CN103239586A - Flavored agastache turbidity-dispelling external preparation as well as preparation method and application thereof - Google Patents
Flavored agastache turbidity-dispelling external preparation as well as preparation method and application thereof Download PDFInfo
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Abstract
The invention relates to a flavored agastache turbidity-dispelling external preparation as well as a preparation method and application thereof. The external preparation is a liquid or semisolid preparation prepared from the active ingredients of flavored agastache turbidity-dispelling medicines and chitosan, povidone and other medical high polymer materials according to a certain ratio. The external preparation has the specific dosage form of gel, ointment, coating and spraying agent. The external preparation can be used for treating eczema, piles, tinea of feet and hands and the like.
Description
Technical field
The present invention relates to a kind of Chinese medicine for external application and preparation method thereof and purposes, be specifically related to external preparation and preparation method thereof and the purposes of health restoring agastache.
Background technology
The ageratum prescription comes from " formulary of peaceful benevolent dispensary volume two " contained huoxiang zhengqi powder, is made up of Pericarpium Arecae, the Radix Angelicae Dahuricae, Folium Perillae, Poria, Pinellia leaven, the Rhizoma Atractylodis Macrocephalae, Pericarpium Citri Reticulatae, Cortex Magnoliae Officinalis, RADIX PLATYCODI, Herba Pogostemonis, Radix Glycyrrhizae; Have the removing dampness of inducing sweat, regulate the flow of vital energy and in effect; Cure mainly affection of exogenous wind-cold, internal injury humidity hysteresis.Modern study shows that this product mainly contains emesis, analgesia, spasmolytic, strengthen cellular immune function and antibacterial wait effect [Lu Wei, Wu Wenjin. ageratum side's pharmacological research makes progress. Chinese Chinese medicine information magazine, 2008,15(supplementary issue): 82-83].
In recent years, along with deepening continuously of drug research, it is found that, HUOXIANG ZHENGQI SHUI not only can be oral, can also external (be coated with the affected part, adopt every day 3-5 time) more diseases such as treatment miliaria, furuncle, mosquito bite, chilblain, miliaria, eczema, urticaria, herpes zoster, tinea capitis, tinea manus and pedis, tinea unguium, lichen planus, skin pruritus, vitiligo, pruritus vulvae, leukoplakia vulvae, hemorrhoid [wide dragon. the new purposes of HUOXIANG ZHENGQI SHUI external. rural area medicine is reported, 2007/July/24 days/the 006th edition; Shi Guirong, Wang Xiuzhen. the HUOXIANG ZHENGQI SHUI dermatosis is newly used. the contemporary Chinese medicinal application, 2010,4(21): 181; The new effect of HUOXIANG ZHENGQI SHUI external. capital medicine, 2008, (8): 47; Yang Deming. external HUOXIANG ZHENGQI SHUI treatment dermatosis. the Shanxi traditional Chinese medical science, 1991,7(4): 41].
At present common ageratum class preparation is all oral formulations clinically, and pill, tablet, capsule, granule, oral liquid, tincture etc. are arranged, and concrete kind is divided into ageratum and health restoring agastache, and it is slightly variant to write out a prescription.Present two class ageratums all do not have the open report of external preparation.
The HUOXIANG ZHENGQI SHUI external has following shortcoming:
1, the effumability of volatile oil and ethanol, water preparation does not have adhesiveness, easily wiped by fabrics such as clothing socks, thus more than what time make medicine bring into play in the short drug effect that influence of the retention time in affected part;
2, thereby ethanol content causes Mucocutaneous zest greatly; Anaphylaxis due to the ethanol;
3, bad smell is big.
In addition, though being the open ageratum of the patent of CN101439084B, publication number can make Chinese medicinal granule with pharmaceutical carrier such as chitosan, but its technical problem to be solved is to obtain Chinese medicinal granule, the technique effect that reaches is to solve the Chinese medicine moisture absorption, problem such as stable, and in embodiment the also prescription of unexposed ageratum and single adjuvant such as chitosan etc.
As seen prior art does not provide the technology enlightenment of ageratum or health restoring agastache external preparation prescription and preparation method.
Summary of the invention
It is that adjuvant prepares the health restoring agastache external preparation that the inventor has invented the employing pharmaceutical polymers by big quantity research, compares with the HUOXIANG ZHENGQI SHUI external, and this external preparation has following beyond thought technique effect:
1, owing to the good film property of these pharmaceutical polymerses, said preparation forms firmer medicine film fast on the surface, affected part, thereby has significantly strengthened the adhesiveness of medicine on the surface, affected part, prolongs administration time, reaches the purpose of raising curative effect of medication.
2, the volatile oil component in the medicine is combined with adjuvant, has greatly prolonged the retention time of volatile oil, not only can improve the curative effect of medicine, and greatly reduces the bad smell of medicine and to the stimulation of skin or mucosa.
3, the drug extract in the health restoring agastache is insoluble in water more, very easily separates out precipitation, and the volatile oil of Herba Pogostemonis and Folium Perillae is water insoluble especially, lamination can occur in water.Even the commercially available HUOXIANG ZHENGQI SHUI of a large amount of ethanol hydrotropies is arranged, also have small amount of precipitate and separate out.Dissolve fully and stable formulation, solved the medicinal liquid problem of unstable and the present invention utilizes the good dispersion of macromolecular material and hydrotropy effect to obtain medicine.
