CN104784206B - A kind of Muhivitamin Formula With Minerals dispersible tablet - Google Patents
A kind of Muhivitamin Formula With Minerals dispersible tablet Download PDFInfo
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- CN104784206B CN104784206B CN201510114483.2A CN201510114483A CN104784206B CN 104784206 B CN104784206 B CN 104784206B CN 201510114483 A CN201510114483 A CN 201510114483A CN 104784206 B CN104784206 B CN 104784206B
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- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Coloring Foods And Improving Nutritive Qualities (AREA)
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Abstract
The invention discloses a kind of Muhivitamin Formula With Minerals dispersible tablet, the present invention redesigns by prescription and filters out auxiliary material optimum amount, using advanced dry granulation, compressing tablet, film coating piece production technology, keeps various vitamin contents constant, domestic advanced tablet formulation is prepared into, compared with ordinary tablet：It is more easy to dissolution in vivo, insoluble drug release and is absorbed by the body；Dispersing uniformity is added, product can be leached in 3 minutes and by No. 2 sieves；And using the dissolution rate of the vitamins such as every vitamin B1 of high performance liquid chromatography micrometric measurement, vitamin B2, niacinamide, more than the 98% of labelled amount is, and ordinary tablet qualitative detection disintegration time limited is less than 30 minutes, product quality is significantly improved.And cooperate with and use in the treatment of stomach cancer, can relief of symptoms, enhancing immunity of organisms.
Description
Technical field
The invention belongs to health medicine technical field, more particularly to a kind of Muhivitamin Formula With Minerals dispersible tablet and preparation method thereof.
Background technology
With the improvement of people ' s living standards with the enhancing of health care consciousness, and people's eating habit and dietary structure change
Change, such as fat, too high refined sugar intake, vegetables and fruit intake deficiency, imbalance diet cause certain that people take in
Nutrient is planted to lack.Quite a few crowd is accustomed to daily some nutritious supplementary pharmaceuticals.Nutrient prime replenisher is to supplement people
For the purpose of nutrient needed for body, the nutrient extracted by one or several kinds through chemical synthesis or from natural animal-plant is raw material system
Into product.It is nutrient supplement with the Muhivitamin Formula With Minerals class nutritious supplementary pharmaceutical of vitamin and trace element supplement for main purpose
The important kind of agent.Multivitamin and minerals tablet (multivitamin tablet) is various vitamins, mineral matter according to the synthesis of doses ratio
Composite dosage form, in vitamin, mineral matter containing the daily Minimum requirements amount of human body largely or entirely.Its main application bag
Including medical application (being used to prevent vitamin, mineral deficiency caused by meals are uneven) and sport-utility (is used for pre- minister of defense
Time moves or the caused vitamin of training, mineral matter missing).B B-complex various brands content is different, in its application
In it has also been found that, except use as nutritious supplementary pharmaceutical in addition to, can also produce and act synergistically with other class medicines, the more preferable curative effect of performance.
Such as multivitamin and minerals tablet, compound Zinc glycyrrhetate granules treatment recurrent oral ulceration, preferable clinical efficacy is achieved.
Because multivitamin and minerals tablet principal component is more, part main ingredient is unstable under the conditions of hot, wet, thus prepare release it is rapid and
Stable tablet has larger difficulty.Dry granulation is that powder material is directly prepared into the graininess production for meeting user's requirement
Bulk density is dramatically increased after product, granulation, be can reach and not only control pollution but also reduce powder waste, improves material outward appearance and flowing
Property, it is easy to store and transports, can control the purposes such as solubility, porosity and specific surface area.Dry granulation process technology is a lot
Aspect has some superiority compared with wet granulation technology, while the consumption of auxiliary material in production prescription can be adjusted suitably, therefore applies wide.
Compressing dry granulation is exactly that the particle of dry granulation is carried out into compressing tablet, is usually used in heat sensitive material, meets the labile medicine of water,
Method is simple, saving of work and time.Dry granulation compressing tablet preparation technology compared with wet granule compression tablet preparation technology, with low cost,
Technique is simple, it is easy to operate the features such as, be conducive to the serialization and automation of tablet manufacturing, suitably to damp and hot unstable medicine,
With vast potential for future development.
