CN102784416B - Novel delivery assisting gel and preparation method and application of novel delivery assisting gel - Google Patents
Novel delivery assisting gel and preparation method and application of novel delivery assisting gel Download PDFInfo
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Abstract
Disclosed is a composition with a lubricating effect. The composition comprises chitosan, polyethylene glycol, a water-soluble thickener, a humectant and optional water. The composition is used for preparing a medical product used as a lubricant for vaginal delivery, has good safety and antibacterial effects, and can effectively assist delivery, so that delivery is carried out easily, and a delivery birth process and delivery time are shortened.
Description
Technical field
The present invention relates to medical product field, relate to a kind of Novel aid childbirth gel, is the compositions with good lubrication and antibacterial action, uses especially in parturient childbirth, the invention still further relates to its preparation method and application.
Background technology
Parturient childbirth is a complicated process, woman produces medical research and proves, childbirth is by the thing of giving a birth (fetus, amniotic membrane, Placenta Hominis), birth canal and the three aspect factor such as minute exert oneself and determine, woman produces medical research and shows, promote that the power of childbirth is uterine contraction and gravity, and the power that suppresses childbirth is the resistance of orifice of uterus and birth canal, people baby's childbirth is divided into 3 stages: opening phase, the phase of giving birth to and rear term.Primipara's normal labor persistent period average out to 12 hours, and multipara's normal labor persistent period average out to 8 hours, compare with primipara, the tension force that multipara's average childbirth shorter reason of persistent period is birth canal reduces, because multipara's soft tissue pipeline [uterus section-cervical canal-soft tissue attachment tube (vagina and vulva) ］ pass through previous vaginal delivery and attenuation.Therefore, about the give a birth main theory of mechanics of people is: the tension force of birth canal (open birth canal, stretch birth canal and make the required power of birth canal attenuation) is considered to the power of important obstruction childbirth.
The misery of puerpera in spontaneous labor process is unmodifiable objective fact, due to painful and frightened in when childbirth of puerpera, often make birth process be full of all multi-risk Systems, not only can cause huge injury to puerpera's health, also can make baby and cause brain injury because of difficult labour, anoxia, even also can cause mother or baby dead, therefore, a lot of puerperas select laparotomy ventrotomy when childbirth, but because laparotomy ventrotomy exists certain risk, not only be unfavorable for multiple extensive after parturient childbirth, nor be beneficial to baby's growth.
World Health Organization (WHO) (WHO) repeatedly writes articles and appeals to encourage spontaneous labor, reduce non-adaptive card and cut open palace product, suggestion is controlled at the warning line that cuts open palace productive rate below 15%, WHO recent statistics in 2010 are announced the Sampling Investigation Report of 2007-2008 Asia nine state's childbirth options, point out that China cuts open palace productive rate and reached 46.2%, indivedual hospitals even reach 68%, wherein without Medical indication, cut open palace product ratio and reach 11%, become and cut open in the world one of country that palace productive rate is the highest, World Health Organization's suggestion fixes on 15% by the warning line that cuts open palace productive rate, and China is far apart apart from this target.
Alleviate the misery of puerpera in spontaneous labor, be not only love, produce in the palace of cuing open that is more conducive to reduce without indication, and the hazard event while being more conducive to prevent from giving a birth occurs, and for example puerpera's health excessively injures, baby's injury, even jeopardizes mother and baby's life etc.
According to physics principle, observe birth process, fetal head must meet with the resistance of birth canal while declining in birth canal by uterine contraction, this resistance is mainly derived from the interaction force between fetal head and birth canal, as represented with N, it and fetal head birth canal frictional force (F) are proportionate, the frictional force of the larger generation of pressure between fetal head and birth canal is also just large, and this relation can represent to be F=fN with physics's formula, and f represents coefficient of friction.When strength of uterine contraction is greater than F, fetus just can decline smoothly in birth canal, and when strength of uterine contraction is less than F, fetus declines and just do not occur smoothly difficult labour on the contrary.Now the pressure between fetal head and birth canal significantly increases, can make cranium brain directly dampen or because of intracranial continuous ischemia, edema and hemorrhage, intracranial pressure be raise, finally causing cranium cerebral hyoperfusion, become one of major reason of foetal death, the pressure of understanding as seen between fetal head and birth canal is very important.A kind of new approaches of practise midwifery are, if manage to reduce frictional force between fetal head birth canal, just likely make fetal head parturition become comparatively smooth, according to physics formula F=fN, between prompting fetal head, birth canal, frictional force depends on pressure and coefficient of friction, improves coefficient of friction and has feasibility and operability.As far back as the just existing record that utilizes olive oil and water to deliver a child for horses as lubricant in ancient Greek's period in B.C. 4th century, this maneuver also gradually becomes nowadays veterinary's circle " Golden Rule ".
