CN104083388A - Special ultrafine powder freeze-dried preparation of compound ammonium glycyrrhizinate and preparation method thereof - Google Patents
Special ultrafine powder freeze-dried preparation of compound ammonium glycyrrhizinate and preparation method thereof Download PDFInfo
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- CN104083388A CN104083388A CN201410063364.4A CN201410063364A CN104083388A CN 104083388 A CN104083388 A CN 104083388A CN 201410063364 A CN201410063364 A CN 201410063364A CN 104083388 A CN104083388 A CN 104083388A
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Abstract
The invention discloses a special ultrafine powder freeze-dried preparation of compound ammonium glycyrrhizinate and a preparation method thereof. The special ultrafine powder freeze-dried preparation comprises the following components by mass: 3-5 parts of ammonium glycyrrhizinate; 30-50 parts of glycine; and 2.5-3.5 parts of L-cysteine monohydrochloride. The particle size of the special ultrafine powder freeze-dried preparation of compound ammonium glycyrrhizinate is 0.8-5 micrometers. The prepared compound ammonium glycyrrhizinate preparation has high purity, through regulation of preparation conditions, the particle size of the powder can be controlled in the range of 0.8-5 micrometers and is micrometer scale, and the powder has uniform size distribution and good re-dissolution, and can be conducive to absorption of effective components in the drug, thereby enhancing the efficacy of the drug. The preparation method involved in the invention has the characteristics of mild reaction conditions, simple steps and process, and easy control, and can be convenient to realize mass production of the special ultrafine powder freeze-dried preparation of compound ammonium glycyrrhizinate.
Description
Technical field
The present invention is specifically related to extraordinary superfine powder lyophilized formulations of a kind of compound ammonium glycyrrhizinato and preparation method thereof, belongs to medical technical field.
Background technology
The main effective ingredient of compound ammonium glycyrrhizinato is ammonium glycyrrhizinate (Monoammonium Glycyrrhizinate), its molecular formula is C42H65NO165H2O, there is strong sweet taste, sugariness is about 200 times of sucrose, conventionally can be used as the sweeting agent in food additive, for canned meat, flavouring agent, confection, cookies, fruit jelly and beverage etc.
Monoammonium glycyrrhizinate has stronger affinity to liver at sterin metabolic enzyme, thereby hinders the deactivation of hydrocortisone and aldosterone, shows obvious 17-hydroxy-11-dehydrocorticosterone sample effect, as effects such as antiinflammatory action, antiallergic and protecting film structures after using; Without obviously 17-hydroxy-11-dehydrocorticosterone sample side effect.This product can promote bile pigments metabolism, reduces ALT, AST and discharges; Induce γ-IFN and interleukin II, improve NK cytoactive and OKT4/OKT8 ratio and activate reticuloendothelial system; Suppress mastocyte and discharge histamine; Suppress cell membrane phospholipid enzyme A2(PL-A2) and formation and the granulomatous reaction of PGE2 (PGE2); Suppress generation and the formation of free radical and lipid peroxidation, reduce the activity of dried meat ammonia hydroxylase; Regulate calcium channel, protection lysosome membrane and mitochondrion, the damage and the necrosis that alleviate cell; Promote epithelial cell to produce mucopolysaccharide.
Cysteine hydrochloride can be exchanged into methionine in vivo.Be a kind of essential amino acids, can synthesize choline and creatine at human body.Choline is a kind of anti-fattyliver substance, and the toxic hepatitis, the methionine that are caused by organic substances such as arsenical barbiturate, carbon tetrachloride are had to treatment and liver function protecting effect.
Freeze-dried powder is a kind of dosage form of medicine, by medicinal ingredient (raw material) and auxiliary element (adjuvant), after for example, dissolving with solvent (water), be mixed with certain density solution, in sterile closed environment, under low temperature, freeze, then by reducing ambient pressure, slowly the method for rising products temperature makes solvent (for example water) distillation in goods, leaves the loose bulk of solid forms or the preparation that powdery medicine forms.In use, need to add solvent (as water), become solution to be used further to injection or infusion treatment disease medicine dissolution.
The multiple method of preparing compound ammonium glycyrrhizinato preparation is disclosed at present both at home and abroad.But the compound ammonium glycyrrhizinato preparation that these methods are made often exists, and granule is large, granule problem not uniformly, thereby dissolubility in the time being mixed with injection is also poor, thereby is unfavorable for drug absorption.
