CN101849971A - Soft capsule containing coenzyme Q10 and preparation method and application thereof - Google Patents
Soft capsule containing coenzyme Q10 and preparation method and application thereof Download PDFInfo
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Abstract
The invention discloses a Yixingrui Brand soft capsule containing coenzyme Q10 which can improve immunity and fight against cancers, and a preparation method and application thereof. The preparation method comprises the following steps: using 45-55g of raw medicine containing coenzyme Q10 with content more than or equal to 99 percent as an effective ingredient, using 100-300g of perilla herb oil as solvent, preparing the effective ingredient and the solvent into contents at 40-50 DEG C, proportioning 200-300g of gelatin, 100-250g of glycerin, 250-400g of purified water, 0.8-1.2g of pigment and 1-1.2g of pulpy antholeucin to prepare capsule material, adopting sol to prepare the contents and pressing pellets, conducting processes such as drying, pellet picking and the like of a soft capsule preparation technology, and pressing the material medicine into 1000 Yixingrui Brand soft capsules at 50-55 DEG C through a soft capsule pressing technology. The invention is characterized in that the physical efficacy of the coenzyme Q10 is adopted, solvent, vitamin and minerals with collaborative function are screened and the raw medicine is pressed into pellets by adopting the matured Yixingrui Brand soft capsule preparation technology. According to stability tests, evaluative animal safety tests, hygienic tests and efficacy tests, the invention has the advantages of stable form and efficacy ingredients, no toxic and side effects, strong immunologic function, novel anticancer indication effect and promising application prospect.
Description
Technical field
The invention belongs to preventing new tumor indication chemistry I kind new medicine, particularly relate to a kind of enhancing immunity, antitumor, it is auspicious to contain coenzyme Q10 《 Yi Xing " preparation and the utilization of board soft capsule dosage form.
Background technology
Immune function of human body system and nervous system, hormonal system have very complicated mutual regulation relationship, the enhancing of immune function of human body, show antineoplastic action, play the generation of prophylaxis of tumours, also can show lethal effect the tumor cell that has produced.Cancer is one of the highest disease of mortality rate, and the M ﹠ M of cancer is all in rising trend both at home and abroad, and the prevention of cancer and treatment are the key research projects of whole world medical research.The progress of biomedical science and technology has darker understanding to the morbific reason of cancer now.The stability of the generation of cancer and individual inheritance matter DNA, living environment and Nervous and Mental Factors have substantial connection, though existing medical skill also has good effect to the treatment of early-stage cancer, but most of cancer patients are in case diagnosis has been middle and advanced stage and transfer has been arranged that cancer metastasis is the main cause that causes the clinical treatment failure.
Coenzyme Q10 is present in the human body cell mitochondrion, it in the human body respiration chain important step of transmitting electronics, participate in the synthetic of oxidative phosphorylation reaction and energy ATP, coenzyme Q10 has very strong antioxidation and removes the function of free radical, can keep the stability of DAN, prevents cell ageing and mutation, simultaneously, for improving immunoglobulin in the blood, increase the quantity of macrophage, increasing the T cellular immune function has important effect.Coenzyme Q10 also has the history in more than 50 year so far, and it is an important factor in the cell mitochondrial oxidative phosphorylation process, transmits electronics in respiratory chain, and provides energy for cell activities.Metchell with the elaboration of chemiosomotic theory science the mechanism of the synthetic ATP of cell mitochondrial oxidative phosphorylation, obtained Nobel Prize in 1978 for this reason.Coenzyme Q10 plays an important role to preventing the cell ageing sudden change, discover that coenzyme Q10 regulates the function of enhance immunity system in addition, improve the level of immunoglobulin IgG in the blood, increase the quantity of macrophage and strengthen the T cellular immune function, certain therapeutical effect is arranged for chronic hepatitis, infectious disease and cancer.
