—Fungi, e.g. yeasts
- A61K36/07—Basidiomycota, e.g. Cryptococcus
- A61K36/076—Poria
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- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
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- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
- A61K36/232—Angelica
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/42—Cucurbitaceae (Cucumber family)
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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/896—Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
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- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
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Abstract
本发明针对老年人补钙难题,利用生命大数据确定老年人缺钙的核心基因靶点,再利用网络药理大数据筛选获得可用于老年人补钙的药食同源植物组方,由以下质量份数的原料制成:枸杞子5‑30份、黄精5‑30份、当归3‑25份、姜黄2‑20份、茯苓3‑35份,罗汉果5‑40份,配合含400‑800mg钙的食品原料按如下方法进行制备:S1将黄精、当归、茯苓、姜黄、罗汉果进行超微粉碎,破壁后进行功能组份提取;S2提取液经离心分离取上清;S3上清液浓缩后与钙原料、枸杞子的超微粉混合;S4造粒,除菌,按标准压片工艺制备老年人专用钙片。该钙片按生命大数据设计,以药食同源植物原料制备,方法简单。
Description
技术领域
本发明涉及一种老年人专用钙片及其制备方法。
背景技术
随着年龄增加,老年人脏器萎缩、器官机能减退尤其是消化吸收、代谢、排泄;骨骼中无机盐含量增加,而钙含量减少;骨骼的弹性和韧性減低,脆性增加。故老年人易出现骨质疏松症,极易发生骨折。
目前老年人补钙最常用的方法是服用补钙产品。但当下的补钙产品都是单纯增加外源钙(或加入维生素D),都是就补钙而补钙,在未完全了解钙的吸收转化机制及老年人特殊生理特性的情况下单纯增加外源钙而忽略钙吸收的其他必要条件,导致钙的吸收量远远达不到钙的日需量,造成只补不吸收的局面。而且中国老年学学会缺钙委员会维生素D学科组专家委员会指出:“下述给药方法已证明无效,或无效和中毒的风险增加,因此不推荐使用活性维生素D 制剂” 【中国缺钙杂志2014年9月第20卷第9期】。
中国专利CN201210422523.6公开了一种钙制剂及其制备方法和用途,配方由钙盐、维生素D、维生素K、甘露醇和葡萄糖组成。中国专利CN200910082672.0公开了一种微乳钙制剂及其制备方法和应用,以微乳结构作为钙源的载体,配合使用维生素、卵磷脂、山梨醇使用。这些补钙产品只是单一从钙吸收角度设计,均未针对老年人生理特性及分子机制进行补钙,不能从根本上解决老年人的缺钙问题。没有从造成老年人骨质疏松的分子机制出发筛选最适宜的药物组方,缺乏科学性和有效性。
另外,食品安全国家标准《食品营养强化剂使用标准 》(GB 14880—2012 ) 规定的饮料中钙的添加量为160 mg/kg - 1350 mg/kg ,目前国内钙制剂相关液体食品的日食用量大约在100mL左右,按法律法规所限的钙添加量最高只有135 mg,远远达不到老年人每日钙摄入量1000-1300mg /天的要求,对老年人补钙的效果微乎其微,其他种类食品也存在此问题。
发明内容
针对老年人补钙的上述不足,本发明利用生命大数据确定老年人缺钙的核心基因靶点,再利用网络药理大数据筛选获得可用于老年人补钙的药食同源植物组方:枸杞子5-30份、黄精5-30份、当归3-25份、姜黄2-20份、茯苓3-35份,罗汉果5-40份,配合使用含400-800mg钙的食品原料,按如下方法进行制备:S1 将黄精、当归、茯苓、姜黄、罗汉果进行超微粉碎,破壁后进行功能组份提取;S2提取液经离心分离取上清;S3上清液浓缩后与钙原料、枸杞子的超微粉混合;S4造粒,除菌,按标准压片工艺制备老年人专用钙片。
优选地,搅拌浸提参数为:液料比为5-12、提取温度90℃-沸腾、提取时间0.5-2小时、提取次数1-2次。
优选地,提取液优选磷酸盐溶液,保证组分溶出体系的酸碱度稳定和提高钙吸收利用效率。
优选地,采用连续离心技术获得上清液,优选管式离心机进行。
优选地,钙是食品安全法中规定的含钙原料。
具体实施方式