4, by to utilizing the comparison of the health restoring agastache external preparation bacteriostasis that various macromolecular materials make, we find to contain chitosan and derivant thereof is that the Mlc of the external preparation made of adjuvant is lower than the preparation that health restoring agastache medicinal liquid, HUOXIANG ZHENGQI SHUI and chitosan solution and other adjuvants are made, and shows that the health restoring agastache external preparation is not only stronger than the HUOXIANG ZHENGQI SHUI fungistatic effect; And the two has synergism health restoring agastache active constituents of medicine and chitosan.
5, health restoring agastache external preparation of the present invention does not contain ethanol, can avoid the anaphylaxis due to the ethanol.
Concrete technical scheme is as follows:
The invention provides a kind of health restoring agastache external preparation, it is characterized in that: this external preparation is liquid or the semi-solid preparation of being made by following active constituents of medicine and pharmaceutic adjuvant, wherein:
1) active constituents of medicine: formed for 50 parts by 150 parts of Herba Pogostemonis, 50 parts of Folium Perillaes, 50 parts of the Radixs Angelicae Dahuricae, 100 parts of Rhizoma Atractylodis Macrocephalae (parched)s, 100 parts of Pericarpium Citri Reticulataes, 100 parts of Rhizoma Pinelliae Preparata, 100 parts of Sichuan Cortex Magnoliae Officinalis (processed with Rhizoma Zingiberis Recens), 50 parts in Poria, 100 parts of Radix Platycodoniss, 100 parts in Radix Glycyrrhizae, Pericarpium Arecae;
2) pharmaceutic adjuvant: be selected from one or more the pharmaceutical polymers in sodium carboxymethyl cellulose, hydroxypropyl emthylcellulose, sodium alginate, chitosan and chitosan derivatives, polyvidone, polyvinyl alcohol, the carbomer;
3) active constituents of medicine is 1:0.01-3.0 (g/g) (we are representative with monarch drug Herba Pogostemonis medical material inventory, to determine supplementary product consumption in the preparation) in the proportion of Herba Pogostemonis and pharmaceutic adjuvant.
Health restoring agastache external preparation provided by the invention, described active constituents of medicine is 1:0.2-2.0 (g/g) in the preferred proportion of Herba Pogostemonis and pharmaceutic adjuvant.
Health restoring agastache external preparation provided by the invention, described active constituents of medicine is 1:0.3-1.0 (g/g) in the preferred proportion of Herba Pogostemonis and pharmaceutic adjuvant.
Wherein one or more of health restoring agastache external preparation provided by the invention, the glycerol, propylene glycol, ethylene glycol, Tween 80 that can add described external preparation cumulative volume 1-20% in the described excipient substance.
Health restoring agastache external preparation provided by the invention, described chitosan derivatives can be one or more the mixture in chitosan lactate, chitosan hydrochlorate, chitosan itrated compound, carboxymethyl chitosan, hydroxypropyl chitosan, chitosan acetate, chitosan propionic ester, chitosan succinate, chitosan glutarate, chitosan adipate ester, succinylation chitosan, the maleylation chitosan.
Health restoring agastache external preparation provided by the invention, described external preparation can be gel, ointment, liniment, spray-filming agent.
The preparation method of health restoring agastache external preparation provided by the invention comprises the following steps:
A) standby by 150 parts of proportioning raw materials weighting raw materials Herba Pogostemonis, 50 parts of Folium Perillaes, 50 parts of the Radixs Angelicae Dahuricae, 100 parts of Rhizoma Atractylodis Macrocephalae (parched)s, 100 parts of Pericarpium Citri Reticulataes, 100 parts of Rhizoma Pinelliae Preparata, 100 parts of Sichuan Cortex Magnoliae Officinalis (processed with Rhizoma Zingiberis Recens), 50 parts in Poria, 100 parts of Radix Platycodoniss, 100 parts in Radix Glycyrrhizae, 50 parts of Pericarpium Arecae;
B) Cortex Magnoliae Officinalis adds the 50-80% alcohol heating reflux, and it is standby to get the Cortex Magnoliae Officinalis ethanol extract; Herba Pogostemonis, Folium Perillae, Rhizoma Atractylodis Macrocephalae (parched), Pericarpium Citri Reticulatae, the Radix Angelicae Dahuricae are soaked, and steam distillation extracts volatile oil and collects distillate, and the aqueous solution after the distillation filters, and it is standby to get filtered solution 1; Rhizoma Pinelliae Preparata, Poria, Radix Platycodonis, Radix Glycyrrhizae, Pericarpium Arecae, Rhizoma Zingiberis Recens, Fructus Jujubae decoct with water, and filter, and it is standby to get filtered solution 2.Merging filtrate 1 and filtrate 2 concentrate, and add ethanol and make precipitation, filter, and get filtered solution 3, and filtered solution 3 and Cortex Magnoliae Officinalis ethanol extract are merged, and reclaim ethanol, get extracting solution; Volatile oil and distillate are added in the extracting solution, and mixing makes medicinal liquid;
C) get it filled and use macromolecular material, add water or sour water in stirring and dissolving, get pharmaceutical polymers solution;
D) medicinal liquid is added in the pharmaceutical polymers solution stir, make the health restoring agastache external preparation.
