CN112353813A - Vitamin D and vitamin K soft capsules with good calcium supplementing effect - Google Patents

Vitamin D and vitamin K soft capsules with good calcium supplementing effect Download PDF

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Publication number
CN112353813A
CN112353813A CN202011434262.0A CN202011434262A CN112353813A CN 112353813 A CN112353813 A CN 112353813A CN 202011434262 A CN202011434262 A CN 202011434262A CN 112353813 A CN112353813 A CN 112353813A
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China
Prior art keywords
vitamin
calcium
parts
soft capsule
oil
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Pending
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CN202011434262.0A
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Chinese (zh)
Inventor
刘刚
乔德敏
孙王宁
钱琴莲
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Zhejiang Ailande Biotechnology Co ltd
Zhejiang Aland Biotechnology Co Ltd
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Zhejiang Ailande Biotechnology Co ltd
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Priority to CN202011434262.0A priority Critical patent/CN112353813A/en
Publication of CN112353813A publication Critical patent/CN112353813A/en
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61K33/10—Carbonates; Bicarbonates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/12—Ketones
    • A61K31/122—Ketones having the oxygen directly attached to a ring, e.g. quinones, vitamin K1, anthralin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/59—Compounds containing 9, 10- seco- cyclopenta[a]hydrophenanthrene ring systems
    • A61K31/593—9,10-Secocholestane derivatives, e.g. cholecalciferol, i.e. vitamin D3
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4816—Wall or shell material
    • A61K9/4825—Proteins, e.g. gelatin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4858—Organic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A61P19/10—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/20—Hypnotics; Sedatives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/12—Drugs for disorders of the metabolism for electrolyte homeostasis
    • A61P3/14—Drugs for disorders of the metabolism for electrolyte homeostasis for calcium homeostasis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/04—Immunostimulants

Abstract

The invention discloses a vitamin D and vitamin K soft capsule with a good calcium supplementing effect, which is prepared from the following raw materials in parts by weight: 60-70 parts of calcium carbonate; 30.1-2 parts of vitamin D; vitamin K21-3 parts; 20-30 parts of vegetable oil; 0.1-3 parts of phospholipid; the capsule material is 100 portions and 150 portions. The traditional calcium supplement needs to be accurately migrated to bones to supplement bones, and three major factors of the true calcium supplement of blood calcium are ignored: the first is an adequate source of calcium; secondly, vitamin D3 promotes good intestinal calcium absorption; thirdly, vitamin K2 is sufficient to play the role of leading calcium into bones. The soft capsule is prepared from calcium carbonate, vitamin D3 and vitamin K2, and has good synergistic effect and better calcium supplement effect. The calcium supplement soft capsule of the invention can promote calcium absorption, prevent pain of waist and legs of patients, and simultaneously play a role in improving sleep and regulating emotion.