下面将结合本发明实施例,对本发明实施例中的技术方案进行清楚、完整地描述。显然,所描述的实施例仅仅是本发明一部分实施例,而不是全部的实施例。基于本发明中的实施例,本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例,都属于本发明保护的范围。
实施例1
一种老年人专用钙片及其制备方法,具体步骤如下:S1将以下原料:枸杞子5份、黄精5份、当归3份、姜黄2份、茯苓3份,罗汉果5份,进行超微粉碎后按比例混合;S2搅拌浸提,具体参数为:0.1M磷酸盐溶液(pH7.0),液料比5,提取温度90℃、提取时间0.5小时、提取次数2次,利用微波辅助提取技术加速溶出,提取使用管式离心机获取上清,转速16000 rpm取上清;S3上清液经真空浓缩后,与含400mg钙的碳酸钙原料、5份枸杞子微超粉进行混合;S4按标准造粒工艺进行造粒,无菌处理后按压片标准工艺制备老年人专用钙片。
实施例2
一种老年人专用钙片及其制备方法,具体步骤如下:S1将以下原料:枸杞子30份、黄精30份、当归25份、姜黄20份、茯苓35份,罗汉果40份进行超微粉碎后按比例混合;S2搅拌浸提,具体参数为:0.2M磷酸盐溶液(pH7.0),液料比12,提取温度煮沸提取、提取时间2小时、提取次数1次,利用微波辅助提取技术加速溶出,提取使用管式离心机获取上清,转速16000rpm取上清;S3上清液经真空浓缩后,与含800mg钙的氯化钙原料微超粉、30份枸杞子进行混合;S4按标准造粒工艺进行造粒,无菌处理后按压片标准工艺制备老年人专用钙片。
实施例3
一种老年人专用钙片及其制备方法,具体步骤如下:S1将以下原料:黄精10份、当归10份、茯苓10份、枸杞子10份、姜黄10份、罗汉果10份进行超微粉碎后按比例混合;S2搅拌浸提,具体参数为:纯水提取,液料比5,提取温度90℃、提取时间1小时、提取次数2次,利用微波辅助提取技术加速溶出,提取使用管式离心机获取上清,转速16000 rpm取上清;S3上清液经真空浓缩后,与含600mg钙的碳酸钙和200mg钙的磷酸钙原料、枸杞子10份的微超粉进行混合;S4按标准造粒工艺进行造粒,无菌处理后按压片标准工艺制备老年人专用钙片。
临床验证
实施例1、实施例2、实施例3均按照以下方法进行临床验证:
(一)方法
1病例纳入标准
年龄50-80岁;自愿受试,按时服药,定期复诊。
2排除标准
年龄在50岁以下或80岁以上者;合并有肝肾、心脑血管和造血障碍等原发性疾病,精神病患者;原发性高血压,原发性低血压及慢性贫血者;近3个月内使用过性激素类药物者;未按规定服药,无法判定疗效者;资料不全等影响疗效或安全性判定者。
3临床验证
对老年人骨质疏松症病例进行统计,以单独服用某钙片为对照组,以服用实施例钙片的为验证组,各20例。服用方法:某钙片按照使用说明一日3次;本发明所述实施例钙片,2片/次,一日3次;连续服用3个月。
骨密度测量:分别于服用前和服用后(3个月后)采用双能 X 线骨密度测量仪,测定 各组患者腰椎 L2~4、左股骨颈 Wards 三角的骨密度。
统计学方法 采用SPSS 20.0 统计学软件进行数据分析,计量资料用 x±s 表示,比较采用 t 检验,计数资料比较采用 χ2 检验。P<0.05表示差异有统计学意义。
(二)验证结果
实施例1服用前后骨密度比较(g/cm3,Mean±SD)
实施例2服用前后骨密度比较(g/cm3,Mean±SD)
实施例3服用前后骨密度比较(g/cm3,Mean±SD)
临床验证结果表明:对照组和验证组在服用 3个月后腰椎、股骨颈的骨密度均有不同程度的提升。各实施例验证组骨密度提高水平高于对照组,说明本发明实施例所述钙片对于缓解老年人骨质疏松的效果优于对照组。
本发明中包括上述本发明说明书的发明内容和具体实施方式部分的任意组合,限于篇幅并为使说明书简明而没有将这些组合构成的各方案全部进行描述。凡在本发明的精神和原则之内,所做的任何修改、等同替换、改进等,均应包含在本发明的保护范围之内。
Claims (6)
1.一种老年人专用钙片及其制备方法,其特征在于,配方的质量份数比为:枸杞子5-30份、黄精5-30份、当归3-25份、姜黄2-20份、茯苓3-35份,罗汉果5-40份,配合含400-800mg钙的食品原料按如下方法进行制备:S1 将黄精、当归、茯苓、姜黄、罗汉果进行超微粉碎,破壁后进行功能组份提取;S2提取液经离心分离取上清;S3上清液浓缩后与钙原料、枸杞子的超微粉混合;S4造粒,除菌,按标准压片工艺制备老年人专用钙片。
2.根据权利要求1所述的老年人专用钙片及其制备方法,其特征在于,搅拌浸提参数为:液料比为5-12、提取温度90℃-沸腾、提取时间0.5-2小时、提取次数1-2次。
3.根据权利要求1所述的老年人专用钙片及其制备方法,其特征在于,提取液优选磷酸盐溶液,保证组分溶出体系的酸碱度稳定和提高钙吸收利用效率。
4.根据权利要求1所述的老年人专用钙片及其制备方法,其特征在于,采用连续离心技术获得上清液,优选管式离心机进行。
5.根据权利要求1所述的老年人专用钙片及其制备方法,其特征在于,钙是食品安全法中规定的含钙原料。
6.保护以上方法制备的老年人专用钙片及在老年人补钙中的应用。
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