CN1634554A - Reduced glutathione soft capsule and manufacturing process thereof - Google Patents
Reduced glutathione soft capsule and manufacturing process thereof Download PDFInfo
- Publication number
- CN1634554A CN1634554A CN 200410090680 CN200410090680A CN1634554A CN 1634554 A CN1634554 A CN 1634554A CN 200410090680 CN200410090680 CN 200410090680 CN 200410090680 A CN200410090680 A CN 200410090680A CN 1634554 A CN1634554 A CN 1634554A
- Authority
- CN
- China
- Prior art keywords
- soft capsule
- reduced glutathione
- glycerol
- antioxidant
- weight
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Landscapes
- Medicinal Preparation (AREA)
Abstract
The invention discloses a kind of reduced glutathione soft capsule and manufacturing process, wherein the product comprises soup and capsule shell, wherein each capsule of the soup 100-500mg of reduced glutathione, 2.0-3.2% of stabilizer, anti-oxidizing agent and base material, while the capsule shell contains 10 weight parts of gelatin, 4-4.5 parts by weight of glycerine, 10 parts by weight of water and right amount of preservative agent. The capsule has the advantages of good compliance for patients and better constancy.
Description
Technical field
The present invention relates to a kind of reduced glutathione soft capsule oral formulations and preparation method thereof, belong to the technical field of medicine and preparation thereof.
Technical background
Reduced glutathion is the important component of all cells, mainly contains two kinds of physiological actions, the one, and antioxidation, the 2nd, integrate Detoxication.It can remove free radical, and also reducible other used antioxidants make it recirculation and use; Active group sulfydryl in the reduced glutathion molecule can combine with some material and have the integration Detoxication.Clinical detoxifcation, Radiation sickness and radiation protection, the liver protecting etc. of being mainly used in.The reduced glutathion of listing is a glutathione for injection at present, clinical use is convenient not as oral formulations, the patient has certain misery, compliance is relatively poor, develop reduced glutathion sheet and two kinds of peroral dosage forms of buccal tablet in addition of research at present, but because reduced glutathion more easily is oxidized to the glutathion of oxidized form in air, and have stronger draw moist, so make tablet and buccal tablet is unstable.
Summary of the invention
Purpose of the present invention is exactly at the problems referred to above, and a kind of reduced glutathione soft capsule and preparation technology thereof are provided.Product is a kind of oral administered dosage form, and patient dependence is good, again owing to medicine in the shell is hedged off from the outer world, and has added antioxidant targetedly, has improved the stability of reduced glutathion, has overcome the shortcoming of existing dosage form.
The present invention is made of medicinal liquid and softgel shell two large divisions, it is characterized in that medicinal liquid by weight every contain 100-500mg reduced glutathion, 2.0-3.2% stabilizing agent and antioxidant and substrate, the gelatin that contains 10 parts of weight in the softgel shell, 4-4.5 the glycerol of part weight, the water of 10 parts of weight and an amount of antiseptic.
Substrate is one or more in PEG400, Macrogol 600, the glycerol, is preferably the mixture of Polyethylene Glycol and glycerol, most preferably is the Polyethylene Glycol mixture that contains 10% glycerol.When Polyethylene Glycol is done substrate, the situation of softgel shell moisture can occur absorbing, influence the softgel shell soft or hard, experimental results show that adding glycerol then can improve because of its absorption property.The different proportion of according to the form below substrate, the compacting soft capsule, reserved sample observing is an index with the content weightening finish, determines rational prescribing.
| The prescription number | Polyethylene Glycol (%) | Glycerol (%) | The content weightening finish |
| ????1 | ????100 | ????- | ????9.2％ |
| ????2 | ????95 | ????5 | ????5.5％ |
| ????3 | ????90 | ????10 | ????3.5％ |
| ????4 | ????85 | ????15 | ????3.7％ |
The result shows, effect is best when adding 10% glycerol, can significantly improve content and absorb softgel shell moisture.
Stabilizing agent is selected polyethylene glycol 6000 or Macrogol 4000, and consumption is 2.0-3.2%.Select the different amounts of stabilizing agent, draft 5 prescriptions, preparation glutathion Polyethylene Glycol suspension, room temperature left standstill 72 hours, measured sedimentation coefficient.
| Consumption (%) | 2.0 | ?2.4 | ?2.8 | ?3.2 | ?3.6 |
| Sedimentation coefficient | 0.817 | ?0.994 | ?0.993 | ?0.997 | ?0.998 |
| Mobile | Good | Good | Good | Good | Difference |
Conclusion: stabilizing agent dosage is 2.0% when above, and homogeneity is better, but surpass 3.2% mobile relatively poor, so influence between the consumption selection 2.0～3.2% of packing stabilizing agent.