The present invention also provides the preferred for preparation method of health restoring agastache external preparation, comprises the following steps:
A) standby by 150 parts of proportioning raw materials weighting raw materials Herba Pogostemonis, 50 parts of Folium Perillaes, 50 parts of the Radixs Angelicae Dahuricae, 100 parts of Rhizoma Atractylodis Macrocephalae (parched)s, 100 parts of Pericarpium Citri Reticulataes, 100 parts of Rhizoma Pinelliae Preparata, 100 parts of Sichuan Cortex Magnoliae Officinalis (processed with Rhizoma Zingiberis Recens), 50 parts in Poria, 100 parts of Radix Platycodoniss, 100 parts in Radix Glycyrrhizae, 50 parts of Pericarpium Arecae;
B) Cortex Magnoliae Officinalis adds the 50-80% alcohol heating reflux, and it is standby to get the Cortex Magnoliae Officinalis ethanol extract; Herba Pogostemonis, Folium Perillae, Rhizoma Atractylodis Macrocephalae (parched), Pericarpium Citri Reticulatae, the Radix Angelicae Dahuricae are soaked, and steam distillation extracts volatile oil and collects distillate, and the aqueous solution after the distillation filters, and it is standby to get filtered solution 1; Rhizoma Pinelliae Preparata, Poria, Radix Platycodonis, Radix Glycyrrhizae, Pericarpium Arecae, Rhizoma Zingiberis Recens, Fructus Jujubae decoct with water, and filter, and it is standby to get filtered solution 2.Merging filtrate 1 and filtrate 2 concentrate, and add ethanol and make precipitation, filter, and get filtered solution 3, and filtered solution 3 and Cortex Magnoliae Officinalis ethanol extract are merged, and reclaim ethanol, get extracting solution; Volatile oil and distillate are added in the extracting solution, and mixing makes medicinal liquid;
C) get it filled and use macromolecular material, add water or sour water in stirring and dissolving, get pharmaceutical polymers solution;
D) with in glycerol, propylene glycol, ethylene glycol, Tween 80 one or more adding medicinal liquids wherein, add pharmaceutical polymers solution again, stir, make the health restoring agastache external preparation.
The preparation method of health restoring agastache external preparation provided by the invention, described sour water refer to contain one or more the mixed aqueous solution in an amount of hydrochloric acid, sulphuric acid, acetic acid, the nitric acid.
The application of health restoring agastache external preparation provided by the invention in preparation miliaria, furuncle, mosquito bite, chilblain, miliaria, eczema, urticaria, herpes zoster, tinea capitis, tinea manus and pedis, tinea unguium, lichen planus, skin pruritus, vitiligo, pruritus vulvae, leukoplakia vulvae, treatment of hemorrhoid medicine.
The invention will be further described to provide the specific embodiment below, but be not limited thereto.
The specific embodiment:
The preparation of preparation example 1 health restoring agastache active constituents of medicine (abbreviation medicinal liquid):
Standby in Chinese Pharmacopoeia ratio weighting raw materials Herba Pogostemonis 1500g, Folium Perillae 500g, Radix Angelicae Dahuricae 500g, Rhizoma Atractylodis Macrocephalae (parched) 1000g, Pericarpium Citri Reticulatae 1000g, Rhizoma Pinelliae Preparata 1000g, Sichuan Cortex Magnoliae Officinalis (processed with Rhizoma Zingiberis Recens) 1000g, Poria 500g, Radix Platycodonis 1000g, Radix Glycyrrhizae 1000g, Pericarpium Arecae 500g.
Cortex Magnoliae Officinalis adds 60% alcohol heating reflux 1 hour, and it is standby to get ethanol liquid.Herba Pogostemonis, Folium Perillae, Rhizoma Atractylodis Macrocephalae (parched), Pericarpium Citri Reticulatae, the Radix Angelicae Dahuricae are soaked, and steam distillation extracts volatile oil and collects distillate, and the aqueous solution after the distillation filters, and is standby; Rhizoma Pinelliae Preparata, Poria, Radix Platycodonis, Radix Glycyrrhizae, Pericarpium Arecae, Rhizoma Zingiberis Recens 150g, Fructus Jujubae 250g decoct with water, and filter, and merge above-mentioned each filtrate, being concentrated into relative density is 1.10-1.20(50 ℃), add 2 times of amount ethanol and make precipitation, filter, filtrate and Cortex Magnoliae Officinalis ethanol extract merge, and reclaim ethanol; Add volatile oil and distillate, mixing makes medicinal liquid, and every 100ml contains the medicinal liquid of Herba Pogostemonis medical material 60g.
The preparation of embodiment 1 health restoring agastache gel
Get Acritamer 940 30g altogether, add suitable quantity of water, stirring and dissolving is made substrate, the medicinal liquid 250ml(that gets preparation example 1 preparation contains Herba Pogostemonis 150), add the 10ml propylene glycol, with the substrate mix homogeneously, add an amount of ethylenediamine, stir evenly, make the uniform liquid of 1000ml, namely get the health restoring agastache gel of the little suffering of flavor.
The preparation of embodiment 2 health restoring agastache liniment
Get polyvinyl alcohol 150g, add suitable quantity of water, stirring and dissolving is made substrate, the medicinal liquid 250ml(that gets preparation example 1 preparation contains Herba Pogostemonis 150g), add the 30ml propylene glycol, with the substrate mix homogeneously, make the uniform glop of 1000ml, namely get the health restoring agastache liniment of the little suffering of flavor.
The preparation of embodiment 3 health restoring agastache liniment
Get polyvidone 45g, add suitable quantity of water, stirring and dissolving, make substrate, the medicinal liquid 250ml(that gets preparation example 2 preparations contains Herba Pogostemonis 150g), add 30ml propylene glycol and 20ml glycerol, with the substrate mix homogeneously, make the uniform liquid of 1000ml, namely get the health restoring agastache liniment of the little suffering of flavor.
