CN103705760B - A kind of suppository preparation method for postpartum perineum pain - Google Patents

A kind of suppository preparation method for postpartum perineum pain Download PDF

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CN103705760B
CN103705760B CN201410013836.5A CN201410013836A CN103705760B CN 103705760 B CN103705760 B CN 103705760B CN 201410013836 A CN201410013836 A CN 201410013836A CN 103705760 B CN103705760 B CN 103705760B
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parts
herba
gained
powder
mixing
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CN103705760A (en
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于栋丽
王梅
修永红
石英
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Shi Ying
Wang Mei
Xiu Yonghong
Yu Dongli
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Abstract

The invention discloses a kind of suppository preparation method for postpartum perineum pain, to solve postpartum perineum pain problem.It is characterized in that preparation method comprises: it is for subsequent use that (1) will go back bobbin, Herba Dendrobii coarse powder, Herba Moslae, Cortex Ponciri trifoliatae coarse powder, Bulbus Allii Fistulosi extracts volatile oil; (2) by gelatinum oxhide, that Nostoc is ground into fine powder is for subsequent use; (3) by gained medicinal residues water extract-alcohol precipitation in Herba Bulbophylli inconspicui, Radix Tylophorae arenicolae, Retinervus Luffae Fructus, Herba Moslae, Hai Qian, Usnea and step 1, extracting centrifugal liquid concentrate drying is ground into dried cream powder; (4) gained volatile oil in step 1 is sprayed in step 3 gained dried cream powder, to add in step 2 mixing of gained fine powder, add substrate and cosolvent, stir at 60 DEG C, inject vaginal suppository mould, cooling, arrange, Qi Mo and get final product.Clinical trial certificate: the present invention is applicable to postpartum perineum pain and uses, has good effect and the higher feature of safety, clinic application, promotes.

Description

A kind of suppository preparation method for postpartum perineum pain
Technical field
The present invention relates to the field of Chinese medicines, be specifically related to a kind of suppository preparation method for postpartum perineum pain.
Background technology
The position of perineum is the whole piece region between vagina and anus.In time giving a birth, the head of fetus is revealed in vaginal orifice, is referred to as hat (crowning), if hat continued of a specified duration, part obstetrist can cut a wound, giving birth in order to fetus usually in this stage in perineum place, this method of disposal is referred to as Perineal defect; In addition, can cause the lacerated wound of perineum during natural production, this lacerated wound generally can be divided into 4 grades, first and second degree laceration is more common lacerated wound, 3rd degree of laceration is the fracture of anal sphincter, if laceration reaches rectal mucosa, that is exactly four degree of lacerations.Lacerated wound during childbirth all can cause the perineal wound pain in puerperal, and this pain is conducted via pudendal nerve, and pain may badly influence seat, stands, walks about, urinate and even sleep.
According to the report of document, have 93.33% without Perineal defect or tear medical history vaginal delivery puerpera main suit 3d in puerperal in perineum pain, and physical examination do not have visual blood stasis, swelling or other obviously damage, puerperal, the ratio of 2 weeks constant pains dropped to about about 66.67%.Another clinical research shows, occurs perineum pain condition in the 1 week puerperal of puerpera having the cesarean mode of 43.75% to give a birth.Above two researchs show, although Perineal defect or the factor that mainly starts of tearing as perineum pain, but the pain of not damaged background is important too, it occurs producing great variety with hormone in vivo level in puerperal, and local nerve function sensitive improves clearly relevant thereupon.
Because postpartum breastfeeding phase analgesic uses limited, so now in general can only with puerperal local cold compress and warm water demibain hocket and alleviate, but this physical property modification method limited efficiency, and local cold compress is unfavorable for patient's postpartum recovery, easily causes side effect.
Summary of the invention
Technical assignment of the present invention is for above the deficiencies in the prior art, provides a kind of curative effect certainly and the little suppository preparation method for postpartum perineum pain of side effect.