Antioxidant is folic acid, vitamin C; reduced glutathion is a water-soluble substances; so selection water soluble antioxidant; vitamin C has been compared its special advantages with other water soluble antioxidants commonly used; because reversibly hydrogenation or dehydrogenation of vitamin C; play an important role in many in vivo redox reaction; vitamin C can make oxidized form of glutathione change reduced glutathion into; the hydrogen-peroxide reduction that organism metabolism is produced, vitamin C also can protect vitamin A, E and some vitamin B group to avoid oxidation.Therefore, during the utilization glutathion,, can improve its effect with vitamin C and usefulness.Folic acid is a kind of essential vitamin B group of human body, synthetic and the reparation that participates in DNA is arranged, radioprotective, effects such as antioxidation, be extensive use of by the anemia of pregnant woman in recent years, play U.S. FDA in 1998 and come into effect the regulation that to strengthen folic acid in the cereal products, recently, there are more American-European experts to advise after deliberation in common food, adding folic acid, carry out folic acid and add plan, having antioxidative character according to folic acid, is again water-soluble substances, we folic acid as the antioxidant in the reduced glutathione soft capsule, checking experimentizes, press the usual amounts 0.05% of antioxidant, prepare different samples, placed 10 days down for 40 ℃, with content and related substance is index, relatively the effect of antioxidant.
| Index | Folic acid | Vitamin C | Methionine | Cysteine |
| Content (%) | ????97.9 | ????98.5 | ????83.9 | ????88.2 |
| Related substance (%) | ????0.25 | ????0.22 | ????1.22 | ????1.36 |
Experiment showed, rice usefulness folic acid and vitamin C as antioxidant, effect is better than general water soluble antioxidant, again because folic acid also can promote reduced glutathion in the intravital absorption of people, so be preferably folic acid.
The optimum weight ratio of gelatin, glycerol, water is determined by the following method in the softgel shell, and the prescription of according to the form below prepare different capsule casing materials, suppresses the glutathion soft capsule, with outward appearance and disintegration be the ratio that index is determined gelatin and glycerol.
| The prescription number | Gelatin | Glycerol | Outward appearance | Disintegration (min) |
| ????1 | ??1kg | ??0.35kg | Harder | ????32 |
| ????2 | ??1kg | ??0.40kg | Soft or hard is suitable | ????18 |
| ????3 | ??1kg | ??0.45kg | Soft or hard is suitable | ????15 |
| ????4 | ??1kg | ??0.50kg | Softer | ????11 |
Conclusion: the consumption of glycerol is that 0.35 o'clock soft capsule is harder, and disintegration is longer; And consumption is 0.50 when above, and soft capsule is softer, and disintegration is shorter, and optimum amount is 0.40～0.45 o'clock, and soft or hard is suitable, and disintegration is qualified.
Contained antiseptic is one or more in ethyl hydroxybenzoate, methyl parahydroxybenzoate, ethylparaben, propyl p-hydroxybenzoate, the butyl p-hydroxybenzoate in the softgel shell.
Preparation technology of the present invention is for mixing in gelatin, glycerol, water, putting of the antiseptic glue jar, again with this mixture heated to about 70-80 ℃, mix homogeneously, evacuation, filtration, insulation is left standstill, and is stand-by; Get substrate, the mix homogeneously of recipe quantity, add the reduced glutathion and the antioxidant of recipe quantity again, fully mix, measure content, degassing back is put drop in the forming machine and to be finalized the design, after the washing drying, promptly in the soft capsule maker after the compacting.
Medicine of the present invention is guaranteeing by selecting adjuvant for use, reduced glutathion to be made suspension under the suitable prerequisite of principal agent dosage without compression process, and disintegrate and rate of dispersion are fast, and taking convenience and listing kind relatively have the high advantage of patient's compliance.Again owing to be soft capsule, medicine is hedged off from the outer world in the shell, can be moistureproof, anti-oxidation, and added high-efficiency antioxidant agent targetedly, improved the stability of this product greatly, overcome reduced glutathion more easily is oxidized to oxidized form of glutathione in air defective, the stability height is one of maximum characteristics of the present invention, has done following test for proving these characteristics:
1. exposure experiments to light
Test specimen placed under 45001x ± 500lx illumination placed 10 days, carry out every inspection respectively at sampling in the 0th, 5,10 day, related substance, character, dissolution etc. the results are shown in Table 1.