Human body can the endogenous synthesizing coenzyme Q 10, also can from food, obtain, coenzyme Q10 content in the heart, liver, kidney and pancreatic tissue is organized relative higher than other, coenzyme Q10 content in vivo also can change with age, the content of coenzyme Q10 is higher than teenager and adult in the infant tissue, old people's content is minimum, and existing coenzyme Q10 lacks the substantial connection that has with many chronic degenerative diseases, as chronic cardiovascular disease, diabetes, nervimotion disease etc.The concentration of coenzyme Q10 also is lower than normally in many cancer human bloods, as hepatocarcinoma, breast carcinoma, carcinoma of prostate, intestinal cancer, myeloma, cervical cancer, melanoma, leukemia, renal carcinoma, and tumor of head and neck.
The sixties in last century, Japan was used for the clinical treatment congestive heart failure to coenzyme Q10 the earliest, started the history of coenzyme Q10 clinical treatment, development along with research, coenzyme Q10 now has been widely used in the auxiliary treatment numerous disease, as heart disease, hypertension, diabetes, neuromotor system disease, Parkinson's disease, alzheimer disease.The seventies, coenzyme Q10 was used for cancer patient, and beginning is mainly as the auxiliary treatment of chemotherapy, radiotherapy, and purpose is to alleviate amycin, the rubidomycin toxic and side effects to myocardial cell, improves the toleration of patient to chemotherapy, radiotherapy.
The progress of coenzyme Q10 showed in recent years, cancerous cell In vitro culture controlled trial finds that coenzyme Q10 suppresses prostate gland cancer cell PC3 and increases, do not increase and do not suppress normal cell PNT2, coenzyme Q10 is also to human cervical carcinoma Hela, breast carcinoma MCF-7 and carcinoma of prostate DUI45, the growth of leukemia HL-60 cell have direct repression, can cause cancer cell-apoptosis.Fear with carcinogen dimethyl phenylpropyl alcohol and to induce female rats breast carcinoma model test, compare with matched group, estrogen receptor antagon TAM (10 milligrams/kg body weight/day) and coenzyme Q10 (40 milligrams/kg body weight/day) share, the obviously breast carcinoma of inhibition test group rat growth, and recovered body anti-oxidation function by carcinogen infringement, induce rat intestinal cancer model test with carcinogen azoxymethane chemical compound, coenzyme Q10 can alleviate carcinogenic effect, reduces the generation of intestinal cancer.
The clinic trial of external coenzyme Q10 is in the observation of curative effect of oncotherapy, though can pick up rope to many bibliographical informations, owing to lack strict controlled trial, the case load of various degrees and therapeutic scheme design the defective of not enough standard.Though coenzyme Q10 has manifested multiple use and has been suitable for disease in clinical practice at home, as antioxidation, fatigue alleviating, auxiliary antilipemic etc., but because coenzyme Q10 limits to as medicinal approval, the dosage regulation only is 5mg, 10mg, 15mg, the application of coenzyme Q10 is restricted, and effect can not manifest.Coenzyme Q10 is being in anxious situation leaved for development aspect the treatment for cancer indication.
Summary of the invention
The present invention can overcome the deficiency in the above-mentioned present situation, and a kind of enhancing immunity, antitumor are provided, and contains the preparation and the utilization of coenzyme Q10 " beneficial Xing Rui " board soft capsule dosage form.It is characterized in that its composite formula is: the coenzyme Q10 crude drug 50g with 〉=99% (Yuxi Jiankun Biotechnology Pharmaceutical Co., Ltd.'s production) is an effective component, with the 200g perilla oil is solvent, make content at 40-50 ℃, join with 250g gelatin, 150g glycerol, 275g purified water, 0.8g pigment, 1g antholeucin (pulpous state) and make the capsule material, it is auspicious to be pressed into 1000 《 Yi Xing at 50-55 ℃ through soft capsule " the board soft capsule.