The present inventor, which is intended to redesign by prescription, filters out auxiliary material optimum amount, using advanced dry granulation, pressure
Piece, film coating piece production technology, keep various vitamin contents constant, are prepared into domestic advanced tablet formulation, and general
Logical multivitamin and minerals tablet is compared：It is more easy to dissolution in vivo, insoluble drug release and is absorbed by the body, and in the treatment of stomach cancer, there is association
With the effect of strengthen immunity.
The content of the invention
The purpose of the present invention can be achieved through the following technical solutions：
The present invention adjusts each component content so that quality is significantly improved, and it is easily molten in vivo using brand-new advanced formulation
Go out, insoluble drug release and be absorbed by the body, and in the treatment of stomach cancer, there is the effect for coordinating strengthen immunity.The present invention's is more
The non-prescribed medicine that dimension element dispersible tablet is made up of 21 kinds of vitamins and mineral matter class, for preventing and treating because of vitamin and ore deposit
Various diseases caused by material want.Vitamin is the special body eubolism of dimension and healthy essential with mineral matter
Important substance, the two is the important composition for constituting a variety of coenzyme and hormone, and dysbolism can be caused during shortage and is led to a variety of
Disease.Suitable for each age group, crowd uses, convenient to take, drug safety.
The present invention redesigns by prescription on the basis of multivitamin and minerals tablet original prescription and filters out auxiliary material optimum amount, adopt
With advanced dry granulation, compressing tablet, film coating piece production technology, keep various vitamin contents constant, be prepared into domestic first
The tablet formulation entered, compared with ordinary tablet：It is more easy to dissolution in vivo, insoluble drug release and is absorbed by the body；Add scattered equal
Even property, product can be leached in 3 minutes and by No. 2 sieves；And every vitamin B1 of use high performance liquid chromatography micrometric measurement,
The dissolution rate of the vitamins such as vitamin B2, niacinamide, is more than the 98% of labelled amount, and during the disintegration of ordinary tablet qualitative detection
Limit is less than 30 minutes, and product quality is significantly improved.
Chitosan has amino, as unique oligosaccharides for carrying net positive charge in nature, with very unique life
Manage biochemical function.The physiological function of chitosan mainly has：Body's immunity, antitumor, antibacterial and bacteriostasis, row are improved comprehensively
Removing heavy metals ion, reducing blood lipid, conciliation blood glucose, regulation blood pressure, promotion intestinal beneficial flora propagation, improve digestive function, conciliation
Acid-base value, maintains the acid-base balance of body, removes free radical, the activity of antioxidase is activated, so as to improve the anti-oxidant energy of lipid
Power, the healing ... for promoting fracture, etc..(being referred to as the key element of life the 6th).Chitosan is the oligosaccharides with amino, is referred to as
" amino-oligosaccharide (amino-oligosaccharin), as a kind of inducer of oligosaccharide kind (elicitor), can induce plant
The expression of thing defensin gene group, so as to improve disease-resistant crops ability, coordinate plant growth.(oligosaccharide is referred to as opening plant
The key of gene)
Chitosan is in medicine, and food is agriculture, and the numerous areas such as light industry has application prospect widely.Chitosan
Function and the degree of polymerization of chitosan (DP) are closely related:The many Physiology and biochemistries activity and the degree of polymerization distribution of chitosan of chitosan
Scope is closely related, such as in terms of strengthen immunity, has been reported that the chitosan that the degree of polymerization is 6-8 (or 4-7,5-7) has well
Antibacterial, strengthen immunity, antitumor activity, wherein six sugared [sugar (GlcNAc) 6 of chitin six and the sugar of shell six (GlcN) 6] are shown
Higher antitumor activity；In terms of disease resistance of plant is induced, have been reported that the chitosan that the degree of polymerization is 4-6 can regulate and control plant root nodule
The generation of bacterium, degree of polymerization 4-11 chitosan effectively can resist the ability of pathogenic microorganism by activated plant；In terms of blood glucose is adjusted,
There are some researches show the chitosan of molecular weight 1700 or so is adapted to the sugared patient of hyperlipemia, it is possible to decrease Xue Tang ﹑ improve oxidation resistance
Play a role in health care；In terms of bacteria resistance function, have been reported that the chitosan (3 sugar) of mean molecule quantity 610 has necessarily to raw milk
Fungistatic effect, the rear acidifying to Yoghourt serves obvious inhibitory action etc..Therefore the molecular weight and the degree of polymerization of chitosan divide
Cloth scope is the important indicator for reflecting chitosan product quality.
