CN105125990A - Traditional Chinese medicine gel for promoting wound healing in lateral perineotomy - Google Patents
Traditional Chinese medicine gel for promoting wound healing in lateral perineotomy Download PDFInfo
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Abstract
The invention belongs to the field of traditional Chinese medicine and discloses traditional Chinese medicine gel for promoting wound healing in lateral perineotomy. The traditional Chinese medicine gel is prepared from, by weight, 10%-20% of traditional Chinese medicine extractive, 0.5%-4.5% of carbomer 940, 0.5%-3.5% of polyvinylpyrolidone K30, 3%-10% of glycerinum, 0.5%-1.3% of polysorbate, 0%-10% of triethanolamine, 0.3%-0.5% of ethylparaben, 0.5%-5% of azone and the balance water. The traditional Chinese medicine extractive is prepared from longpeduncle kadsura roots, folium ilicis chinensis, Indian lalimeris herb, stahlianthus involucratus and adina pilulifera leaves. The gel can promote the blood circulation at a wound part, seepage and absorption of medicine in local tissue is promoted from the outside to the inside, and the purposes of dredging the channel, promoting blood circulation to remove blood stasis, relieving pain and promoting wound healing are achieved; the gel is uniform and fine in texture, is easy to smear after being spread, the pH value of the gel is closer to the skin environment, neither a puerpera nor lactation of a baby can be influenced, the compliance of the patient for accepting treatment is greatly improved, and the living quality of puepera and the baby are improved.
Description
Technical field
The invention belongs to the field of Chinese medicines, be specifically related to a kind of Chinese medicine gel promoting lateral episiotomy wound healing.
Background technology
Lateral episiotomy is operation common in obstetric delivery, the object that side is cut be shorten that the second stage of labor delivery of fetus of avoiding prolonged second stage of labor to cause is obstructed, fetal distress, prolonged labor and soft tissue damage ensure that after the birth, mother and child were doing well.In recent years in childbirth, primipara is on the increase the fetus scale of construction in the trend risen, and reducing the unnecessary damage of mother and baby, adopting the showed increased of episiotomy in order to avoid there is complication, but in stages of labor, repeated multiple times anus is examined and vagina operation operation, and Whole Layer Lateral Perineotomy can be caused to infect.Can be there is local scleroma, pain, suppuration after infecting in Whole Layer Lateral Perineotomy, affect the healing of otch; Simultaneously because sweat gland secretion in puerperal is vigorous, vagina discharges lochia etc., easily cause local abnormal flavour and skin infection, even occurring can vaginal eczema.The generation of therefore stopping surgery cut infection, minimizing postoperative complication and sequela in lateral episiotomy just seems extremely important.
Traditional care method adopts povidone iodine to clean perineal wound, but some puerpera is unsuitable for using this Therapeutic Method to povidone iodine allergy, cannot be widely used in the clinical generation easily causing again perineal position eczema.More existing hospitals use preparation in its institute to carry out fumigation and wash method, cleaning or soak to puerpera perineum side joint-cutting conjunction postoperative wound, early postoperation wound pain is alleviated to reach, promote the object of wound healing, but these drug treating times are short, because being lotion or powder, medicine arrives after focus can not the delay of long period, makes the course for the treatment of long, uses still not very convenient; On the other hand because perineal wound exposes and lochia is discharged, be subject to poison heresy and pollute, the infection rate of perineal incision is higher.
The repair in trauma content of homeland pharmacy is very abundant, and think that the reparation of wound is that after wound is formed, heresy just disaccords, heresy is moved back and just won, and evil poison gradually removes, stagnant mostization of the stasis of blood, and meridians lead to again, internal organs and tune, and healthy energy is recovered, the progressive process that QI and blood is led to again.Traditional Chinese medical science more holistic idea, thinks that repair in trauma is not limited to wound itself, and relates to the various aspects of tissue repair and regeneration, the destruction of the anatomic tissue integrity namely caused by a variety of causes and its repair process.Therefore it is still very feasible to find a kind of quick, effective, workable method alleviating incision pain in motherland's medical science.