The technical scheme that the present invention solves its technical problem is: a kind of pharmaceutical composition for postpartum perineum pain, it is characterized in that being prepared from by the crude drug of following weight proportion: Herba Bulbophylli inconspicui 10 ~ 30 parts, Radix Tylophorae arenicolae 6 ~ 12 parts, Retinervus Luffae Fructus 3 ~ 10 parts, alizarin 6 ~ 12 parts of sea, Herba Moslae 3 ~ 10 parts, gelatinum oxhide 6 ~ 12 parts, go back 6 ~ 12 parts, bobbin, Cortex Ponciri trifoliatae 6 ~ 12 parts, Nostoc 6 ~ 12 parts, Herba Dendrobii 1 ~ 5 part, Usnea 3 ~ 10 parts, Bulbus Allii Fistulosi 10 ~ 25 parts.
Chinese medicine of the present invention can be prepared from by following method:
(1) bobbin, Herba Dendrobii coarse powder, Herba Moslae, Cortex Ponciri trifoliatae coarse powder, Bulbus Allii Fistulosi will be gone back and extract volatile oil with vapor distillation respectively, and mixing for standby use after collecting, for subsequent use after the medicinal residues mixing after extraction;
(2) gelatinum oxhide, Nostoc were pulverized 150 mesh sieves respectively, for subsequent use after drying and sterilizing at fine powder mixes 60 DEG C;
(3) gained medicinal residues mixing in Herba Bulbophylli inconspicui, Radix Tylophorae arenicolae, Retinervus Luffae Fructus, Hai Qian, Usnea and step 1 is added 10 times of water yields, decoct with water 2 times, each 1 hour, collecting decoction, leave standstill; Then in decocting liquid, add the ethanol of 95% of 3 ~ 4 times of medicinal liquids, leave standstill 15 minutes, then with 3000rpm/min centrifugal 20 minutes, extracting centrifugal liquid concentrate drying, be ground into dried cream powder, for subsequent use;
(4) gained volatile oil in step 1 is sprayed in step 3 gained dried cream powder, to add in step 2 mixing of gained mixing fine powders, add substrate and cosolvent, stir at 60 DEG C, inject vaginal suppository mould, cooling, arrange, Qi Mo and get final product.
Above-mentioned substrate can be one or several the mixture in polyethylene glycols, poloxamer, carbomer, sodium stearate, glycerin gelatine, stearic acid, glyceryl monostearate, hexadecanol, octadecanol, insect wax, hydrogenated vegetable oil.
Above-mentioned cosolvent can be propylene glycol or poly yamanashi esters.。
Wherein said: Herba Bulbophylli inconspicui is the orchid family Bulbophyllum platymiscium Herba Bulbophylli inconspicui BulbophylluminconspicuumMaxim., with all herbal medicine.Nature and flavor are sweet; Pungent; Cool; Nontoxic.Return lung; Stomach warp.Merit can heat clearing away YIN nourishing; Nourishing the lung to arrest cough.
Radix Tylophorae arenicolae, for the spirit of asclepiadaceae plant bamboo disappears the root of Cynanchuminamoenum (Maxim.) Loes. or aerial parts.Nature and flavor are bitter; Micro-pungent; Property is put down.Return lung meridian.Merit can the kidney invigorating, spleen invigorating, removing toxic substances.
Retinervus Luffae Fructus is cucurbitaceous plant Fructus Luffae Luffacylindrica(L.) vascular bundle of the dry mature fruit of Roem..Sweet, flat.Return lung, stomach, Liver Channel.Merit can dredging collateral, invigorates blood circulation, dispels the wind.
Hai Qian is Sargassaceae plant Alga Sgrgassi Enerves SargassumenerveC.Ag., Sargassum henslowianum SargassumhenslowianumC.Ag., sargassum thunbergii Sargassumthunbergii(Mert.) O.Kuntze or Sargassum phyllocystum Tseng et Lu,Sargassum horneri (Turn.) C. Ag. (Fucus horneri (Turn.)C.Ag.,Spongocarpus horneri Kutz.) argassumhorneri(Turn.) frond of C.Ag.Nature and flavor are salty; Cold.Return liver; Stomach; Kidney channel.Merit can hard masses softening and resolving; Removing heat-phlegm.
Herba Moslae is the dry aerial parts of labiate Mosla chinensis Maxim..Nature and flavor are pungent, tepor.Attach to the lung and stomach meridians.Merit can relieving the exterior syndrome by diaphoresis, and middle dampness removing.