The present invention contains the soft capsule of coenzyme Q10, being characterised in that: its compositions contains 〉=and 99% coenzyme Q10 crude drug percentage by weight is 4～7%, perilla oil or edible oil and fat percentage by weight are 18～22%, the gelatin percentage by weight is 30～40%, the glycerol percentage by weight is 14～17%, the purified water percentage by weight is 30～40%, the pigment percentage by weight is 0.05～0.1%, pulpous state antholeucin percentage by weight is 0.1～0.3%, vitamin A, B, C, D, E, K, in the bata-carotene one or more, its percentage by weight is 3～7%, mineral magnesium, selenium, ketone, ferrum, in the trace element one or more, its percentage by weight are 0.01～0.05%.
Contain the application of soft capsule in preparation enhancing immunity or antitumor drug of coenzyme Q10.
The present invention contains the preparation method of the soft capsule dosage form of coenzyme Q10, it is characterized in that its composition contains: the coenzyme Q10 crude drug percentage by weight with 〉=99% is 4～7%, be effective component, with percentage by weight is that 18～22% perilla oil is a solvent, make content at 40～50 ℃, joining with percentage by weight is 30～40% gelatin, percentage by weight is 14～17% glycerol, percentage by weight is 30～40% purified water, the pigment percentage by weight is 0.05～0.1% pigment, shape antholeucin percentage by weight is 0.1～0.3% to make the capsule material, and adopt colloidal sol to prepare content and suppress pill, drying, pick up the soft capsule preparation technology of ball operation, be pressed into soft capsule through soft capsule at 50～55 ℃.
In above-mentioned composition, also add vitamin A, B, C, D, E, K or bata-carotene, the preferred vitamin E of vitamin, vitamin C or bata-carotene, more preferably bata-carotene, preferred vitamin E especially.
In above-mentioned composition, also add to select for use and have synergistic mineral magnesium, selenium, ketone, iron microelement, the rich magnesium material of preferred trace element magnesium and magnesium, the more preferably rich material of selenium and selenium, in rich magnesium material: magnesium chloride, magnesium carbonate, magnesium citrate, grape saccharic acid magnesium, magnesium lactate, magnesium hydrogen phosphate, magnesium phosphate, magnesium glycerophosphate, preferred grape saccharic acid magnesium, magnesium carbonate, magnesium glycerophosphate, more preferably magnesium glycerophosphate.
The formula range of described magnesium is for being equivalent to intake 100mg-300mg/ days, in rich selenium material: select selenocarrageenan, selenocysteine, cereuisiae fermentum rich in selenoaminoacid, sodium selenate, sodium selenite or Selenomethionine, preferred cereuisiae fermentum rich in selenoaminoacid, more preferably sodium selenate, selenic prescription is an intake≤50 μ g every day, also selects other edible oil and fat of medicine-food two-purpose on solvent is selected for use except that perilla oil for use.
Every contains the effective component coenzyme Q10 is 50mg, and content is 0.25g-0.5g, 60 every bottle-100.
The effective component vitamin content: being equivalent to the intake vitamin A is 1 μ g-10 μ g/ days, and vitaminB10 .5mg-10mg/ days, vitamin B2 are that 0.5mg-20mg/ days, vitamin B6 are that 0.5mg-10mg/ days, vitamin B12 1 μ g-10 μ g/ days, vitamin C are that 30mg-500mg/ days, vitamin E are that 5mg-150mg/ days, vitamin K are that 20 μ g-100 μ g/ days, bata-carotene are 1.5mg-5mg/ days.
Effective component coenzyme Q10 of the present invention, vitamins, used solvent was a perilla oil when micro element mineral was made content, soybean oil, Testa oryzae oil, Fructus Maydis oil, walnut oil, fish oil, bathypelagic fish oil, Radix Oenotherae erythrosepalae oil, Oleum Bulbus Allii, Oleum Brassicae campestris, Oleum Arachidis hypogaeae semen, Oleum sesami, Princepia utilis oil, Cai spends seed oil, Oleum Vitis viniferae, the pinus yunnanensis faranch seed oil, armand pine seed oil, preferred perilla oil, Testa oryzae oil, pinus yunnanensis faranch seed oil or Oleum Bulbus Allii or its mixture, more preferably perilla oil or Oleum Bulbus Allii, preferred especially perilla oil, the solvent consumption is the effective component coenzyme Q10, vitamin, 3～5 times of the made content of mineral.
