CN106344500A - Oral liquid preparation capable of enhancing immunity - Google Patents
Oral liquid preparation capable of enhancing immunity Download PDFInfo
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- CN106344500A CN106344500A CN201610942245.5A CN201610942245A CN106344500A CN 106344500 A CN106344500 A CN 106344500A CN 201610942245 A CN201610942245 A CN 201610942245A CN 106344500 A CN106344500 A CN 106344500A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
- A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/425—Thiazoles
- A61K31/427—Thiazoles not condensed and containing further heterocyclic rings
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
- A61K38/05—Dipeptides
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/46—Ingredients of undetermined constitution or reaction products thereof, e.g. skin, bone, milk, cotton fibre, eggshell, oxgall or plant extracts
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
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Abstract
The invention discloses an oral liquid preparation capable of enhancing immunity, which can stimulate human immunoreaction, obviously reduce the emergent onset times and degree of infectious diseases, and shorten the development and progression courses of diseases. The oral liquid preparation contains components of pidotimod, chemical stabilizers, flavoring agents, and the like. The stability and flavor of the oral liquid preparation can be obviously improved through the quantitative proportion and synergic action by adopting water as a solvent, the bioavailability of the oral liquid preparation is obviously higher than that of a solid preparation, the dispersion degree is large, and the oral liquid preparation is more suitable for carrying and oral administration of old people or children.
Description
Technical field
The present invention relates to a kind of oral liquid strengthening immunity, belong to technical field of medicine.
Background technology
Immunomodulating refers between the immunocyte in immune system and immune molecule, and with other systems as nerve is interior
Interaction between excretory system is so that immunne response maintains optimal level with form the most appropriate.It is that body is known
Not with exclusion antigenicity foreign body, maintain own physiological dynamic equilibrium stable with relative, immunomodulating is to rely on immune system
(immune system) is come to realize；Immunomodulating reaction in human body includes specific immune response and nonspecific immunity
Reaction, directly affects the health status of human body.Pidotimod is one kind safely and effectively Immunopromoter, a kind of full conjunction
The immunostimulation modulators becoming, it is similar to that dipeptides, and oral and intramuscular injection has good bioavailability, by thorn
Sharp nonspecific innate immunity, humoral immunization and cellular immunization produce effect.It is acute and chronic toxic effect is all very low.Dynamic
Thing experimental dogs have no any toxic reaction for 6 months with 40 50 times of highest therapeutic dose oral administrations.Pharmacokineticss show mouth
Take 1.8 native 0.1 hour serum-concentration peaking after 400mg pidotimod, biological utilisation is 42%, half-life t1/2=4.4 soil 0.2
Hour；It is not metabolized decomposition after oral, is discharged through kidney with original shape, zoopery and clinical experiment all show, although pidotimod
No direct antibacterial and antiviral activity, but by the regulation to body's immunity, can significantly play its therapeutical effect and be suitable for
In the low patient of body's immunity: lower respiratory tract repeated infection (pharyngitis, tracheitiies, bronchitis etc.)；Department of otorhinolaryngology is anti-
Multiple infection (rhinitis, tonsillitiss, sinusitis, otitis media)；Urinary system infection and gynecological infection simultaneously can be used for preventing acute sense
Dye, shortens the course of disease, reduces the order of severity of disease, reduces number of times and the degree of acute disease outbreak, shortens the mistake of disease development
Journey, can be used as the adjuvant drug of acute infection period.
Pidotimod is bonded by peptide by two aminoacid as a kind of Immunopromoter of chemosynthesis, its structure
Connect；The raw material of general synthesis is l- cysteine and l- pyroglutamic acid, and these aminoacid are all the aminoacid that human body needs, so
One of feature of product is avirulence, and it is acute and chronic toxic effect is all very low, up to the present, should used pidotimod
Patient do not have any Reporting of harms.
Worldwide, the listing dosage form of pidotimod has tablet, granule, oral solution and injection.Wherein,
With oral solution using the most convenient, quite welcome by most of patients, especially child and gerontal patient.But, due to
Many not morals are similar to that dipeptides, and its aqueous solution is all unstable under acid, alkali, heat, oxidizing condition, so in pidotimod medicine
During thing preparation, the stability of solution of pidotimod is a very crucial problem.
In prior art, Chinese patent literature cn102525903a discloses a kind of oral liquid of pidotimod,
Described oral liquid contains the components such as pidotimod, chemical stabilizer, ph regulator and correctivess, and adopts three hydroxyl first
Base aminomethane, as ph regulator, by quantitative proportioning and the synergism of each component, can effectively improve the steady of solution
Qualitative.But, comprise saccharide in the correctivess that above-mentioned pidotimod oral solution formulation contains, be unfavorable for diabeticss and its
He should not be taken with sugared patient.Adopt sodium hydroxide to adjust ph value simultaneously, increased operation, also bring some products unstable
Property.