Description

Vitamin D and vitamin K soft capsules with good calcium supplementing effect
Technical Field
The invention relates to the technical field of calcium supplements, in particular to a vitamin D and vitamin K soft capsule with good calcium supplement effect.
Background
Calcium is the most abundant inorganic salt in the human body, and accounts for about 2% of the body weight. Calcium is not only a main mineral component constituting bone tissues, but also plays an important role in various physiological and biochemical processes of the body, and the traditional way of supplementing calcium by food provides extremely limited calcium, and meanwhile, the calcium is eaten together with other foods to influence the absorption of the calcium. The calcium tablet and the capsule become the first choice for calcium supplement of consumers, while the soft capsule can better cover the bad smell, retain the activity of the effective components to the maximum extent, improve the quality and the curative effect of the medicine, and is more popular among consumers.
The traditional calcium supplement is to increase the intake of calcium and vitamin D. The traditional concept holds that the absorption of calcium in the intestinal tract is difficult, the key of calcium supplement is to improve the absorption efficiency of calcium in the intestinal tract, the intake of calcium and vitamin D is increased, and the improvement of blood calcium can prevent and treat osteoporosis of the middle-aged and the elderly people and promote healthy growth of children bones. However, this "old concept" neglects an important step, namely that the blood calcium needs to be precisely migrated to the bone to "replenish the bone", and the mere increase of the blood calcium cannot achieve "leading the calcium into the bone". In order to achieve a better calcium supplement effect, the invention provides a vitamin D and vitamin K soft capsule with a good calcium supplement effect.
Disclosure of Invention
Based on the technical problems in the background art, the invention provides a vitamin D and vitamin K soft capsule with good calcium supplement effect.
The technical scheme of the invention is as follows:
a vitamin D and vitamin K soft capsule with good calcium supplementing effect is composed of the following raw materials in parts by weight:
60-70 parts of calcium carbonate;
30.1-2 parts of vitamin D;
vitamin K21-3 parts;
20-30 parts of vegetable oil;
0.1-3 parts of phospholipid;
the capsule material is 100 portions and 150 portions.
Preferably, the vegetable oil is any one or combination of soybean oil, sunflower oil, olive oil, perilla oil, linseed oil, corn oil and palm oil.
Preferably, the phospholipid source is any one of soybean and sunflower seed.
Preferably, the calcium carbonate, the vitamin D3, the vitamin K2, the vegetable oil and the phospholipid are stored separately, and the storage environment is a constant temperature and humidity environment with the temperature of 0-25 ℃ and the R.H. of 0-65%, so that the raw materials can be stored for a long time.
Preferably, the capsule wall material is prepared from the following components in parts by weight (0.6-1.0): (0.4-0.6): (0.8-1.0) gelatin, glycerol and water.
A preparation method of vitamin D and vitamin K soft capsules with good calcium supplementing effect comprises the following steps:
A. pulverizing calcium carbonate, vitamin D3 and vitamin K2, mixing, adding vegetable oil, and grinding to obtain soft capsule liquid;
B. then adding phospholipid as emulsifier into the liquid medicine;
C. mixing gelatin, glycerol and water at a certain proportion to obtain capsule wall material; making into soft capsule according to the ratio of the medicinal liquid and capsule wall material.
Calcium carbonate contains calcium, which is an element essential to living beings. Ca is useful in human body in muscle, nerve, body fluid and bone2+A bound protein. Calcium is the main inorganic component of human bone and teeth, and is also involved in neurotransmission, muscle contraction, blood coagulation, hormone releaseAnd essential elements for milk secretion and the like. Calcium accounts for about 1.4% of the mass of a human body, participates in metabolism, and must be supplemented every day; the deficiency or excess of calcium in human body can affect growth and health.
Vitamin D3 can promote bone calcification by increasing calcium and phosphorus absorption in small intestine, vitamin D3 deficiency can cause calcium absorption and bone mineralization disorder, and can cause rickets, and children lack of sunlight for a long time are prone to poor bone growth due to insufficient bone calcification. If vitamin D3 is insufficient, the requirement of bone calcification can not be met by simply increasing the calcium in the food.
Vitamin K2 maintains bone health primarily through three aspects: (1) promoting carboxylation of osteocalcin. (2) Promoting osteoblast activity, and inhibiting osteoclast activity. (3) By inhibiting the proliferation of immune T cells in bones, an immunomodulatory effect is exerted. Among them, vitamin K2 is particularly important for promoting the carboxylation of osteocalcin. Osteocalcin is also called bone gamma-carboxyl glutamate protein, is a protein secreted by osteoblasts, and is a specific executor of 'leading calcium into bone'. It has no physiological activity when it is secreted, and must exert physiological action through an organic chemical reaction called carboxylation. Vitamin K2 is an essential enzyme involved in the whole reaction process. Osteocalcin can firmly 'grab' calcium salt only after carboxylation, promote calcium salt deposition and improve bone mineralization rate. Therefore, the vitamin K2 is very important for maintaining bone health and preventing and treating osteoporosis. If the body lacks vitamin K2, osteocalcin cannot form "calcium claws" as if the human hand had no thumb, the ability to grasp the bone is reduced and a large amount of calcium is lost from the bone, resulting in osteoporosis.
The invention has the advantages that: the traditional calcium supplement needs to be accurately migrated to bones to supplement bones, and three major factors of the true calcium supplement of blood calcium are ignored: the first is an adequate source of calcium; secondly, vitamin D3 promotes good intestinal calcium absorption; thirdly, vitamin K2 is sufficient to play the role of leading calcium into bones. Therefore, the 'accurate calcium supplement' can be realized well. The soft capsule is prepared from calcium carbonate, vitamin D3 and vitamin K2, and has good synergistic effect and better calcium supplement effect; is especially suitable for the elderly and children. The calcium supplement soft capsule of the invention can promote calcium absorption, prevent pain of waist and legs of patients, and simultaneously play a role in improving sleep and regulating emotion.
Detailed Description
The technical solution of the present invention will be further specifically described below by way of specific examples. It is to be understood that the practice of the invention is not limited to the following examples, and that any variations and/or modifications may be made thereto without departing from the scope of the invention.