The preparation of embodiment 4 health restoring agastache gels
Get sodium carboxymethyl cellulose 300g, add suitable quantity of water, stir swelling, make substrate, the medicinal liquid 250ml(that gets preparation example 2 preparations contains Herba Pogostemonis 150g), add 40ml ethylene glycol, with the substrate mix homogeneously, make the uniform glop of 1000ml, namely get the health restoring agastache gel of the little suffering of flavor.
The preparation of embodiment 5 health restoring agastache ointment
Get hydroxypropyl emthylcellulose 100g, sodium alginate 350g, add suitable quantity of water, stirring and dissolving, make substrate, add 30ml glycerol and 10ml ethylene glycol, the medicinal liquid 250ml(that gets preparation example 1 preparation contains Herba Pogostemonis 150g), with the substrate mix homogeneously, make the semi-solid thick paste of 1000g, namely get the health restoring agastache ointment of the little suffering of flavor.
The preparation of embodiment 6 health restoring agastache spray-filming agents
Get maleylation chitosan 1.5g; add suitable quantity of water, stirring and dissolving is made substrate; the medicinal liquid 250ml(that gets preparation example 2 preparations contains Herba Pogostemonis 150g); add the 200ml propylene glycol, with the substrate mix homogeneously, add an amount of dilute hydrochloric acid and transfer pH3.0; stir; make the uniform liquid of 1000ml, add automiser spray, namely get the health restoring agastache spray-filming agent of the little suffering of flavor.
The preparation of embodiment 7 health restoring agastache ointment
Get chitosan hydrochlorate 150g, add suitable quantity of water, stirring and dissolving is made substrate, and the medicinal liquid 250ml(that gets preparation example 1 preparation contains Herba Pogostemonis 150g), add 100ml ethylene glycol, with the substrate mix homogeneously, add an amount of dilute sulfuric acid and transfer pH6.0, stir, make the uniform semi-solid thick paste of 1000gl, namely get the health restoring agastache ointment of the little suffering of flavor.
The preparation of embodiment 8 health restoring agastache gels
Get succinylation chitosan 45g; add suitable quantity of water; stirring and dissolving is made substrate, and the medicinal liquid 250ml(that gets preparation example 1 preparation contains Herba Pogostemonis 150g); add 60ml ethylene glycol; with the substrate mix homogeneously, add an amount of rare nitric acid acid and transfer pH4.0, stir; make the uniform glop of 1000ml, namely get the health restoring agastache gel of the little suffering of flavor.
The preparation of embodiment 9 health restoring agastache ointment
Get chitosan lactate 300g, add suitable quantity of water, stirring and dissolving is made substrate, and the medicinal liquid 250ml(that gets preparation example 2 preparations contains Herba Pogostemonis 150g), add 80ml ethylene glycol and 60ml propylene glycol, with the substrate mix homogeneously, add an amount of glacial acetic acid and transfer pH5.0, stir, make the uniform glop of 1000ml, namely get the health restoring agastache gel of the little suffering of flavor.
The preparation of embodiment 10 health restoring agastache gels
Get chitosan 45g, add suitable quantity of water, add glacial acetic acid 20ml, stirring and dissolving, make substrate, the medicinal liquid 250ml(that gets preparation example 1 preparation contains Herba Pogostemonis 150g), add the 120ml propylene glycol, with the substrate mix homogeneously, add an amount of glacial acetic acid and transfer pH4.5, stir, make the uniform glop of 1000ml, namely get the health restoring agastache gel of the little suffering of flavor.
The preparation of embodiment 11 health restoring agastache gels
Get chitosan 60g, add suitable quantity of water, add dilute hydrochloric acid 40ml, stirring and dissolving, make substrate, the medicinal liquid 250ml(that gets preparation example 1 preparation contains Herba Pogostemonis 150g), add 100ml propylene glycol and 30ml glycerol, with the substrate mix homogeneously, add an amount of glacial acetic acid and transfer pH4.5, stir, make the uniform glop of 1000ml, namely get the health restoring agastache gel of the little suffering of flavor.
The preparation of embodiment 12 health restoring agastache gels
Get carboxymethyl chitosan 90g, add suitable quantity of water, stirring and dissolving is made substrate, and the medicinal liquid 250ml(that gets preparation example 2 preparations contains Herba Pogostemonis 150g), add 100ml ethylene glycol and 30ml glycerol, with the substrate mix homogeneously, add an amount of dilute hydrochloric acid and transfer pH3.5, stir, make the uniform glop of 1000ml, namely get the health restoring agastache gel of the little suffering of flavor.
The preparation of embodiment 13 health restoring agastache gels
Get hydroxypropyl chitosan 75g, add suitable quantity of water, stirring and dissolving is made substrate, and the medicinal liquid 250ml(that gets preparation example 1 preparation contains Herba Pogostemonis 150g), add 10ml glycerol and 80ml propylene glycol, with the substrate mix homogeneously, add an amount of dilute hydrochloric acid and glacial acetic acid mixed liquor and transfer pH4.2, stir, make the uniform glop of 1000ml, namely get the health restoring agastache gel of the little suffering of flavor.