The present invention has verified specific formula and ratio by countless experiments, selection specified molecular weight and content
The chitosan of chitosan, especially 1300-1600 molecular weight, can prepare the excellent Muhivitamin Formula With Minerals dispersible tablet of index, it is not
Only there is physiological function, the dispersive property of dispersible tablet is had an effect on.And especially, cooperate with and use in curing gastric cancer, can be with
Significantly improve immunity.Generally, it is considered that the degree of polymerization has strengthen immunity, antitumor work for 6-8 (or 4-7,5-7) chitosan
Property, but inventors have surprisingly discovered that, the chitosan of 1300-1600 molecular weight water solubles, effect preferably, is disintegrated in the component
Degree, dissolution rate, raising immunity effect is all fine, and effect is better than degree of polymerization 6-8's on the contrary.
Technical solution of the present invention is as follows：
A kind of preparation method of Muhivitamin Formula With Minerals dispersible tablet：
(1) raw material is prepared：
The raw material is prepared into 1000；
(2) particle is prepared：Above-mentioned raw materials are divided into A, B, C material, A, B, C material use dry granulating machine after being pre-mixed respectively
Particle is made, then by A, B, C material particle addition magnesium stearate, PVP K30, PVPP are well mixed to pelletize；
The A expects：Vitamine A acetate powder, vitamin E powder, vitamine D3, vitamin B2, vitamin B12, dimension life
Plain B1, vitamin B6, magnesia, potassium sulfate, manganese sulfate, zinc oxide, calcium monohydrogen phosphate, microcrystalline cellulose 13-20g, pregelatinated form sediment
Powder, low-substituted hydroxypropyl cellulose, carboxyrnethyl starch sodium, PVP K30；
The B expects：Vitamin C, niacinamide, lipotropin, lysine hydrochloride, calcium pantothenate, inositol, phosphoric acid hydrogen
Calcium, water soluble chitosan, microcrystalline cellulose, pregelatinized starch, low-substituted hydroxypropyl cellulose, carboxyrnethyl starch sodium, PVP
K30；
The C expects：KI, cupric oxide, ferrous fumarate, microcrystalline cellulose, pregelatinized starch, carboxyrnethyl starch sodium,
PVP K30；
The technique of the dry granulating machine is：Nip pressure 60-80bar, roll rotational speed 45-50r/min, material transmission speed
Spend for 10-20r/min；
(3) compressing tablet：Qualified particle carries out compressing tablet on request；
(4) coating：From water-soluble coating material Ka Lekang Opadry Y-1-7000, coating solution mass fraction is
18%, using high-efficiency coating machine turnadle pan coating；
The molecular weight of the chitosan is 1300-1600；
It is coated control condition as follows：EAT is 60-70 DEG C, and atomizing pressure is 0.3-0.4MPa, and spouting velocity is
160g/mL, is coated to obtained label, increases quality 2-3%
The multivitamin and minerals tablet of the present invention, has had surprisingly been found that and has aided in using in the treatment of stomach cancer, can help to alleviate
Symptom, improves immunity of organisms.
The present invention is advantageous in that：
(1) many multivitamin and minerals tablets are had on the market, but most of disintegration times are long, dissolution rate is low, bioavilability
Not high, auxiliary material materials are more, unstable, and multivitamin and minerals tablet disintegration of the invention is fast, and product can be leached in 3 minutes and by No. 2
Sieve, dissolution rate is high, and bioavilability is high, and definite effect is stable.
(2) multivitamin and minerals tablet of the invention selects the chitosan of specified molecular weight, with synergy, not only improves and divides
The dispersive property of discrete piece, moreover it is possible in the treatment of stomach cancer, can alleviate its symptom, strengthen the effect of immunity of organisms.
(3) multivitamin and minerals tablet manufacture craft of the invention is simple, and quality is high, with good market prospects.
