CN114617266A - Multivitamin composition for Parkinson disease patients and application thereof - Google Patents

Multivitamin composition for Parkinson disease patients and application thereof Download PDF

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CN114617266A
CN114617266A CN202210354516.0A CN202210354516A CN114617266A CN 114617266 A CN114617266 A CN 114617266A CN 202210354516 A CN202210354516 A CN 202210354516A CN 114617266 A CN114617266 A CN 114617266A
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vitamin
calcium
composition
parkinson
essence
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艾立
冯浩
王孝广
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Suzhou Lanming Medical Technology Co ltd
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Abstract

According to the nutrient deficiency characteristics of target people of Parkinson patients, vitamins with synergistic functions are screened for scientific composition, accurate nutrition supplement is implemented, and the composition comprises 310-50 parts of vitamin B; 62-10 parts of vitamin B; 120.005-0.05 parts of vitamin B; 20-150 parts of vitamin E; 100-1000 parts of calcium. The vitamin B3, the vitamin B6, the vitamin B12 and the vitamin E are supplemented in a targeted manner, and the action effect is obviously stronger than that of the components singly or jointly. The composition of the present invention is not only simple in supplementing nutrition, but also capable of improving motor dysfunction of Parkinson's disease and protecting nervous system from damage by oxidation.

Description

Multivitamin composition for Parkinson disease patients and application thereof
Technical Field
The invention relates to the field of medicines, in particular to a multivitamin composition for a Parkinson disease patient and application thereof.
Background
Parkinson's Disease (PD) is a common nervous system degenerative disease of middle-aged and elderly people, and is mainly characterized by pathological changes of progressive degeneration of dopaminergic neurons in the substantia nigra and formation of lewy bodies, biochemical changes of dopamine transmitter reduction in striatum regions and imbalance of dopamine and acetylcholine transmitter, and clinical manifestations of non-motor symptoms such as tremor, myotonia, bradykinesia, dyskinesia of postural equilibrium, dyssomnia, olfactory disorder, autonomic nerve dysfunction, cognitive and mental disorders.
Epidemiological investigation research shows that the prevalence rate of people over 65 years old in China is 1.7 percent, which is similar to that of European and American countries. China is the most populated country in the world, and the number of Parkinson disease patients in China will rise from 199 thousands in 2005 to 500 thousands in 2030 years in the future, and almost accounts for half of the number of Parkinson disease patients in the world. As the disease progresses, motor and non-motor symptoms of parkinson's disease become increasingly severe.
Both parkinson's disease and levodopa-related formulations using gold standard therapy tend to result in vitamin B6, vitamin B12 deficiencies. In addition, vitamin B3 deficiency is also common in many parkinson's disease patients.
At present, no medicine or nutritional supplement or health food which is used for implementing accurate nutritional supplement for people with Parkinson's disease and has certain treatment and/or alleviation effects on motor dysfunction of Parkinson's disease and damage caused by oxidation of nervous system exists.
Disclosure of Invention
The invention provides a nutrient composition, which consists of multipurpose vitamins, trace elements and edible auxiliary materials, can be used for accurately supplementing nutrition for people suffering from Parkinson's disease and has a certain treatment and/or alleviation effect.
The technical scheme of the invention is as follows:
the first purpose of the invention is to provide a composition, which comprises the following raw materials in parts by weight:
Figure BDA0003582265950000011
further, the composition comprises the following raw materials in parts by weight:
Figure BDA0003582265950000021
further, vitamin B3 is selected from nicotinic acid or nicotinamide.
Further, vitamin B6 is selected from pyridoxine hydrochloride.
Further, vitamin B12 is selected from substances capable of releasing/generating cobalamins in vivo; preferably, the vitamin B12 is selected from cobalamin or derivatives thereof; further preferably, the vitamin B12 is selected from cobalamin, methylcobalamin, 5-deoxyadenosylcobalamin, hydroxocobalamin, cyanocobalamin or derivatives of other cobalamins.
Further, the vitamin E is selected from natural vitamin E or dl-alpha-tocopherol acetate, dl-alpha-tocopherol, and vitamin E calcium succinate; further, the natural vitamin E is selected from D-tocopherol, D-tocopheryl acetate and D-alpha-tocopheryl succinate.