The preparation of embodiment 14 health restoring agastache gels
Get chitosan itrated compound 105g, add suitable quantity of water, stirring and dissolving, make substrate, the medicinal liquid 250ml(that gets preparation example 2 preparations contains Herba Pogostemonis 150g), with the substrate mix homogeneously, add an amount of dilute hydrochloric acid and glacial acetic acid mixed liquor and transfer pH4.2, stir, make the uniform glop of 1000ml, namely get the health restoring agastache gel of the little suffering of flavor.
The preparation of embodiment 15 health restoring agastache gels
Get maleylation chitosan 60g; add suitable quantity of water; stirring and dissolving is made substrate, and the medicinal liquid 250ml(that gets preparation example 1 preparation contains Herba Pogostemonis 150g); add 80ml ethylene glycol and 60ml propylene glycol; with the substrate mix homogeneously, add an amount of glacial acetic acid and transfer pH4.0, stir; make the uniform glop of 1000ml, namely get the health restoring agastache gel of the little suffering of flavor.
The preparation of embodiment 16 health restoring agastache gels
Get chitosan acetate 90g, add suitable quantity of water, stirring and dissolving is made substrate, and the medicinal liquid 250ml(that gets preparation example 2 preparations contains Herba Pogostemonis 150g), add 50ml glycerol and 70ml ethylene glycol and 30ml propylene glycol, with the substrate mix homogeneously, add an amount of dilute hydrochloric acid and glacial acetic acid mixed liquor and transfer pH4.2, stir, make the uniform glop of 1000ml, namely get the health restoring agastache gel of the little suffering of flavor.
The preparation of embodiment 17 health restoring agastache gels
Get each 30g of hydroxypropyl chitosan and chitosan hydrochlorate, add suitable quantity of water, stirring and dissolving is made substrate, and the medicinal liquid 250ml(that gets preparation example 1 preparation contains Herba Pogostemonis 150g), add 60ml glycerol, with the substrate mix homogeneously, add an amount of glacial acetic acid and transfer pH4.7, stir, make the uniform glop of 1000ml, namely get the health restoring agastache gel of the little suffering of flavor.
The preparation of embodiment 18 health restoring agastache gels
Get chitosan 60g and 30g polyvinyl alcohol, add suitable quantity of water, add glacial acetic acid 25ml, stirring and dissolving, make substrate, the medicinal liquid 250ml(that gets preparation example 1 preparation contains Herba Pogostemonis 150g), add the 120ml propylene glycol, with the substrate mix homogeneously, add an amount of glacial acetic acid and transfer pH4.5, stir, make the uniform glop of 1000ml, namely get the health restoring agastache gel of the little suffering of flavor.
The preparation of embodiment 19 health restoring agastache gels
Get chitosan hydrochlorate 50g and 20g polyvidone, add suitable quantity of water, add glacial acetic acid 20ml, stirring and dissolving, make substrate, the medicinal liquid 250ml(that gets preparation example 1 preparation contains Herba Pogostemonis 150g), add 50ml propylene glycol and 20ml glycerol, with the substrate mix homogeneously, add an amount of glacial acetic acid and transfer pH4.5, stir, make the uniform glop of 1000ml, namely get the health restoring agastache gel of the little suffering of flavor.
The preparation of embodiment 20 health restoring agastache gels
Get hydroxypropyl chitosan 70g and polyvinyl alcohol 10g and polyvidone 10g, add suitable quantity of water, stirring and dissolving, make substrate, the medicinal liquid 250ml(that gets preparation example 1 preparation contains Herba Pogostemonis 150g), with the substrate mix homogeneously, add an amount of glacial acetic acid and transfer pH4.5, stir, make the uniform glop of 1000ml, namely get the health restoring agastache gel of the little suffering of flavor.
The preparation of embodiment 21 health restoring agastache gels
Get maleoyl chitosan 40g and 30g sodium carboxymethyl cellulose, add the suitable quantity of water stirring and dissolving, make substrate, the medicinal liquid 250ml(that gets preparation example 1 preparation contains Herba Pogostemonis 150g), add the 50ml propylene glycol, with the substrate mix homogeneously, add an amount of glacial acetic acid and transfer pH4.5, stir, make the uniform glop of 1000ml, namely get the health restoring agastache gel of the little suffering of flavor.
The preparation of embodiment 22 health restoring agastache gels
Get chitosan itrated compound 80g and 10g hydroxypropyl emthylcellulose, add the suitable quantity of water stirring and dissolving, make substrate, the medicinal liquid 250ml(that gets preparation example 1 preparation contains Herba Pogostemonis 150g), add 120ml ethylene glycol, with the substrate mix homogeneously, add an amount of glacial acetic acid and transfer pH4.5, stir, make the uniform glop of 1000ml, namely get the health restoring agastache gel of the little suffering of flavor.
The preparation of embodiment 23 health restoring agastache gels
Get chitosan lactate 60g and sodium alginate 75g, add the suitable quantity of water stirring and dissolving, make substrate, the medicinal liquid 250ml(that gets preparation example 1 preparation contains Herba Pogostemonis 150g), add the 70ml propylene glycol, with the substrate mix homogeneously, add an amount of glacial acetic acid and transfer pH4.5, stir, make the uniform glop of 1000ml, namely get the health restoring agastache gel of the little suffering of flavor.
The preparation of embodiment 24 health restoring agastache gels
Get polyvidone 20g, polyvinyl alcohol 30g and sodium carboxymethyl cellulose 30g, add the suitable quantity of water stirring and dissolving, make substrate, the medicinal liquid 250ml(that gets preparation example 1 preparation contains Herba Pogostemonis 150g), add the 100ml propylene glycol, with the substrate mix homogeneously, add an amount of glacial acetic acid and transfer pH4.5, stir, make the uniform glop of 1000ml, namely get the health restoring agastache gel of the little suffering of flavor.