Embodiment
The unique component of composition is defaulted as using whole amount, and the component repeatedly occurred gives every time specific consumption.
Embodiment 1：
WP50N/75 type calenders are manufactured from German Alexanders Co. Ltd.；
The water soluble chitosan of the present embodiment is purchased from the red trade Co., Ltd of Guangzhou sheng, can also be according to prior art certainly
Prepared by row, the molecular weight of the chitosan is 1300-1600.
A kind of preparation method of Muhivitamin Formula With Minerals dispersible tablet：
Following raw materials are prepared into 1000；
Prepare particle：Above-mentioned raw materials are divided into A, B, C material, A, B, C material use non-slurry pelletizing mechanism after being pre-mixed respectively
Particle is obtained, then by A, B, C material particle addition magnesium stearate, PVP K30 6g, PVPP are well mixed to pelletize；
The A expects：Vitamine A acetate powder, vitamin E powder, vitamine D3, vitamin B2, vitamin B12, dimension life
Plain B1, vitamin B6, magnesia, potassium sulfate, manganese sulfate, zinc oxide, calcium monohydrogen phosphate, microcrystalline cellulose 13g, pregelatinized starch
20g, low-substituted hydroxypropyl cellulose 3g, carboxyrnethyl starch sodium 4g, PVP K30 7g；
The B expects：Vitamin C, niacinamide, lipotropin, lysine hydrochloride, calcium pantothenate, inositol, phosphoric acid hydrogen
Calcium, water soluble chitosan, microcrystalline cellulose 11g, pregelatinized starch 12g, low-substituted hydroxypropyl cellulose 2g, carboxyrnethyl starch sodium
3g, PVP K30 6g；
The C expects：KI, cupric oxide, ferrous fumarate, microcrystalline cellulose 11g, pregelatinized starch 18g, carboxylic first are formed sediment
Powder sodium 3g, PVP K30 6g；
The technique of the dry granulating machine is：Nip pressure 60-80bar, roll rotational speed 45-50r/min, material transmission speed
Spend for 10-20r/min；
Compressing tablet is carried out on request to qualified particle；
From water-soluble coating material Ka Lekang Opadry Y-1-7000, coating solution mass fraction is 18%, using height
Imitate seed-coating machine turnadle pan coating；It is coated control condition as follows：EAT is 70 DEG C, and atomizing pressure is 0.4MPa, spouting velocity
For 160g/mL, obtained label is coated, increases quality 3%.
Embodiment 2：
WP50N/75 type calenders are manufactured from German Alexanders Co. Ltd.；
The water soluble chitosan of the present embodiment is purchased from the red trade Co., Ltd of Guangzhou sheng, can also be according to prior art certainly
Prepared by row, the molecular weight of the chitosan is 1300-1600.
A kind of preparation method of Muhivitamin Formula With Minerals dispersible tablet：
Following raw materials are prepared into 1000；
Prepare particle：Above-mentioned raw materials are divided into A, B, C material, A, B, C material use non-slurry pelletizing mechanism after being pre-mixed respectively
Particle is obtained, then by A, B, C material particle addition magnesium stearate, PVP K30 7.25g, PVPP are well mixed to pelletize；
The A expects：Vitamine A acetate powder, vitamin E powder, vitamine D3, vitamin B2, vitamin B12, dimension life
Plain B1, vitamin B6, magnesia, potassium sulfate, manganese sulfate, zinc oxide, calcium monohydrogen phosphate, microcrystalline cellulose 14.5g, pregelatinized starch
20g, low-substituted hydroxypropyl cellulose 4g, carboxyrnethyl starch sodium 4.5g, PVP K30 8g；
The B expects：Vitamin C, niacinamide, lipotropin, lysine hydrochloride, calcium pantothenate, inositol, phosphoric acid hydrogen
Calcium, water soluble chitosan, microcrystalline cellulose 13g, pregelatinized starch 20g, low-substituted hydroxypropyl cellulose 4g, carboxyrnethyl starch sodium
3g, PVP K30 5g；
The C expects：KI, cupric oxide, ferrous fumarate, microcrystalline cellulose 11g, pregelatinized starch 20g, carboxylic first are formed sediment
Powder sodium 3g, PVP K30 5g；
The technique of the dry granulating machine is：Nip pressure 60-80bar, roll rotational speed 45-50r/min, material transmission speed
Spend for 10-20r/min；
Compressing tablet is carried out on request to qualified particle；
From water-soluble coating material Ka Lekang Opadry Y-1-7000, coating solution mass fraction is 18%, using height
Imitate seed-coating machine turnadle pan coating；It is coated control condition as follows：EAT is 60 DEG C, and atomizing pressure is 0.3MPa, spouting velocity
For 160g/mL, obtained label is coated, increases quality 2%.
