CN101987195A - Reduced glutathione medicine absorbed through oral mucosa - Google Patents

Reduced glutathione medicine absorbed through oral mucosa Download PDF

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Publication number
CN101987195A
CN101987195A CN2009100602880A CN200910060288A CN101987195A CN 101987195 A CN101987195 A CN 101987195A CN 2009100602880 A CN2009100602880 A CN 2009100602880A CN 200910060288 A CN200910060288 A CN 200910060288A CN 101987195 A CN101987195 A CN 101987195A
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medicine
composition
reduced glutathion
sodium
amount
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CN101987195B (en
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黄华
陈晓华
黄春雷
马国宏
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FUHUA PHARMALEUTICAL INDUSTRY Co Ltd SHANGHAI
SHANGHAI FORWARD PHARMACEUTICAL CO Ltd
CHONGQING LIYANG PHARMACEUTICAL DEVELOPMENT Co Ltd
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FUHUA PHARMALEUTICAL INDUSTRY Co Ltd SHANGHAI
SHANGHAI FORWARD PHARMACEUTICAL CO Ltd
CHONGQING LIYANG PHARMACEUTICAL DEVELOPMENT Co Ltd
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Abstract

The invention relates to a reduced glutathione medicine absorbed through an oral mucosa. The reduced glutathione medicine comprises reduced glutathione as an effective medicine component and acceptable auxiliary components in the oral mucosa medicine, wherein the auxiliary components contain pH adjusting components; and the pH value is 3.3 to 5.3, preferably 3.5-5.0 when the concentration of the aqueous solution of the medicine is 0.03g/ml. The medicine has no irritation on the oral cavity and can obviously enhance the bioavailability and curative effect of the medicine so that patients have satisfied compliance.

Description

The reduced glutathion medicine that oral transmucosal absorbs
Technical field
The present invention relates to the absorptive-type medicine of a kind of oral transmucosal, but specifically be the reduced glutathion medicine that a kind of oral transmucosal absorbs, comprise that a mouthful buccal tablet, buccal tablet, Sublingual tablet, oral cavity adhesion tablet and mouth paster etc. can be all or mainly by the pharmaceutical preparation of oral mucosas such as buccal mucosa and/or hypoglossis mucous membrane absorption.
Background technology
Reduced glutathion (Glutathione), chemical name are N-(N-L-γ-Gu Anxianji-L-cysteinyl-) glycine, are three peptides that contain sulfydryl (SH), participate in multiple important biochemical metabolism reaction in the body.Pharmaceutical research confirms that this chemical compound can be used for viral, ethanol toxicity, drug toxicity (as tumor chemotherapeutic drug, antituberculotics, spiritual department of neurology medicine, antidepressant drug, acetaminophen etc.) liver injury that causes and the control of aspects such as metal poisoning and radiotherapy infringement.
Glutathion belongs to tripeptide compound, and oral back absorbs at upper part of small intestine, is vulnerable to ereptic degraded and loses pharmacological function, and bioavailability is low.For this reason, among the Chinese patent publication number CN1408427A a kind of reduced type glutathione lozenge has been proposed, with the reduced glutathion is principal agent, form jointly with adjuvants such as filler, disintegrating agent, binding agent, absorption enhancer, correctives, lubricants, oral back is absorbed by oral mucosa, directly enter blood circulation by jugular vein and superior vena cava, can avoid medicine in the intestines and stomach, to be decomposed, improve bioavailability by erepsin.But discover that further part patient has certain zest in the oral cavity when taking this buccal tablet medicine, and cause salivation to increase, thereby the part medicine swallowed into stomach with saliva that its zest to the oral cavity has also caused patient's compliance undesirable.These are all in the performance that has to a certain degree influenced this bioavailability of medicament and curative effect.
Summary of the invention
At above-mentioned situation, the reduced glutathion medicine that the present invention will provide a kind of improved oral transmucosal to absorb on this basis to address the above problem, significantly improves this bioavailability of medicament and curative effect, and makes the patient can have ideal compliance.