The present invention also adds the vitamin effective component, trace element becomes content through scientific formula and preferred edible oil and fat through heating for dissolving except that containing the coenzyme Q10 effective component, become the 《 Yi Xing auspicious by the soft capsule preparation prepared " the board soft capsule.
The present invention is auspicious at preparation 《 Yi Xing " adopt sophisticated soft capsule preparation technology (colloidal sol, preparation content, compacting pill, drying, pick up operation such as ball) on the technology of board soft capsule.《 Yi Xing is auspicious " the board soft capsule preparation detects qualifiedly through effective component, and stability test, acute toxicity test, safety evaluatio meet the requirements, and carry out enhancing immunity function, antitumor efficacy test by efficacy test unit.
The specific embodiment
Further specify flesh and blood of the present invention with example below, but content of the present invention is not limited to this.
Embodiment 1
Prescription: (wherein percentage composition is weight percentage)
Preparation: adjuvant gelatin 250g, glycerol 150g, purified water 275g, pigment 0.8g, antholeucin (pulpous state) 1g is stand-by by changing glue process (heating, dissolving, vacuum defoamation, leave standstill, be incubated) preparation, in addition effective component coenzyme Q10 50g, perilla oil 200g are prepared by content preparing process (weigh, feed intake, heat, dissolve).To prepare content and change the glue glue and roll into ball through the pattern of rolling " beneficial Xing Rui " board soft capsule Zhanang technology, through finalizing the design, wash ball, drying, pick up ball, checking to such an extent that coenzyme Q10 《 Yi Xing is auspicious " the board soft capsule, specification: every 0.25g, 60 every bottle (the theoretical granulation 1000).
Embodiment 2
Prescription:
Preparation:
Adjuvant gelatin 300g, glycerol 180g, purified water 330g, pigment 0.96g, antholeucin (pulpous state) 1.2g is stand-by by changing glue process (heating, dissolving, vacuum defoamation, leave standstill, be incubated) preparation, in addition effective component coenzyme Q10 50g, vitamin E 50g, perilla oil 300g are prepared by content preparing process (weigh, feed intake, heat, dissolve).To prepare content and change the glue glue and roll into ball through the pattern of rolling " beneficial Xing Rui " board soft capsule Zhanang technology, through the typing, wash ball, drying, pick up ball, check coenzyme Q10 " beneficial Xing Rui " board soft capsule, specification: every 0.4g, 60 every bottle (the theoretical granulation 1000).
Embodiment 3
Prescription:
Preparation:
Adjuvant gelatin 250g, glycerol 150g, purified water 275g, pigment 0.8g, antholeucin (pulpous state) 1g is stand-by by changing glue process (heating, dissolving, vacuum defoamation, leave standstill, be incubated) preparation, in addition with effective component coenzyme Q10 50g, bata-carotene 5g, Oleum Bulbus Allii 100g, perilla oil 100g prepares by content preparing process (weigh, feed intake, heat, dissolve).To prepare content and change the glue glue and roll into ball through rolling pattern soft capsule Zhanang technology, through typing, wash ball, drying, pick up ball, check to such an extent that coenzyme Q10 《 Yi Xing is auspicious " the board soft capsule, specification: every 0.255g, 60 every bottle (the theoretical granulation 1000).
