A kind of oral cream for external use and manufacture method thereof
The present invention relates to a kind of oral cream for external use and manufacture method thereof with antibacterial, antiinflammatory, analgesic hemostatic function, this medicine is applicable to the treatment and the prevention of gingivitis periodontitis, and this medicament is hereinafter to be referred as Amosan.
A kind of method for preparing effective remedy for toothache is disclosed in CN85108762, it is through air-dry or oven dry with Folium Caryophylli and the Radix Astragali, by Flos Caryophylli 95%, the mixed of the Radix Astragali 5% is ground into powder and incapsulates patent medicine, so its weak point at oral medicine, belongs to constitutional treatment, anti-inflammatory analgesic effect is slow, and the efficacy component of Folium Caryophylli belongs to little poison, orally easily has side effects.Oleum Caryophylli from the extraction of Ocimum Basilicum grass.Can be used as dentistry analgesia and disinfectant, belong to local topical tooth medicine, but it can only be used for the dentistry clinical treatment, can not enter family as the medicine commonly used of treatment and prevention oral disease; Being used for the treatment of the BINGPENG SAN that the throat ability to speak swells and ache, is the powder medicine that Borax and Cinnabaris, Matrii Sulfas Exsiccatus, Borneolum Syntheticum etc. are developed into altogether, powder must be blown the right-falling stroke affected part during treatment, uses, packs all very inconvenient.
The object of the present invention is to provide a kind of drug effect height, easy to use, the unguentum medicine for external use and the manufacture method thereof that are used for the treatment of oral disease that have no side effect again.
The objective of the invention is to finish by following scheme, with wetting agent, binding agent, calcium carbonate and water is substrate, and Oleum Caryophylli and Borax are drug effect master part, makes the unguentum medicine for external use of treatment oral disease, its prescription is (to fill a prescription by weight, with the gram is that unit provides, as follows): binding agent 0.8~2g, wetting agent 8~20g, calcium carbonate 45~60g, Borax 2~5g, Oleum Caryophylli 0.5~1g, water 25~35g.
Preparing this medicament must be through operations such as scale material, glue, mediation, grinding, the degassing, packings, and its concrete technology is: weigh needed raw material by prescription; Binding agent dropped in the wetting agent to stir fast cause gelatinizing and evenly do not have caking, the Borax aqueous solution of making soluble in water is poured into wherein refluxes again stirs and makes glue; Put into after grinding by colloid mill then that storage tank is quiet puts that to cause gelatinizing even, generally be no less than 6 hours; Stirring in the uniform glue of Oleum Caryophylli input gelatinizing, Oleum Caryophylli is dispersed in the glue; And then add calcium carbonate and stir into emulsifiable paste, quiet putting causes solid phase, and liquid phase and medicine fully are in harmonious proportion evenly; The good emulsifiable paste that is in harmonious proportion grinds through colloid mill again, and quiet putting makes its solid phase and liquid phase fully be in harmonious proportion the even final vacuum degassing, and packing gets final product.
Oleum Caryophylli described in the present invention is to distill the volatile oil that obtains by the herb process of labiate Ocimum Basilicum, and wherein eugenol content is more than 85%;
Also be added with 0.6~1g correctives in the prescription of the present invention, correctives with drop into again in the uniform glue of gelatinizing after Oleum Caryophylli mixes, in order to remove uncomfortable flavour of a drug, adjust the taste of unguentum;
Also be added with 2~4g foaming agent sodium lauryl sulfate in the prescription of the present invention, feed intake, to promote the abstersive function of unguentum moistening foaming emulsifying with calcium carbonate.
The invention has the advantages that:, the character Oleum Caryophylli different with state and Borax are gone into to in the dose the first, owing to taked cream preparation.Oleum Caryophylli is water-fast herb ingredients, be liquid condition, and Borax is water-soluble solids, therefore, existing water preparation, powder medicine for external use all can not be gone into Oleum Caryophylli and Borax to in the dose, it is that substrate is made cream preparation that the present invention adopts with wetting agent, binding agent, calcium carbonate and water, Oleum Caryophylli and Borax is evenly distributed in the unguentum, thereby has solved this problem; The second, the drug effect height, drug effect master's part Oleum Caryophylli and Borax, its fungistatic effect has complementarity, and is stronger to staphylococcus aureus and colibacillary bacteriostasis as Oleum Caryophylli, and Borax is stronger to the Streptococcus mutans bacteriostasis.This medicament contains above-mentioned two kinds of drug effect master parts simultaneously, and bacteriostasis strengthens, and drug effect is remarkable, and through clinical verification, 14 days effective percentage reach 100% after the medication of this medicament, and significantly rate reaches 84.4%; The 3rd, cream preparation is easy to press down and is put on the gingiva affected part, the agent that gives the massage of also available emulsifiable paste is carried out slight massage at affected area, particularly because contain foaming agent in the prescription, can be used for brushing teeth, treatment, the prevention oral disease combines with brushing teeth every day to clean the teeth, very easy to use, the 4th, this medicament has adopted correctives, uncomfortable flavour of a drug have not only been removed, also can have various fragrance popular to people, be regardless of old children and all like to use the 5th, drug effect master part Oleum Caryophylli belongs to little poison in this medicament, but the content in each consumption has only a few percent milligram, and is local topical, outside the most discharge opening in back, therefore absorbtivity is very few, can not produce any side effect.
Below in conjunction with embodiment the present invention is described in detail.Binding agent can adopt starch or carboxymethyl cellulose among the present invention, and wetting agent can adopt in glycerol, propylene glycol, the mannitol any one, and correctives adopts in Borneolum Syntheticum, Mentholum, Foeniculi oil, citrus seed oil, the saccharin sodium whole or several arbitrarily; Drug effect master's part Oleum Caryophylli and Borax will meet the pharmacopeia regulation.