The reduced glutathion medicine that oral transmucosal of the present invention absorbs is the active drug composition equally with the reduced glutathion, forms jointly with acceptable auxiliary element in the oral mucosa medicament.Wherein, contain the pH regulator composition in the said auxiliary element, and to make the pH value of aqueous solution when concentration is 0.03g/ml of medicine by said pH regulator composition be 3.3~5.3, wherein preferred pH value scope is 3.5~5.0.
Said pH regulator composition in the said medicine of the present invention, can select in the pharmacy to allow the composition commonly used that uses, comprise changing/carbonate of regulator solution pH value or bicarbonate composition be (as sodium carbonate, potassium carbonate, calcium carbonate, sodium bicarbonate, potassium bicarbonate etc.), phosphate or its acid salt composition are (as calcium phosphate, calcium hydrogen phosphate, sodium hydrogen phosphate, dipotassium hydrogen phosphate, sodium dihydrogen phosphate, potassium dihydrogen phosphate etc.), the citrate composition is (as sodium citrate, sodium citrate dihydrate, potassium citrate etc.), the lactate composition is (as sodium lactate, potassium lactate etc.), the malate composition is (as natrium malicum, potassium malate, calcium malate etc.), the tartrate composition is (as Soluble tartar., sodium potassium tartrate tetrahydrate etc.), vitamin C salt constituents is (as sodium ascorbate, vitamin C potassium, calcium ascorbate, vitamin C phosphoric ester sodium etc.), the alginate constituents is (as sodium alginate, potassium alginate, calcium alginate etc.), succinate composition (as sodium succinate), acetate composition (as sodium acetate etc.), the amino acids composition is (as arginine, histidine, lysine, cysteine etc.) at least a in.
Acceptable auxiliary element in the said oral mucosa medicament can be selected the common multiple adjunct ingredient that needs and/or use in the oral mucosa medicament preparation at present, comprising:
Disintegrating agent: as in polyvinylpolypyrrolidone, carboxymethyl starch sodium, cross-linking sodium carboxymethyl cellulose, low-substituted hydroxypropyl cellulose, microcrystalline Cellulose, microcrystalline Cellulose-micropowder silica gel, amylum pregelatinisatum, dried starch, starch, sodium alginate, alginic acid, hydroxypropyl starch, the carboxymethylcellulose calcium one or more, consumption generally can be 0.1%~50% of tablet total weight amount;
Diluent: as microcrystalline Cellulose, lactose, lactose complex Ludipress (forming), Ludipress LCE (forming), Ludiflash by lactose and Kollidon 30 by lactose, Kollidon 30 and KollidonCL (by 90%Mannitol, 5%
Figure B2009100602880D0000021
CL-SF and 5%
Figure B2009100602880D0000022
SR 30D composition), one or more in Cellactose 80, Tablettose 80, MicroceLac 100, StarLac, Prosolv HD 90, amylum pregelatinisatum, starch, Icing Sugar, glucose, calcium sulfate, dextrin, mannitol, erythritol, maltose, maltose alcohol, maltodextrin, sorbitol, the xylitol;
Binding agent: as polyvidone constituents commonly used (as Kollidon VA 64, Kollidon VA 64 Fine, PlasdoneS-630), starch slurry, hydroxypropyl emthylcellulose, methylcellulose, carrageenin, carbomer, guar gum, gelatin, arabic gum, xanthan gum, alginic acid or as sodium alginate, potassium alginate, its esters compositions such as calcium alginate, in the various compositions such as propylene glycol alginate one or more, sodium starch phosphate, chitosan, in dextrin and the syrup one or more;
Wetting agent: as in commonly used water, ethanol, dehydrated alcohol and the Different concentrations of alcohol solution one or more;
Taste masking (flavoring) agent: as glycyrrhizin commonly used, aspartame, crystalline maltose, handle agar (TAG), stevioside, sucralose, xanthan gum, glucide, vitamin C, fructose, glucosan, cyclamate, Suo Matian, glucide, menthol etc. and allow the sweeting agent that uses and/or in the edible essence composition one or more.