Embodiment 4
Prescription:
| Raw material (effective component) | Formula ratio (g) | Adjuvant | Formula ratio (g) | Solvent | Formula ratio (g) |
| Coenzyme Q10 | ??50 | Gelatin | ??250 | Oleum Bulbus Allii | ??50 |
| Sodium selenate | ??0.1 | Glycerol | ??150 | Perilla oil | ??150 |
| Raw material (effective component) | Formula ratio (g) | Adjuvant | Formula ratio (g) | Solvent | Formula ratio (g) |
| Purified water | ??275 | ||||
| Pigment | ??0.8 | ||||
| Antholeucin (pulpous state) | ??1 |
Preparation:
Adjuvant gelatin 250g, glycerol 150g, purified water 275g, pigment 0.8g, antholeucin (pulpous state) 1g is stand-by by changing glue process (heating, dissolving, vacuum defoamation, leave standstill, be incubated) preparation, in addition with effective component coenzyme Q10 50g, sodium selenate 0.1g, Oleum Bulbus Allii 50g, perilla oil 150g prepares by content preparing process (weigh, feed intake, heat, dissolve).To prepare content and change the glue glue and roll into ball through rolling pattern soft capsule Zhanang technology, through typing, wash ball, drying, pick up ball, check to such an extent that coenzyme Q10 《 Yi Xing is auspicious " the board soft capsule, specification: every 0.25g, 60 every bottle (the theoretical granulation 1000).
Embodiment 5
Prescription:
| Raw material (effective component) | Formula ratio (g) | Adjuvant | Formula ratio (g) | Solvent | Formula ratio (g) |
| Coenzyme Q10 | ??50 | Gelatin | ??350 | Perilla oil | ??300 |
| Magnesium glycerophosphate | ??100 | Glycerol | ??210 | ||
| Purified water | ??385 | ||||
| Pigment | ??1.12 | ||||
| Antholeucin (pulpous state) | ??1.4 |
Preparation:
Adjuvant gelatin 350g, glycerol 210g, purified water 385g, pigment 1.12g, antholeucin (pulpous state) 1.4g is stand-by by changing glue process (heating, dissolving, vacuum defoamation, leave standstill, be incubated) preparation, in addition effective component coenzyme Q10 50g, magnesium glycerophosphate 100g, perilla oil 300g are prepared by content preparing process (weigh, feed intake, heat, dissolve).To prepare content and change the glue glue and roll into ball through rolling pattern soft capsule Zhanang technology, through typing, wash ball, drying, pick up ball, check to such an extent that coenzyme Q10 《 Yi Xing is auspicious " the board soft capsule, specification: every 0.45g, 60 every bottle (the theoretical granulation 1000).
Stability test, toxicological assessment test and efficacy test
One. stability test
1. Shi Yan purpose: it is auspicious to be that examination contains coenzyme Q10 《 Yi Xing " stability of board soft capsule preparation functional component.Understand the stabilizing factor that influences preparation,, provide foundation for the effect duration of formulating product simultaneously for this product production technology, packing, condition of storage provide scientific basis.
2. content of the test: 37 ℃-40 ℃ of accelerated test condition temperature, humidity 75%.
3. test unit: Guangxi Center for Disease Control and Prevention
4. test lot number: 20080120-1 20080120-2 20080120-3
5. inspection item and assay:
The 《 Yi Xing that contains coenzyme Q10 is auspicious " the board soft capsule preparation in inspection item, mainly check the stability of effective component coenzyme Q10, stable through four months accelerated tests proof coenzyme Q10 functional component, result of the test sees the following form:
Annotate: the method for inspection adopts " Pharmacopoeia of People's Republic of China (2005 editions) "
Two. the toxicological assessment test
1 purpose:
It is auspicious to be to examine or check the 《 Yi Xing that contains coenzyme Q10 " toxic and side effects of board soft capsule preparation, for accomplishing the effective and safe of medicine.
2. content of the test:
Acute toxicity test in mice, Salmonella reversion test, mouse marrow cell micro nuclear test, mouse sperm deformity test, 30 days feeding trials of rat.
3. test specimen:
Contain coenzyme Q10 " beneficial Xing is auspicious " board soft capsule preparation three lot number: 20080120-1,20080120-2,20080120-3, human oral recommend consumption for everyone once a day, each one, become body weight for humans press 60kg and calculate, amounting to metering is 7.2mg/kg.