The preparation of embodiment 25 health restoring agastache gels
Get sodium alginate 120g, add suitable quantity of water, stirring and dissolving is made substrate, adds the 30ml Tween 80, and the medicinal liquid 250ml(that gets preparation example 1 preparation contains Herba Pogostemonis 150g), with the substrate mix homogeneously, make 1000ml, namely get the health restoring agastache gel of the little suffering of flavor.
The preparation of embodiment 26 health restoring agastache liniment
Get polyvidone 45g, add suitable quantity of water, stirring and dissolving is made substrate, and the medicinal liquid 250ml(that gets preparation example 2 preparations contains Herba Pogostemonis 150g), with the substrate mix homogeneously, make the uniform liquid of 1000ml, namely get the ageratum liniment of the little suffering of flavor.
The preparation of embodiment 27 health restoring agastache gels
Get sodium carboxymethyl cellulose 300g, add suitable quantity of water, stir swelling, make substrate, the medicinal liquid 250ml(that gets preparation example 2 preparations contains Herba Pogostemonis 150g), with the substrate mix homogeneously, make the uniform glop of 1000ml, namely get the ageratum gel of the little suffering of flavor.
The preparation of embodiment 28 health restoring agastache ointment
Get hydroxypropyl emthylcellulose 100g, sodium alginate 350g, add suitable quantity of water, stirring and dissolving, make substrate, the medicinal liquid 250ml(that gets preparation example 1 preparation contains Herba Pogostemonis 150g), with the substrate mix homogeneously, make the semi-solid thick paste of 1000g, namely get the ageratum ointment of the little suffering of flavor.
The preparation of embodiment 29 health restoring agastache spray-filming agents
Get maleylation chitosan 1.5g; add suitable quantity of water; stirring and dissolving is made substrate, and the medicinal liquid 250ml(that gets preparation example 2 preparations contains Herba Pogostemonis 150g); with the substrate mix homogeneously; add an amount of dilute hydrochloric acid and transfer pH3.0, stir, make the uniform liquid of 1000ml; add automiser spray, namely get the ageratum spray-filming agent of the little suffering of flavor.
The preparation of embodiment 30 health restoring agastache ointment
Get chitosan hydrochlorate 150g, add suitable quantity of water, stirring and dissolving, make substrate, the medicinal liquid 250ml(that gets preparation example 1 preparation contains Herba Pogostemonis 150g), with the substrate mix homogeneously, add an amount of dilute sulfuric acid and transfer pH6.0, stir, make the uniform semi-solid thick paste of 1000gl, namely get the ageratum ointment of the little suffering of flavor.
The preparation of embodiment 31 health restoring agastache gels
Get polyvinyl alcohol 30g, add suitable quantity of water, stirring and dissolving is made substrate, and the medicinal liquid 250ml(that gets preparation example 1 preparation contains Herba Pogostemonis 150), with the substrate mix homogeneously, stir evenly, make the uniform liquid of 1000ml, namely get the ageratum gel of the little suffering of flavor.
Experimental example 1 external bacteriostatic experiment
1, tried strain:
Trichophyton, Candida albicans, staphylococcus aureus: buy in Bei Jingbei and receive wound connection Bioteknologisk Institut.
2, experimental technique:
Adopting medicine base test tube method to carry out minimum inhibitory concentration (MIC) measures, with health restoring agastache gel 1(embodiment 10 preparation), health restoring agastache gel 2(embodiment 3 preparations), health restoring agastache medicinal liquid (preparation example preparation), HUOXIANG ZHENGQI SHUI (commercially available product), each 50ml of chitosan be mixed with the 50% above-mentioned sabouraud's agar 100ml that is tried thing and be the 1st and manage concentration, then with doubly dilutions such as sabouraud's agar works, be the 2nd pipe to the 9 pipes, be followed successively by 25%, 12.5% ... 0.195% concentration, the 10th pipe is control tube (simple sabouraud's agar).Inoculation is placed in 25 ℃ of constant incubators its growing state of observed and recorded day by day, in totally 4 weeks, judges that with naked eyes the lowest drug concentration test tube of asepsis growth is minimum bacteria concentration processed.
3, experimental result:
The result shows: the health restoring agastache gel fungistatic effect that with the chitosan is adjuvant is better than health restoring agastache medicinal liquid, HUOXIANG ZHENGQI SHUI and chitosan, and health restoring agastache active constituents of medicine and chitosan have synergism.
The irritation test of experimental example 2 health restoring agastache external preparation
1, laboratory animal:
Rabbit, 4 every group, female, hero half and half is divided into health restoring agastache gel (pressing the preparation of embodiment 10 methods) group, HUOXIANG ZHENGQI SHUI (commercially available product) group, adopts consubstantiality left and right sides self matching type.Test preceding 24 hours to the back processing of losing hair or feathers.Left and right each 3 cm * 3 cm of unhairing scope.The irritation test of damaged skin adopts at agents area with the sand paper mill or draw " well " word and the method for degree of being with the oozing of blood.
2, medication:
Get and tried thing 0.5 ml and directly coat on the plucked skin of a side, use two layers of gauze (2.5 cm * 2.5 cm) and one deck cellophane to cover then, reuse nonirritant adhesive plaster and binder are fixed; Opposite side coating excipient compares.Application time 4 hours.After sticking end, remove and tried thing and with warm water or nonirritant solvent cleaned medicine-feeding part.