Gelatinum oxhide is the glue that the gelatinum oxhide skin that is bovid cattle BostaurusdomesticusGmelin is made.Sweet in the mouth; Property is put down.Return lung; Large intestine channel.Merit can be nourshing Yin and drynsessmoistening prescription; Nourishing blood and hemoslasis; Promoting blood circulation and detumescence; Removing toxic substances.
Also bobbin is the fruit of orchid Rhizoma Gastrodiae GastrodiaelataBl..Sweet in the mouth; Cold in nature.Merit can tonify deficiency subduing the wind syndrome.Main dizzy; Pupil; Wind syndrome of head is had a headache; Weak breath consumption of essence; Early whitening of beard and hair.
Cortex Ponciri trifoliatae is rutaceae Fructus Ponciri Trifoliatae (Fructus Ponciri Trifoliatae Immaturus) Poncirustuifoliata(L.) bark of Raf. bits or peel bits.Nature and flavor are pungent; Temperature.Return liver; Kidney channel.Merit can endogenous wind stopping relieving convulsion; Eleminating phlegm and freeing channels.
Nostoc is algae Cyanophyceae nostocaceae nostoc nostoc NostoccommuneVauch..Nature and flavor are light, cold.Return liver, heart channel.Merit can heat clearing away, convergence, QI invigorating, improving eyesight.
Herba Dendrobii is the fresh or dry stem of orchid dendrobium loddigesii Rolfe DendrobiumloddigesiiRolfe., Herba Dendrobii oculati DendrobiumfimbriatumHook.var.oculatumHook., HERBA DENDROBII DendrobiumchrysanthumWall., Herba Dendrobii DendrobiumcandidumWall.exLindl. or Dendrobium nobile DendrobiumnobileLindl..Nature and flavor are sweet, are slightly cold.Return stomach, kidney channel.Merit can reinforcing stomach reg fluid, nourishing YIN and clearing away heat.
Usnea is the thallus (thallus) of Usneaceae Usnea plant USNEA Usnea diffracta (female trailing plants, Herba Cucubali) UsneadiffractaVain. or Usnea Longissima (Scolopendra Usnea, Herba Stellariae Alsines) U.longissimaAch..Nature and flavor are sweet, flat.Merit can heat-clearing and toxic substances removing, and hemostasia and promoting granulation, pain relieving, liver heat removing and eyesight improving, moves back nebula.
Bulbus Allii Fistulosi, be the cauloid of Liliaceae allium Herba Alii fistulosi, merit can be delivered and activate yang, removing toxic substances parasite killing.
Composition principle: Perineal defect or the factor that mainly starts of tearing as perineum pain, but the pain of not damaged background is important too, and it occurs producing great variety with hormone in vivo level in puerperal, and local nerve function sensitive improves clearly relevant thereupon.Because postpartum breastfeeding phase analgesic uses limited, so now in general can only with puerperal local cold compress and warm water demibain hocket and alleviate, but this physical property modification method limited efficiency, and local cold compress is unfavorable for patient's postpartum recovery, easily causes side effect.In prior art, Chinese medicine carries out pain relieving in puerperal, mostly adopts dispelling the damp pathogen with drugs of bitter in taste and cold in nature or blood circulation promoting and blood stasis dispelling method for the treatment of, but uses puerperal dispelling the damp pathogen with drugs of bitter in taste and cold in nature medicine easily cause cold inverse and upwards affect recovery, and blood circulation promoting medicine too much can cause again the untoward reaction such as local telangiectasis.