In the present invention, all parts and percentages are by weight, unless otherwise specified, and the equipment and materials used are commercially available or commonly used in the art. The methods in the following examples are conventional in the art unless otherwise specified.
The reagents used in the following examples, unless otherwise specified, were purchased from conventional biochemical reagent stores.
Example 1
The vitamin D and vitamin K soft capsule with good calcium supplementing effect is prepared from the following raw materials in parts by weight:
65 parts of calcium carbonate;
30.5 parts of vitamin D;
21.5 parts of vitamin K;
22 parts of vegetable oil;
1.8 parts of phospholipid;
120 parts of capsule wall material.
The vegetable oil is soybean oil.
The phospholipid source is soybean.
The calcium carbonate, the vitamin D3, the vitamin K2, the vegetable oil and the phospholipid are stored separately, and the storage environment is a constant temperature and humidity environment with the temperature of 0-25 ℃ and the R.H. of 0-65%.
The capsule wall material is prepared from the following components in parts by weight of 1.0: 0.4: 0.85 of gelatin, glycerol and water.
A preparation method of vitamin D and vitamin K soft capsules with good calcium supplementing effect comprises the following steps:
A. pulverizing calcium carbonate, vitamin D3 and vitamin K2, mixing, adding vegetable oil, and grinding to obtain soft capsule liquid;
B. then adding phospholipid as emulsifier into the liquid medicine;
C. mixing gelatin, glycerol and water at a certain proportion to obtain capsule wall material; making into soft capsule according to the ratio of the medicinal liquid and capsule wall material.
Example 2
The vitamin D and vitamin K soft capsule with good calcium supplementing effect is prepared from the following raw materials in parts by weight:
70 parts of calcium carbonate;
30.1 parts of vitamin D;
23 parts of vitamin K;
20 parts of vegetable oil;
3 parts of phospholipid;
100 parts of capsule wall material.
The vegetable oil is sunflower seed oil.
The phospholipid source is sunflower seeds.
The calcium carbonate, the vitamin D3, the vitamin K2, the vegetable oil and the phospholipid are stored separately, and the storage environment is a constant temperature and humidity environment with the temperature of 0-25 ℃ and the R.H. of 0-65%.
The capsule wall material is prepared from the following components in parts by weight of 1.0: 0.4: 0.85 of gelatin, glycerol and water.
A preparation method of vitamin D and vitamin K soft capsules with good calcium supplementing effect comprises the following steps:
A. pulverizing calcium carbonate, vitamin D3 and vitamin K2, mixing, adding vegetable oil, and grinding to obtain soft capsule liquid;
B. then adding phospholipid as emulsifier into the liquid medicine;
C. mixing gelatin, glycerol and water at a certain proportion to obtain capsule wall material; making into soft capsule according to the ratio of the medicinal liquid and capsule wall material.
Example 3
A vitamin D and vitamin K soft capsule with good calcium supplementing effect is composed of the following raw materials in parts by weight:
60 parts of calcium carbonate;
32 parts of vitamin D;
21 parts of vitamin K;
30 parts of vegetable oil;
0.1 part of phospholipid;
150 parts of capsule wall material.
The vegetable oil is a combination of olive oil, perilla seed oil, linseed oil, corn oil and palm oil in a weight ratio of 1:1:1:1: 1.
The phospholipid source is a combination of soybean and sunflower seeds in a weight ratio of 3: 1.
The calcium carbonate, the vitamin D3, the vitamin K2, the vegetable oil and the phospholipid are stored separately, and the storage environment is a constant temperature and humidity environment with the temperature of 0-25 ℃ and the R.H. of 0-65%.
The capsule wall material comprises the following components in parts by weight: 0.4: 0.85 of gelatin, glycerol and water.
The preparation method of the vitamin D and vitamin K soft capsule with good calcium supplementing effect comprises the following steps:
A. pulverizing calcium carbonate, vitamin D3 and vitamin K2, mixing, adding vegetable oil, and grinding to obtain soft capsule liquid;
B. then adding phospholipid as emulsifier into the liquid medicine;
C. mixing gelatin, glycerol and water at a certain proportion to obtain capsule wall material; making into soft capsule according to the ratio of the medicinal liquid and capsule wall material.
Comparative example 1
The vitamin D3 in example 1 was removed, and the rest of the formulation and preparation method were unchanged.
Comparative example 2
The vitamin K2 in example 1 was removed, and the rest of the formulation and preparation method were unchanged.
The calcium supplement function of the calcium supplement composition is described in the following animal test.
80 SPF-grade SD female rats with the weight of 300-320g are selected. 70 were taken for ovariectomy and 10 remaining were sham operated. After 5 days of ovariectomy, examination of vaginal pictures was performed to confirm complete ovariectomy in the rats. 70 rats subjected to ovariectomy were randomly divided into 7 groups of 10 rats each, which were the example 1-3 groups, the comparative example 1-2 groups, the model group and the control group, respectively. The sham-operated 10 rats were set as the sham-operated group. Wherein, the sham operation group and the model group are both filled with distilled water by intragastric administration, the soft capsules prepared in the examples 1 to 3 and the comparative examples 1 to 4 are respectively filled with intragastric administration for 2 times a day, and the intragastric administration dosage is 2 g/kg. The control group is administered with a capsule for increasing bone density of WEIGUKANG sold in market by intragastric administration at a dosage of 2g/kg for 2 times per day. Each group of rats was gavaged continuously for 90 days. The density of the femoral bone is measured by adopting a DPX-L dual-energy X-ray bone densitometer, and the calcium content of the femoral bone is measured by adopting an atomic absorption spectrophotometry. The results are shown in Table 1 below.
TABLE 1
Femoral bone density (g/m)2） Bone calcium content (g/g)
Artificial operation group 0.277±0.015 0.225±0.013
Model set 0.235±0.010 0.176±0.010
Control group 0.252±0.012 0.192±0.011
EXAMPLE 1 group 0.281±0.011 0.243±0.012
EXAMPLE 2 group 0.285±0.012 0.248±0.013
EXAMPLE 3 group 0.283±0.012 0.244±0.012
Comparative example 1 group 0.250±0.012 0.197±0.010
Comparative example 2 group 0.248±0.014 0.204±0.012
As can be seen from Table 1, the calcium supplement effect of the soft capsules prepared in examples 1 to 3 is significantly better than the therapeutic effect of the commercially available Weigukang capsules for increasing bone density.
The above description is only for the preferred embodiment of the present invention, but the scope of the present invention is not limited thereto, and any person skilled in the art should be considered to be within the technical scope of the present invention, and the technical solutions and the inventive concepts thereof according to the present invention should be equivalent or changed within the scope of the present invention.