3, the result observes and estimates
Under available light or full gloss spectrum light, observe dermoreaction.After removing medicine 30-60 minute, perusal in 24,48 and 72 hours was also recorded coating part and is had or not situations such as erythema and edema.By " Chinese medicine, natural drug local irritation and hemolytic investigative technique guideline " standards of grading skin erythema and edema are marked.Calculate and put the mean scores that each group is tried thing and excipient dermoreaction integration each observing time, carry out the stimulus intensity evaluation by " Chinese medicine, natural drug local irritation and hemolytic investigative technique guideline ".
4, experimental result and conclusion
The result shows: the health restoring agastache gel is that the external preparation skin irritation of representative significantly reduces.
The research of experimental example 3 medicine stabilities
The sample of getting by embodiment 3,10,19, the preparation of 28 methods carries out study on the stability.Investigation method and result are as follows:
1, centrefuge experiment
Take by weighing each 59g of preparation of 3 different lot numbers respectively, place the 10mL centrifuge tube, with 4000r.min
-1Centrifugal 30min observes the outward appearance of gel and the variation of stretchability.
2, heat-resistant experiment
After the preparation of 3 different lot numbers being placed the vial sealing respectively, put into (60 soil 2) ℃ baking oven, take out behind the 24h, recover room temperature, observe the variation of outward appearance, stretchability and pH value, and measure the content content of magnolol.
3, cold-resistant experiment
After the preparation of 3 different lot numbers being placed the vial sealing respectively, put in people's (2 ℃ in 15 soil) refrigerator, take out behind the 24h, recover room temperature, observe the variation of outward appearance, stretchability and pH value, and measure the content content of magnolol.
4, acid-base value is measured
Take by weighing each 29g of preparation of 3 different lot numbers respectively in small beaker, add people 50mL distilled water diluting, measure pH value with pHS one 2C type acidometer.
5, the room temperature reserved sample observing takes by weighing respectively about each 10g of preparation of 3 different lot numbers, pack with aluminum pipe, and setting-out under room temperature, and in 0,1, the outward appearance of gel and the variation of stretchability are observed in sampling in the time of 2,3,6,12 months, and survey the content content of magnolol.
6, constant temperature accelerates experiment
Take by weighing respectively about each 10g of preparation of 3 different lot numbers, pack with aluminum pipe, in (30 scholar 2) ℃, under RH (60 scholar 5) the % condition continuously setting-out observed 3 months, and in 0, l, 2, take a sample respectively in the time of 3 months, detect by the content detection requirement, and observe the variation of outward appearance and stretchability.
7, experimental result:
1) each preparation of health restoring agastache is evenly distributed after centrifugal test, no layering, deposited phenomenon, the no significant change of pH value.
2) after placing 24h under (60 scholar 2) ℃ condition, the content content of magnolol slightly descends, but does not have layering, deposited phenomenon, the no significant change of pH value.
When 3) depositing under (15 scholar 2) ℃ condition, content and the color of magnolol have no significant change, and also do not have layering, deposited phenomenon, the no significant change of pH value.
4) room temperature keeps sample and accelerates experimental result and shows that content, color, the uniformity of each preparation magnolol in probation do not have significant change, and stretchability is good, the no significant change of pH value.
Claims (10)
1. health restoring agastache external preparation, it is characterized in that: this external preparation is liquid or the semi-solid preparation of being made by following active constituents of medicine and pharmaceutic adjuvant, wherein:
1) active constituents of medicine: formed for 50 parts by 150 parts of Herba Pogostemonis, 50 parts of Folium Perillaes, 50 parts of the Radixs Angelicae Dahuricae, 100 parts of Rhizoma Atractylodis Macrocephalae (parched)s, 100 parts of Pericarpium Citri Reticulataes, 100 parts of Rhizoma Pinelliae Preparata, 100 parts of Sichuan Cortex Magnoliae Officinalis (processed with Rhizoma Zingiberis Recens), 50 parts in Poria, 100 parts of Radix Platycodoniss, 100 parts in Radix Glycyrrhizae, Pericarpium Arecae;
2) pharmaceutic adjuvant: be selected from one or more the pharmaceutical polymers in sodium carboxymethyl cellulose, hydroxypropyl emthylcellulose, sodium alginate, chitosan and chitosan derivatives, polyvidone, polyvinyl alcohol, the carbomer;
3) active constituents of medicine is 1:0.01-3.0 (g/g) in the proportion of Herba Pogostemonis and pharmaceutic adjuvant.
2. the described health restoring agastache external preparation of claim 1 is characterized in that: described active constituents of medicine is 1:0.2-2.0 (g/g) in the proportion of Herba Pogostemonis and pharmaceutic adjuvant.
3. the described health restoring agastache external preparation of claim 1 is characterized in that: described active constituents of medicine is 1:0.3-1.0 (g/g) in the proportion of Herba Pogostemonis and pharmaceutic adjuvant.
4. the arbitrary described health restoring agastache external preparation of claim 1-3 is characterized in that: wherein one or more of the glycerol, propylene glycol, ethylene glycol, Tween 80 that can add described external preparation cumulative volume 1-20% in the described excipient substance.