Lubricant: as in the compositions such as magnesium stearate commonly used, stearic acid, sodium stearyl fumarate, sodium lauryl sulphate, Macrogol 4000 (or polyethylene glycol 6000), micropowder silica gel, Pulvis Talci one or more.
In the above-mentioned pH regulator composition of the present invention, some can also have the function of others because of it, thereby when using as the pH regulator composition, can also have and bring into play the corresponding function of other auxiliary element simultaneously concurrently.
Reduced glutathion during the above-mentioned oral transmucosal of the present invention absorbs the drug, be containing in oral cavity (mainly in the mouth buccal), all or basically be by comprising that intraoral mucosal tissue such as buccal mucosa and hypoglossis mucous membrane absorbs onset, its concrete dosage form can comprise existing at present mouth buccal tablet, buccal tablet, Sublingual tablet, oral cavity adhesion tablet and the mouth paster etc. that use.
In the said medicine of the present invention, the content of said active drug composition reduced glutathion in pharmaceutical preparation, generally can be 1%~70% of medicine gross weight, the consumption of above-mentioned auxiliary element then can be respectively by the usual manner use of each corresponding preparations at present, the unitary content specification of pharmaceutical preparation can have 50mg, 100mg, 300mg, 500mg etc. by present usual way.
The preparation that the above-mentioned oral transmucosal of the present invention absorbs the drug can adopt the usual manner of present similar pharmaceutical preparation to prepare.With the buccal tablet medicine is example, and its typical preparation method can have:
A. wet granulation mode: with active drug composition reduced glutathion and selected pH regulator composition and other auxiliary element mix homogeneously, after adding binding agent granulation and drying, adding adds disintegrating agent and the abundant mixing of lubricant again, and tabletting makes the buccal tablet finished product.
B. direct compression mode: with active drug composition reduced glutathion and selected pH regulator composition and other auxiliary element mix homogeneously, direct compression makes the buccal tablet finished product.
Result of the test shows, the medicine of the above-mentioned form of the present invention can solve oral stimulation problems such as the existing acid of present similar medicine, puckery, fiber crops satisfactorily, good mouthfeel when the patient is on probation has ideal compliance, thereby has guaranteed the abundant absorption and the curative effect performance of medicine oral transmucosal.Simultaneously, the preparation method of this buccal tablet is simple, need not special installation, is easy to industrialization, the production efficiency height, and cost is low.
The specific embodiment by the following examples is described in further detail foregoing of the present invention again.But this should be interpreted as that the scope of the above-mentioned theme of the present invention only limits to following example.Do not breaking away under the above-mentioned technological thought situation of the present invention, various replacements or change according to ordinary skill knowledge and customary means are made all should comprise within the scope of the invention.
The specific embodiment
Embodiment 1 (buccal tablet)
Form: reduced glutathion 300g
Tablettose?80 60g
Microcrystalline Cellulose 30g
Natrium carbonicum calcinatum is an amount of
Histidine is an amount of
Mannitol 60g
Aspartame 3g
Magnesium stearate 3g
Make 1000
Preparation method: behind auxiliary element mix homogeneously such as reduced glutathion raw material and Tablettose 80, microcrystalline Cellulose, natrium carbonicum calcinatum, histidine, direct compression promptly, pH4.8-5.0.
