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Pharmaceutical technologies | THE CHAPTER 17

  TO RETURN ON MAIN PAGE of the unit " Pharmaceutical technologies "

    Chapter 17  Soft medicinal Forms.
     Ointment. Requirements to ointments. Classification of bases for ointments. Technology of ointments. Introduction of medicinal substances in an ointment. The basic directions of perfection of quality and technology Ointments.
     Soft medicinal forms.
    Definition. An ointment - soft LF, intended for drawing on A leather, wounds or mucous membranes. Ointments will consist of a basis and One or several medicinal substances, in regular intervals in her Distributed. The structure of ointments includes stabilizers, Preservatives.
    The characteristic and classification. Ointments are widely applied in Various areas of medicine: at treatment dermatological Diseases, in otolaryngology, surgical, proktologicheskoj, To gynecologic practice, and also as means of protection of a leather from Adverse external influences (organic substances, Acids, alkalis). Recently ointments are applied and for Influences on internal bodies and all organism with the purpose Treatments, preventive maintenance and diagnostics of diseases.
    In the form of ointments the medicinal substances concerning to are applied To all pharmacological groups: antiseptics, anestetiki, Hormones, vitamins, protivogribkovye means, analgetiki, a/b and Other
    Depending on a consistence distinguish: ointments, pastes, creams, Gels, linimenty.
    Requirements to ointments:
    Should have a soft consistence for convenience of their drawing on A leather and mucous membranes and educations on a surface equal A continuous film.
    Medicinal substances in ointments should be maximum dispergirovany also are distributed on all ointment for achievement Necessary therapeutic effect and accuracy of batching Medicinal substance.
    Should be stable, not contain mechanical inclusions.
    Their structure should not change at storage and application.
    Concentration of medicinal substances and weight of an ointment should To correspond written out in the recipe.
    There are some classifications: in a place of application, To character of action and type of dispersive system.
    In a place of drawing of an ointment:
    dermatolog;
    For a nose;
    The stomatologist;
    vaginalnye;
    rektalnye; with the help of special syringes.
    Urethral.

    This classification has basically medical value, though Somewhere and the certain technological process. For example, ointments, Rendered on a mucous membrane are sensitive to microorganisms, Therefore for them prepare in asepticheskih conditions. Besides a dispersion Than eye ointments is much higher, than at dermatolog.
    On character of action:
    Ointments, have local an effect on the top layer of a leather or A surface of a mucous membrane;
    Ointments rezorbtivnogo actions (rezorbtsija - absorption, vsasyvanie), depth pronikanija in a leather or a mucous membrane, Reaches krov. Channels an effect also has on all organism (the ointment "nitrong" - contains 2 % an oil solution of nitroglycerine and Is accepted for prof. Attacks of a stenocardia. The effect comes Through 30 - 40 mines also are saved 3 - 5 ÷).
    From the point of view of technology classification has the greater value As dispersive system:
    Homogeneous ointments;
    Heterogeneous ointments.
    Homogeneous - in them medicinal substances are distributed in a basis As a solution, i.e. are finished with molecular dispersiveness.
    Heterogeneous - are characterized by presence of an interphase surface Between medicinal substances and a basis.
    Bases for ointments. Bases provide necessary weight of an ointment and Thus appropriate concentration of medicinal substances, A soft consistence, render essential influence on Stability of ointments. A degree of liberation of medicinal substances From ointments, speed and their completeness rezorbtsii in many respects depend from The nature and properties of a basis. For example, an ointment of an acid boric 2 % on konsistentnoj emulsionnoj to a basis show same Therapeutic activity, as a similar ointment of 10 % The concentration, prepared on vaseline. Akim in the image, an ointment It is necessary to consider as a unit, and a basis as active A part of an ointment. To bases are showed a number of requirements Submitted on the circuit:

    à) the soft consistence is necessary for convenience of drawing on a leather And mucous membranes.
    á) Chemical inertness of bases guarantees absence Interactions with medicinal substances, changes under Action of external factors (air, light, a moisture, temperature) and, Hence, stability of an ointment is provided.
    â) absence allergez. razdrazhitelej and sensibilizirujushchego Actions of ointments depends on harmless biological bases.
    ã) it is important, that bases did not break physiological functions of a leather. The external layer of a leather possesses sour reaction, which Interferes with duplication of microorganisms. Therefore preservation Initial value rN leather is of great importance.
    ä) presence of microorganisms can cause repeated infitsirovanija the inflamed leather and mucous, and also decrease Activity of medicinal substances.
    å) the large value has a question on ease of removal of the rests Ointments from linen, surfaces of a leather, it is especial with their fibrous Sites.
    æ) properties of a basis should correspond to the purpose of purpose of ointments.
    Bases for superficially working ointments should not To promote depth vsasyvaniju medicinal substances. Bases For ointments rezorbtivnogo actions, on the contrary, for maintenance vsasyvanija medicinal substances through a layer of a leather. Bases Protective ointments should dry up quickly and densely adjoin to Surfaces of a leather. Some classifications of bases are known for Ointments: on physical properties, on a chemical compound, To a source of reception, etc.
    The most expedient is classification on a degree Relationship of properties of medicinal substances and bases, whenever possible Dissolution of medicinal substances and a basis. According to This principle mazevye bases divide all into 3 groups: lipofilnye, gidrofilnye, lipofilno-gidrofilnye bases.