Further, the calcium is selected from calcium carbonate, calcium acetate, calcium chloride, calcium citrate, calcium gluconate, calcium lactate, calcium hydrogen phosphate, calcium dihydrogen phosphate, tricalcium phosphate, calcium sulfate, L-calcium lactate, calcium glycerophosphate, and calcium citrate malate.
Further, the composition further comprises other vitamins or trace elements, such as iron, zinc, selenium, vitamin A, vitamin D3, vitamin B1, vitamin B2, folic acid, biotin, pantothenic acid, etc.
The second purpose of the invention is to provide an oral preparation, which comprises the composition and pharmaceutically acceptable auxiliary materials.
Furthermore, the dosage form of the oral preparation of calcium is common tablets, chewable tablets, soft capsules, hard capsules, powder, effervescent tablets, pills, powder, oral liquid, sustained-release and controlled-release preparations or granules.
In the invention, the pharmaceutically acceptable auxiliary materials are selected from one or a combination of more of a filling agent (dispersing agent), a suspending agent, a wetting agent, an adhesive, a disintegrating agent, a lubricating agent, a flavoring agent, a stabilizing agent, an embedding substance, a coating premix and an edible pigment.
The filler (dispersing agent) comprises one or more of starch, soluble starch, dextrin, maltodextrin, potato starch, corn starch, wheat starch, D-mannitol, calcium hydrogen phosphate, anhydrous calcium hydrogen phosphate, maltose, xylitol, sorbitol, microcrystalline cellulose, isomaltulose, milk powder, low-substituted hydroxypropyl cellulose, sucrose, glucose, lactose, pregelatinized starch, edible vegetable oil polyethylene glycol and the like.
The suspending agent comprises one or more of beeswax, insect wax, lecithin, glyceryl monostearate, ethyl cellulose and the like, the wetting agent comprises purified water and ethanol, and the adhesive comprises one or more of hydroxypropyl methyl cellulose povidone, hydroxypropyl cellulose, sodium carboxymethyl cellulose, starch, methyl cellulose, ethyl cellulose, gelatin, polyethylene glycol, pregelatinized starch, sucrose, glucose and the like.
The adhesive is selected from one or more of povidone K30, starch slurry, cellulose, polyethylene glycol, polyvinyl alcohol, sucrose, liquid glucose, acrylic resin, corn starch, peach gum, maltitol and the like.
The disintegrant comprises one or more of starch, carboxymethyl starch sodium, crospovidone, croscarmellose sodium, low-substituted hydroxypropyl cellulose (such as hydroxypropyl methylcellulose E5), sodium bicarbonate and citric acid.
The lubricant comprises one or more of magnesium stearate, stearic acid, talcum powder, silicon dioxide, hydrogenated vegetable oil, polyethylene glycol, sodium dodecyl sulfate, glyceryl behenate, sodium stearyl fumarate and the like.
The flavoring agent comprises one or more of fruit powder edible essence, high sweetener, sour agent and the like, wherein the fruit powder comprises one or more of orange powder, lemon powder, cherry powder, apple powder, strawberry powder, kiwi fruit powder, orange powder, sea buckthorn fruit powder, green plum fruit powder, bitter fruit powder, mulberry fruit powder, hawthorn fruit powder, watermelon fruit powder, pineapple fruit powder, blueberry fruit powder, honey peach fruit powder, hami melon fruit powder, grape fruit powder, vanilla fruit powder, pomegranate fruit powder, rose fruit powder and the like.
The edible essence comprises one or more of vanilla essence, sweet orange essence, milk essence, apple essence, grape essence, strawberry essence, pineapple essence, juicy peach essence, Hami melon essence, lemon essence, cherry essence, sweet corn essence, banana essence, grape essence, rose essence, blackcurrant essence, green apple essence, mango essence, green mango essence, orange essence, fragrant orange essence, snow pear essence, strawberry essence, green plum essence, blueberry essence, waxberry essence, grapefruit essence, pineapple essence, guava essence, passion fruit essence, kiwi fruit essence, cherry essence, kiwi fruit essence, watermelon essence, papaya essence, Hami melon essence, durian essence, lychee essence, hawthorn essence, olive essence, mulberry essence and the like.