Summary of the invention
In order to solve the deficiencies in the prior art, the invention provides a kind of Chinese medicine gel promoting Whole Layer Lateral Perineotomy to heal, it can shorten the postoperative wound healing time of anemia of pregnant woman's perineum side cutting, alleviate early postoperation wound pain, reduce postoperative complication and sequela, evident in efficacy, safe and reliable, to have no side effect and easy to use, there is wide potential applicability in clinical practice.
For achieving the above object, the present invention adopts following technical scheme:
A kind of Chinese medicine gel promoting lateral episiotomy wound healing, be prepared from primarily of following raw material: by weight percentage, Chinese medicine extract 10% ~ 20%, Acritamer 940 0.5% ~ 4.5%, polyvinylpyrrolidone k300.5-3.5%, glycerol 3-10%, Polysorbate 0.5-1.3%, triethanolamine 0% ~ 10%, ethyl hydroxybenzoate 0.3-0.5%, azone 0.5-5%, surplus are water;
Described Chinese medicine extract is made up of following raw material: Radix Kadsurae longipedunculatae, Folium Ilicis Purpureae, Herba Kalimeridis, Rhizoma Stahlianthi Involucrati, water body floral leaf.
Although although the indivedual single medicinal materials in the present invention have the effects such as dissipating blood stasis for subsidence of swelling, alleviating pain and detumescence, heat-clearing and toxic substances removing, be all not enough to that there is good clinical therapeutic efficacy.In order to increase the synergism of effective active composition in Chinese medicine extract, inventor is in conjunction with modern Chinese medicine theory of development, from improving curative effect of medication, reducing the angle of side effect, carry out screening to Chinese medicine ingredients to extract and prescription test, optimize following technical scheme further: a kind of Chinese medicine gel promoting Whole Layer Lateral Perineotomy to heal, it is characterized in that described Chinese medicine extract is made up of the raw material of following weight portion: Radix Kadsurae longipedunculatae 9-19 part, Folium Ilicis Purpureae 15-35 part, Herba Kalimeridis 20-40 part, Rhizoma Stahlianthi Involucrati 15-30 part, water body floral leaf 15-30 part.
Further preferably, Chinese medicine extract described above is made up of the raw material of following weight portion: Radix Kadsurae longipedunculatae 12-15 part, Folium Ilicis Purpureae 28-33 part, Herba Kalimeridis 25-30 part, Rhizoma Stahlianthi Involucrati 18-23 part, water body floral leaf 20-25 part.
Further preferably, Chinese medicine extract described above is made up of the raw material of following weight portion: Radix Kadsurae longipedunculatae 12 parts, Folium Ilicis Purpureae 30 parts, Herba Kalimeridis 26 parts, Rhizoma Stahlianthi Involucrati 20 parts, water body floral leaf 22 parts.Fang Zhong: Folium Ilicis Purpureae energy heat-clearing and toxic substances removing, promoting blood circulation and hemostasis, promoting tissue regeneration and ulcer healing, anti-inflammation ability is better, is monarch drug.Rhizoma Stahlianthi Involucrati is apt to dissipating blood stasis for subsidence of swelling, promoting blood circulation and hemostasis, promoting the circulation of QI to relieve pain, is ministerial drug.The cooling blood for hemostasis of Herba Kalimeridis energy, clearing away heat-damp and promoting diuresis, removing toxic substances and promoting subsidence of swelling, can strengthen the merit of the heat-clearing and toxic substances removing of monarch drug, also has good dampness removing effect; Radix Kadsurae longipedunculatae is apt to dispelling wind and removing obstruction in the collateral, promoting blood circulation and detumescence, regulating QI to relieve pain; Help ministerial drug reducing swelling and alleviating pain; Water body floral leaf can help monarch-minister drug clearing heat and expelling damp, eliminating stasis to stop pain, can also arresting bleeding and healing up ulcer, and all medicine compatibilities play effect of heat-clearing and toxic substances removing, promoting blood circulation to remove blood stasis, reducing swelling and alleviating pain, promoting tissue regeneration and ulcer healing altogether.
The pharmacological property of each herbal medicine of the present invention is as follows:
Radix Kadsurae longipedunculatae: [nature and flavor] are pungent; Bitter; Warm in nature.[return through] spleen; Stomach; Liver Channel.[function cures mainly] regulating QI to relieve pain; Dispelling wind and removing obstruction in the collateral; Promoting blood circulation and detumescence.Main stomachache; Stomachache; Rheumatic arthralgia; Dysmenorrhea; Menoxenia; Puerperal abdonimal pain; Laryngopharynx swelling and pain; Hemorrhoid; Innominate toxic swelling; Traumatic injury is hindered.