Embodiment 3：
WP50N/75 type calenders are manufactured from German Alexanders Co. Ltd.；
The water soluble chitosan of the present embodiment is purchased from the red trade Co., Ltd of Guangzhou sheng, can also be according to prior art certainly
Prepared by row, the molecular weight of the chitosan is 1300-1600.
A kind of preparation method of Muhivitamin Formula With Minerals dispersible tablet：
Following raw materials are prepared into 1000；
Prepare particle：Above-mentioned raw materials are divided into A, B, C material, A, B, C material use non-slurry pelletizing mechanism after being pre-mixed respectively
Particle is obtained, then by A, B, C material particle addition magnesium stearate, PVP K30 5g, PVPP are well mixed to pelletize；
The A expects：Vitamine A acetate powder, vitamin E powder, vitamine D3, vitamin B2, vitamin B12, dimension life
Plain B1, vitamin B6, magnesia, potassium sulfate, manganese sulfate, zinc oxide, calcium monohydrogen phosphate, microcrystalline cellulose 15g, pregelatinized starch
20g, low-substituted hydroxypropyl cellulose 3g, carboxyrnethyl starch sodium 5g, PVP K30 5g；
The B expects：Vitamin C, niacinamide, lipotropin, lysine hydrochloride, calcium pantothenate, inositol, phosphoric acid hydrogen
Calcium, water soluble chitosan, microcrystalline cellulose 15g, pregelatinized starch 18g, low-substituted hydroxypropyl cellulose 3g, carboxyrnethyl starch sodium
5g, PVP K30 5g；
The C expects：KI, cupric oxide, ferrous fumarate, microcrystalline cellulose 15g, pregelatinized starch 17g, carboxylic first are formed sediment
Powder sodium 4g, PVP K30 5g；
The technique of the dry granulating machine is：Nip pressure 60-80bar, roll rotational speed 45-50r/min, material transmission speed
Spend for 10-20r/min；
Compressing tablet is carried out on request to qualified particle；
From water-soluble coating material Ka Lekang Opadry Y-1-7000, coating solution mass fraction is 18%, using height
Imitate seed-coating machine turnadle pan coating；It is coated control condition as follows：EAT is 65 DEG C, and atomizing pressure is 0.4MPa, spouting velocity
For 160g/mL, obtained label is coated, increases quality 3%.
Embodiment 4：
WP50N/75 type calenders are manufactured from German Alexanders Co. Ltd.；
The water soluble chitosan of the present embodiment is purchased from the red trade Co., Ltd of Guangzhou sheng, can also be according to prior art certainly
Prepared by row, the molecular weight of the chitosan is 1300-1600.