Embodiment 2 (buccal tablet)
Form: reduced glutathion 300g
Ludipress?LCE 70g
Microcrystalline Cellulose 30g
Sorbitol 50g
Calcium hydrogen phosphate is an amount of
Potassium alginate is an amount of
Cyclamate 1g
Sucralose 8g
Make 1000
Preparation method: adopt the mode of embodiment 1, direct compression promptly.pH3.6-3.8。
Embodiment 3 (buccal tablet)
Form: reduced glutathion 300g
MicroceLac?100 70g
Microcrystalline Cellulose 30g
Sodium bicarbonate is an amount of
Lysine is an amount of
Mannitol 60g
Menthol 3g
Steviosin 10g
Sucralose 6g
Make 1000
Preparation method: adopt the mode of embodiment 1, direct compression promptly.pH4.4-4.6。
Embodiment 4 (buccal tablet)
Form: reduced glutathion 100g
Tablettose?80 30g
Pregelatinized Starch 10g
10% starch slurry is an amount of
Erythritol 25g
Low-substituted hydroxypropyl cellulose 4g (inside and outside half and half)
Menthol 0.1g
Sucralose 5g
Pulvis Talci 3g
Make 1000
Preparation method: reduced glutathion and auxiliary element mix homogeneously such as Tablettose 80 and pregelatinized Starch with recipe quantity, add 10% starch slurry, granulate, drying, granulate, adding adds low-substituted hydroxypropyl cellulose and Pulvis Talci, mixing, tabletting are promptly.pH3.0-3.1。
Embodiment 5 (buccal tablet)
Form: reduced glutathion 300g
Xylitol 50g
Mannitol 70g
Pregelatinized Starch 30g
Sodium citrate is an amount of
Calcium ascorbate is an amount of
Polyvinylpolypyrrolidone 15g (inside and outside half and half)
0.5% xanthan gum solution is an amount of
Sucralose 12g
Magnesium stearate 2g
Make 1000
Preparation method: with reduced glutathion and xylitol, mannitol, pregelatinized Starch, in add auxiliary element mix homogeneously such as polyvinylpolypyrrolidone, sodium citrate and calcium ascorbate, add 0.5% xanthan gum solution, granulate, dry, granulate, adding adds polyvinylpolypyrrolidone and magnesium stearate, and mixing, tabletting are promptly.pH3.7-3.9。
Embodiment 6 (buccal tablet)
Form: reduced glutathion 300g
Cellactose?80 60g
Microcrystalline Cellulose 50g
Xylitol 40g
Polyvinylpolypyrrolidone 14g (inside and outside half and half)
0.8% xanthan gum solution is an amount of
Sucralose 16g
Magnesium stearate 2g
Make 1000
Preparation method: auxiliary element mix homogeneously such as reduced glutathion and Cellactose 80, pregelatinized Starch, xylitol and sucralose, add 0.8% xanthan gum solution, granulate, drying, granulate, adding adds polyvinylpolypyrrolidone and magnesium stearate, mixing, tabletting, promptly.pH3.1-3.2。
Embodiment 7 (buccal tablet)
Form: reduced glutathion 100g
Ludiflash 18g
Pregelatinized Starch 15g
Xylitol 20g
Sodium citrate is an amount of
Sodium ascorbate is an amount of
0.4% xanthan gum solution is an amount of
Sucralose 5g
Pulvis Talci 3g
Make 1000
Preparation method: reduced glutathion and auxiliary element mix homogeneously such as Ludiflash, pregelatinized Starch, xylitol, sodium citrate and sodium ascorbate with recipe quantity add 0.4% xanthan gum solution, mixing, granulate drying, granulate, add Pulvis Talci, mixing, tabletting are promptly.pH4.0-4.2。
Embodiment 8 (buccal tablet)
Form: reduced glutathion 300g
Cellactose?80 50g
Pregelatinized Starch 40g
Erythritol 60g
Sodium alginate is an amount of
Sodium succinate is an amount of
Cross-linking sodium carboxymethyl cellulose 12g (in add)
5%Kollidon VA64 is an amount of
Sucralose 14g
Magnesium stearate 2g
Make 1000
Preparation method: with auxiliary element mix homogeneously such as reduced glutathion and Cellactose 80, pregelatinized Starch, mannitol, cross-linking sodium carboxymethyl cellulose, sodium alginate and sodium succinates, it is an amount of to add 5%Kollidon VA64 aqueous solution, granulate, dry, granulate, add magnesium stearate, tabletting promptly.pH4.6-4.8。