Summary of the invention
The object of the present invention is to provide extraordinary superfine powder lyophilized formulations of a kind of compound ammonium glycyrrhizinato and preparation method thereof, preparation-obtained compound ammonium glycyrrhizinato preparation purity is high, powder particle is big or small is micron order, and even particle size distribution, solubility is good, is conducive to drug absorption.
For addressing the above problem, the invention provides extraordinary superfine powder lyophilized formulations of a kind of compound ammonium glycyrrhizinato and preparation method thereof, there is such feature, the component that contains following mass fraction: 3~5 parts of ammonium glycyrrhizinates; 30~50 parts of glycine; And 2.5~3.5 parts of Cys hydrochlorates, the granularity of the extraordinary superfine powder lyophilized formulations of compound ammonium glycyrrhizinato is 0.8~5 μ m.
The preparation method of the extraordinary superfine powder lyophilized formulations of compound ammonium glycyrrhizinato of the present invention, can also there is such feature, comprise the following steps: the strong aqua ammonia that is 25% by mass fraction adds glycyrrhizic acid concentrated solution, obtain the first solution, stirring and regulating pH is 7~8, obtains Triammonium glycyrrhizinate precipitation; Glacial acetic acid and Triammonium glycyrrhizinate precipitation is added in deionized water and stirred, obtain ammonium glycyrrhizinate solution, and to regulate pH be 4.5~5.5; Ammonium glycyrrhizinate solution is carried out to purification, obtain ammonium glycyrrhizinate after purification; Ammonium glycyrrhizinate, glycine and Cys hydrochlorate after purification are dissolved in deionized water by constant weight umber, obtain compound glycyrrbizic acid ammonium salt solution; Compound glycyrrbizic acid ammonium salt solution is carried out to lyophilisation, obtain lyophilized products; Lyophilized products is carried out to comminution by gas stream under certain air velocity, obtain the extraordinary superfine powder lyophilized formulations of compound ammonium glycyrrhizinato, constant weight umber is 3~5 parts, 30~50 parts, 2.5~3.5 parts, and certain air velocity is 350~600m/s.
The preparation method of the extraordinary superfine powder lyophilized formulations of compound ammonium glycyrrhizinato of the present invention, can also have such feature: ammonium glycyrrhizinate is 4 parts, and glycine is 40 parts, and Cys hydrochlorate is 3 parts.
The preparation method of the extraordinary superfine powder lyophilized formulations of compound ammonium glycyrrhizinato of the present invention, can also have such feature: the pH of the first solution is 7.5.
The preparation method of the extraordinary superfine powder lyophilized formulations of compound ammonium glycyrrhizinato of the present invention, can also have such feature: the pH of ammonium glycyrrhizinate solution is 4.5.
The preparation method of the extraordinary superfine powder lyophilized formulations of compound ammonium glycyrrhizinato of the present invention, can also have such feature: ammonium glycyrrhizinate after purification employing macroporous resin adsorption separation and purification.
The preparation method of the extraordinary superfine powder lyophilized formulations of compound ammonium glycyrrhizinato of the present invention, can also have such feature: certain umber is 4 parts, 40 parts, 3 parts.
The preparation method of the extraordinary superfine powder lyophilized formulations of compound ammonium glycyrrhizinato of the present invention, can also have such feature: the pre-freeze temperature of lyophilisation is~40 DEG C.
Further, the preparation method of the extraordinary superfine powder lyophilized formulations of compound ammonium glycyrrhizinato of the present invention, can also have such feature: certain air velocity is 450~500m/s, and granularity is 0.8~2 micron.
Effect and the effect of invention
According to extraordinary superfine powder lyophilized formulations of the compound ammonium glycyrrhizinato the present invention relates to and preparation method thereof, preparation-obtained compound ammonium glycyrrhizinato preparation purity is high, the granularity of powder particle can be controlled within the scope of 0.8~5 μ m by the adjusting of preparation condition, for micron order, and size of powder particles is evenly distributed, compared with prior art, its solubility is good, is conducive to the absorption of effective ingredient in medicine, thereby can medicament curative effect enhancement.Preparation method reaction condition gentleness of the present invention, step and technique are simple, are easy to regulation and control, can conveniently realize the volume production of the extraordinary superfine powder lyophilized formulations of compound ammonium glycyrrhizinato.
Detailed description of the invention
Below in conjunction with specific embodiment, embodiment of the present invention are described in detail.Should be appreciated that enforcement of the present invention is not limited to the following examples, any pro forma accommodation that the present invention is made and/or change all will fall into protection scope of the present invention.