Inventors believe that, in the component of pidotimod oral formulations and preparation, fully take into account, all groups of preparation
/ synergism, component is more few better simultaneously.That is, accounting for for pidotimod oral formulations stability
When it is impossible to only consider ph value regulator interpolation, simultaneously consideration other components regulation, thus it is higher to obtain stability
Pidotimod oral formulations.
Content of the invention
Present invention aim at providing the rational proportion between a kind of component by adjustment, making its steady quality, be easy to steady
The pidotimod oral liquid of fixed storage.
To achieve these goals, the present invention adopts the following technical scheme that
Strengthen the oral liquid of immunity, described oral liquid comprises pidotimod, sodium chloride, stabilizer, ph regulation
Agent, preservative, correctivess and pigment；In parts by weight, contain following component: pidotimod 20-60 in every 700 ml oral liquids
Gram, 0.56 gram of sodium chloride, 0.3-0.4 gram of stabilizer, 15.48-23.22 gram of ph regulator；Preservative: 1.0-1.4 gram, correctivess
142-213 gram, 0.8-1.2 gram of pigment.
Described stabilizer is one of disodiumedetate, sodium sulfite, sodium thiosulfate and sodium pyrosulfite
Or it is multiple.
Described ph regulator be in N-tris hydroxymethyl aminomethane and sodium citrate one or two.
Described preservative is Sodium Methyl Hydroxybenzoate, P-hydroxybenzoic acid ice ester sodium, p-hydroxyanisole, benzoic acid
One or two combinations in sodium, chlorobutanol.
Described correctivess are sweeting agent and aromatic composition.
Described sweeting agent is by one or more of Mannitol, 2,4- hexadiene alcohol, acesulfame potassium, saccharin sodium；Described fragrance
Agent is one or more in natural raspberry extract, natural blueberry extract and edible essence.
Described pigment is carmine, one or two combinations of blueberry anthocyanin, Grape cyanidins.
The ph value of described oral liquid is 5.5-7.5.
Described oral liquid be true solution, syrupy shape runny purplish red to dark red liquid.
The oral liquid configuration of the present invention includes procedure below, adds correctivess and preservative in dispensing containers,
Add appropriate purified water (ph 6.0 ± 1) to dissolve, add ph regulator, sodium chloride and stabilizer and add water to nearly scale, plus
Many not morals and pigment add purified water to full dose, measure ph value, scope is between ph 5.5-7.5.
Pidotimod and related component are configured to purplish red to wine-colored supernatant liquid by the present invention, and taste is sweet, and mouthfeel is suitable,
It is applied to Most patients, be particularly suited for child and old people takes；Its composition proportion is suitable, adopts and uses water as solvent, medicine
Thing is safe and stable, reliable, taking convenience, and compliance is strong.
The present invention, during configuration, according to suitable ingredients proportioning, without adjusting ph, enormously simplify preparation process,
Cost-effective, it is excessive and lead to medicine degeneration to it also avoid ph regulator consumption during adjusting, also ensure that simultaneously technique and
The stability of product, masks pidotimod bitterness completely by the suitable proportion of various correctivess and is unfavorable for oral shortcoming,
Make the more mellow silk floss of mouthfeel of PIDOTIMOD ORAL SOLUTION soft, strengthen this product compliance.
Specific embodiment
For the ease of more fully being understood to technical solutions according to the invention, enter to advance below with reference to embodiment
The explanation of one step.
Embodiment 1:
By weight, contain following component in every 700 ml oral liquids: 20 grams of pidotimod, 0.56 gram of sodium chloride, ethylenediamine tetraacetic
0.30 gram of acetic acid disodium, 19.35 grams of N-tris hydroxymethyl aminomethane；1.00 grams of soluble metyl hydroxybenzoate, 0.15 gram of soluble propylhydroxybenzoate, acesulfame potassium
0.4 gram, 150 grams of 2,4- hexadiene alcohol, 2.0 grams of bramble natural essence, 1.0 grams of blueberry anthocyanin, 50 milligrams of carmine, remaining
For water.
150 grams of 2,4- hexadiene alcohol, 0.4 gram of acesulfame potassium, 2.0 grams of bramble natural essence, Ni Bo is added in dispensing containers
1.00 grams of tortoise beetle ester sodium and 0.15 gram of soluble propylhydroxybenzoate, the appropriate purified water of addition (ph6.0 ± 1) dissolving, then plus slow hematic acid
19.35 grams of ammonium, 0.56 gram of sodium chloride, 0.3 gram of disodiumedetate add water to nearly scale, add 20 grams of pidotimod, indigo plant
2.0 grams of certain kind of berries anthocyanidin, 50 milligrams of carmine, finally add water to full dose, are dissolved to clarification, measure ph value, scope is in ph5.5-
Between 7.5.