Embodiment 9 (buccal tablet)
Form: reduced glutathion 100g
Erythritol 40g
Pregelatinized Starch 20g
Tricalcium phosphate is an amount of
Natrium malicum is an amount of
10% starch slurry 8g
Polyvinylpolypyrrolidone 3g (adding)
Glycyrrhizin 6g
Aspartame 3g
Stearic acid 2g
Make 1000
Preparation method: reduced glutathion and auxiliary element mix homogeneously such as erythritol, pregelatinized Starch, tricalcium phosphate and natrium malicum with recipe quantity add 10% starch slurry, mixing, granulate drying, granulate, add polyvinylpolypyrrolidone and stearic acid, mixing, tabletting are promptly.pH5.5-5.6。
Embodiment 10 (buccal tablet)
Form: reduced glutathion 300g
Cellactose?80 60g
Pregelatinized Starch 40g
Xylitol 50g
Sodium citrate is an amount of
Sodium ascorbate is an amount of
Low-substituted hydroxypropyl cellulose 15g (inside and outside half and half)
0.5% xanthan gum solution is an amount of
Sucralose 12g
Magnesium stearate 2g
Make 1000
Preparation method: with reduced glutathion and Cellactose 80, pregelatinized Starch, xylitol, in add auxiliary element mix homogeneously such as low-substituted hydroxypropyl cellulose, sodium citrate and sodium ascorbate, add 0.5% xanthan gum solution, granulate, dry, granulate, adding adds low-substituted hydroxypropyl cellulose and magnesium stearate, and mixing, tabletting are promptly.pH3.5-3.6。
Embodiment 11 (buccal tablet)
Form: reduced glutathion 100g
Tablettose?80 18g
Pregelatinized Starch 15g
Xylitol 25g
Sodium ascorbate is an amount of
Cysteine is an amount of
10% starch slurry is an amount of
Low-substituted hydroxypropyl cellulose 4g (inside and outside half and half)
Sucralose 5g
Magnesium stearate 3g
Make 1000
Preparation method: with the reduced glutathion and the auxiliary element mixings such as Tablettose 80, pregelatinized Starch, xylitol, sodium ascorbate, cysteine and sucralose of recipe quantity, add 10% starch slurry of preparation in advance, mix homogeneously, granulate, drying, granulate adds low-substituted hydroxypropyl cellulose and magnesium stearate, mixing, tabletting are promptly.pH3.8-3.9。
Embodiment 12 (buccal tablet)
Form: reduced glutathion 300g
Cellactose?80 50g
Pregelatinized Starch 40g
Erythritol 60g
Sodium citrate is an amount of
Sodium ascorbate is an amount of
Cross-linking sodium carboxymethyl cellulose 16g (inside and outside half and half)
0.5% xanthan gum solution is an amount of
Sucralose 14g
Magnesium stearate 2g
Make 1000
Preparation method: with reduced glutathion and Cellactose 80, pregelatinized Starch, erythritol, in add auxiliary element mix homogeneously such as cross-linking sodium carboxymethyl cellulose, sodium citrate, sodium ascorbate and sucralose, add 0.5% xanthan gum solution, granulate, dry, add and add cross-linking sodium carboxymethyl cellulose and magnesium stearate, mixing, tabletting are promptly.pH3.6-3.8。
Embodiment 13 (mouth paster or oral cavity adhesion tablet)
Form: reduced glutathion 300g
Maltose 60g
Sodium acetate is an amount of
Sodium lactate is an amount of
Mannitol 60g
Carbomer 8g
Hydroxypropyl emthylcellulose 6g
The sweet 2g of rope horse
Micropowder silica gel 5g
Make 1000
Preparation method: with the reduced glutathion and the auxiliary element mix homogeneously such as maltose, mannitol, sodium acetate, sodium lactate, Suo Matian, carbomer and hydroxypropyl emthylcellulose of recipe quantity, tabletting promptly.pH4.3-4.5。
Embodiment 14 (buccal tablet)
Form: reduced glutathion 500g