Embodiment mono-
The strong aqua ammonia that is 25% by mass fraction adds glycyrrhizic acid concentrated solution, stir and make its mix homogeneously, and the pH of regulator solution is 7.5, and along with the carrying out of reaction, Triammonium glycyrrhizinate precipitation appears in solution bottom, takes out precipitation; Rapidly glacial acetic acid and Triammonium glycyrrhizinate precipitation is added in deionized water and be uniformly mixed it is dissolved, obtain ammonium glycyrrhizinate solution, and regulate pH to 5; Utilize macroporous resin adsorption to carry out absorption and purification to ammonium glycyrrhizinate solution, obtain ammonium glycyrrhizinate after purification; Press constant weight umber, ammonium glycyrrhizinate, 40 parts of glycine and 3 parts of Cys hydrochlorates after 4 parts of purification are dissolved in deionized water, obtain compound glycyrrbizic acid ammonium salt solution.
Compound glycyrrbizic acid ammonium salt solution is carried out to lyophilisation, dry front pre-freeze 2 hours, pre-freeze temperature is~40 DEG C, then carries out vacuum drying, obtains and take out presenting loose poroid lyophilized products after 48 hours; Adopt jet mill, lyophilized products is carried out under the air velocity of 500m/s to comminution by gas stream, obtain the extraordinary superfine powder lyophilized formulations of compound ammonium glycyrrhizinato, be 0.8~2 μ m through measuring granularity, the extraordinary superfine powder lyophilized formulations of compound ammonium glycyrrhizinato again comminution by gas stream being obtained reclaims, and according to dosage subpackage, finally obtain the extraordinary superfine powder lyophilized formulations of compound ammonium glycyrrhizinato finished product.
The effect of embodiment mono-and effect
Extraordinary superfine powder lyophilized formulations of the compound ammonium glycyrrhizinato relating to according to the present embodiment and preparation method thereof, the granularity of the powder particle of preparation-obtained compound ammonium glycyrrhizinato preparation is 0.8~2 μ m, for micron order, and size of powder particles is evenly distributed, solubility is good, be conducive to the absorption of effective ingredient in medicine, thus medicament curative effect enhancement.
Embodiment bis-
The strong aqua ammonia that is 25% by mass fraction adds glycyrrhizic acid concentrated solution, stir and make its mix homogeneously, and the pH of regulator solution is 7.5, and along with the carrying out of reaction, Triammonium glycyrrhizinate precipitation appears in solution bottom, takes out precipitation; Rapidly glacial acetic acid and Triammonium glycyrrhizinate precipitation is added in deionized water and be uniformly mixed it is dissolved, obtain ammonium glycyrrhizinate solution, and regulate pH to 5; Utilize macroporous resin adsorption to carry out absorption and purification to ammonium glycyrrhizinate solution, obtain ammonium glycyrrhizinate after purification; Press constant weight umber, ammonium glycyrrhizinate, 40 parts of glycine and 3 parts of Cys hydrochlorates after 4 parts of purification are dissolved in deionized water, obtain compound glycyrrbizic acid ammonium salt solution.
Compound glycyrrbizic acid ammonium salt solution is carried out to lyophilisation, dry front pre-freeze 2 hours, pre-freeze temperature is~40 DEG C, then carries out vacuum drying, obtains and take out presenting loose poroid lyophilized products after 48 hours; Adopt jet mill, lyophilized products is carried out under the air velocity of 350m/s to comminution by gas stream, obtain the extraordinary superfine powder lyophilized formulations of compound ammonium glycyrrhizinato, be 1.8~4 μ m through measuring granularity, the extraordinary superfine powder lyophilized formulations of compound ammonium glycyrrhizinato again comminution by gas stream being obtained reclaims, and according to dosage subpackage, finally obtain the extraordinary superfine powder lyophilized formulations of compound ammonium glycyrrhizinato finished product.
The effect of embodiment bis-and effect
Extraordinary superfine powder lyophilized formulations of the compound ammonium glycyrrhizinato relating to according to the present embodiment and preparation method thereof, the granularity of the powder particle of preparation-obtained compound ammonium glycyrrhizinato preparation is 1.8~4 μ m, for micron order, and size of powder particles is evenly distributed, solubility is good, be conducive to the absorption of effective ingredient in medicine, thus medicament curative effect enhancement.