Embodiment 2:
By weight, contain following component in every 700 ml oral liquids: 40 grams of pidotimod, 0.56 gram of sodium chloride, ethylenediamine tetraacetic
0.35 gram of acetic acid disodium, 19.3 grams of N-tris hydroxymethyl aminomethane；1.03 grams of soluble metyl hydroxybenzoate, 0.16 gram of soluble propylhydroxybenzoate, acesulfame potassium
0.5 gram, 175 grams of 2,4- hexadiene alcohol, 2.1 grams of bramble natural essence, 1.0 grams of blueberry anthocyanin, 50 milligrams of carmine, remaining
For water.
175 grams of 2,4- hexadiene alcohol, 0.5 gram of acesulfame potassium, 2.1 grams of bramble natural essence, Ni Bo is added in dispensing containers
1.03 grams of tortoise beetle ester sodium and 0.16 gram of soluble propylhydroxybenzoate, the appropriate purified water of addition (ph6.0 ± 1) dissolving, then plus N-tris hydroxymethyl aminomethane
19.3 grams, 0.56 gram of sodium chloride, 0.35 gram of disodiumedetate add water to nearly scale, add 40 grams of pidotimod, blue berry
1.0 grams of anthocyanidin, 50 milligrams of carmine, finally add water to full dose, are dissolved to clarification, measure ph value, scope is in ph5.5-7.5
Between.
Embodiment 3:
By weight, contain following component in every 700 ml oral liquids: 60 grams of pidotimod, 0.56 gram of sodium chloride, ethylenediamine tetraacetic
0.40 gram of acetic acid disodium, 23.3 grams of N-tris hydroxymethyl aminomethane；1.03 grams of soluble metyl hydroxybenzoate, 0.1 gram of p-hydroxyanisole, acesulfame potassium 0.5
Gram, 185 grams of 2,4- hexadiene alcohol, 2.1 grams of bramble natural essence, 1.0 grams of blueberry anthocyanin, 50 milligrams of carmine, remaining is
Water.
185 grams of 2,4- hexadiene alcohol, 0.5 gram of acesulfame potassium, 2.1 grams of bramble natural essence, Ni Bo is added in dispensing containers
1.03 grams of tortoise beetle ester sodium and 0.1 gram of p-hydroxyanisole, the appropriate purified water of addition (ph 6.0 ± 1) dissolving, then plus N-tris hydroxymethyl aminomethane
19.3 grams, 0.56 gram of sodium chloride, 0.4 gram of disodiumedetate and 40 grams of pidotimod add water to nearly scale, and dissolving is clarified,
Adding 1.0 grams of blueberry anthocyanin, 50 milligrams of carmine, dissolving, adding water to enough, measure ph value, scope is in ph 5.5-7.5
Between.
PIDOTIMOD ORAL SOLUTION stability accelerates to investigate result
Through study on the stability, condition of investigating is to accelerate 40 DEG C 0 month to the oral liquid of the present invention, January, 2 months, March, 6 monthly examinations
Examine；Result is as follows:
| Embodiment 1 | ||||
| 40 DEG C of acceleration | Appearance character | ph | Content (%) | Relevant material (%) |
| 0 month | Purplish red solution supernatant liquid | 6.88 | 99.88 | Always miscellaneous: 0.35 |
| January | Purplish red solution supernatant liquid | 6.88 | 99.82 | Always miscellaneous: 0.35 |
| 2 months | Purplish red solution supernatant liquid | 6.82 | 99.83 | Always miscellaneous: 0.35 |
| March | Purplish red solution supernatant liquid | 6.51 | 99.75 | Always miscellaneous: 0.55 |
| June | Purplish red solution supernatant liquid | 6.46 | 99.65 | Always miscellaneous: 0.60 |
| Embodiment 2 | ||||
| 40 DEG C of acceleration | Appearance character | ph | Content (%) | Relevant material (%) |
| 0 month | Purplish red solution supernatant liquid | 6.51 | 99.93 | Always miscellaneous: 0.25 |
| January | Purplish red solution supernatant liquid | 6.50 | 99.83 | Always miscellaneous: 0.30 |
| 2 months | Purplish red solution supernatant liquid | 6.47 | 99.83 | Always miscellaneous: 0.38 |
| March | Purplish red solution supernatant liquid | 6.45 | 99.85 | Always miscellaneous: 0.45 |
| June | Purplish red solution supernatant liquid | 6.20 | 99.76 | Always miscellaneous: 0.58 |
| Embodiment 3 | ||||
| 40 DEG C of acceleration | Appearance character | ph | Content (%) | Relevant material (%) |
| 0 month | Purplish red solution supernatant liquid | 6.18 | 99.79 | Always miscellaneous: 0.32 |
| January | Purplish red solution supernatant liquid | 6.18 | 99.72 | Always miscellaneous: 0.35 |
| 2 months | Purplish red solution supernatant liquid | 6.12 | 99.77 | Always miscellaneous: 0.35 |
| March | Purplish red solution supernatant liquid | 6.10 | 99.65 | Always miscellaneous: 0.55 |
| June | Purplish red solution supernatant liquid | 5.94 | 99.55 | Always miscellaneous: 0.60 |
As can be seen from the above table, experiment is investigated in 40 DEG C of acceleration through 6 months, and PIDOTIMOD ORAL SOLUTION appearance character is more steady
Fixed, it is aubergine supernatant liquid, ph value stabilization, content has no obvious decay, and relevant material has no and rises appreciably, and shows this
Bright immunoregulatory oral liquid quality safety, stable, reliable.