Tablettose?80 100g
Microcrystalline Cellulose 40g
Xylitol 80g
Natrium malicum is an amount of
Arginine is an amount of
Polyvinylpolypyrrolidone 18g (inside and outside half and half)
4% gelatin is an amount of
Glycyrrhizin 14g
Polyethylene glycol 6000 6g
Make 1000
Preparation method: reduced glutathion and Tablettose 80, microcrystalline Cellulose, xylitol, natrium malicum, arginine and glycyrrhizin mix homogeneously with recipe quantity, add 4% gelatin solution, granulate, drying, granulate adds polyethylene glycol 6000, mixing, tabletting are promptly.pH3.3-3.5。
Embodiment 15 (Sublingual tablet)
Form: reduced glutathion 50g
Maltodextrin 30g
Microcrystalline Cellulose 10g
Soluble tartar. is an amount of
Carboxymethyl starch sodium 3g
Sucralose 3g
Aspartame 0.5g
Make 1000
Preparation method: the reduced glutathion and the auxiliary elements such as maltodextrin, microcrystalline Cellulose, carboxymethyl starch sodium and Soluble tartar. of recipe quantity are crossed 100 mesh sieves, and mix homogeneously, direct compression are promptly.pH5.1-5.3。
Embodiment 16 (buccal tablet)
Form: reduced glutathion 300g
Erythritol 30g
Microcrystalline Cellulose 30g
Xylitol 70g
Cysteine is an amount of
Calcium ascorbate is an amount of
Cross-linking sodium carboxymethyl cellulose 16g (inside and outside half and half)
15% starch slurry is an amount of
Sucralose 15g
Stearic acid 2g
Make 1000
Preparation method: with auxiliary element mix homogeneously such as reduced glutathion and erythritol, microcrystalline Cellulose, cysteine and calcium ascorbates, it is an amount of to add 15% starch slurry, granulates, drying, granulate, adding adds cross-linking sodium carboxymethyl cellulose and stearic acid, mixing, tabletting are promptly.pH4.2-4.3。
The pH value detection method of the various embodiments described above medicine: get the medicine of each embodiment respectively, fully dissolve with distilled water, be mixed with the solution that concentration is 0.03g/ml after, measure its pH value with PHS-3C type pH meter.
By following comparative test result, the various embodiments described above medicine that has different pH value as can be seen respectively is to eliminating oral stimulation and improving the effect that the bioavailability aspect is had.
One, oral mucosa irritation test
Test method: 10 of healthy Golden Hamster are divided into 2 groups at random, after the anesthesia buccal tablet are placed the utmost point lower of the central buccal mucosa in animal left side, and right side not administration of buccal mucosa in contrast.Wherein (embodiment 6 for one group of reduced type glutathione lozenge that gives not add the pH regulator agent, pH3.2-3.3), another group gives the adding pH regulator agent of Isodose, and (embodiment 16, pH4.2-4.3) reduced type glutathione lozenge, every day 1 time, successive administration seven days is put to death animal, perusal medicine-feeding part situation, and make tissue slice.
Result of the test:
Perusal: in the animal groups that gives embodiment 6 medicines, relatively little rough of mucosa that 1/5 animal contacts with medicine and normal mucosa is arranged, little have a red and swollen phenomenon; Give in the animal groups of embodiment 16 medicines, the buccal mucosa color and luster that contacts with medicine is normal, does not see coarse, red and swollen phenomenon.
Two, the healthy volunteer takes mouthfeel test (20 people)
Test method: get the foregoing description medicine each 1, place buccal between subject oral cavity buccal mucosa and gums respectively.Result of the test is as shown in table 1.