Compared with prior art, the present invention has following characteristics:
1, prescription is unique: get Herba Bulbophylli inconspicui in side, Radix Tylophorae arenicolae is monarch, the cooperation of described Herba Bulbophylli inconspicui, Radix Tylophorae arenicolae, the two is lung meridian medication, the main skin of lung, so the two can enter skin network; The feature of Herba Bulbophylli inconspicui is heat clearing away, but nature and flavor are sweet cool; There is the merit of sweet profit, simultaneously can YIN nourishing, be suitable for using puerperal; For in rat inflammatory pain model, the Herba Bulbophylli inconspicui Aqueous extracts of 1mg/kg can reduce localized heat shock protein (HSP) expresses, and HSP is then one of factor representing the state of high stress; Radix Tylophorae arenicolae toil, pungent and walk to alter and disperse, helping Herba Bulbophylli inconspicui in local skin channels passes through, Radix Tylophorae arenicolae: when Herba Bulbophylli inconspicui is 1:2 ratio, and HSP expresses minimum;
2, getting Herba Moslae in side is minister, the outer dampness of Herba Moslae solution Intradermal film, and Herba Moslae volatile oil can weaken rabbit local inflammation response strength;
3, get Retinervus Luffae Fructus promoting blood circulation to remove obstruction in the collateral, Cortex Ponciri trifoliatae eleminating phlegm and freeing channels, Usnea hemostasia and promoting granulation, extra large alizarin dissipating phlegm and resolving masses be minister, and inventor for many years Clinical and experimental study show, Cortex Ponciri trifoliatae, extra large madder can alleviate rapidly the pain that local nerve high sensitive strip is come; Get and go back bobbin tonify deficiency subduing the wind syndrome, gelatinum oxhide is nourshing Yin and drynsessmoistening prescription to nourish blood, auxiliary Radix Tylophorae arenicolae kidney and spleen invigorating; Herba Bulbophylli inconspicui nourishing YIN and clearing away heat assisted by Herba Dendrobii;
4, gelatinum oxhide is rich in colloidality, Nostoc is rich in algae active substance, and the two local uses and contributes to alleviating local mucous membrane and stimulate;
5, Bulbus Allii Fistulosi merit can be delivered and activate yang, and the effect in we increases the overall transdermal absorption factor of medicine;
6, avoid using analgesic drug product, avoid analgesic on the impact of baby, analgesic of the present invention principle is to reduce local nerve hypersensitivity;
7, medicine material survival dose of the present invention is groped to sum up to draw through inventor in a large number, and each crude drug consumption is for all to have good curative effect in following weight parts scope.
Detailed description of the invention
Below in conjunction with practical situation, the specific embodiment of the present invention is elaborated.
Embodiment 1, crude drug weight proportion: Herba Bulbophylli inconspicui 20 parts, Radix Tylophorae arenicolae 10 parts, Retinervus Luffae Fructus 6 parts, alizarin 10 parts of sea, Herba Moslae 6 parts, gelatinum oxhide 10 parts, go back 10 parts, bobbin, Cortex Ponciri trifoliatae 10 parts, Nostoc 10 parts, Herba Dendrobii 2 parts, Usnea 6 parts, Bulbus Allii Fistulosi 20 parts.
The preparation method of embodiment 1 is: by Herba Bulbophylli inconspicui, Radix Tylophorae arenicolae, Retinervus Luffae Fructus, Hai Qian, Herba Moslae, gelatinum oxhide, go back bobbin, Cortex Ponciri trifoliatae, Nostoc, Herba Dendrobii, Usnea, the decoction of Bulbus Allii Fistulosi mixing and water adding, filtrate is got after 30 minutes, medicinal residues add water continue decoction get filtrate after 20 minutes, twice filtrate merges, and gets local wet dressing around appropriate perineum sooner or later every day.
Embodiment 2, crude drug weight proportion: Herba Bulbophylli inconspicui 10 parts, Radix Tylophorae arenicolae 6 parts, Retinervus Luffae Fructus 3 parts, alizarin 6 parts of sea, Herba Moslae 3 parts, gelatinum oxhide 6 parts, go back 6 parts, bobbin, Cortex Ponciri trifoliatae 6 parts, Nostoc 6 parts, Herba Dendrobii 1 part, Usnea 3 parts, Bulbus Allii Fistulosi 10 parts.Selected substrate is glycerin gelatine, and cosolvent is propylene glycol.
Embodiment 3, crude drug weight proportion: Herba Bulbophylli inconspicui 20 parts, Radix Tylophorae arenicolae 10 parts, Retinervus Luffae Fructus 6 parts, alizarin 10 parts of sea, Herba Moslae 6 parts, gelatinum oxhide 10 parts, go back 10 parts, bobbin, Cortex Ponciri trifoliatae 10 parts, Nostoc 10 parts, Herba Dendrobii 2 parts, Usnea 6 parts, Bulbus Allii Fistulosi 20 parts.Selected substrate is Macrogol 4000, and cosolvent is propylene glycol.