A kind of preparation method of Muhivitamin Formula With Minerals dispersible tablet：
Following raw materials are prepared into 1000；
Prepare particle：Above-mentioned raw materials are divided into A, B, C material, A, B, C material use non-slurry pelletizing mechanism after being pre-mixed respectively
Particle is obtained, then by A, B, C material particle addition magnesium stearate, PVP K30 2g, PVPP are well mixed to pelletize；
The A expects：Vitamine A acetate powder, vitamin E powder, vitamine D3, vitamin B2, vitamin B12, dimension life
Plain B1, vitamin B6, magnesia, potassium sulfate, manganese sulfate, zinc oxide, calcium monohydrogen phosphate, microcrystalline cellulose 22g, pregelatinized starch
18g, low-substituted hydroxypropyl cellulose 4g, carboxyrnethyl starch sodium 10g, PVP K30 3g；
The B expects：Vitamin C, niacinamide, lipotropin, lysine hydrochloride, calcium pantothenate, inositol, phosphoric acid hydrogen
Calcium, water soluble chitosan, microcrystalline cellulose 18g, pregelatinized starch 19g, low-substituted hydroxypropyl cellulose 3g, carboxyrnethyl starch sodium
8g, PVP K30 3g；
The C expects：KI, cupric oxide, ferrous fumarate, microcrystalline cellulose 15g, pregelatinized starch 20g, carboxylic first are formed sediment
Powder sodium 7g, PVP K30 2g；
The technique of the dry granulating machine is：Nip pressure 60-80bar, roll rotational speed 45-50r/min, material transmission speed
Spend for 10-20r/min；
Compressing tablet is carried out on request to qualified particle；
From water-soluble coating material Ka Lekang Opadry Y-1-7000, coating solution mass fraction is 18%, using height
Imitate seed-coating machine turnadle pan coating；It is coated control condition as follows：EAT is 61 DEG C, and atomizing pressure is 0.3MPa, spouting velocity
For 160g/mL, obtained label is coated, increases quality 3%.
Embodiment 5：
Contrast experiment：
WP50N/75 type calenders are manufactured from German Alexanders Co. Ltd.；
The water soluble chitosan of the present embodiment is purchased from the red trade Co., Ltd of Guangzhou sheng, can also be according to prior art certainly
Prepared by row, the molecular weight of the chitosan is 1300-1600.
Every 1000 auxiliary materials used are：
It is coated control condition as follows：EAT is 75 DEG C, and atomizing pressure is 0.5MPa, and spouting velocity is 180g/mL, right
Obtained label is coated, and increases quality 1.5%.
Other specification is and embodiment 1 is identical.
Embodiment 6：Effect is tested and assessed
(1) to the disintegration and hardness of embodiment 1-5 multivitamin and minerals tablet, dissolution rate, stability is measured, as a result such as
Shown in table 1.
Apparatus selection：LC-20AT high performance liquid chromatographs (Japanese Shimadzu), ZB-1B intelligent disintegration testers, 101A-5 types
Electric heating blast dry oven (Nanjing circle in the air dry refrigeration plant factory).
Table 1
Embodiment 1-4 product can be leached in 3 minutes and by No. 2 sieves, the contrast test disintegration rate of embodiment 5
For 8min, hence it is evident that be inferior to the disintegration rate of the present invention.
Under conditions of Packing Sound, 40 DEG C ± 2 DEG C are put, is placed 10 months under the conditions of the accelerated test of RH75% ± 5%,
Embodiment 1-4 disintegrations are unchanged, and the disintegration of embodiment 5 was become 20 minutes by 8 minutes, was remarkably decreased；Embodiment 1-5 collapses
After solution various vitamins relative to the percentage composition of labelled amount without significant change.
As can be seen here, this product disintegration is very fast, well beyond the 30min of the conventional multivitamin and minerals tablet of in the market, and
Dissolution rate is high, and stability is also greatly improved.Especially the disintegration rate of embodiment 2 is only 2 minutes, and dissolution rate is also all very high,
It is the preferred forms of the present invention.
Embodiment 1-4 effect is substantially better than the control experiment of embodiment 5, illustrates the selection of auxiliary material, the molecule of chitosan
Amount all serve unexpected synergy in the present invention, the ratio of each raw material is also very crucial, all can to result produce compared with
Big influence.It may determine that have when the molecular weight of chitosan is 1300-1600 in the preparation of the multidimensional piece and expect
Less than synergy.
(2) auxiliary treatment stomach cancer measure of merit：
The Muhivitamin Formula With Minerals dispersible tablet of the present invention can not only supplement necessary vitamin, moreover it is possible to adjust human immunity, in practice
Middle discovery has good effect to auxiliary treatment stomach cancer.