Folium Ilicis Purpureae: [nature and flavor] are bitter; Puckery; Cool.[function cures mainly] heat-clearing and toxic substances removing; Promoting tissue regeneration and ulcer healing; Promoting blood circulation and hemostasis.Main cough due to lung-heat; Laryngopharynx swelling and pain; Dysentery; Diarrhoea; Biliary tract infection; Urinary tract infection; Angina pectoris; Burn and scald; Pyretic toxicity carbuncle; Ulcer of the lower limb; Leprelcosis; Eczema; Chilblain; Chap; Thromboangiitis obliterans; Traumatic hemorrhage.
Herba Kalimeridis: [nature and flavor] acrid in the mouth; Cool in nature.[return through] returns lung; Liver; Stomach; Large intestine channel.[function cures mainly] cooling blood for hemostasis; Clearing away heat-damp and promoting diuresis; Removing toxic substances and promoting subsidence of swelling.Main haematemesis; Epistaxis; Dysentery; Metrorrhagia; Wound hemorrhage; Jaundice; Edema; Stranguria with turbid discharge; Flu; Cough; Pharyngalgia sore throat; Hemorrhoid; Carbuncle; Erysipelas; Infantile malnutrition.
Rhizoma Stahlianthi Involucrati: [nature and flavor] pungent micro-hardship, temperature.[function cures mainly] dissipating blood stasis for subsidence of swelling, promoting blood circulation and hemostasis, promoting the circulation of QI to relieve pain.Control traumatic injury stasis of blood pain, rheumatic ostalgia, spit blood, epistaxis, menorrhagia, worm venom.
Water body floral leaf: [source] medical material Ji Yuan: be branch and leaf [nature and flavor] bitter in the mouth, puckery, cool in nature of dicotyledon medicine Maguireothamnus speciosus Ramulus et Folium Adinae Piluliferae.[return through] liver; Spleen; Large intestine channel.[function cures mainly] clearing heat and expelling damp; Eliminating stasis to stop pain; Arresting bleeding and healing up ulcer.Main dysentery; Intestinal is scorching; Edema; Carbuncle sore tumefacting virus; Eczema; Ulcer being unable to heal; Wound hemorrhage.
Present invention also offers a kind of preparation method of the Chinese medicine gel promoting Whole Layer Lateral Perineotomy to heal: it comprises the following steps:
8-10 times of water gaging will be added through the finished Radix Kadsurae longipedunculatae of micronizing, Rhizoma Stahlianthi Involucrati, soak 2-5h, adopt extraction by steam distillation total volatile oil; Take lecithin, cholesterol, add ether to make it to dissolve, ether is removed under reduced pressure at 50-60 DEG C, add appropriate distilled water, in 50-60 DEG C of hatching 20-30min, carry out homogenizing with high speed dispersion homogenizer, add Radix Kadsurae longipedunculatae, Rhizoma Stahlianthi Involucrati total volatile oil, carry out homogenizing with high speed dispersion homogenizer, the liposome of Radix Kadsurae longipedunculatae, Rhizoma Stahlianthi Involucrati volatile oil must be contained;
Get Folium Ilicis Purpureae, Herba Kalimeridis, water body floral leaf, add 6-10 times amount water soaking 1-5h, add Radix Kadsurae longipedunculatae again, Rhizoma Stahlianthi Involucrati extracts remaining medicinal residues after volatile oil, decoct with water secondary, collecting decoction, filter, filtrate reduced in volume to relative density is 1.10-1.20 (60 DEG C of survey), adding ethanol makes the volumn concentration of ethanol reach 60% ~ 70% (preferably 65%), and precipitate with ethanol leaves standstill 12h; Get supernatant and reclaim ethanol, and to be concentrated into relative density be 1.10 ~ 1.15 (60 DEG C record), Chinese medicine clear paste;
Using stand-by as matrix solution for Acritamer 940 swelling a few hours in distilled water; Get Polysorbate, glycerol, polyvinylpyrrolidone k30, add suitable quantity of water in 50-60 DEG C of heated and stirred solution, add while hot in carbomer solution to stir and make substrate; Then add in substrate by above-mentioned Chinese medicine clear paste and stearopten plastid, mixing stirs evenly, and adds ethyl hydroxybenzoate, azone, and finally add triethanolamine and adjust PH to 6.5 ~ 7.0, adding distil water supplies weight, obtains Chinese medicine gel of the present invention.