4. conclusion (of pressure testing):
1. acute oral toxicity test: after giving mouse stomach with the sample of maximum dosage-feeding (dosage is 30000mg/kgBW), do not see that animal has poisoning symptom, no animal dead, result of the test is dissected animal, observes no abnormality seen, and acute oral toxicity belongs to no toxic agent.Test data sees the following form:
Table 1 acute oral toxicity test
| Sex | Number of animals (only) | Approach | Dosage (mg/kg BW) | Initial body weight (g) | The 7th day body weight (g) | The 14th day body weight (g) | Poisoning symptom number of animals (only) appears | Death toll (only) |
| Male | ??10 | Per os | ??30000 | ??20.1±??1.5 | ??26.4±??1.5 | ??33.5±??1.8 | ??0 | ??0 |
| Female | ??10 | Per os | ??30000 | ??20.0±??1.2 | ??25.0±??1.5 | ??31.3±??1.6 | ??0 | ??0 |
From table one as seen, give the mice coloclysis with the sample of maximum dosage-feeding (dosage is 30000mg/kg BW) after, growth of animal is good, does not see that body weight is affected.Tried mice and there is no poisoning symptom, observed 14 days no animal deads.Animal is dissected in off-test, gross examination of skeletal muscle, major organs such as the liver,kidney,spleen heart, lung, stomach, intestinal show no obvious abnormalities change, and according to the toxicity grading standard in " health food check and technical specification " (version in 2003), the acute oral toxicity of this sample belongs to nontoxic level.
2. genetic toxicity test: the result is all negative for three genetic toxicity tests (Ames, mouse marrow cell micro nuclear test, mouse sperm deformity test).Test data sees the following form:
2, positive control: TA97a+S9, TA98+S9, TA100+S9 adopt 2-aminofluorene (dosage is 10); TA98-S9 adopts daunorubicin (dosage is 6); TA97a-S9, TA102-S9 adopt fenaminosulf (dosage is 50); TA100-S9 adopts sodium azide (dosage is 1.5); TA102+S9 adopts 1,8-dihydroxyanthraquinone (dosage is 50).Table 3 together.
The Ames test
The auspicious board coenzyme Q10 of table 2 Yi Xing soft capsule Salmonella reversion test result (for the first time)
Annotate: 1, above result (clump count) is the means standard deviation of 3 plates.
From table 2, table 3 as seen, to TA97a, TA98, four kinds of test strains of TA100, TA102, no matter whether add S-9, returning of each dosage group of sample becomes the bacterium colony number average above return the twice that becomes clump count from method, also do not have dose-response relationship, it is negative that surperficial this tried thing mutagenesis testing result.
The auspicious board coenzyme Q10 of table 3 Yi Xing soft capsule Salmonella reversion test result (for the second time)
Annotate: above result (clump count) is the means standard deviation of 3 plates.
Dissect gross examination of skeletal muscle and histological examination result
Experiment finishes to dissect animal, and each treated animal of gross examination of skeletal muscle is not all found obvious pathological changes.So the high dose group of a sampling product and the main organs of control animals are carried out the tissue pathological slice inspection, through seeing Table 18～table 24.The result shows, high dose group has 1 female Mus, matched group to have the visible slight inflammatory cell in liver portal area of 2 (each one of male and female) rats to soak, high dose group has 1 female Mus, matched group that the visible a small amount of protein cast of kidney cortex portion of 1 male Mus is arranged, high dose group has the visible slight inflammatory cell of the stomach submucosa of 1 female Mus to soak, above lesion tissue belongs to the spontaneous pathological changes of animal, and the lesion degree of two treated animals is similar, is due to the sample so can get rid of; Other organs and tissues do not see that histopathology changes, and shows the above-mentioned organs and tissues harmless effect of this sample to rat.