Claims (9)
1. a kind of oral liquid strengthening immunity is it is characterised in that described oral liquid comprises pidotimod, chlorination
Sodium, stabilizer, ph regulator, preservative, correctivess and pigment；In parts by weight, contain following one-tenth in every 700 ml oral liquids
Point: 20-60 gram of pidotimod, 0.56 gram of sodium chloride, 0.3-0.4 gram of stabilizer, 15.48-23.22 gram of ph regulator；Anti-corrosion
Agent: 1.0-1.4 gram, 142-213 gram of correctivess, 0.8-1.2 gram of pigment.
2. strengthen the oral liquid of immunity according to claim 1 it is characterised in that described stabilizer is ethylenediamine
One or more of tetraacethyl disodium, sodium sulfite, sodium thiosulfate and sodium pyrosulfite.
3. strengthen the oral liquid of immunity according to claim 1 it is characterised in that described ph regulator is slow hematic acid
In ammonium and sodium citrate one or two.
4. strengthen the oral liquid of immunity according to claim 1 it is characterised in that described preservative is para hydroxybenzene
One or two groups in methyl formate sodium, P-hydroxybenzoic acid ice ester sodium, p-hydroxyanisole, sodium benzoate, chlorobutanol
Close.
5. strengthen according to claim 1 immunity oral liquid it is characterised in that described correctivess be sweeting agent and
Aromatic forms.
6. the oral liquid strengthening immunity according to claim 5 is it is characterised in that described sweeting agent is by manna
One or more of alcohol, 2,4- hexadiene alcohol, acesulfame potassium, saccharin sodium；Described aromatic is natural raspberry extract, natural indigo plant
One or more in certain kind of berries extract and edible essence.
7. strengthen the oral liquid of immunity according to claim 1 it is characterised in that described pigment is carmine, indigo plant
One or two combinations of certain kind of berries anthocyanidin, Grape cyanidins.
8. strengthen the oral liquid of immunity according to claim 1 it is characterised in that described oral liquid
Ph value is 5.5-7.5.
9. according to claim 1 oral liquid it is characterised in that described oral liquid be true solution, sugar
Pulpous state runny purplish red to dark red liquid.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610942245.5A CN106344500A (en) | 2016-11-02 | 2016-11-02 | Oral liquid preparation capable of enhancing immunity |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610942245.5A CN106344500A (en) | 2016-11-02 | 2016-11-02 | Oral liquid preparation capable of enhancing immunity |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN106344500A true CN106344500A (en) | 2017-01-25 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201610942245.5A Pending CN106344500A (en) | 2016-11-02 | 2016-11-02 | Oral liquid preparation capable of enhancing immunity |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107510650A (en) * | 2017-08-31 | 2017-12-26 | 山东达因海洋生物制药股份有限公司 | A kind of Pidotimod oral administration solution and preparation method thereof |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102525903A (en) * | 2012-01-20 | 2012-07-04 | 江苏吴中医药集团有限公司 | Oral liquid preparation of pidotimod |
-
2016
- 2016-11-02 CN CN201610942245.5A patent/CN106344500A/en active Pending
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102525903A (en) * | 2012-01-20 | 2012-07-04 | 江苏吴中医药集团有限公司 | Oral liquid preparation of pidotimod |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107510650A (en) * | 2017-08-31 | 2017-12-26 | 山东达因海洋生物制药股份有限公司 | A kind of Pidotimod oral administration solution and preparation method thereof |
| CN107510650B (en) * | 2017-08-31 | 2021-03-26 | 山东达因海洋生物制药股份有限公司 | Pidotimod oral solution and preparation method thereof |
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