Embodiment 4, crude drug weight proportion: Herba Bulbophylli inconspicui 30 parts, Radix Tylophorae arenicolae 12 parts, Retinervus Luffae Fructus 10 parts, alizarin 12 parts of sea, Herba Moslae 10 parts, gelatinum oxhide 12 parts, go back 12 parts, bobbin, Cortex Ponciri trifoliatae 12 parts, Nostoc 12 parts, Herba Dendrobii 5 parts, Usnea 10 parts, Bulbus Allii Fistulosi 25 parts.Selected substrate is stearic acid, and cosolvent is Polysorbate.
The Chinese medicine of embodiment 2 ~ 4 can be prepared from by following method:
(1) bobbin, Herba Dendrobii coarse powder, Herba Moslae, Cortex Ponciri trifoliatae coarse powder, Bulbus Allii Fistulosi will be gone back and extract volatile oil with vapor distillation respectively, and mixing for standby use after collecting, for subsequent use after the medicinal residues mixing after extraction;
(2) gelatinum oxhide, Nostoc were pulverized 150 mesh sieves respectively, for subsequent use after drying and sterilizing at fine powder mixes 60 DEG C;
(3) gained medicinal residues mixing in Herba Bulbophylli inconspicui, Radix Tylophorae arenicolae, Retinervus Luffae Fructus, Hai Qian, Usnea and step 1 is added 10 times of water yields, decoct with water 2 times, each 1 hour, collecting decoction, leave standstill; Then in decocting liquid, add the ethanol of 95% of 3 ~ 4 times of medicinal liquids, leave standstill 15 minutes, then with 3000rpm/min centrifugal 20 minutes, extracting centrifugal liquid concentrate drying, be ground into dried cream powder, for subsequent use;
(4) gained volatile oil in step 1 is sprayed in step 3 gained dried cream powder, to add in step 2 mixing of gained mixing fine powders, add substrate and cosolvent, stir at 60 DEG C, inject vaginal suppository mould, cooling, arrange, Qi Mo and get final product.
Described substrate can be one or several the mixture in polyethylene glycols, poloxamer, carbomer, sodium stearate, glycerin gelatine, stearic acid, glyceryl monostearate, hexadecanol, octadecanol, insect wax, hydrogenated vegetable oil.
Selected cosolvent can be propylene glycol or poly yamanashi esters.
The efficient combination of said medicine, coordinates mutually, effectively reach the object being applicable to the use of postpartum perineum pain, and side effect is less.The above results is clinical data sufficient proof, and interrelated data is as follows.
1 object and method.
1.1 object.
1.1.1 case selection: childbirth puerpera 120 example of main suit's perineum pain in June, 2012 ~ 2013 year 24 hours puerperal of June, exclusion standard: 1. Perineal defect; 2. laceration of perineum.More than get rid of object to be to get rid of the interference caused because of local wound.
1.1.2 ordinary circumstance: puerpera age 20 ~ 42 years old, wherein primipara 86 example, multipara 34 example; Pregnant all 37 ~ 40 weeks; Transvaginal spontaneous labor 48 example, cesarean 72 example.
1.1.3 divide into groups: be divided into matched group 40 example at random, soak group 36 example, suppository group 44 example.Three groups of cases are all healthy, and without complication, in age, pregnant week, childbirth options, no significant difference (P>0.05), has comparability.
1.2 method.
1.2.1 Therapeutic Method: cold saline soak is used, 2 times/d in matched group local; Soak group with local wet dressing around gained decoction perineum in the embodiment of the present invention 1,2 times/d; Suppository group with the embodiment of the present invention 3 gained suppository, 2 times/d.Above case was all 1 course for the treatment of with 7d, judged curative effect after 1 course for the treatment of.
1.2.2 criterion of therapeutical effect: recovery from illness: clinical symptoms, sign disappear; Effective: clinical symptoms, sign turn for the better by and large, perineum pain non-standing, does not affect life; Effective: clinical symptoms, sign alleviate, perineum pain lasts, does not affect life; Invalid: clinical symptoms, sign, perineum ache influence are lived.
1.2.3 statistical analysis: SPSS13.0 carries out statistical analysis.Measurement data t checks, enumeration data χ 2inspection.
2 results.
2.1 3 groups for the treatment of performances: all cases all at least ensure the former Regimen Chemotherapy of 3d, soak group and suppository group patient all can expire course of therapy without the need to adding other analgesic, and analgesics after having 11 routine 3d in matched group 40 example, is added because of invalid, 4 examples are had to add analgesics because of invalid after 7d, above case because completing the Primary Care of 3d, so count Ineffective Cases.Three groups for the treatment of performances compare, and soak group and suppository group are obviously better than matched group (P<0.01).