Preparation method provided by the invention substantially increases the effective ingredient of product, improves the quality of product; The homogeneous exquisiteness of the gel finally obtained, easily coating after launching, its pH value, closer to skin environment, smears the sense of rear wound surface foreign, good stability etc.
The drug loading of liposome has certain relation with the consumption of the film material lecithin and cholesterol of preparing liposome, if dosage is very few, liposome drug loading is just on the low side; If dosage is too much, beyond the bearing capacity of phospholipid, then liposome stability reduces preferably, and lecithin described above and the mass ratio of cholesterol are 3-8:1; The mass ratio of volatile oil and lecithin is 1:0.2-0.35; Further preferably, lecithin described above and the mass ratio of cholesterol are 5.5:1; When the mass ratio of volatile oil and lecithin is 1:0.25, the envelop rate of the liposome prepared, mobility, homogeneity are all better.
In order to verify beneficial effect of the present invention, inventors performed following experimentation, comprising safety evaluation and clinical trial etc. to Chinese medicine composition of the present invention.
One, the stability experiment of Chinese medicine gel of the present invention
(1) centrifugal test
Low-speed centrifugal is tested: take each 5g of Chinese medicine gel prepared by embodiment of the present invention 1-8 respectively, be placed in 10mL centrifuge tube, with the centrifugal 30min of 3000r/min, observes outward appearance and the stretchability of gel.
High speed centrifugation is tested: take each 0.5g of Chinese medicine gel prepared by embodiment of the present invention 1-8 respectively, be placed in 1.5mL centrifuge tube, with the centrifugal 30min of 12000r/min, observes outward appearance and the stretchability of gel.
Result: institute's test sample product are under 3000r/min and 12000r/min after centrifugal 30min, and gel appearance transparent is evenly in brown color, and non-layering, stretchability is good.
(2) accelerated test
Get each 3 batches of Chinese medicine gel test sample prepared by embodiment of the present invention 1-8, be placed in cillin bottle, sealing, in temperature (25 ± 2) DEG C, place 3 months under the condition of relative humidity (60 ± 5) %, monthly sample 1 time, detect, compared with the result of 0 day by gel stability high spot reviews project.
Result shows, under acceleration conditions, embodiment of the present invention 1-6 prepares Chinese medicine gel appearance character and significant change does not occur, and stretchability is also better, other every stability inspection items do not have significant change yet, and these all show that Traditional Chinese medicine compound gel agent has good stability.
(3) long term test
Get each 3 batches of Chinese medicine gel test sample prepared by embodiment of the present invention 1-3, be placed in cillin bottle, airtight, place 6 months under 4 ± 2 DEG C of conditions, respectively at the 1st, 3, sampling in June, check, compared with the result of 0 day by investigation project demand.
Long-term test results shows, embodiment of the present invention 1-3 prepares Chinese medicine gel lucifuge under 4 ± 2 DEG C of conditions and places 6 months, and outward appearance is good, and stretchability is good, with 0 month epidemic situation comparison without significant difference.Chinese medicine gel every high spot reviews index under long term test condition is substantially unchanged, illustrates that this reagent stability is good.
Two, the safety evaluation test of Chinese medicine gel of the present invention
1. skin sensibiligen experiment choosing is healthy
New zealand white rabbit 12, body weight 2.5-3.0kg, male and female half and half, spinal column lateral symmetry region, back 8% sodium sulfide unhairing, unhairing district is body surface area 10% (about 150cm
2), sub-cage rearing, observes 24h, is divided into 3 groups at random, often organizes 4.1. blank group: excipient 2g/ is only coated in spinal column epilating area; 2. gel intact skin group: be only coated in epilating area, spinal column both sides with gel 2g/ prepared by the embodiment of the present invention 1; 3. gel damaged skin group: be only coated in epilating area, spinal column both sides with gel 2g/ prepared by the embodiment of the present invention 1, the making of damaged skin adopt sterilization syringe needle unhairing is sterilized skin draw " # " word with oozing of blood degree of being.Give by after reagent 24h.Wash away residue.And in 1,24,48,72h to 7d, the change of each rabbit body weight of observed and recorded every day, skin and hair, eye and mucosa and breathing, central nervous system are unified the situation of the systems such as quadruped locomotion.