United States Patent (USP) 3,814,797 disclose moisture lubricating composition, and it is based on (A) potassium metaphosphate, (B) alginic acid, carboxymethyl cellulose, carboxymethyl starch and salt thereof, and (C) sodium salt of weak acid, for example sodium carbonate or sodium phosphate;
United States Patent (USP) 3,971,848 disclose the lubricant compositions for mucosa, the mixture that it contains fucoidin and alginate, said composition can optionally be mixed with carboxymethyl cellulose, sodium polyacrylate, sodium polyphosphate potassium, poly(ethylene oxide) etc., and for making childbirth easily;
United States Patent (USP) 4,267,168 disclose a kind of liquid biocidal composition, and it can be used as abluent, surface disinfectant or vaginal lubricant.Said composition comprises lauryl diglycollic amide, propylene glycol, glycerol, poly-pectic acid sodium and silver ion;
JP46,024,256 discloses a kind of lubricant compositions, and it is comprised of polyacrylate substantially, is used as promotion property uterine luminal fluid in Bing Ke veterinary;
JP45,000,153 and JP4,500,012 disclose a kind of in veterinary for promoting the lubricated chaste tree compositions of childbirth, the salt that it comprises alginic acid or ester and arabic gum;
JP46,034,991 discloses the lubricant compositions that a kind of poly-epoxy second being included in liquid is burnt powder, and the organic solvent that described liquid is >80% by concentration, hydroxypropyl cellulose, sodium sulfate and detergent form.In veterinary, said composition can be in the laggard enforcement of dilution in order to contribute to the taking-up of fetus;
PCT/EP03/0054 discloses on physiology organic substance without a doubt for the preparation of the purposes of compositions that does not contain the alkali metal salt of Metaphosphoric acid, and described compositions is used as lubricant in women's vaginal delivery.Many examples of organic substance have without a doubt been mentioned on suitable physiology.The target of this invention is, by that recognize, important in the medical science that makes with lubricator to reduce in people to give a birth, to hinder childbirth power, i.e. frictional force between childbirth thing and birth canal;
International publication WO2006/050951(China Patent Publication No. CN101087587A) disclose a kind of people of making and given a birth and be easy to have the gel combination of good adhesion character and lubrication, contained Carbomer polyacrylic acid, water-soluble cellulose class thickening agent, wetting agent and water etc.;
China Patent Publication No. CN102228720A discloses a kind of childbirth with lubricator, water, sodium chloride, propylene glycol, glycerol, natrosol and xanthan gum, consists of.
But, not enough is, on the one hand, due to puerpera, in birth process, have the physiological fluids such as amniotic fluid, blood and flow out from birth canal, tend to weaken the lubricant effect of lubricant compositions, although puerpera's soft tissue pipeline is convenient to clean for water miscible lubricant, but affine better for the natural composition with greasy property, can not make physiological fluid weaken its lubricant effect, therefore, the lubricant effect of the compositions that technique scheme provides is not good enough; And on the other hand, the situation of reality is, because puerpera and the fetus immune level in birth process is very low, birth canal is understood hemorrhage and is tended to carry out perineal incision art, very likely increases the chance of local and systemic infection in birth process, therefore, making practise midwifery lubricant not only have efficient lubricant effect, safety but also have anti-microbial property not only, be very important, but antibiotics chemical substance is used at practise midwifery lubricant, often unfavorable to baby, or even danger close.
Summary of the invention
Target of the present invention is to provide a kind of childbirth gel combination that helps, people is given a birth easily, and described compositions is safe physical compatibility, the lubrication having had and sticking property, and there is good antibacterial action, and the material of this anti-microbial property is safe to baby and puerpera; The present invention also provides this to help the preparation method and application of childbirth gel.
The inventor finds pleasantly surprisedly, the gel that contains chitosan has certain film property, under vagina wet environment, there is good lubricity and adhesiveness, and because chitosan is a kind of natural biological polymer, it is the only macromolecule alkalescence polysaccharide that nature exists, there is very excellent biocompatibility and good anti-microbial property, more make the inventor pleasantly surprised be, Polyethylene Glycol can significantly improve the lubricity of chitosan gel rubber, the compositions of chitosan and Polyethylene Glycol, has more outstanding lubrication.
The present invention is by using natural materials safety and that have antibacterial action---and chitosan and Polyethylene Glycol be as the composition that helps childbirth gel, and the adhesive composite by having short lubrication is to reach target of the present invention.
And, discovery in addition, chitosan gel rubber is except having good greasy property, the compatible and adhesion property good with puerpera's soft tissue pipeline, more pleasantly surprised discovery, chitosan gel rubber has good solubility property for the slip agent of oils, when the slip agent of chitosan and oils exists, the slip agent of oils can be easy to wash clean, is unlikely to make gel to produce greasy feeling.
Chitosan (Chitosan), chemistry by name poly-(1,4)-2-amino-2-deoxidation-β-D-Glucose, it is a kind of natural biological polymer obtaining after the partly or entirely de-acetyl of chitin, it is the only macromolecule alkalescence polysaccharide that nature exists, be called again soluble chitin, Chitosan, chitosan, chitosan, there is good biocompatibility, the feature such as abundant that has no side effect, is easily absorbed, originates, in the field such as synthetic of food industry, chemical industry, medical macromolecular materials, obtain development and application widely.
Chitosan is the fabulous natural high molecular substance of biocompatibility.
The present invention helps childbirth gel, is a kind of compositions with lubrication, comprises (a) chitosan, (b) Polyethylene Glycol, (c) water-soluble thickener and (d) wetting agent and (e) optional water.