Claims (6)

1. The vitamin D and vitamin K soft capsule with good calcium supplementing effect is characterized by comprising the following raw materials in parts by weight:
60-70 parts of calcium carbonate;
30.1-2 parts of vitamin D;
vitamin K21-3 parts;
20-30 parts of vegetable oil;
0.1-3 parts of phospholipid;
the capsule material is 100 portions and 150 portions.
2. The vitamin D and vitamin K soft capsule with good calcium supplement effect according to claim 1, wherein the vegetable oil is one or more of soybean oil, sunflower seed oil, olive oil, perilla seed oil, linseed oil, corn oil and palm oil.
3. The vitamin D and vitamin K soft capsule with good calcium supplementing effect according to claim 1, wherein the phospholipid source is any one of soybean and sunflower seed.
4. The vitamin D and vitamin K soft capsule with good calcium supplementing effect according to claim 1, wherein the calcium carbonate, the vitamin D3, the vitamin K2, the vegetable oil and the phospholipid are stored separately, and the storage environment is a constant temperature and humidity environment with 0-25 ℃ and 0-65% of R.H.
5. The vitamin D and vitamin K soft capsule with good calcium supplementing effect according to claim 1, wherein the capsule wall material is prepared from (0.6-1.0) by weight: (0.4-0.6): (0.8-1.0) gelatin, glycerol and water.
6. The vitamin D and vitamin K soft capsule having a good calcium supplement effect according to any one of claims 1 to 5, wherein the preparation method comprises the steps of:
A. pulverizing calcium carbonate, vitamin D3 and vitamin K2, mixing, adding vegetable oil, and grinding to obtain soft capsule liquid;
B. then adding phospholipid as emulsifier into the liquid medicine;
C. mixing gelatin, glycerol and water at a certain proportion to obtain capsule wall material; making into soft capsule according to the ratio of the medicinal liquid and capsule wall material.
CN202011434262.0A 2020-12-10 2020-12-10 Vitamin D and vitamin K soft capsules with good calcium supplementing effect Pending CN112353813A (en)