Stomach cancer is to current existing chemotherapeutics relative insensitivity, its offer limited effectiveness, and elder patients with gastric cancer is older,
Body tolerance is poor.The Muhivitamin Formula With Minerals dispersible tablet clinic of the present invention coordinates in chemotherapeutic treatment stomach cancer, is improving life in patients,
Good therapeutic effect is achieved in terms of raising immunity of organisms.Immunology Today research shows that generation, development and the treatment of tumour are equal
Closely related with immunosupress and immune deficiency, when body immune system imbalance or hypofunction, tumour growth exceedes immune
During monitoring control, tumour cell continued growth simultaneously forms tumour.Cellular immunity plays more important in body GVT
Effect, lymphocyte subgroup the immune response of body is regulated and controled and maintain it is immune it is stable play an important role, cell for it is immune should
Middle key reaction cell is answered, cell can produce cell mediated cytotoxicity to target cell, while having modulability to cell
Inhibitory action, ratio can directly reflect Immune Function state.Therefore detection peripheral blood cells subgroup is to understanding tumour place
Cellular immune function in main body plays an important role.Treatment neoplastic process in, strengthen body cellular immune function with directly
Killing tumor cell has identical important effect.
Sufferer 150 is selected, men and women distinguishes 78 and 72, met《Newest domestic surgery disease treatment standard》It is related
Standard, is diagnosed as stomach cancer, no significant difference between being randomly divided into 3 groups, 3 groups, with statistics comparativity.
Patient gives conventional improvement chemotherapy regimen.The multivitamin and minerals tablet of the present invention is given simultaneously by treatment group, and 2 tablets once, often
It is once continuously taken 2 months.Control group 1 only carries out chemotherapy, and control group 2 takes the multivitamin and minerals tablet of embodiment 5, and every time 2
Piece, once a day, continuously takes 2 months.
The detection of lymphocyte subgroup and natural killer cell activity is carried out before and after treatment using flow cytometry, observation is suffered from
The change of person's cellular immune function.Change to lymphocyte subgroup and cytoactive it has also been discovered that, the CD3 for the treatment of group,
CD4, CD8 are less than control group obviously higher than control group, NK.As a result it is as shown in table 2.
The change of the lymphocyte subgroup of table 2 and cytoactive
| Group | CD3 | CD4 | CD8 | NK (%) |
| Before control group 1 is treated | 62.9 | 42.8 | 35.3 | 22.8 |
| After control group 1 is treated | 52.3 | 32.2 | 49.5 | 18.1 |
| Before control group 2 is treated | 62.6 | 42.7 | 35.7 | 22.9 |
| After control group 2 is treated | 62.1 | 41.1 | 29.7 | 22.1 |
| Before treatment group's treatment | 62.8 | 43.5 | 34.8 | 22.4 |
| After treatment group's treatment | 69.5 | 48.1 | 25.3 | 28.5 |
This shows that the multivitamin and minerals tablet of the present invention in the chemotherapeutic treatment of stomach cancer, can significantly improve the immune response to body
Ability and its immune surveillance function, further improve immunity of organisms, have obvious prevention and repair the adverse reaction of chemotherapy.It is real
The control experiment of example 5 is applied, effect is significantly lower than embodiment 1-4 effect, this should be the component of the present invention, ratio, formula, work
Skill serves synergy, the especially selection to chitosan molecule amount and molecular weight distribution.
The foregoing is intended to be a preferred embodiment of the present invention, but protection scope of the present invention is not limited thereto,
Any one skilled in the art the invention discloses technical scope in, technique according to the invention scheme and its
Inventive concept is subject to equivalent or change, should all be included within the scope of the present invention.
Claims (3)
1. it is a kind of have collaboration strengthen immunity effect Muhivitamin Formula With Minerals dispersible tablet, it is characterised in that it is made up of following raw material：
The unit of vitamine A acetate powder 2,500,000, in terms of vitamin A
Vitamin E powder 5g
Vitamin B2 2.5g
Vitamin B12 0.5mg
Niacinamide 7.5g
Lipotropin 25g
Ferrous fumarate 5g, in terms of iron
Cupric oxide 0.5g, in terms of copper
Magnesia 0.5g, in terms of magnesium
KI 50mg, in terms of iodine
Lysine hydrochloride 12.5g
The unit of vitamine D3 200,000
Vitamin B1 2.5g
Vitamin B6 0.25g
Vitamin C 25g
Calcium pantothenate 2.5g
Inositol 25g
Potassium sulfate 5g, in terms of potassium
Manganese sulfate 0.5g, in terms of manganese
Zinc oxide 0.25g, in terms of zinc
Calcium monohydrogen phosphate 279g
Water soluble chitosan 5-8g
Pregelatinized starch 50-60g
Low-substituted hydroxypropyl cellulose 5-8g
Microcrystalline cellulose 35-55g
PVPP 8-10g
PVP K30 10-25.25g
Carboxyrnethyl starch sodium 10-25g
Magnesium stearate 2-5.21g
The molecular weight of the chitosan is 1300-1600；
The raw material is prepared into 1000.