It is chitosan and derivant thereof that the present invention helps the component (a) of childbirth gel, include but not limited to carboxymethyl chitosan, chitosan hydrochlorate, chitosan lactate, chitosan acetate, chitosan sulfate fat, chitosan quaternary amine, Chitosan oligosaccharide, hyaluronic acid-like chitosan or chitin, etc., molecular weight is generally at least 20000D, preferably until 300000D, or selecting its normal viscosity is the chitosan of 20mPa.S～50000mPa.S, the chitosan that most preferably normal viscosity is 20mPa.S～100mPa.S, 20mPa.S for example, 30mPa.S, 40mPa.S, 50mPa.S, 60mPa.S, 70mPa.S, 80mPa.S, etc., deacetylation is greater than 90% conventionally, be preferably greater than 95%,
The mass ratio of component (a) in helping childbirth gel gross mass can be in wide scope, 0.1%～10% range changing for example, particularly when described compositions exists as moisture gel, the mass ratio of component (a) is preferably 0.2%～8%, particularly preferably 0.3%～5%, be more preferably 0.4%～4%, this mass ratio most preferably is 0.5%～3%;
The present invention helps component (b) Polyethylene Glycol of childbirth gel to comprise the Polyethylene Glycol of various different polymerization degrees, for example PEG400, Macrogol 600, cetomacrogol 1000, polyethylene glycol 1500, Macrogol 4000 or polyethylene glycol 6000, etc.,
Component (b) helps mass ratio in childbirth gel gross mass normally 0.5%～20% in the present invention, and preferably 1%～18%, particularly preferably 3%～15%, most preferably 5%～10%;
The present invention helps component (c) water-soluble thickener of childbirth gel or the mixture of multiple thickening agent, preferred example is cellulose derivative, polyvinyl alcohol, poloxamer or carbomer, concrete, cellulose derivative is hydroxyethyl-cellulose for example, hydroxypropyl cellulose, carboxymethyl cellulose, the mixture of one or more of hydroxypropyl emthylcellulose, polyvinyl alcohol comprises the polyvinyl alcohol of different polymerization degree and alcoholysis degree, for example include but not limited to PVA17-88, PVA17-92, PVA17-99, poloxamer comprises the models such as poloxamer-188 or poloxamer-407, carbomer comprises Carbomer-940, carbomer-941, the model such as carbomer-934 or carbomer-1342.Preferably, select hydroxyethyl-cellulose as the present invention, to help the thickening agent of childbirth gel, hydroxyethyl-cellulose comprises that its normal viscosity is the product of the viscosity models such as 1000mPa.S～100000mPa.S, preferred standard viscosity is the hydroxyethyl-cellulose of 10000mPa.S～80000mPa.S viscosity model, the hydroxyethyl-cellulose of viscosity models such as 80000mPa.S, 60000mPa.S, 50000mPa.S, 40000mPa.S or 30000mPa.S, etc.;
Component (c) helps mass ratio in childbirth gel gross mass normally 0.1%～10% in the present invention, and preferably 0.2%～8%, particularly preferably 0.5%～5%, most preferably 1%～3%;
It is the mixture of wetting agent or multiple wetting agent that the present invention helps the component (d) of childbirth gel, and preferred example is glycerol or propylene glycol, particularly glycerol, 1,2-PD,
Component (d) helps mass ratio in childbirth gel gross mass normally 0.5%～20% in the present invention, and preferably 1%～18%, particularly preferably 3%～15%, most preferably 5%～10%;
It is water that the present invention helps the component (e) of the optional existence of childbirth gel, comprise purified water, deionized water, distilled water, water for injection etc., the mass ratio of water in helping childbirth gel gross mass normally 50%～95%, preferably 60%～90%, particularly preferably 70%～85%.Certainly, optional, compositions also can be usingd to have compared with low water content or dry form (for example, as powder, granule) and existed and use, or/and dilute soon or be dissolved into before use the gel form of suitable viscosity and concentration.
Further, optionally, the present invention helps childbirth gel also to contain slip agent, the mixture of slip agent preferably vegetable oil or animal oil or multiple oils and fats, olive oil for example, refined maize oil, soybean oil, Oleum Arachidis hypogaeae semen, Oleum Ricini, Oleum Brassicae campestris, Fructus Maydis oil, soybean salad oil, rape salad oil, Semen Maydis salad oil, Petiolus Trachycarpi oil, Oleum Gossypii semen, Oleum sesami, Oleum Helianthi, chilli oil, oleic acid, ethyl oleate, hydrogenated vegetable oil, lecithin, fabaceous lecithin, plant embryo oil, lanoline or vitamin E, etc., refined maize oil most preferably, olive oil, soybean oil, soybean phospholipid, lanoline or vitamin E, slip agent can make the present invention help the greasy property of childbirth gel better, but its content need to be controlled suitably, otherwise the slip agent of these oils can change the water solublity feature that helps childbirth gel, make compositions have greasy feeling, be unfavorable for the clean and childbirth of the birth canal work of delivering a child, the mass ratio of slip agent in practise midwifery gel of the present invention normally 0.1%～5%, preferably 0.3%～3%, particularly preferably 0.5%～2%.Pleasantly surprised is, the solidifying existence of chitosan makes the slip agent of oils have hydrophilic and makes practise midwifery gel of the present invention keep the characteristic of good aqueous gel, the existence of slip agent can make practise midwifery gel of the present invention have more outstanding birth canal lubricity and affinity, certainly, before the present invention, set forth, the existence of chitosan can make the slip agent of oils can be easy to wash clean, is unlikely to make gel to produce greasy feeling.
Except above mentioned component, practise midwifery gel of the present invention also can comprise other auxiliary agent, for example surfactant, dispersant, other thickening agent, pH adjusting agent, carrier, filler, stabilizing agent, and described compositions is preferably containing antiseptic.
Necessary, the present invention helps childbirth gel preferably to comprise for adjusting the reagent of substantially first-class infiltration molar concentration of oozing, sodium chloride for example, and its mass ratio is generally and helps 0.1%～0.9% of childbirth gel gross mass, preferably 0.2%～0.8%, particularly preferably 0.3%～0.5%.
The present invention helps the pH value of childbirth gel by adding suitable acid-base reagent to be adjusted to 4～8, and particularly preferably 5～6, acid is lactic acid, hydrochloric acid or acetic acid for example, and alkali is sodium hydroxide, potassium hydroxide or triethanolamine for example.