The high-power sweetener comprises sucralose, aspartame, mogroside, neotame and stevioside, the sour agent comprises citric acid, malic acid, lactic acid, tartaric acid and fumaric acid, the edible pigment comprises caramel color, gardenia yellow, curcumin, chlorophyll, capsicum orange, capsanthin, grape skin red, carmine and aluminum lake thereof, sunset yellow and aluminum lake thereof, brilliant blue and aluminum lake thereof, indigo blue and aluminum lake thereof, beet red, natural amaranth, gardenia blue, plant carbon black, iron oxide red, black bean red, quinoline yellow, lycopene, monascus red, yellow iron oxide, cocoa shell color, safflower yellow, monascus yellow and the like.
The stabilizing agent comprises dibutyl hydroxy toluene (BHT), Butyl Hydroxy Anisol (BHA) and vitamin C.
The embedding substance comprises one or more of beta-cyclodextrin, alpha-cyclodextrin, gamma-cyclodextrin, dextrin, starch, edible modified starch, sucrose, maltodextrin, gum arabic and the like.
The preservative comprises one or more of p-hydroxybenzoate, benzoic acid and salt, potassium sorbate, sodium diacetate, streptococcus lactis, natamycin and the like.
The third purpose of the invention is to provide the application of the composition or the oral preparation in preparing medicines or nutritional supplements or health-care foods for treating and/or relieving motor dysfunction caused by Parkinson's disease and/or treating and/or relieving oxidative damage to the nervous system caused by Parkinson's disease.
The method comprises the following steps:
the application of the composition or the oral preparation in preparing medicines or nutritional supplements or health-care foods for treating and/or relieving motor dysfunction caused by Parkinson's disease.
Application of composition or oral preparation in preparation of medicine or nutritional supplement or health food for treating and/or relieving oxidative damage of nervous system caused by Parkinson's disease
The use of the aforementioned composition or the aforementioned oral preparation in the manufacture of a medicament or nutritional supplement or health food for the treatment and/or alleviation of motor dysfunction and the treatment and/or alleviation of oxidative damage to the nervous system caused by parkinson's disease.
Compared with the prior art, the technical scheme of the invention has the following beneficial effects:
both parkinson's disease and levodopa-related formulations using gold standard therapy tend to result in vitamin B6, vitamin B12 deficiencies. In addition, vitamin B3 deficiency is also common in many parkinson's disease patients. In the aspect of age, the Parkinson's disease is mostly aged patients, and osteoporosis caused by calcium loss of the aged is a common phenomenon, and the patients are difficult to recover once falling down. The Parkinson's disease is characterized by slow action, poor body balance and easy falling, so that calcium supplement of Parkinson's disease patients is more important.
According to the nutrient deficiency characteristics of target population of Parkinson patients, vitamins with synergistic functions are screened for scientific composition, accurate nutrition supplement is implemented, and the action effect is remarkably stronger than that of single or combined components.
The vitamin B3, the vitamin B6, the vitamin B12 and the vitamin E are pertinently supplemented in a proper amount, so that the vitamin B3 caused by the Parkinson disease can be prevented, and the vitamin B6 and the vitamin B12 are deficient due to the use of dopaminergic medicaments. In addition, the supplement of vitamin E can also make the dopaminergic medicament better play a role in improving symptoms of the Parkinson disease and assist the dopaminergic medicament in better maintaining the curative effect. The calcium supplement can improve the bone quality of the Parkinson disease crowd, reduce the falling condition and be beneficial to the recovery after falling.
Meanwhile, the composition not only simply supplements nutrition, but also simultaneously improves the motor dysfunction of the Parkinson's disease and protects the nervous system from being damaged by oxidation.
By supplementing vitamin D, vitamin E and vitamin B12 with proper dosage, especially for the middle-aged and the elderly who are easy to lack the three vitamins, the health-care tea can play the roles of preventing hypomnesis, resisting oxidation, delaying aging, assisting the health care of Parkinson patients and the like.
Detailed Description
Embodiments of the present invention are further described below with reference to examples. The amounts of active vitamins listed in the following examples are based on the active ingredient.