Table 1 exposure experiments to light is investigated the result
| Time (my god) | The investigation project | ||||
| Character | Dissolution | Disintegration | Related substance | Content | |
| ????0 | Bright and clean crack-free, content does not have precipitation | ??98.1％ | ????12′21″ | ????0.31％ | ??100.0％ |
| ????5 | Bright and clean crack-free, content does not have precipitation | ??97.2％ | ????11′48″ | ????0.58％ | ??102.3％ |
| ????10 | Bright and clean crack-free, content does not have precipitation | ??97.0％ | ????12′01″ | ????0.54％ | ??104.1％ |
*Content was 100% in 0 day
Exposure experiments to light is the result show, this product through illumination after 10 days each inspection item do not have significant change, the reduced glutathione soft capsule photostability of trial-production is good.
2. hot test
Test specimen is placed glass dish, placed 10 days under 40 ℃ of temperature, every inspection was carried out in sampling respectively in the 0th, 5,10 day, and check results such as hot test character, content, related substance, dissolution see Table 2.
The result is investigated in table 2 hot test
| Time (my god) | The investigation project | |||||
| Character | Dissolution | Disintegration | Related substance | Weightless | Content | |
| ????0 | Bright and clean, crack-free, content does not have precipitation | 98.5％ | ??12′11″ | ????0.31％ | - | 100.0％ |
| ????5 | Bright and clean, easily break, content does not have precipitation | 98.3％ | ??12′42″ | ????0.57％ | 3.51％ | 101.3％ |
| ????10 | Bright and clean, easily break, content does not have precipitation | 96.7％ | ??13′13″ | ????0.61％ | 4.22％ | 105.1％ |
*Content was 100% in 0 day
Hot test is the result show, after 10 days, character, content, related substance, dissolution are not seen obvious change through 40 ℃ of placements.
3. high wet test
Test specimen is placed plate, (saturated NaCl solution is put exsiccator bottom to place the environment of relative humidity (RH) 75%, sample is put on the dividing plate of tool hole), placed 10 days down in room temperature condition, in sampling in the 0th, 5,10 day, carry out every inspection, high humidity test character, content, related substance, and item check result such as dissolution see Table 3.
The high wet test of table 3 is investigated the result
| Time (my god) | The investigation project | |||||
| Character | Dissolution | Disintegration | Related substance | Weightening finish | Content | |
| ????0 | Bright and clean, crack-free, content does not have precipitation | ??97.3％ | ????12′21″ | ????0.31％ | - | 100.0％ |
| ????5 | Bright and clean, easily break, content does not have precipitation | ??96.1％ | ????11′48″ | ????0.53％ | 3.52％ | 102.3％ |
| ????10 | Bright and clean, easily break, content does not have precipitation | ??95.2％ | ????12′01″ | ????0.52％ | 4.41％ | 103.1％ |
*In 0 day content was 100%
The high humidity result of the test shows that this product is placed after 10 days in the environment of relative humidity (RH) about 75%, character, content, dissolution and related substance there is no obvious change.
The present invention can be made into common soft capsule and two kinds of forms of special-shaped soft capsule, and special-shaped soft capsule also can be called the capsule-type drop, can be made into olive shape, ellipse, Pear-Shaped etc., good looking appearance, directly splash in the mouth after can be oral can puncturing again, or splash into the Sublingual and take, extremely easy to use.
The present invention easily packs, transports, storage, content accurately, good uniformity, and satisfy such dosage form and rationalize standard aspect stable in outward appearance, disintegration etc., stability is high, and can cover the special odor of reduced glutathion preferably, taste and abnormal smells from the patient zest are all not strong, easily be accepted, patient dependence is good.
Specific embodiments
The detailed component of the present invention is provided by the following example (being as the criterion with 1000), but protection scope of the present invention is not limited to this.)
Embodiment 1
With mixing in 1kg gelatin, 450g glycerol, 1kg water, putting of the 2.5g ethyl hydroxybenzoate glue jar, again with this mixture heated to about 70-80 ℃, mix homogeneously, evacuation filters, insulation is left standstill, and is stand-by; Get 20g glycerol, 180g PEG400, mix homogeneously add the 7.5g polyethylene glycol 6000, add 100g reduced glutathion and 0.15g folic acid again, the abundant mixing, measure content, after suppress degassing back in the soft capsule maker, put in the forming machine and finalize the design, after the washing drying, promptly.