The present invention helps the viscosity of childbirth gel to be preferably 0.5～30Pa.S, particularly preferably 2～20Pa.S, most preferably 5～20Pa.S, most preferably 0.8～18Pa.S.
The present invention helps childbirth gel to exist with aseptic form, wherein can be by steam moist hear heat test for example or/and carry out sterilizing by gamma Rays.
The present invention helps the preparation method of childbirth gel to comprise the following steps:
(1) the first mixture of being comprised of chitosan (a) and water (e) of preparation, optional, by adding sour example hydrochloric acid, lactic acid or acetic acid to regulate pH value, or/and by adding sodium chloride the degree of oozing such as to regulate, wherein said the first mixture is preferably gel form,
(2) the second mixture that preparation is comprised of water-soluble thickener (c), wetting agent (d) and water (e), wherein said the second mixture is preferably gel form,
(3) merge above-mentioned two kinds of mixture and Polyethylene Glycol (b), mix homogeneously,
(4) optional, carry out homogenize, and
(5) optional, carry out sterilizing.
This preparation process or its indivedual steps can depend on to the present invention is helped the childbirth operation predetermined of gel or depends on the additive that may exist and change, for example, in this process, can remove at least in part or/and add water or/and wetting agent.
Especially, according to above-mentioned the present invention, help childbirth gel, optimize following several formula and form:
Scheme one, a kind of childbirth gel that helps, contains by percentage to the quality:
Chitosan 0.1%～10%, preferably 0.2%～5%,
PEG-4000 or-600 1%～15%, preferably 3%～10%,
Hydroxyethyl-cellulose 0.1%～10%, preferably 0.5%～4%,
Glycerol or propylene glycol 0.5%～20%, preferably 3%～15%,
Sodium chloride 0.1%～0.9%, preferably 0.2%～0.8%,
Lactic acid or hydrochloric acid are appropriate, regulate chitosan gel rubber pH to 3～6,
Purified water surplus;
Preparation method: (1) adds chitosan in appropriate purified water, stirs, and adds gradually appropriate lactic acid or hydrochloric acid, makes reactant form gel, and makes the pH value of gel 3～6, and add sodium chloride to dissolve, and stirs, and obtains the first mixture gel;
(2) hydroxyethyl-cellulose is dispersed in appropriate purified water, after abundant swelling, adds glycerol or propylene glycol, mix, obtain the second mixture gel;
(3) merge above-mentioned two kinds of mixture gels and PEG-4000 or Polyethylene Glycol-600, mix homogeneously, and to regulate pH be 5～6, mixes, homogenize, degassed, sterilizing, obtains the present invention and helps childbirth gel.
Scheme two, a kind of childbirth gel that helps, contains by percentage to the quality:
Chitosan 0.1%～10%, preferably 0.2%～8%,
PEG-6000 or PEG-4000 1%～15%, preferably 2%～5%,
Hydroxyethyl-cellulose 0.2%～8%, preferably 0.5%～5%,
Glycerol or propylene glycol 0.5%～20%, preferably 5%～15%,
Sodium chloride 0.1%～0.9%, preferably 0.3%～0.5%,
Lactic acid or hydrochloric acid are appropriate, regulate chitosan gel rubber pH to 3～6,
Purified water surplus;
Preparation method: (1) adds chitosan in appropriate purified water, stirs, and adds gradually appropriate lactic acid or hydrochloric acid, makes reactant form gel, and makes the pH value of gel 3～6, and add sodium chloride to dissolve, and stirs, and obtains the first mixture gel;
(2) hydroxyethyl-cellulose is dispersed in appropriate purified water, after abundant swelling, adds glycerol or propylene glycol, mix, obtain the second mixture gel;
(3) merge above-mentioned two kinds of mixture gels and PEG-6000 or PEG-4000, dissolve and mix homogeneously, and to regulate pH be 5～6, mix, homogenize, degassed, sterilizing, obtains the present invention and helps childbirth gel.
Scheme three, a kind of childbirth gel that helps, contains by percentage to the quality:
Chitosan 0.3%～5%, preferably 0.5%～2%,
PEG-4000 or Polyethylene Glycol-600 1%～15%, preferably 3%～10%,
Carbomer 0.1%～5%, preferably 0.3%～2%,
Glycerol or propylene glycol 1%～15%, preferably 5%～10%,
Sodium chloride 0.1%～0.9%, preferably 0.2%～0.8%,
Sodium hydroxide or triethanolamine are appropriate, regulate carbomer gel pH to 7～7.5,
Lactic acid or hydrochloric acid are appropriate, regulate chitosan gel rubber pH to 3～6,
Purified water surplus;
Preparation method: (1) adds chitosan in appropriate purified water, stirs, and adds gradually appropriate lactic acid or hydrochloric acid, makes reactant form gel, and makes the pH value of gel 3～6, and add sodium chloride to dissolve, and stirs, and obtains the first mixture gel;
(2) carbomer is dispersed in appropriate purified water, after abundant swelling, mixes, with sodium hydroxide or triethanolamine, regulate pH to 7～7.5, obtain carbomer gel, will arrive carbomer gel and glycerol or mixed with propylene glycol even, obtain the second mixture gel;
(3) merge above-mentioned two kinds of mixture gels and PEG-4000 or Polyethylene Glycol-600, mix homogeneously, and to regulate pH be 5～6, mixes, homogenize, degassed, sterilizing, obtains the present invention and helps childbirth gel.