Result of the test: each treated animal is all survived, coating treated animal is searched for food, body weight, depilation district skin, eyes conjunctiva and oral mucosa, and breathing, circulation, central nervous system and extremity activity are showed no obvious abnormalities.Therefore, the present composition is very little to new zealand white rabbit dermal toxicity, points out its clinical drug safety.
2. Skin Irritation Test
New zealand white rabbit 20, before administration, 24h is by rabbit spinal column both sides 8% sodium sulfide unhairing, and unhairing district is body surface area 10% (about 150cm
2), after unhairing, 24h checks that whether skin of unhairing is injured because of unhairing.Be divided into 4 groups, i.e. intact skin matched group, intact skin administration group, damaged skin matched group and damaged skin administration group, the making of damaged skin adopts sterilization syringe needle unhairing to be sterilized on skin and draws " # " word, and with skin oozing of blood for degree, the damaged degree of left and right sides skin is basically identical.1. intact skin matched group: be only coated in spinal column epilating area with gel substrate 2g/ prepared by the embodiment of the present invention 1; 2. intact skin administration group: be only coated in spinal column epilating area with gel 2g/ prepared by the embodiment of the present invention 1; 3. damaged skin matched group: be only coated in spinal column epilating area with gel substrate 2g/ prepared by the embodiment of the present invention 1; 4. damaged skin administration group: be only coated in spinal column epilating area with gel 2g/ prepared by the embodiment of the present invention 1.With except tested material observing after 24h, then smear identical tested material, continuous 3d, and after last coating 1,24,48,72h observes depilation district dermoreaction.There is erythema and edema score value in record, goes forward side by side to assassinate and swash intensity evaluation.
Result of the test: in experiment, single-dose and multiple dosing damaged skin group have 1 rabbit skin to occur slight erythema respectively, but can disappear voluntarily in 48h, other has no erythema and edema reaction.Result is by skin irritation intensity evaluation, and display said preparation contacts nonirritant to guinea pig skin.
3. skin allergy test
Cavia porcellus 30, male and female half and half, body weight 280-300g.Remove both sides, back by hair, area 3cm × 3cm with depilatory before experiment, observe after 24h and determine not damaged.Cavia porcellus after process is divided into three groups at random, often organizes 10.First group to tested material (the Chinese medicine gel 0.2g/ of the embodiment of the present invention 1 preparation only), second group of blank (the substrate 0.2g/ of drug containing is not only), 3rd group of positive controls (1% 2,4-dinitro-chloro-benzene solution, positive excimer is 0.1%2,4-dinitrochlorobenzene), then observe evaluating skin allergic conditions respectively at 0h, 24h, 48h, 72h.
Result shows: erythema and edema do not appear in tested group and each 10 guinea pig skins of blank group, occur erythema after positive controls animal skin tested district self-excitation administration 1h, 6h is the most obvious, and 24h disappears gradually, after 72h, erythema is still visible reluctantly, and sensitization rate reaches 100%.Do not occur in 72h after tested group of guinea pig skin tested district self-excitation administration that erythema and edema are formed, compare indifference with blank group, illustrate that Chinese medicine gel of the present invention can not cause skin allergy.
Three, clinical observation test
1 data and method
1.1 physical data: puerpera 200 example choosing my institute vaginal delivery perineum side cutting in February ,-2015 in March, 2014, be numbered, wherein odd number is treatment group even number is matched group, often organizes each 100 examples.At 21 ~ 33 years old treatment group age, parity is 1 time, and pregnant week is full-term pregnancy, and the fetus position is head position, all without pregnancy complication; At matched group 60 22 ~ 35 years old age of example, parity is 1 time, and pregnant week is full-term pregnancy, and the fetus position is head position, all without pregnancy complication.Two groups of puerpera ages, pregnant week, parity, fetus position etc. are compared, and the equal not statistically significant of difference (P > 0.05), has comparability.