Example 1: tablet preparation (1000 tablets) of the health food of the invention
The formula is as follows:
Figure BDA0003582265950000051
the preparation method comprises the following steps: preparing binder from polyvidone K30 with 50% ethanol solution, adding vitamin E into the binder, and stirring. Mixing vitamin B3, vitamin B6, vitamin B12, calcium and sucralose with pregelatinized starch, sieving, adding milk essence, carboxymethyl starch sodium and dextrin, mixing, adding prepared binder, making into soft mass, granulating with 24 mesh sieve, drying at 55 deg.C for 2 hr, sieving with 24 day sieve, adding magnesium stearate, mixing, and tabletting. And preparing the coating premix into a solution, and coating plain tablets to obtain the tablets of the nutritional supplement.
Example 2: tablet preparation (1000 tablets) of the health food of the invention
The formula is as follows:
Figure BDA0003582265950000052
Figure BDA0003582265950000061
the preparation method comprises the following steps: preparing binder from polyvidone K30 with 50% ethanol solution, adding vitamin E into the binder, and stirring. Mixing vitamin B3, vitamin B6, vitamin B12, calcium and sucralose with pregelatinized starch, sieving, adding milk essence, carboxymethyl starch sodium and dextrin, mixing, adding prepared binder, making into soft mass, granulating with 24 mesh sieve, drying at 55 deg.C for 2 hr, sieving with 24 day sieve, adding magnesium stearate, mixing, and tabletting. And (3) preparing the coating premix into a solution, and coating plain tablets to obtain the tablets of the nutritional supplement.
Example 3: the invention relates to the preparation of soft capsules (1000 capsules)
The formula is as follows:
Figure BDA0003582265950000062
Figure BDA0003582265950000071
the preparation method comprises the following steps: adding Cera flava into soybean oil, heating at 50 deg.C to dissolve Cera flava, standing to room temperature, and adding vitamin B3, vitamin B6, vitamin B12, vitamin E, and calcium into soybean oil to obtain suspension. Preparing gelatin solution from gelatin, purified water, caramel color and p-hydroxybenzoate, pelleting the obtained mixture by a pelleting machine to obtain soft capsules, and carrying out shaping, washing and drying treatment to obtain the soft capsules of the nutritional supplement.
Example 4: hard capsule preparation (1000 granules) of health food of the invention
The formula is as follows:
Figure BDA0003582265950000072
the preparation method comprises the following steps: mixing vitamin E, vitamin B3, vitamin B6, calcium and 20% microcrystalline cellulose, sieving, adding vitamin B12, mixing, gradually increasing the amount of the obtained raw material mixture and the residual microcrystalline cellulose, adding lactose and magnesium stearate, mixing, filling by using a full-automatic capsule filling machine, and polishing to obtain the hard capsule of the health food.
Example 5: preparation of granules of health food (1000 weight portions) according to the invention
The formula is as follows:
Figure BDA0003582265950000073
Figure BDA0003582265950000081
the preparation method comprises the following steps: pulverizing sucrose, and sieving with 100 mesh sieve; preparing polyvidone K30 into binder with 50% ethanol solution, adding vitamin E into the binder, and stirring. Mixing vitamin B3, vitamin B6, vitamin B12 and calcium with sucrose, sieving, adding apple powder, apple essence, carboxymethyl starch sodium and maltodextrin, mixing, adding the prepared adhesive to prepare a soft material, granulating by a 24-mesh sieve, drying at 55 ℃ for 2 hours, and finishing granules by the 24-mesh sieve to obtain the health food granules.
Example 6: preparation of granules of the health food (1000 parts by weight)
The formula is as follows:
Figure BDA0003582265950000082
Figure BDA0003582265950000091
the preparation method comprises the following steps: pulverizing sucrose, and sieving with 100 mesh sieve; preparing binder from polyvidone K30 with 50% ethanol solution, adding vitamin E into the binder, and stirring. Mixing vitamin B3, vitamin B6, vitamin B12 and calcium with sucrose, sieving, adding apple powder, apple essence, carboxymethyl starch sodium and maltodextrin, mixing, adding the prepared adhesive to prepare a soft material, granulating by a 24-mesh sieve, drying at 55 ℃ for 2 hours, and finishing granules by the 24-mesh sieve to obtain the health food granules.