Scheme four, a kind of childbirth gel that helps, contains by percentage to the quality:
Chitosan 0.3%～5%, preferably 0.5%～2%,
PEG-4000 or Polyethylene Glycol-600 1%～15%, preferably 3%～10%,
Hydroxyethyl-cellulose or poloxamer 0.2%～8%, preferably 0.5%～2.5%,
Glycerol or propylene glycol 3%～15%, preferably 5%～8%,
Sodium chloride 0.1%～0.9%, preferably 0.2%～0.7%,
Lactic acid or hydrochloric acid are appropriate, regulate chitosan gel rubber pH to 3～6,
Olive oil or refined maize oil or soybean oil or vitamin E 1%～5%, preferably 0.3%～3%,
Purified water surplus;
Preparation method: (1) adds chitosan in appropriate purified water, stir, add gradually appropriate lactic acid or hydrochloric acid, make reactant form gel, and make the pH value of gel 3～6, and add sodium chloride to dissolve, stir, and mix homogeneously with olive oil or refined maize oil or soybean oil or vitamin E, obtain the first mixture gel;
(2) hydroxyethyl-cellulose or poloxamer are dispersed in appropriate purified water, after abundant swelling, stirring and evenly mixing, adds glycerol or propylene glycol, obtains the second mixture gel;
(3) merge above-mentioned two kinds of mixture gels and PEG-4000 or Polyethylene Glycol-600, mix homogeneously, and to regulate pH be 5～6, mixes, homogenize, degassed, sterilizing, obtains the present invention and helps childbirth gel.
Scheme five, a kind of childbirth gel that helps, contains by percentage to the quality:
Chitosan 0.3%～5%, preferably 0.5%～3%,
PEG-4000,4000 or 6,000 1%～15%, preferably 5%～10%,
Polyvinyl alcohol 0.1%～10%, preferably 1%～5%,
Glycerol or propylene glycol 1%～15%, preferably 5%～10%,
Sodium chloride 0.1%～0.9%, preferably 0.2%～0.8%,
Lactic acid or hydrochloric acid are appropriate,
Purified water surplus,
Wherein said polyvinyl alcohol comprises PVA17-88, PVA17-92 or PVA17-99;
Preparation method: (1) adds chitosan in appropriate purified water, stirs, and adds gradually appropriate lactic acid or hydrochloric acid, makes reactant form gel, and makes the pH value of gel 3～6, and add sodium chloride to dissolve, and stirs, and obtains the first mixture gel;
(2) polyvinyl alcohol is fallen apart in appropriate purified water, after abundant swelling, mix, further even with glycerol or mixed with propylene glycol, obtain the second mixture gel;
(3) merge above-mentioned two kinds of mixture gels and PEG-4000,4000 or 6000, dissolve and mix homogeneously, and to regulate pH be 5～6, mix, homogenize, degassed, sterilizing, obtains the present invention and helps childbirth gel.
The present invention helps the dosage unit form preferably packed with the volume of 5～100ml of childbirth gel, the dosage unit form of particularly preferably packing with the volume of 8～20ml, and preferably 10ml, 11ml, 15ml, etc.For example, the present invention helps favourable being packaged in wide mouthed bottle, syringe (preferably disposable syringe) or pipe of childbirth gel, or it can be used as vaginal suppository and uses, particularly preferred, the present invention help childbirth gel pack and be sealed in disposable vagina or birth canal administrator in, and the size of so selection packing, thereby make the present invention help the amount of childbirth gel enough for single, to use; Can use pipe or the syringe of prolongation, their length and birth canal length are basically identical, and the outlet that helps childbirth gel for the present invention is installed on its end, for example conventionally use in hospital not with syringe or its improved packaged form of syringe needle.
Puerpera is when childbirth, and before well-regulated uterine contraction starts, in the opening phase, or/and the interim the present invention of using that gives birth to helps childbirth gel, use is simple and highly effective, uses and can carry out one or many.For example at opening, before the phase, can have the following advantages soon or interim the using of opening: the tissue in birth canal is softened, promote extraly thus childbirth.Same, the present invention helps childbirth gel also to can be used for promoting placental separation.
In a preferred embodiment, the present invention helps childbirth gel can comprise in addition the active substance of one or more materia medicas, it is the medicine at the indication of birth process for some, for example, for easing the pain or suppressing childbirth or promote childbirth or the antibiotic etc active component of hemostasis or synthetic, the amount of this active constituents of medicine can be for example compositions gross mass (W/W) 0.0001～50%, preferably 0.01～10%, particularly preferably 0.01～5%.
Some examples of the material of guiding childbirth are oxytocin, dinoprostone, sulprostone, misoprostol and hyaluronidase.Some examples that suppress the material of childbirth are chondroitin sulfate, hexoprenaline, fenoterol, magnesium sulfate, atosiban, calcium Hangzhoupro short of money agent and nitroglycerin.Some examples of analgesic substance are bupivacaine, marcaine, lignocaine, mepivacaine, Rapidocain, Mepivacaine Hydrochloride, Solarcain and lidocaine hydrochloride.
Some examples of anti-infective antiviral material that is antibacteriums or/and anti-emblem is biological, for example quaternary ammonium compound, chlorhexidine, povidone iodine and iodine, and containing iodine compound, the antibiotic of the synthetic such as penicillin or cephalosporin or Macrolide.Mixing antiviral substance for example nucleoside analog, nucleoside reverse transcriptase inhibitor, non-nucleoside reverse transcriptase inhibitor and protease inhibitor, for example, for preventing herpes or HIV to propagate to baby from mother, is particularly advantageous.Similarly, mixing antibacterium material as chlorhexidine, for example, for preventing Type B streptococcus to propagate to baby from mother, is particularly advantageous.The verified pulmonary surfactant (Curosurf) that mixes is as Colfosceril Palmitate, beractant, and described pulmonary surfactant can promote neonate at puerperal respiratory activity.