5. the described health restoring agastache external preparation of claim 1 is characterized in that: described chitosan derivatives can be one or more the mixture in chitosan lactate, chitosan hydrochlorate, chitosan itrated compound, carboxymethyl chitosan, hydroxypropyl chitosan, chitosan acetate, chitosan propionic ester, chitosan succinate, chitosan glutarate, chitosan adipate ester, succinylation chitosan, the maleylation chitosan.
6. the arbitrary described health restoring agastache external preparation of claim 1-4, it is characterized in that: described external preparation can be gel, ointment, liniment, spray-filming agent.
7. the preparation method of the arbitrary described health restoring agastache external preparation of claim 1-3 is characterized in that comprising the following steps:
A) standby by 150 parts of proportioning raw materials weighting raw materials Herba Pogostemonis, 50 parts of Folium Perillaes, 50 parts of the Radixs Angelicae Dahuricae, 100 parts of Rhizoma Atractylodis Macrocephalae (parched)s, 100 parts of Pericarpium Citri Reticulataes, 100 parts of Rhizoma Pinelliae Preparata, 100 parts of Sichuan Cortex Magnoliae Officinalis (processed with Rhizoma Zingiberis Recens), 50 parts in Poria, 100 parts of Radix Platycodoniss, 100 parts in Radix Glycyrrhizae, 50 parts of Pericarpium Arecae;
B) Cortex Magnoliae Officinalis adds the 50-80% alcohol heating reflux, and it is standby to get the Cortex Magnoliae Officinalis ethanol extract; Herba Pogostemonis, Folium Perillae, Rhizoma Atractylodis Macrocephalae (parched), Pericarpium Citri Reticulatae, the Radix Angelicae Dahuricae are soaked, and steam distillation extracts volatile oil and collects distillate, and the aqueous solution after the distillation filters, and it is standby to get filtered solution 1; Rhizoma Pinelliae Preparata, Poria, Radix Platycodonis, Radix Glycyrrhizae, Pericarpium Arecae, Rhizoma Zingiberis Recens, Fructus Jujubae decoct with water, and filter, and it is standby to get filtered solution 2; Merging filtrate 1 and filtrate 2 concentrate, and add ethanol and make precipitation, filter, and get filtered solution 3, and filtered solution 3 and Cortex Magnoliae Officinalis ethanol extract are merged, and reclaim ethanol, get extracting solution; Volatile oil and distillate are added in the extracting solution, and mixing makes medicinal liquid;
C) get it filled and use macromolecular material, add water or sour water in stirring and dissolving, get pharmaceutical polymers solution;
D) medicinal liquid is added in the pharmaceutical polymers solution stir, make the health restoring agastache external preparation.
8. the preparation method of the described health restoring agastache external preparation of claim 4 is characterized in that comprising the following steps:
A) standby by 150 parts of proportioning raw materials weighting raw materials Herba Pogostemonis, 50 parts of Folium Perillaes, 50 parts of the Radixs Angelicae Dahuricae, 100 parts of Rhizoma Atractylodis Macrocephalae (parched)s, 100 parts of Pericarpium Citri Reticulataes, 100 parts of Rhizoma Pinelliae Preparata, 100 parts of Sichuan Cortex Magnoliae Officinalis (processed with Rhizoma Zingiberis Recens), 50 parts in Poria, 100 parts of Radix Platycodoniss, 100 parts in Radix Glycyrrhizae, 50 parts of Pericarpium Arecae;
B) Cortex Magnoliae Officinalis adds the 50-80% alcohol heating reflux, and it is standby to get the Cortex Magnoliae Officinalis ethanol extract; Herba Pogostemonis, Folium Perillae, Rhizoma Atractylodis Macrocephalae (parched), Pericarpium Citri Reticulatae, the Radix Angelicae Dahuricae are soaked, and steam distillation extracts volatile oil and collects distillate, and the aqueous solution after the distillation filters, and it is standby to get filtered solution 1; Rhizoma Pinelliae Preparata, Poria, Radix Platycodonis, Radix Glycyrrhizae, Pericarpium Arecae, Rhizoma Zingiberis Recens, Fructus Jujubae decoct with water, and filter, and it is standby to get filtered solution 2; Merging filtrate 1 and filtrate 2 concentrate, and add ethanol and make precipitation, filter, and get filtered solution 3, and filtered solution 3 and Cortex Magnoliae Officinalis ethanol extract are merged, and reclaim ethanol, get extracting solution; Volatile oil and distillate are added in the extracting solution, and mixing makes medicinal liquid;
C) get it filled and use macromolecular material, add water or sour water in stirring and dissolving, get pharmaceutical polymers solution;
D) with in glycerol, propylene glycol, ethylene glycol, Tween 80 one or more adding medicinal liquids wherein, add pharmaceutical polymers solution again, stir, make the health restoring agastache external preparation.
9. the preparation method of claim 7,8 described health restoring agastache external preparation is characterized in that: described sour water refers to contain one or more the mixed aqueous solution in an amount of hydrochloric acid, sulphuric acid, acetic acid, the nitric acid.
10. the application of the described health restoring agastache external preparation of claim 1-4 in preparation miliaria, furuncle, mosquito bite, chilblain, miliaria, eczema, urticaria, herpes zoster, tinea capitis, tinea manus and pedis, tinea unguium, lichen planus, skin pruritus, pruritus vulvae, leukoplakia vulvae, hemorrhoid, therapy for vitiligo medicine.
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| CN109010759A (en) * | 2018-08-03 | 2018-12-18 | 陈冠卿 | The tincture for preventing and treating affection by exopathogenic cold-wind type nettle rash |
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