Result of the test shows, the said medicine of the present invention is to the zest effect of oral mucosa, the influence that changed by the medicine pH value is remarkable: pH value is during less than 3.3 (0.03g/ml solution), mouthfeel has acid, puckery zest, and salivation increases (embodiment 4:pH3.0-3.1, embodiment 6:pH3.2-3.3), and pH was greater than 5.3 o'clock, the saline taste excitement is then arranged, and salivation increases equally slightly that (embodiment 9, pH5.5-5.6).And in the said pH value scope of the present invention, particularly in preferred pH value scope, then can significantly improve and eliminate the existing oral mucosa pessimal stimulation sense that causes the salivation amount to increase of present similar medicine.If adopt the correctives of suitable consumption to cooperate down simultaneously again, can further make medicine can have good mouthfeel, the secretory volume of saliva does not increase substantially, thereby has guaranteed that effectively the abundant oral transmucosal of medicine absorbs onset, guarantees therapeutic effect.
Table 1 healthy volunteer takes mouthfeel result of the test (20 people)
Trial drug Oral stimulation sense/number The irriate salivation increases situation/number
Embodiment 1 Do not have Do not have
Embodiment 2 Do not have Do not have
Embodiment 3 Do not have Do not have
Embodiment 4 Mouthfeel is acid, puckery/3 Have/5
Embodiment 5 Do not have Do not have
Embodiment 6 Mouthfeel is acid/5 Have/4
Embodiment 7 Do not have Do not have
Embodiment 8 Do not have Do not have
Embodiment 9 Mouthfeel is more salty/and 11 Have/2
Embodiment 10 Do not have Do not have
Embodiment 11 Do not have Do not have
Embodiment 12 Do not have Do not have
Embodiment 13 Do not have Do not have
Embodiment 14 Do not have Do not have
Embodiment 15 Do not have Do not have
Embodiment 16 Do not have Do not have

Claims (3)

1. the reduced glutathion medicine that absorbs of oral transmucosal, with the reduced glutathion is the active drug composition, form jointly with acceptable auxiliary element in the oral mucosa medicament, it is characterized in that the pH regulator composition is arranged in the said auxiliary element, and to make the pH value of aqueous solution when concentration is 0.03g/ml of medicine by it be 3.3~5.3.
2. the reduced glutathion medicine that oral transmucosal as claimed in claim 1 absorbs is characterized in that the pH value of aqueous solution when concentration is 0.03g/ml of said medicine is 3.5~5.0.
3. the reduced glutathion medicine that oral transmucosal as claimed in claim 1 or 2 absorbs is characterized in that said pH regulator composition comprises at least a in carbonate or bicarbonate composition, phosphate or its acid salt composition, citrate composition, lactate composition, malate composition, tartrate composition, vitamin C salt constituents, alginate constituents, succinate composition, acetate composition and the amino acids composition.
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CN102416162A (en) * 2010-09-28 2012-04-18 上海复旦复华药业有限公司 Reduction type glutathione medicament absorbed through oral mucosa
US9308234B2 (en) 2012-10-29 2016-04-12 The University Of North Carolina At Chapel Hill Methods and compositions for treating mucosal tissue disorders
CN106692097A (en) * 2015-07-16 2017-05-24 北京万生药业有限责任公司 Reduced glutathione medicinal preparation
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Family Cites Families (1)

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CN1164326C (en) * 2002-08-29 2004-09-01 黄华 Reduced type glutathione lozenge

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US9308234B2 (en) 2012-10-29 2016-04-12 The University Of North Carolina At Chapel Hill Methods and compositions for treating mucosal tissue disorders
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JP2018168103A (en) * 2017-03-30 2018-11-01 株式会社カネカ Method for producing glutathione-containing composition
US11497786B2 (en) 2017-11-17 2022-11-15 Renovion, Inc. Stable ascorbic acid compositions and methods of using the same
US11890315B2 (en) 2017-11-17 2024-02-06 Renovion, Inc. Stable ascorbic acid compositions and methods of using same

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