Described the present invention helps childbirth gel to be particularly suitable as for making the childbirth of people's birth canal easily or/and for promoting the lubricant of placental separation.It can be or/and use one or many before well-regulated uterine contraction starts afterwards as required.Use preferably and carry out in birth canal (comprising orifice of uterus), it is equally also suitable in amniotic membrane, using.
When with lubricator cover orifice of uterus wall before childbirth or/and in birth process or/and during vagina (birth canal) wall, by using described compositions significantly to promote people to give a birth and even reducing the childbirth persistent period, particularly in primipara.At this, not only interim at opening, and giving birth to interimly, can significantly reduce birth canal and the friction of childbirth between thing.In addition, can also reduce or get rid of injured (for example, the infringement of the attenuation of soft tissue attachment tube, pelvic floor, vagina are torn, injury of perineum, rectal injury, uterine rupture, lose blood) risk, and restriction or prevention long-term damage for example urinary incontinence, fecal incontinence, sexual dysfunction and mental maladjustment.In addition, can alleviate by little friction childbirth work, this can cause being avoided or reducing vaginal surgery or cesarotomy.By the present invention, help childbirth gel also to contribute to artificial placental separation.
Preferably, before use, the present invention is helped childbirth gel to take out from packing in the situation that remaining on aseptic condition.Then, in birth process, with hands or other aids by the present invention help childbirth gel intermittently one or many be applied to birth canal, until there is baby's head.In this case, object is to cover birth canal as far as possible completely with this lubricating gel agent.After there is baby's head, the baby's gel on the face that uses cloth to wipe with, and optionally aspirate boil on the nape opposite the mouth-nose position.Ideally, baby's whole childbirth is carried out under the help of cloth, in order to avoid baby is skidded off accidentally from hands.
After minute baby are, or/and minute giving birth to after Placenta Hominis, with aseptic aqueous solution, preferably with gentle aseptic aqueous salt solution, rinse birth canal, to make lubricating gel agent dissolving.This can carry out or carry out independently in the damage process of processing perineum or birth canal.Optionally, the present invention helps childbirth gel to can be used in addition promoting the manual removal of giving birth to of Placenta Hominis or Placenta Hominis.
The present invention help childbirth gel except above-mentioned for making the opening phase at people's birth process and the phase of giving birth to is easy to purposes, and when preparation people vaginal delivery as the application in the medical product of lubricant, can also be for promoting the purposes of placental separation, can also be used as the lubricant of using when gynaecologic vaginal checks and use, and human body lubricants is used.
Advantage of the present invention: the material 1, adopting is all gentleness, safety, high, the non-irritating material of biocompatibility, makes the present invention help childbirth gel to have good safety; 2, practise midwifery gel of the present invention preferably contains the short lubrication prescription of oils, and birth canal lubricant effect significantly improves, and without greasy feeling, and belongs to water-soluable gel, be easy to water clean, without greasy feeling; 3, practise midwifery gel of the present invention has good antibacterial effect, has greatly alleviated the part of causing because of factors such as immune level are low, birth canal is hemorrhage in birth process of puerpera and fetus and the chance of systemic infection.
the specific embodimentin implementation process of the present invention, various embodiments that those of ordinary skills produce on the basis not departing from the scope of the present invention with spirit and modify apparent and be easily to carry out, the invention is not restricted to the scope of specific embodiment as herein described, really, various modification of the present invention, except those that narrated are to be understood by those skilled in the art from narration above.By the following examples, the present invention is done further and illustrated, but do not represent embodiment limitation of the present invention.
Embodiment 1, a kind of childbirth gel that helps, contain:
Chitosan (30～40mPa.S viscosity model) 1g,
PEG-4000 10g,
Hydroxyethyl-cellulose (80,000 mPa.S viscosity model) 1g
Glycerol 10g,
Sodium chloride 0.45g,
Lactic acid or hydrochloric acid are appropriate, regulate chitosan gel rubber pH to 3～6,
Purified water adds to 100g;
Preparation method: (1) adds chitosan in 30ml purified water, stirs, and adds gradually appropriate lactic acid or hydrochloric acid, makes reactant form gel, and makes the pH value of gel 3～6, and add sodium chloride to dissolve, and stirs, and obtains the first mixture gel;
(2) hydroxyethyl-cellulose is scattered in 40ml purified water, after abundant swelling, adds glycerol, mix, obtain the second mixture gel;
(3) merge above-mentioned two kinds of mixture gels and PEG-4000, mix homogeneously, and to regulate pH be 5～6, adds purified water to 100g, mixes, homogenize, degassed, sterilizing, obtains the present invention and helps childbirth gel.
Embodiment 2, a kind of childbirth gel that helps, contain:
Chitosan (40mPa.S viscosity model) 1g,
PEG-4000 10g,
Hydroxyethyl-cellulose (80,000 mPa.S viscosity model) 1g
Glycerol or propylene glycol 10g,
Sodium chloride 0.45g,
Lactic acid or hydrochloric acid are appropriate, regulate chitosan gel rubber pH to 3～6,
Olive oil 0.5g,
Purified water adds to 100g;
Preparation method: (1) adds chitosan in 30ml purified water, stir, add gradually appropriate lactic acid or hydrochloric acid, make reactant form gel, and make the pH value of gel 3～6, and add sodium chloride to dissolve, stir, and even with mixed with olive oil, homogenize, obtain the first mixture gel;
(2) hydroxyethyl-cellulose is scattered in 40ml purified water, after abundant swelling, adds glycerol or propylene glycol, mix, obtain the second mixture gel;
(3) merge above-mentioned two kinds of mixture gels and PEG-4000, mix homogeneously, and to regulate pH be 5～6, adds purified water to 100g, mixes, homogenize, degassed, sterilizing, obtains the present invention and helps childbirth gel.