Example 7: preparation of chewable tablets (1000 tablets) of the health food of the invention
The formula is as follows:
Figure BDA0003582265950000092
the preparation method comprises the following steps: preparing hydroxypropyl methylcellulose E5 into adhesive with 60% ethanol solution, adding vitamin E into the adhesive, and stirring. Mixing vitamin B3, vitamin B6, vitamin B12, calcium and microcrystalline cellulose, sieving, adding stevioside, lemon essence, milk powder and xylitol, mixing, adding a prepared adhesive to prepare a soft material, granulating by using a 24-mesh sieve, drying for 2 hours at 55 ℃, granulating by using the 24-mesh sieve, adding magnesium stearate, mixing, and tabletting to obtain the chewable tablet of the health food.
Example 8: preparation of chewable tablets (1000 tablets) of the health food of the invention
The formula is as follows:
Figure BDA0003582265950000093
Figure BDA0003582265950000101
the preparation method comprises the following steps: preparing hydroxypropyl methylcellulose E5 into adhesive with 60% ethanol solution, adding vitamin E into the adhesive, and stirring. Mixing vitamin B3, vitamin B6, vitamin B12 and calcium with microcrystalline cellulose, sieving, adding stevioside, lemon essence, milk powder and xylitol, mixing, adding a prepared adhesive to prepare a soft material, granulating by using a 24-mesh sieve, drying for 2 hours at 55 ℃, granulating by using the 24-mesh sieve, adding magnesium stearate, mixing, and tabletting to obtain the chewable tablet of the health food.
Example 9 Experimental example
In order to prove that the nutritional supplement is beneficial to improving motor dysfunction of Parkinson's disease and protecting nervous system from damage caused by oxidation, the following experiments are designed, mainly the investigation on the motor coordination and balance of test animals and the detection on superoxide dismutase (SOD) and Malondialdehyde (MDA) antioxidants in brain, and the investigation on the health care effect of the nutritional supplement is carried out.
The nutritional supplement prepared in example 1 was used for safety toxicology evaluation and pharmacodynamic tests.
Acute toxicity:
20 SD rats (female and male halves) are taken from the tablet prepared in the example 1, the tablet is administrated according to the dose of 5g/kg, the tablet is administrated by gastric gavage according to the volume of 40ml/kg, the administration is carried out for 1 time, the SD rats are continuously observed for 14 days, the general condition of the SD rats is not abnormal, and the experimental result shows that the maximum tolerance of the composition to the SD rats is more than 5 g/kg.
The nutritional supplement of the invention is used for researching the transformation efficiency of levodopa and the pharmacodynamics of peripheral nerves:
experimental animals: male 8-week-old C57/BL mice, 20-25 g in weight, purchased from the laboratory animal center of Nantong university, license number: SCXK (Su) 2019-
Feed: common feed for mixed feeding of rats and mice
The molding method comprises the following steps: after the mouse adapts to the environment for 10 days, the model mouse is injected with 1-methyl-4-phenyl-1, 2, 3, 6-tetrahydropyridine (MPTP) by the intraperitoneal injection of 30mg/kg, and the Parkinson disease model is prepared by continuous injection for 7 days 1 time per day. Normal group was injected i.p. with corresponding amount of normal saline 1 time daily for 7 days.
Grouping experiments: except for the normal group, the other 60 model mice were randomly divided into a model group and a dosing group, each group containing 10 animals, and the dosing group was as follows:
group 1: 20mg/kg vitamin B3+100mg/kg vitamin E dose group,
and 2, group: 5mg/kg vitamin B6+20 mug/kg vitamin B12 dose group,
and 3, group: compositions described in the examples: 20mg/kg vitamin B3+100mg/kg vitamin E +5mg/kg vitamin B6+20 mug/kg vitamin B12+500mg/kg calcium dose group,
4 groups: 2mg/kg vitamin B3+10mg/kg vitamin E + 500. mu.g/kg vitamin B6+ 2. mu.g/kg vitamin B12+50mg/kg calcium low dose group,
and 5, group: 500mg/kg calcium dose group.
After the molding is finished, the medicine is continuously administrated by stomach irrigation for 6 weeks according to groups.