Embodiment 2
With mixing in 1kg gelatin, 400g glycerol, 1kg water, putting of the 2.5g propyl p-hydroxybenzoate glue jar, again with this mixture heated to about 70-80 ℃, mix homogeneously, evacuation filters, insulation is left standstill, and is stand-by; Get 20g glycerol, 380g PEG400, mix homogeneously add the 18g polyethylene glycol 6000, add 200g reduced glutathion and 0.12g vitamin C again, the abundant mixing, measure content, after suppress degassing back in the soft capsule maker, put in the forming machine and finalize the design, after the washing drying, promptly.
Embodiment 3
With mixing in 1kg gelatin, 425g glycerol, 1kg water, putting of the 2.5g ethylparaben glue jar, again with this mixture heated to about 70-80 ℃, mix homogeneously, evacuation filters, insulation is left standstill, and is stand-by; Get 30g glycerol, 270g Macrogol 600, mix homogeneously add the 8g Macrogol 4000, add 100g reduced glutathion and 0.2g folic acid again, the abundant mixing, measure content, after suppress degassing back in the soft capsule maker, put in the forming machine and finalize the design, after the washing drying, promptly.
Embodiment 4
With mixing in 1kg gelatin, 450g glycerol, 1kg water, putting of the 2.5g methyl parahydroxybenzoate glue jar, again with this mixture heated to about 70-80 ℃, mix homogeneously, evacuation filters, insulation is left standstill, and is stand-by; Get 75g glycerol, 425g Macrogol 600, mix homogeneously add the 32g Macrogol 4000, add 500g reduced glutathion and 0.6g folic acid again, the abundant mixing, measure content, after suppress degassing back in the soft capsule maker, put in the forming machine and finalize the design, after the washing drying, promptly.
Embodiment 5
With mixing in 1kg gelatin, 425g glycerol, 1kg water, putting of the 2.5g ethyl hydroxybenzoate glue jar, again with this mixture heated to about 70-80 ℃, mix homogeneously, evacuation filters, insulation is left standstill, and is stand-by; Get 200g PEG400, mix homogeneously, add the 12g polyethylene glycol 6000, add 200g reduced glutathion and 0.12g folic acid again, the abundant mixing, measure content, after suppress degassing back in the soft capsule maker, put in the forming machine and finalize the design, after the washing drying, promptly.
Embodiment 6
With mixing in 1kg gelatin, 400g glycerol, 1kg water, putting of the 2.5g ethylparaben glue jar, again with this mixture heated to about 70-80 ℃, mix homogeneously, evacuation filters, insulation is left standstill, and is stand-by; Get 20g glycerol, 80g Macrogol 600, mix homogeneously add the 4g Macrogol 4000, add 100g reduced glutathion and 0.1g vitamin C again, the abundant mixing, measure content, after suppress degassing back in the soft capsule maker, put in the forming machine and finalize the design, after the washing drying, promptly.
Although described the present invention by specific embodiment, some is revised and equivalence is obvious for the technical staff who is proficient in this field, and these variations are believed to comprise within the scope of the present invention.
Claims (9)
1, a kind of reduced glutathione soft capsule, constitute by medicinal liquid and softgel shell two large divisions, it is characterized in that medicinal liquid by weight every contain 100-500mg reduced glutathion, 2.0-3.2% stabilizing agent and antioxidant and substrate, the gelatin that contains 10 parts of weight in the softgel shell, 4-4.5 the glycerol of part weight, the water of 10 parts of weight and an amount of antiseptic.
2,, it is characterized in that substrate is one or more in PEG400, Macrogol 600, the glycerol as the said reduced glutathione soft capsule of claim 1.
3,, it is characterized in that matrix optimization is the mixture of Polyethylene Glycol and glycerol as the said reduced glutathione soft capsule of claim 2.
4,, it is characterized in that substrate most preferably is the Polyethylene Glycol mixture that contains 10% glycerol as the said reduced glutathione soft capsule of claim 3.
5,, it is characterized in that stabilizing agent is polyethylene glycol 6000 or Macrogol 4000 as the said reduced glutathione soft capsule of claim 1.
6,, it is characterized in that antioxidant is folic acid or vitamin C as the said reduced glutathione soft capsule of claim 1.
7,, it is characterized in that antioxidant is preferably folic acid as the said reduced glutathione soft capsule of claim 6.