Embodiment 1, and the concrete prescription of present embodiment is: corn starch 0.8g, propylene glycol 8g, calcium carbonate 45g, Borax 2g Oleum Caryophylli 0.5g, water 25g.Weighing needed raw material by prescription mixes and fully stirs into the emulsifiable paste shape and get final product.For two kinds of drug effect master parts can be dispersed in the emulsifiable paste body more fully, the present invention will pass through operations such as glue, mediation, grinding, the degassing and make unguentum.Promptly stirring in the binding agent corn starch input wetting agent propylene glycol that weighs is caused gelatinizing and evenly do not have caking, again the Borax aqueous solution of making soluble in water is poured into wherein and mixed, reflux to stir and to make glue in 2~5 minutes, put into quiet the putting of storage tank after grinding by colloid mill then and be no less than 6 hours and make its gelatinizing even; Stirring in the uniform glue of Oleum Caryophylli input gelatinizing Oleum Caryophylli is dispersed in the glue; And then add calcium carbonate and stir into emulsifiable paste, quiet putting is no less than 6 hours solid phase, liquid phase and medicine fully is in harmonious proportion evenly; The good emulsifiable paste that is in harmonious proportion grinds through colloid mill again, the gap of colloid mill is 0.5~0.7mm, quiet the putting of emulsifiable paste after the grinding is no less than 4 hours, its solid phase and liquid phase further are in harmonious proportion evenly, and vacuum outgas afterwards is promptly when the vacuum in the vacuum tank reaches 98.7KPa, import creme while stirring, outgased 20 minutes, the paste medicine Amosan of treatment oral disease, can canned PAP in.
Embodiment 2, and the concrete prescription of present embodiment is: carboxymethyl cellulose 2g, mannitol 20g, calcium carbonate 60g, Borax 5g, Oleum Caryophylli 1g, water 35g, correctives 0.6g (saccharin sodium 0.1g wherein, Borneolum Syntheticum 0.1g, Mentholum 0.1g, Foeniculi oil 0.1g, citrus seed oil 0.2g), sodium lauryl sulfate 4g.Weigh needed raw material by prescription, and produce by technology described in the embodiment 1.Stirring in the binding agent carboxymethyl cellulose input wetting agent mannitol that weighs is caused gelatinizing does not evenly have caking, the Borax solution of making soluble in water is poured into wherein again and is mixed, and refluxes to stir and makes glue; Storage tank is quiet to be put 8 hours by putting into after the colloid mill grinding then, made its gelatinizing even, and correctives mixes the back and drops into fully stirring in the uniform glue of gelatinizing with Oleum Caryophylli, Oleum Caryophylli and correctives are dispersed in the glue; And then add calcium carbonate and sodium lauryl sulfate stirs into emulsifiable paste, quiet putting 8 hours, its solid phase, liquid phase fully are in harmonious proportion evenly, mediation emulsifiable paste well after colloid mill grinds, was deposited 6 hours again, and it is even that its solid phase and liquid phase further are in harmonious proportion, afterwards through vacuum outgas Amosan, present embodiment has removed uncomfortable flavour of a drug owing to added correctives, and the delicate fragrance that makes it to become is good to eat, the misery in the time of can reducing patient's medication; Sodium lauryl sulfate has frothing function, also Streptococcus mutans is had bacteriostasis preferably, thus not only help improving drug effect, and make this agent have the function of cleaning the teeth, and treatment prevention oral disease can be combined with brushing teeth every day to clean the teeth, easy to use
Embodiment 3, the concrete prescription of present embodiment is: carboxymethyl cellulose 1.25g, glycerol 12g, calcium carbonate 52g, Borax 2.5g, Oleum Caryophylli 0.8g (being equivalent to eugenol 7g), water 28g, correctives 0.9g (saccharin sodium 0.1g wherein, Borneolum Syntheticum 0.2g, Mentholum 0.2g, Foeniculi oil 0.2g, citrus seed oil 0.2g), sodium lauryl sulfate 2.5g, weigh needed raw material and produce by prescription by the technology among the above embodiment, being about to binding agent carboxymethyl cellulose input wetting agent glycerol is to stir in the glycerol to cause not have caking, again the Borax aqueous solution of making soluble in water is poured into wherein and mixed, backflow stirs into glue, put into after grinding through colloid mill that storage tank is quiet puts that to cause gelatinizing even, the quiet time of putting is no less than 8 hours, by Borneolum Syntheticum, Mentholum, Foeniculi oil, citrus seed oil, stir in the glue after the correctives that mixing such as saccharin sodium are formed mixes with Oleum Caryophylli after quiet the putting of input, Oleum Caryophylli and correctives are dispersed in the glue, and then add calcium carbonate and sodium lauryl sulfate and stir into quiet the putting of emulsifiable paste and make its solid phase more than 8 hours, liquid phase and medicine fully are in harmonious proportion evenly, the good emulsifiable paste that is in harmonious proportion grinds through colloid mill again, quiet putting more than 6 hours, vacuum outgas becomes Amosan more afterwards.This agent is a most preferred embodiment, under the hosting of Liaoning Province Department of Public Health, through Chinese medical university two, three department of stomatology, Hospital, BJ Stomatological Hospital, the stomatological hospital clinical experiment of Bethune medical university, to simple gingivitis, three days effective percentage reach 86.6% after the medication, reach 96%, 14 day in 7 days and reach 100% obvious effective rate and reached 63.2%, 14 day in 7 days and reach 84.4% and bacterial plaque and antibacterial all had tangible cleaning and inhibitory action.