2.2 3 groups of Clinical efficacy comparisons: soak group and suppository group cure rate and matched group difference is (soak group χ extremely obviously 2=8.87, P<0.05; Suppository group χ 2=9.89, P<0.05), soak group and suppository group total effective rate are apparently higher than matched group (soak group χ 2=4.17, P<0.05; Suppository group χ 2=4.94, P<0.05), see the following form.
Group Number of cases Cure Effective Effectively Invalid Total effective rate
Matched group 40 2(5.00%) 12(30.00%) 12(30.00%) 14(35.00%) 65.00%
Soak group 44 20(45.45%) 12(27.27%) 8(18.18%) 4(9.09%) 90.91%
Suppository group 36 18(50.00%) 12(33.33%) 4(11.11%) 2(5.56%) 94.44%
2.2 3 groups of adverse reactions of patients incidence rates compare: when matched group has 2 routine main suit's cold water soak, femoribus internus has sense of twitching, and all the other two groups all do not have obvious adverse reaction to report.
3. conclusion.
This result of study shows, soak group of the present invention and suppository group cure rate, total effective rate are apparently higher than matched group, and the incidence rate of untoward reaction is low, and can relapse rate be reduced, illustrate that the present invention has the advantage that untoward reaction is comparatively light, safety is higher in treatment postpartum perineum pain.

Claims (3)

1. the suppository preparation method for postpartum perineum pain, it is characterized in that, be prepared from by the crude drug of following weight proportion: Herba Bulbophylli inconspicui 10 ~ 30 parts, Radix Tylophorae arenicolae 6 ~ 12 parts, Retinervus Luffae Fructus 3 ~ 10 parts, alizarin 6 ~ 12 parts of sea, Herba Moslae 3 ~ 10 parts, gelatinum oxhide 6 ~ 12 parts, go back 6 ~ 12 parts, bobbin, Cortex Ponciri trifoliatae 6 ~ 12 parts, Nostoc 6 ~ 12 parts, Herba Dendrobii 1 ~ 5 part, Usnea 3 ~ 10 parts, Bulbus Allii Fistulosi 10 ~ 25 parts; Be made up of following steps:
(1) bobbin, Herba Dendrobii coarse powder, Herba Moslae, Cortex Ponciri trifoliatae coarse powder, Bulbus Allii Fistulosi will be gone back and extract volatile oil with vapor distillation respectively, and mixing for standby use after collecting, for subsequent use after the medicinal residues mixing after extraction;
(2) gelatinum oxhide, Nostoc were pulverized 150 mesh sieves respectively, for subsequent use after drying and sterilizing at fine powder mixes 60 DEG C;
(3) gained medicinal residues mixing in Herba Bulbophylli inconspicui, Radix Tylophorae arenicolae, Retinervus Luffae Fructus, Hai Qian, Usnea and step 1 is added 10 times of water yields, decoct with water 2 times, each 1 hour, collecting decoction, leave standstill; Then in decocting liquid, add the ethanol of 95% of 3 ~ 4 times of medicinal liquids, leave standstill 15 minutes, then with 3000rpm centrifugal 20 minutes, extracting centrifugal liquid concentrate drying, be ground into dried cream powder, for subsequent use;
(4) gained volatile oil in step 1 is sprayed in step 3 gained dried cream powder, to add in step 2 mixing of gained mixing fine powders, add substrate and cosolvent, stir at 60 DEG C, inject vaginal suppository mould, cooling, arrange, Qi Mo and get final product.
2. a kind of suppository preparation method for postpartum perineum pain according to claim 1, is characterized in that: described substrate is one or several the mixture in polyethylene glycols, poloxamer, carbomer, sodium stearate, glycerin gelatine, stearic acid, glyceryl monostearate, hexadecanol, octadecanol, insect wax, hydrogenated vegetable oil.
3. a kind of suppository preparation method for postpartum perineum pain according to claim 1, is characterized in that: selected cosolvent is propylene glycol or poly yamanashi esters.
CN201410013836.5A 2014-01-13 2014-01-13 A kind of suppository preparation method for postpartum perineum pain Expired - Fee Related CN103705760B (en)

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