8,, it is characterized in that antiseptic is one or more in ethyl hydroxybenzoate, methyl parahydroxybenzoate, ethylparaben, propyl p-hydroxybenzoate, the butyl p-hydroxybenzoate as the said reduced glutathione soft capsule of claim 1.
9, as the said reduced glutathione soft capsule of claim 1, the preparation technology who it is characterized in that it may further comprise the steps: with mixing in the gelatin of recipe quantity, glycerol, water, putting of the antiseptic glue jar, again with this mixture heated to about 70-80 ℃, mix homogeneously, evacuation, filter, insulation is left standstill, and is stand-by; Get substrate, the mix homogeneously of recipe quantity, add the reduced glutathion and the antioxidant of recipe quantity again, fully mix, measure content, degassing back is put drop in the forming machine and to be finalized the design, after the washing drying, promptly in the soft capsule maker after the compacting.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200410090680 CN1634554A (en) | 2004-11-12 | 2004-11-12 | Reduced glutathione soft capsule and manufacturing process thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200410090680 CN1634554A (en) | 2004-11-12 | 2004-11-12 | Reduced glutathione soft capsule and manufacturing process thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN1634554A true CN1634554A (en) | 2005-07-06 |
Family
ID=34847606
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 200410090680 Pending CN1634554A (en) | 2004-11-12 | 2004-11-12 | Reduced glutathione soft capsule and manufacturing process thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1634554A (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102356879A (en) * | 2011-10-21 | 2012-02-22 | 深圳市俪斯生物科技有限公司 | Functional peptide-reinforced healthcare food |
-
2004
- 2004-11-12 CN CN 200410090680 patent/CN1634554A/en active Pending
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102356879A (en) * | 2011-10-21 | 2012-02-22 | 深圳市俪斯生物科技有限公司 | Functional peptide-reinforced healthcare food |
| CN102356879B (en) * | 2011-10-21 | 2014-08-06 | 深圳市俪斯生物科技有限公司 | Functional peptide-reinforced healthcare food |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN101380340B (en) | Wall-broken glossy ganoderma spore powder antioxidation method | |
| CN1623542A (en) | Butyl benzene phthalein soft capsule and its preparation method | |
| WO2015024218A1 (en) | Pharmaceutical composition, preparation method therefor and use thereof | |
| CN1850135A (en) | Duck-gallbladder-oil enteric coatal soft capsule preparation, its preparing method and use | |
| JP2021523195A (en) | HC-1119 formulation and its manufacturing method and use | |
| CN102028662B (en) | Levamlodipine besylate tablet, preparation process thereof and control method for relevant materials | |
| CN1634554A (en) | Reduced glutathione soft capsule and manufacturing process thereof | |
| CN107773550A (en) | A kind of coenzyme Q10 capsule and preparation method thereof | |
| JPH05505800A (en) | Pharmaceutical compositions containing ipriflavone, their preparation and therapeutic uses | |
| CN1883674A (en) | 'Jiang Tang Ning' preparation for treating diabetes and preparation method thereof | |
| CN111728946A (en) | Acarbose tablet composition and preparation method thereof | |
| CN103417483B (en) | memantine hydrochloride slow-release dry suspension and preparation method thereof | |
| CN1634553A (en) | Reduced glutathione soft capsule and manufacturing process thereof | |
| CN102000040A (en) | Febuxostat capsule drug combination and preparation method thereof | |
| CN103494827A (en) | Compound buccal adhesive tablet containing triamcinolone acetonide and preparation method thereof | |
| CN1331476C (en) | Method for preparing coenzyme-A sublingual lozenge | |
| CN102614143B (en) | High-stability vitamin C tablet and preparing process thereof | |
| CN1891256A (en) | Red sage root dispersible tablet for treating cornary heart diseae and its preparing method | |
| CN1533767A (en) | Vitamic C controlled release pill and its preparation method and use | |
| KR101234253B1 (en) | Oral soft capsule of folic acid having improved stability | |
| CN113575958B (en) | Health care composition and capsule for improving immunity and preparation method thereof | |
| CN114931561B (en) | Capsule composition for treating chronic pain and preparation method thereof | |
| CN103027898B (en) | Sitagliptin sustained-release pellet and preparation method thereof | |
| CN100358500C (en) | Fleabane and earthworm dripping pill and its preparing method | |
| CN1586486A (en) | Cefpodoxime proxetil soft capsule preparation and its preparing method |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C02 | Deemed withdrawal of patent application after publication (patent law 2001) | ||
| WD01 | Invention patent application deemed withdrawn after publication |