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Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113318093A (en) * 2021-06-22 2021-08-31 山东润德生物科技有限公司 Calcium supplement composition containing vitamin K2 and preparation method and application thereof
CN113694037A (en) * 2021-08-25 2021-11-26 南宁富莱欣生物科技有限公司 Soft capsule with high calcium content and preparation key technology
CN114767719A (en) * 2022-05-30 2022-07-22 北京朗迪制药有限公司 Medicinal composition for preventing and treating rickets and preparation method thereof
CN114832020A (en) * 2022-05-30 2022-08-02 北京朗迪制药有限公司 Pharmaceutical composition for preventing and treating child developmental disorder and preparation method thereof
CN115089618A (en) * 2022-05-30 2022-09-23 北京朗迪制药有限公司 A pharmaceutical composition for preventing and treating osteoporosis, and its preparation method
CN116617252A (en) * 2023-03-16 2023-08-22 贵州贵国康业健康产业有限公司 Vitamin D and vitamin K soft capsule

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US20030190369A1 (en) * 2002-04-09 2003-10-09 Lovett William E. Vitamin formulation for enhancing bone strength
WO2011152810A1 (en) * 2010-06-03 2011-12-08 Bilgic Mahmut Formulations comprising calcium, vitamin d and vitamin k for osteoporosis
CN106165905A (en) * 2016-07-07 2016-11-30 海南正康药业有限公司 A kind of calcium adds vitamine soft capsule and preparation method
CN108936687A (en) * 2018-08-08 2018-12-07 深圳极醇健康产业股份有限公司 A kind of soft capsule and preparation method thereof of replenishing vitamins KD calcium

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030190369A1 (en) * 2002-04-09 2003-10-09 Lovett William E. Vitamin formulation for enhancing bone strength
WO2011152810A1 (en) * 2010-06-03 2011-12-08 Bilgic Mahmut Formulations comprising calcium, vitamin d and vitamin k for osteoporosis
CN106165905A (en) * 2016-07-07 2016-11-30 海南正康药业有限公司 A kind of calcium adds vitamine soft capsule and preparation method
CN108936687A (en) * 2018-08-08 2018-12-07 深圳极醇健康产业股份有限公司 A kind of soft capsule and preparation method thereof of replenishing vitamins KD calcium

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113318093A (en) * 2021-06-22 2021-08-31 山东润德生物科技有限公司 Calcium supplement composition containing vitamin K2 and preparation method and application thereof
CN113318093B (en) * 2021-06-22 2022-04-12 山东润德生物科技有限公司 Calcium supplement composition containing vitamin K2 and preparation method and application thereof
CN113694037A (en) * 2021-08-25 2021-11-26 南宁富莱欣生物科技有限公司 Soft capsule with high calcium content and preparation key technology
CN114767719A (en) * 2022-05-30 2022-07-22 北京朗迪制药有限公司 Medicinal composition for preventing and treating rickets and preparation method thereof
CN114832020A (en) * 2022-05-30 2022-08-02 北京朗迪制药有限公司 Pharmaceutical composition for preventing and treating child developmental disorder and preparation method thereof
CN115089618A (en) * 2022-05-30 2022-09-23 北京朗迪制药有限公司 A pharmaceutical composition for preventing and treating osteoporosis, and its preparation method
CN115089618B (en) * 2022-05-30 2023-03-17 北京朗迪制药有限公司 A pharmaceutical composition for preventing and treating osteoporosis, and its preparation method
CN116617252A (en) * 2023-03-16 2023-08-22 贵州贵国康业健康产业有限公司 Vitamin D and vitamin K soft capsule

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