Embodiment tri-
The strong aqua ammonia that is 25% by mass fraction adds glycyrrhizic acid concentrated solution, stir and make its mix homogeneously, and the pH of regulator solution is 7, and along with the carrying out of reaction, Triammonium glycyrrhizinate precipitation appears in solution bottom, takes out precipitation; Rapidly glacial acetic acid and Triammonium glycyrrhizinate precipitation is added in deionized water and be uniformly mixed it is dissolved, obtain ammonium glycyrrhizinate solution, and regulate pH to 4.5; Utilize macroporous resin adsorption to carry out absorption and purification to ammonium glycyrrhizinate solution, obtain ammonium glycyrrhizinate after purification; Press constant weight umber, ammonium glycyrrhizinate, 30 parts of glycine and 2.5 parts of Cys hydrochlorates after 3 parts of purification are dissolved in deionized water, obtain compound glycyrrbizic acid ammonium salt solution.
Compound glycyrrbizic acid ammonium salt solution is carried out to lyophilisation, dry front pre-freeze 2 hours, pre-freeze temperature is~40 DEG C, then carries out vacuum drying, obtains and take out presenting loose poroid lyophilized products after 48 hours; Adopt jet mill, lyophilized products is carried out under the air velocity of 600m/s to comminution by gas stream, obtain the extraordinary superfine powder lyophilized formulations of compound ammonium glycyrrhizinato, be 2~4 μ m through measuring granularity, the extraordinary superfine powder lyophilized formulations of compound ammonium glycyrrhizinato again comminution by gas stream being obtained reclaims, and according to dosage subpackage, finally obtain the extraordinary superfine powder lyophilized formulations of compound ammonium glycyrrhizinato finished product.
The effect of embodiment tri-and effect
Extraordinary superfine powder lyophilized formulations of the compound ammonium glycyrrhizinato relating to according to the present embodiment and preparation method thereof, the granularity of the powder particle of preparation-obtained compound ammonium glycyrrhizinato preparation is 2~4 μ m, for micron order, and size of powder particles is evenly distributed, solubility is good, be conducive to the absorption of effective ingredient in medicine, thus medicament curative effect enhancement.
Embodiment tetra-
The strong aqua ammonia that is 25% by mass fraction adds glycyrrhizic acid concentrated solution, stir and make its mix homogeneously, and the pH of regulator solution is 8, and along with the carrying out of reaction, Triammonium glycyrrhizinate precipitation appears in solution bottom, takes out precipitation; Rapidly glacial acetic acid and Triammonium glycyrrhizinate precipitation is added in deionized water and be uniformly mixed it is dissolved, obtain ammonium glycyrrhizinate solution, and regulate pH to 5.5; Utilize macroporous resin adsorption to carry out absorption and purification to ammonium glycyrrhizinate solution, obtain ammonium glycyrrhizinate after purification; Press constant weight umber, ammonium glycyrrhizinate, 50 parts of glycine and 3.5 parts of Cys hydrochlorates after 5 parts of purification are dissolved in deionized water, obtain compound glycyrrbizic acid ammonium salt solution.
Compound glycyrrbizic acid ammonium salt solution is carried out to lyophilisation, dry front pre-freeze 2 hours, pre-freeze temperature is~40 DEG C, then carries out vacuum drying, obtains and take out presenting loose poroid lyophilized products after 48 hours; Adopt jet mill, lyophilized products is carried out under the air velocity of 450m/s to comminution by gas stream, obtain the extraordinary superfine powder lyophilized formulations of compound ammonium glycyrrhizinato, be 3.1~5 μ m through measuring granularity, the extraordinary superfine powder lyophilized formulations of compound ammonium glycyrrhizinato again comminution by gas stream being obtained reclaims, and according to dosage subpackage, finally obtain the extraordinary superfine powder lyophilized formulations of compound ammonium glycyrrhizinato finished product.
The effect of embodiment tetra-and effect
Extraordinary superfine powder lyophilized formulations of the compound ammonium glycyrrhizinato relating to according to the present embodiment and preparation method thereof, the granularity of the powder particle of preparation-obtained compound ammonium glycyrrhizinato preparation is 3.1~5m, for micron order, and size of powder particles is evenly distributed, solubility is good, be conducive to the absorption of effective ingredient in medicine, thus medicament curative effect enhancement.
Extraordinary superfine powder lyophilized formulations of the compound ammonium glycyrrhizinato that embodiment relates to and preparation method thereof, adjusting by preparation condition can be controlled at the granularity of powder particle within the scope of 0.8~5 μ m, thereby obtain the superfines lyophilized formulations of micron level, its preparation method reaction condition gentleness, step and technique are simple, be easy to regulation and control, can conveniently realize the volume production of the extraordinary superfine powder lyophilized formulations of compound ammonium glycyrrhizinato.