The experimental method comprises the following steps:
and (3) rotating stick behavior test:
the roller test is a classical method for detecting the behavioral impairment of Parkinson's disease mice. Widely used for demonstrating the balance and coordination ability of animals. In the experiment, mice were placed on a rotating stick and tested on a rotating rod at a constant speed of 30r/min for 120 seconds. The time when the mouse first fell off the rod was recorded as latency, indicating its motor coordination ability. Each animal was tested in duplicate 2 times at 1h intervals and the mean time was calculated.
And (3) detecting an antioxidant function:
after the last behavioral test, mice were sacrificed by cervical dislocation, brains were rapidly harvested on an ice bench, hippocampal tissue was harvested, weighed and homogenized with pre-cooled normal saline at 1:10 (w/v). Centrifuging at 3000rpm for 10min, collecting supernatant, and determining contents of superoxide dismutase (SOD) and Malondialdehyde (MDA) according to the method.
Table 1. Effect of the health food of the present invention on the balance and coordination ability of MPTP-induced Parkinson's disease mice
Figure BDA0003582265950000111
Figure BDA0003582265950000121
P <0.05, P < 0.01 compared to normal; compared with the model group, # P <0.05, # P < 0.01;
table 2. Effect of the health food of the present invention on antioxidant stress of MPTP-induced Parkinson's disease mice
Figure BDA0003582265950000122
P <0.05, P < 0.01 compared to normal; compared with the model group, # P <0.05, # P < 0.01;
statistical analysis: statistical processing is carried out on the test data by adopting SPSS 18.0 statistical analysis software; data results are all expressed as X + s. The comparison between groups was performed by ANOVA test, which was set at 0.05, P <0.05 with statistical difference, and P >0.05 without statistical difference.
The experimental results are as follows: see table 1, table 2.
The results show that compared with the composition without the composition or part of the vitamin combination, the composition can obviously improve the motor dysfunction caused by MPTP of mice, can obviously improve SOD level, reduce MDA level, show good antioxidant stress effect, can improve the motor dysfunction of Parkinson's disease, and has the effect of treating and/or relieving the damage of oxidation to nervous system.

Claims (10)

1. The composition is characterized by comprising the following raw materials in parts by weight:
Figure FDA0003582265940000011
2. the composition according to claim 1, characterized in that it comprises the following raw materials in parts by weight:
Figure FDA0003582265940000012
3. the composition of claim 1, wherein vitamin B3 is selected from niacin or niacinamide.
4. The composition according to claim 1, characterized in that vitamin B6 is selected from pyridoxine hydrochloride.
5. The composition according to claim 1, wherein vitamin B12 is selected from the group consisting of substances capable of releasing/generating cobalamins in vivo; preferably, the vitamin B12 is selected from cobalamin or derivatives thereof; further preferably, the vitamin B12 is selected from cobalamin, methylcobalamin, 5-deoxyadenosylcobalamin, hydroxocobalamin, cyanocobalamin or derivatives of other cobalamins.
6. The composition according to claim 1, characterized in that the vitamin E is selected from natural vitamin E or dl-alpha-tocopheryl acetate, dl-alpha-tocopherol, calcium vitamin E succinate; further, the natural vitamin E is selected from D-tocopherol, D-tocopheryl acetate and D-alpha-tocopheryl succinate.
7. The composition of claim 1, wherein the calcium is selected from the group consisting of calcium carbonate, calcium acetate, calcium chloride, calcium citrate, calcium gluconate, calcium lactate, calcium hydrogen phosphate, calcium dihydrogen phosphate, tricalcium phosphate, calcium sulfate, calcium lactate L-lactate, calcium glycerophosphate, and calcium citrate malate.
8. An oral formulation comprising the composition of claim 1 and a pharmaceutically acceptable excipient.
9. The oral preparation according to claim 8, wherein the oral preparation is in the form of a common tablet, a chewable tablet, a soft capsule, a hard capsule, a powder, an effervescent tablet, a pill, a powder, an oral liquid, a sustained-release controlled-release preparation or a granule.
10. Use of the composition of claim 1 or the oral formulation of claim 8 for the manufacture of a medicament or nutritional supplement or health food for the treatment and/or alleviation of motor dysfunction caused by parkinson's disease and/or the treatment and/or alleviation of oxidative damage to the nervous system caused by parkinson's disease.
CN202210354516.0A 2022-04-06 2022-04-06 Multivitamin composition for Parkinson disease patients and application thereof Pending CN114617266A (en)

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