Embodiment 3, a kind of childbirth gel that helps, contain:
Chitosan 0.8g,
PEG-6000 or PEG-4000 5g
Hydroxyethyl-cellulose 1～3g(is depending on different viscosities model),
Glycerol or propylene glycol 12g,
Sodium chloride 0.44g,
Lactic acid or hydrochloric acid are appropriate, regulate chitosan gel rubber pH to 3～6,
Purified water adds to 100g;
Preparation method: (1) adds chitosan in 25ml purified water, stirs, and adds gradually appropriate lactic acid or hydrochloric acid, makes reactant form gel, and makes the pH value of gel 3～6, and add sodium chloride to dissolve, and stirs, and obtains the first mixture gel;
(2) hydroxyethyl-cellulose is scattered in 45ml purified water, after abundant swelling, adds glycerol or propylene glycol, mix, obtain the second mixture gel;
(3) merge above-mentioned two kinds of mixture gels and PEG-6000 or PEG-4000, dissolve and mix homogeneously, and to regulate pH be 5～6, add purified water to 100g, mix, homogenize, degassed, sterilizing, obtains the present invention and helps childbirth gel.
Embodiment 4, a kind of childbirth gel that helps, contain:
Chitosan 1.1g,
Polyethylene Glycol-600 8g,
Carbomer-940 0.4g,
Glycerol or propylene glycol 9g,
Sodium chloride 0.46g,
Sodium hydroxide is appropriate, regulates carbomer gel pH to 7～7.5,
Lactic acid or hydrochloric acid are appropriate, regulate chitosan gel rubber pH to 3～6,
Purified water adds to 100g;
Preparation method: (1) adds chitosan in 30ml purified water, stirs, and adds gradually appropriate lactic acid or hydrochloric acid, makes reactant form gel, and makes the pH value of gel 3～6, and add sodium chloride to dissolve, and stirs, and obtains the first mixture gel;
(2) carbomer is dispersed in 40ml purified water, after abundant swelling, mixes, with sodium hydroxide, regulate pH to 7～7.5, obtain carbomer gel, carbomer gel and glycerol or mixed with propylene glycol is even, obtain the second mixture gel;
(3) merge above-mentioned two kinds of mixture gels and Polyethylene Glycol-600, mix homogeneously, and to regulate pH be 5～6, adds purified water to 100g, mixes, homogenize, degassed, sterilizing, obtains the present invention and helps childbirth gel.
Embodiment 5, a kind of childbirth gel that helps, contain:
Chitosan 1.5g,
PEG-4000 8g,
Poloxamer 2.5g
Sodium chloride 0.41g,
Glycerol or propylene glycol 7.5g
Lactic acid or hydrochloric acid are appropriate, regulate chitosan gel rubber pH to 3～6,
Refined maize oil 0.5g,
Purified water adds to 100g;
Preparation method: (1) adds chitosan in 40ml purified water, stir, add gradually appropriate lactic acid or hydrochloric acid, make reactant form gel, and make the pH value of gel 3～6, and add sodium chloride to dissolve, stir, and mix homogeneously with refined maize oil, obtain the first mixture gel;
(2) poloxamer is dispersed in 30ml purified water, after fully dissolving, stirring and evenly mixing, adds glycerol or propylene glycol, obtains the second mixture gel;
(3) merge above-mentioned two kinds of mixture gels and PEG-4000, mix homogeneously, and to regulate pH be 5～6, adds purified water to 100g, mixes, homogenize, degassed, sterilizing, obtains the present invention and helps childbirth gel.
Embodiment 6, a kind of childbirth gel that helps, contain:
Chitosan 1g,
PEG-4000 8g,
Polyvinyl alcohol 17-88 1.5g,
Glycerol or propylene glycol 10g,
Sodium chloride 0.50g,
Lactic acid or hydrochloric acid are appropriate, regulate chitosan gel rubber pH to 3～6,
Purified water adds to 100g;
Preparation method: (1) adds chitosan in 30ml purified water, stirs, and adds gradually appropriate lactic acid or hydrochloric acid, makes reactant form gel, and makes the pH value of gel 3～6, and add sodium chloride to dissolve, and stirs, and obtains the first mixture gel;
(2) polyvinyl alcohol (17-88 model) is dispersed in 30ml purified water, after abundant swelling, mixes, further even with glycerol or mixed with propylene glycol, obtain the second mixture gel;
(3) merge above-mentioned two kinds of mixture gels and PEG-4000, dissolve and mix homogeneously, and to regulate pH be 5～6, add purified water to 100g, mix, homogenize, degassed, sterilizing, obtains the present invention and helps childbirth gel.
Embodiment 7, security performance test
Get embodiment 1～6 prepared help childbirth gel, according to GB/T16886.10-2005 standard, carry out intradermoreaction test, eye irritant test, oral stimulation test, vaginal irritation test, all show nonirritant reaction, show that the present invention helps childbirth gel to have good safety.
Embodiment 8, performance test and comparison
Get embodiment 1～6 prepared help childbirth gel, and according to the prescription of embodiment 1～6 and preparation method, prepare 6 kinds of not gel products of chitosan-containing (chitosan content is 0) respectively, relatively its lubricity and biocidal property.