    Classification of bases for ointments.
    Lipofilnye bases are diverse in the chemical attitude The substances having strongly pronounced water repellency.
    Fats and their derivatives, voski, hydrocarbons here enter and silikonovye bases. (fats gidrogenizirovannye - products, Received at kataliticheskom gidrogenizirovanii oils Vegetative. Thus nonlimiting glitseridy pass in Limiting, and liquid oils change a consistence on soft and Firm depending on a degree gidrogenizatsii. Gidrogenizirovannye fats are steadier at storage).
    Gidrofilnye bases - prominent feature is Ability of dissolution in water. Gidrofilnye bases do not leave Fat traces, are better washed off from a leather and linen.
    Lack of them is small stability to microbic kontaminatsii. Gels VM of carbohydrates and fibers here enter, Synthetic Naval Forces, inorganic substances.
    Lipofilno-gidrofilnye bases - in them can be entered easily as vodo-, and fat-soluble substances, water solutions Medicinal substances. As obligatory components here Enters emulgator PEAHENS.
    Technology of ointments.
    The main task of technology at manufacturing ointments will be, That medicinal substances were as much as possible dispergirovany and Are in regular intervals distributed on all weight of a basis; a consistence of an ointment Would provide ease of drawing and uniform distribution on Leather or a mucous membrane; stability of an ointment would guarantee An invariance of its structure at application and storage.
    The technology of an ointment will consist of the following stages:
    Preparation of a basis for ointments and medicinal substances;
    Introduction of medicinal substances in a basis;
    Homogenization of ointments;
    Standardization;
    Packing and storage.

    Preparation of a basis for ointments. A basis rasplavljajut in a flank or a tank (in a sphere) also move to the cooking boiler. If a little Components, plavjatsja start with refractory substances. At Necessities filter a basis through a canvas or a gauze. Medicinal substance crush sifting through a sieve.
    Introduction of medicinal substances in a basis. Addition Medicinal substances to a basis it is carried out in 2 valtsovyh Amalgamators or in reactors with a steam shirt or electric Warmed, supplied 3-ìÿ powerful mixers: anchor, lopastnoj, turbine, providing good hashing and peretiranie components of an ointment.

    Introduction of medicinal substances in an ointment.

    Depending on a way of introduction of medicinal substances and Character of their distribution in bases of an ointment are classified: Homogeneous, suspenzionnye, emulsionnye and combined.
    Ointments - alloys (a combination 2 or several mutually soluble
    Components)
    Homogeneous
    Ointments - solutions (containing lek. The substances dissolved of a basis.
    Preparation of ointments begin with fusion of a basis, then in
    Received rasplave dissolve medicinal substances).
    Suspenzionnye - the ointments containing medicinal substances, not Soluble in water and a basis, distributed in her on type Suspensions.
    Emulsionnye - are characterized by presence liquid dispersive Phases, not rastvorjaemoj in a basis and distributed in her on type emulsii (a dispersive phase - Í2Î2, linetol, glycerin, tar, Liquid Burova, and also solutions of medicinal substances).
    Combined - the most complex multicomponent systems Containing a liquid and a firm component, one of which Another is dissolved in water, in a basis, the third - neither there, nor there.

    Homogenization of ointments - if at hashing is not possible to receive A necessary degree of dispersiveness of medicinal substances. It is carried out in zhernovyh mills or valkovyh mazeterkah, and Also device RPA.
    Standardization - an ointment standardize under the maintenance medicinal Substances, to value rN and degrees of dispersiveness it is firm. ch. In susp. M.
    Packing and storage - in glass banks, p/e and aluminium tubas. Packing in tubas - with the help turbonabivochnyh automatic devices. Store Ointments in the cool place protected from light. An ointment, Prepared to a drugstore, store 10 day.

    The basic directions of perfection of quality and technology Ointments.
    Expansion of assortment mazevyh bases and their choice in dependence From application of an ointment and from age of the patient.
    Raised physical stability suspenzionnyh and emulsionnyh Ointments can be achieved by addition of thickeners, emulgatorov, etc. auxiliary substances.
    Chemical stability - application of antioxidants (butiloksianizol, α-òîêîôåðîë, etc.)
    M-á stability - with the help of preservatives (an acid sorbinovaja 0,2 %, a mix 1:3 nipagina and nipazola, spirit benzilovyj 0,9 %).
    A problem of packing - in connection with modern requirements to a level Microbic kontaminatsii in not sterile medical products. The combined (laminated) materials are created, combined The best properties of an aluminium foil, polymers, papers. Are created Packings disposable using.

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