Claims (9)
1. the extraordinary superfine powder lyophilized formulations of compound ammonium glycyrrhizinato, is characterized in that the component that contains following mass fraction:
3~5 parts of ammonium glycyrrhizinates;
30~50 parts of glycine; And
2.5~3.5 parts of Cys hydrochlorates,
Wherein, the granularity of the extraordinary superfine powder lyophilized formulations of described compound ammonium glycyrrhizinato is 0.8~5 μ m.
2. a preparation method of preparing the extraordinary superfine powder lyophilized formulations of compound ammonium glycyrrhizinato as claimed in claim 1, comprises the following steps, and it is characterized in that:
The strong aqua ammonia that is 25% by mass fraction adds glycyrrhizic acid concentrated solution, obtains the first solution, and stirring and regulating pH is 7~8, obtains Triammonium glycyrrhizinate precipitation;
Glacial acetic acid and described Triammonium glycyrrhizinate precipitation is added in deionized water and stirred, obtain ammonium glycyrrhizinate solution, and to regulate pH be 4.5~5.5;
Described ammonium glycyrrhizinate solution is carried out to purification, obtain ammonium glycyrrhizinate after purification;
Ammonium glycyrrhizinate, glycine and Cys hydrochlorate after described purification are dissolved in deionized water by constant weight umber, obtain compound glycyrrbizic acid ammonium salt solution;
Described compound glycyrrbizic acid ammonium salt solution is carried out to lyophilization, obtain lyophilized products;
Described lyophilized products is carried out to comminution by gas stream under certain air velocity, obtains the extraordinary superfine powder lyophilized formulations of described compound ammonium glycyrrhizinato,
Wherein, described constant weight umber is 3~5 parts, 30~50 parts, 2.5~3.5 parts,
Described certain air velocity is 350~600m/s.
3. the extraordinary superfine powder lyophilized formulations of compound ammonium glycyrrhizinato as claimed in claim 1, is characterized in that:
Wherein, described ammonium glycyrrhizinate is 4 parts, and described glycine is 40 parts, and described Cys hydrochlorate is 3 parts.
4. the preparation method of the extraordinary superfine powder lyophilized formulations of compound ammonium glycyrrhizinato as claimed in claim 2, is characterized in that:
Wherein, the pH of described the first solution is 7.5.
5. the preparation method of the extraordinary superfine powder lyophilized formulations of compound ammonium glycyrrhizinato as claimed in claim 2, is characterized in that:
Wherein, the pH of described ammonium glycyrrhizinate solution is 4.5.
6. the preparation method of the extraordinary superfine powder lyophilized formulations of compound ammonium glycyrrhizinato as claimed in claim 2, is characterized in that:
Wherein, described purification adopt macroporous resin adsorption and separate described purification after ammonium glycyrrhizinate.
7. the preparation method of the extraordinary superfine powder lyophilized formulations of compound ammonium glycyrrhizinato as claimed in claim 2, is characterized in that:
Wherein, described certain umber is 4 parts, 40 parts, 3 parts.
8. the preparation method of the extraordinary superfine powder lyophilized formulations of compound ammonium glycyrrhizinato as claimed in claim 2, is characterized in that:
Wherein, described cryodesiccated pre-freeze temperature is~40 DEG C.
9. the preparation method of the extraordinary superfine powder lyophilized formulations of compound ammonium glycyrrhizinato as claimed in claim 2, is characterized in that:
Wherein, described certain air velocity is 450m/s, and described granularity is 0.8~2 μ m.
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Cited By (1)
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CN105343016A (en) * | 2015-11-10 | 2016-02-24 | 瑞阳制药有限公司 | Compound glycyrrhizin lyophilized powder for injection and preparation method of compound glycyrrhizin lyophilized powder for injection |
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CN1450081A (en) * | 2002-04-10 | 2003-10-22 | 东北林业大学 | Process for extracting purified glycyrrhizic acid from licorice residue |
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CN1450081A (en) * | 2002-04-10 | 2003-10-22 | 东北林业大学 | Process for extracting purified glycyrrhizic acid from licorice residue |
CN1582945A (en) * | 2004-06-09 | 2005-02-23 | 贵阳云岩西创药物科技开发有限公司 | Powder injections of composite monoammonium glycyrrhizinate and their preparation |
Non-Patent Citations (1)
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CN105343016A (en) * | 2015-11-10 | 2016-02-24 | 瑞阳制药有限公司 | Compound glycyrrhizin lyophilized powder for injection and preparation method of compound glycyrrhizin lyophilized powder for injection |
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