30 days feeding trial rat livers of the auspicious board coenzyme Q10 of table 4 Yi Xing soft capsule histopathological examination result
30 days feeding trial rat kidney of the auspicious board coenzyme Q10 of table 5 Yi Xing soft capsule histopathological examination result
30 days feeding trial Rats Spleen of the auspicious board coenzyme Q10 of table 6 Yi Xing soft capsule histopathological examination result
In the combinations thereof composition formula, except that the effective component coenzyme Q10, also add vitamin A, B, C, D, E, K, bata-carotene, also select for use have synergistic mineral magnesium, selenium, ketone, ferrum, etc. trace element, compatibility in addition.On selecting for use, except that perilla oil, also selects solvent other edible oil and fat of medicine-food two-purpose for use.Vitamin A and bata-carotene can increase the quantity of specificity lymphocyte subgroup, strengthen NK cell and phagocyte and activity, and stimulate the generation of various cytokines.Vitamin A or vitamin A add bata-carotene, and every days 250, μ g-800 μ was g/ days.Vitamin E intake every day is 5mg-150mg.Vitamin B6 intake every day is 0.5mg-10mg.Selenium intake every day is 15 μ g/-100 μ g/.Trace element magnesium intake every day is 100mg-300mg.Trace element zinc intake every day is 5mg-20mg.
Perilla oil is the oils and fats that can be used for health food of state approval, also be traditional edible oil and fat of China resident, its alpha-linolenic acid content higher (containing alpha-linolenic acid 50%-60%), contain vitamin E 50-60mg/100g in addition, alpha-linolenic acid can be used as precursor conversion in human body be EPA and DHA, edible alpha-linolenic acid can play the health-care effect effect of bathypelagic fish oil equally, and the someone likens " plant bathypelagic fish oil " to.Perilla oil helps the raising of the bioavailability of coenzyme Q10 as the solvent of functional component coenzyme Q10, and the effect performance of alpha-linolenic acid and vitamin E in the perilla oil.Perilla oil is as the solvent of effective component coenzyme Q10, vitamin, and every is 3-5 times of effective component quality.
Oleum Bulbus Allii is made up of more than 40 kinds of sulfide compounds, Oleum Bulbus Allii has tangible antioxidation, aspect the inhibition tumor, discover, can activate by anticancer, induce and separate toxenzyme, accelerate carcinogenic drainage, stop the formation of the adduct of DNA, can also suppress ornithine, the deshydroxy enzyme, organize the formation of polyamines, disturb the location of P21rax at cell membrane, the form of Oleum Bulbus Allii to gastric cancer BGC-823 cell also found in research, propagation, cell-cell communication and carcinogenecity have tangible influence, Oleum Bulbus Allii can make cyclic adenosine monophosphate (cAMP) level rising 209.6% in the cancerous cell, presses down the metabolism of cancer factor cAMP in transferring, and reaches anticancer effect.In addition, Oleum Bulbus Allii also has blood fat reducing, stops blood fat to be piled up and the alleviation atheroma, and fat-reducing, resisting fatigue, diabetes-alleviating oxidation, enhance immunity are done, antiphlogistic antibacterial, and good preventing and therapeutic value are arranged.Oleum Bulbus Allii is as the solvent of effective component coenzyme Q10, vitamin, and every is 3-5 times of effective component quality.
Claims (9)
1. soft capsule that contains coenzyme Q10, being characterised in that: its compositions contains 〉=and 99% coenzyme Q10 crude drug percentage by weight is 4～7%, perilla oil or edible oil and fat percentage by weight are 18～22%, the gelatin percentage by weight is 30～40%, the glycerol percentage by weight is 14～17%, the purified water percentage by weight is 30～40%, the pigment percentage by weight is 0.05～0.1%, pulpous state antholeucin percentage by weight is 0.1～0.3%, vitamin A, B, C, D, E, K, in the bata-carotene one or more, its percentage by weight is 3～7%, mineral magnesium, selenium, ketone, ferrum, in the trace element one or more, its percentage by weight are 0.01～0.05%.
2. the application of soft capsule in preparation enhancing immunity or antitumor drug that contains coenzyme Q10 as claimed in claim 1.
3. preparation method that contains the soft capsule dosage form of coenzyme Q10, it is characterized in that its composition contains: the coenzyme Q10 crude drug percentage by weight with 〉=99% is 4～7%, be effective component, with percentage by weight is that 18～22% perilla oil is a solvent, make content at 40～50 ℃, joining with percentage by weight is 30～40% gelatin, percentage by weight is 14～17% glycerol, percentage by weight is 30～40% purified water, the pigment percentage by weight is 0.05～0.1% pigment, shape antholeucin percentage by weight is 0.1～0.3% to make the capsule material, and adopt colloidal sol to prepare content and suppress pill, drying, pick up the soft capsule preparation technology of ball operation, be pressed into soft capsule through soft capsule at 50～55 ℃.