2. it is a kind of have collaboration strengthen immunity effect Muhivitamin Formula With Minerals dispersible tablet preparation method, it is characterised in that its step is such as
Under：
（1）Prepare raw material：
The unit of vitamine A acetate powder 2,500,000, in terms of vitamin A
Vitamin E powder 5g
Vitamin B2 2.5g
Vitamin B12 0.5mg
Niacinamide 7.5g
Lipotropin 25g
Ferrous fumarate 5g, in terms of iron
Cupric oxide 0.5g, in terms of copper
Magnesia 0.5g, in terms of magnesium
KI 50mg, in terms of iodine
Lysine hydrochloride 12.5g
The unit of vitamine D3 200,000
Vitamin B1 2.5g
Vitamin B6 0.25g
Vitamin C 25g
Calcium pantothenate 2.5g
Inositol 25g
Potassium sulfate 5g, in terms of potassium
Manganese sulfate 0.5g, in terms of manganese
Zinc oxide 0.25g, in terms of zinc
Calcium monohydrogen phosphate 279g
Water soluble chitosan 5-8g
Pregelatinized starch 50-60g
Low-substituted hydroxypropyl cellulose 5-8g
Microcrystalline cellulose 35-55g
PVPP 8-10g
PVP K30 10-25.25g
Carboxyrnethyl starch sodium 10-25g
Magnesium stearate 2-5.21g
The raw material is prepared into 1000；
The molecular weight of the chitosan is 1300-1600；
（2）Prepare particle：Above-mentioned raw materials are divided into A, B, C material, A, B, C material are made after being pre-mixed respectively with dry granulating machine
Particle, then by A, B, C material particle addition magnesium stearate, PVP K30, PVPP are well mixed to pelletize；
The A expects：Vitamine A acetate powder, vitamin E powder, vitamine D3, vitamin B2, vitamin B12, vitamin B1,
Vitamin B6, magnesia, potassium sulfate, manganese sulfate, zinc oxide, calcium monohydrogen phosphate, microcrystalline cellulose, pregelatinized starch, low substitution hydroxyl
Propyl cellulose, carboxyrnethyl starch sodium, PVP K30；
The B expects：Vitamin C, niacinamide, lipotropin, lysine hydrochloride, calcium pantothenate, inositol, calcium monohydrogen phosphate, water
Soluble chitosan, microcrystalline cellulose, pregelatinized starch, low-substituted hydroxypropyl cellulose, carboxyrnethyl starch sodium, PVP K30；
The C expects：KI, cupric oxide, ferrous fumarate, microcrystalline cellulose, pregelatinized starch, carboxyrnethyl starch sodium, poly- dimension
Ketone K30；
The technique of the dry granulating machine is：Nip pressure 60-80 bar, roll rotational speed 45-50 r/min, material transfer rate
For 10-20r/min；
（3）Compressing tablet：Qualified particle carries out compressing tablet on request；
（4）Coating：From water-soluble coating material Ka Lekang Opadry Y-1-7000, coating solution mass fraction is 18%, is adopted
Use high-efficiency coating machine turnadle pan coating；
It is coated control condition as follows：EAT is 60-70 DEG C, and atomizing pressure is 0.3-0.4 MPa, and spouting velocity is 160
G/mL, is coated to obtained label, increases quality 2-3%.
3. the Muhivitamin Formula With Minerals dispersible tablet that the method described in claim 2 is prepared.
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Denomination of invention: A multidimensional element dispersion tablet Effective date of registration: 20231101 Granted publication date: 20170714 Pledgee: Zhejiang Deqing Rural Commercial Bank Co.,Ltd. Dixin Green Branch Pledgor: ZHEJIANG SUBKOM PHARMACEUTICAL CO.,LTD. Registration number: Y2023980063249 |
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