(1) greasy property test.
Model preparation: selecting specification is 100 object sand paper, prepare several models, measure respectively help childbirth gel and not the gel phase of chitosan-containing (chitosan content is 0) for the ratio of the frictional force size of glycerol, with this, judge that the present invention helps the greasy property of the gel of giving a birth.
Get long 30 centimetres, the sand paper of wide 8 centimetres is fixed on horizontal table top, sand paper particle-surface outwardly, the counterweight of separately getting 10 grammes per square metres is placed in length, wide, height is all in the plastic casing of 5 centimetres, the bottom of plastic casing is pasted and is fixed with length, wide is all the sand paper of 5 centimetres, sand paper particle-surface outwardly, getting appropriate glycerol is applied in respectively on the sand paper that is fixed on the sand paper strip of desktop and the bottom of plastic casing, applying amount is as the criterion just in time to fill and lead up sand paper particle voids, plastic casing is placed on the sand paper strip that is fixed on horizontal table top, with spring scale, with pulling force at the uniform velocity, pull plastic casing, recording its pulling force size is N
0(newton), needs are measured help childbirth gel and not the gel of chitosan-containing to record its pulling force size be N in accordance with the law
m(newton), the friction ratio r=N of relative glycerol
m/ N
0.
Result: the friction ratio r value of the relative glycerol of the gel products of chitosan-containing (chitosan content is 0) is not all greater than 0.86, and the prepared friction ratio r value of relative glycerol that helps childbirth gel of embodiment 1～6 is all less than 0.23, show that it is the more than 4 times of glycerol that the present invention helps the greasy property of childbirth gel, shows good greasy property.
(2) bacteriostasis property test.
Method: the circular filter paper sheet that is 6mm by diameter is put into together high pressure steam sterilization (120 ℃, 0.12MPa) 20min of various gel solutions.Get each bacteria suspension 100uL and evenly spread upon culture medium plate surface, with aseptic nipper, each filter paper is attached to containing on bacterium plate, at 37 ℃, cultivate 24h, measure the antibacterial circle diameter of circle filter paper.
Result: the antibacterial circle diameter of the gel products of chitosan-containing (chitosan content is 0) is not all less than 1.3mm, and the prepared antibacterial circle diameter that helps childbirth gel of embodiment 1～6 is all greater than 12.5mm, shows good anti-microbial property.
Antibacterial circle diameter is all greater than 12.5mm, shows good anti-microbial property.
Embodiment 8,
The childbirth gel that helps described in embodiment 1～6 is used as the application in the medical product of lubricant when preparation people vaginal delivery;
The childbirth gel that helps described in embodiment 1～6 helps childbirth easily to carry out, shorten the application in the medical product of childbirth labor and delivery time in preparation;
The application of gel described in embodiment 1～6 in the medical product for the preparation of promotion placental separation;
The application of gel described in embodiment 1～6 in the medical product of lubricant of preparing gynaecologic vaginal inspection use;
The application of gel described in embodiment 1～6 in preparing the medical product of human body lubricants.
Claims (1)
1. help a childbirth gel, contain:
The chitosan 1g of 30～40mPa.S viscosity model,
PEG-4000 10g,
The hydroxyethyl-cellulose 1g of 80000 mPa.S viscosity models,
Glycerol 10g,
Sodium chloride 0.45g,
Lactic acid or hydrochloric acid are appropriate, regulate chitosan gel rubber pH to 3～6,
Purified water adds to 100g;
Preparation method: (1) adds chitosan in 30ml purified water, stirs, and adds gradually appropriate lactic acid or hydrochloric acid, makes reactant form gel, and makes the pH value of gel 3～6, and add sodium chloride to dissolve, and stirs, and obtains the first mixture gel;
(2) hydroxyethyl-cellulose is scattered in 40ml purified water, after abundant swelling, adds glycerol, mix, obtain the second mixture gel;
(3) merge above-mentioned two kinds of mixture gels and PEG-4000, mix homogeneously, and to regulate pH be 5～6, adds purified water to 100g, mixes, homogenize, degassed, sterilizing, obtains.
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| CN102772426A (en) * | 2012-08-29 | 2012-11-14 | 福州乾正药业有限公司 | Medical applications of chitosan serving as component of parturition assistant lubricating agent |
| CN103040728A (en) * | 2013-02-03 | 2013-04-17 | 福州乾正药业有限公司 | Chitosan gel for women as well as preparation method and medical application thereof |
| CN103536969B (en) * | 2013-09-29 | 2014-09-24 | 辽宁亿灵科创生物医药科技有限公司 | Lubrication composition having certain viscosity and used for preventing birth trauma |
| CN107412885B (en) * | 2014-01-13 | 2020-04-28 | 成都英诺新科技有限公司 | Gel for midwifery and preparation method thereof |
| CN104188896A (en) * | 2014-08-25 | 2014-12-10 | 漳州片仔癀药业股份有限公司 | Chitosan polyelectrolyte composite gel as well as preparation method and applications thereof |
| CN105727377A (en) * | 2014-12-31 | 2016-07-06 | 托夸氏健康服务医疗清洁及化学产品工业及贸易有限公司 | Midwifery gel |
| CN108057134B (en) * | 2017-12-26 | 2020-12-01 | 湖北回盛生物科技有限公司 | Dairy cow midwifery lubricant and preparation method thereof |
| CN111066964A (en) * | 2019-12-26 | 2020-04-28 | 湖北回盛生物科技有限公司 | Liquid lubricant for ruminants and preparation method thereof |
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