4. a kind of preparation method that contains the soft capsule dosage form of coenzyme Q10 according to claim 3, it is characterized in that: in above-mentioned composition, also add vitamin A, B, C, D, E, K or bata-carotene, the preferred vitamin E of vitamin, vitamin C or bata-carotene, more preferably bata-carotene, special preferred vitamin E.
5. a kind of preparation method that contains the soft capsule dosage form of coenzyme Q10 according to claim 3, it is characterized in that: in above-mentioned composition, also add to select for use and have synergistic mineral magnesium, selenium, ketone, iron microelement, the rich magnesium material of preferred trace element magnesium and magnesium, the more preferably rich material of selenium and selenium, in rich magnesium material: magnesium chloride, magnesium carbonate, magnesium citrate, grape saccharic acid magnesium, magnesium lactate, magnesium hydrogen phosphate, magnesium phosphate, magnesium glycerophosphate, preferred grape saccharic acid magnesium, magnesium carbonate, magnesium glycerophosphate, more preferably magnesium glycerophosphate.
6. a kind of preparation method that contains the soft capsule dosage form of coenzyme Q10 of stating according to claim 5, it is characterized in that: the formula range of described magnesium is for being equivalent to intake 100mg-300mg/ days, in rich selenium material: select selenocarrageenan, selenocysteine, cereuisiae fermentum rich in selenoaminoacid, sodium selenate, sodium selenite or Selenomethionine, preferred cereuisiae fermentum rich in selenoaminoacid, more preferably sodium selenate, selenic prescription is an intake≤50 μ g every day, also selects other edible oil and fat of medicine-food two-purpose on solvent is selected for use except that perilla oil for use.
7. a kind of preparation method that contains the soft capsule dosage form of coenzyme Q10 according to claim 3 is characterized in that: every contains the effective component coenzyme Q10 is 50mg, and content is 0.25g-0.5g, 60 every bottle-100.
8. a kind of preparation method that contains the soft capsule dosage form of coenzyme Q10 according to claim 3, it is characterized in that the effective component vitamin content: being equivalent to the intake vitamin A is 1 μ g-10 μ g/ days, and vitaminB10 .5mg-10mg/ days, vitamin B2 are that 0.5mg-20mg/ days, vitamin B6 are that 0.5mg-10mg/ days, vitamin B12 1 μ g-10 μ g/ days, vitamin C are that 30mg-500mg/ days, vitamin E are that 5mg-150mg/ days, vitamin K are that 20 μ g-100 μ g/ days, bata-carotene are 1.5mg-5mg/ days.
9. a kind of preparation method that contains the soft capsule dosage form of coenzyme Q10 according to claim 3, it is characterized in that the effective component coenzyme Q10, vitamins, used solvent was a perilla oil when micro element mineral was made content, soybean oil, Testa oryzae oil, Fructus Maydis oil, walnut oil, fish oil, bathypelagic fish oil, Radix Oenotherae erythrosepalae oil, Oleum Bulbus Allii, Oleum Brassicae campestris, Oleum Arachidis hypogaeae semen, Oleum sesami, Princepia utilis oil, Cai spends seed oil, Oleum Vitis viniferae, the pinus yunnanensis faranch seed oil, armand pine seed oil, preferred perilla oil, Testa oryzae oil, pinus yunnanensis faranch seed oil or Oleum Bulbus Allii or its mixture, more preferably perilla oil or Oleum Bulbus Allii, preferred especially perilla oil, the solvent consumption is the effective component coenzyme Q10, vitamin, 3～5 times of the made content of mineral.
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| CN102488207A (en) * | 2011-12-14 | 2012-06-13 | 广州善元堂医药科技有限公司 | Coenzyme Q10 soft capsule and its preparation method |
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