1.2 Therapeutic Method:
Matched group: postoperative 12h, cleans wound every day 2 times with 0.5% povidone iodine cotton balls, perineal incision have edema or red and swollen time, report without delay doctor, with 50% magnesium sulfate hot-wet compress;
Treatment group: Chinese medicine gel prepared by the invention process 1, is evenly coated on postoperative wound surface, every day 1-2 time.
1.3 observation of curative effect: two groups of puerpera perineum side joint-cuttings close the wound pain situation of postoperative 24 and 48h, and wound healing situation, perineal position eczema situation after Episiotomy.
Wound pain evaluation criterion: the standard envisages writing " Fundamental Nursing " (Beijing: People's Health Publisher: 2005:160) with reference to Yin Lei, is divided into I ~ IV level: I level: wound pain is not all felt in the not obvious sitting and lying walking of pain only to stimulate and press wound sense mild pain; II level: longitude pain, does not feel the wound pain Chinese and sits and sad mouth mild pain of walking when bed and distractibility; III level: can not subjective sensation be affected during moderate pain distractibility, sitting and lying and walking all feel wound pain, but can stand; IV level: severe pain limitation of activity can not be sat and walk, lies in bed and stands up all sad mouth ache influence and have a rest and sleep.
Two groups evaluation criterion: write " gynecological nursing " (Beijing: People's Health Publisher, 2003:71) according to Zheng Xiuxia and be divided into first class: wound healing is good, the initial stage healing had no adverse reaction; Second class: wound healing is not good enough, healing place has inflammatory reaction, as scorching in redness, scleroma and the end of a thread etc.; Third class: wound occurs pyogenic infection or splits.
1.4 statistical procedures: application SPSS16.0 statistical software.Measurement data with
represent, and adopt t inspection to data, enumeration data adopts X 2 test, and P < 0.05 has statistical significance for difference.
2 results
2.1 liang of group perineum side cutting postoperative wound pain situations compare: the wound pain situation that two groups of puerpera perineum side joint-cuttings close the postoperative 48h of postoperative 24h compares, observation group is all better than matched group, and difference has statistical significance (P < 0.01) in table 1.
The table 1 liang postoperative wound pain situation of group perineum side cutting compares
2.2 liang of postoperative wound healing situations of group perineum side cutting compare: treatment group Wound healing by first intention rate is 98%, matched group Wound healing by first intention rate is 83%, two groups of comparing differences have statistical significance (P < 0.05), in addition the healing time for the treatment of group is shorter, patient satisfaction is higher, difference all has statistical significance (P < 0.05), in table 2.
A table 2 liang group maternal wound heal situation compares (n)
Note: compare with matched group, * P < 0.05.
There is eczema situation in 2.3 liang of group puerpera perineum portions: eczema 1 example (accounting for 1.0%) occurs in treatment group puerpera perineum portion, and be less than matched group 7 example (accounting for 7%), difference has statistical significance (P < 0.05).
In a word, the present invention compared with prior art has following advantage: Chinese medicine gel of the present invention is very remarkable for the therapeutic effect of skin trauma after Episiotomy, full side plays effect of heat-clearing and toxic substances removing, promoting blood circulation to remove blood stasis, reducing swelling and alleviating pain, promoting tissue regeneration and ulcer healing altogether, wound location blood circulation can be promoted, from outward appearance to inner essence promote that medicine permeates, absorbs in local organization, reaches dredging the meridian, blood circulation promoting and blood stasis dispelling and lenitive object; Medicine directly contacts wound, is conducive to wound clearing heat for detumescence, putrefaction-removing granulation-promoting, promotes wound healing; In addition Chinese medicine gel uniform and smooth of the present invention, easily coating after launching, holdup time grows again not skin tightening, release is stable, good stability, without any side effects, both can not affect puerpera, also can not affect baby nursing, drastically increase the compliance for the treatment of patients, improve the quality of life of pregnant baby.
Detailed description of the invention
Further describe the present invention below by way of detailed description of the invention, but the present invention is not limited only to following examples.Within the scope of the invention or not departing from content of the present invention, spirit and scope, the present invention is suitably improved, replaces the identical component of effect, will become apparent to those skilled in the art that they are all deemed to be included within scope of the present invention.
Embodiment 1
Chinese medicine extract forms: Radix Kadsurae longipedunculatae 12 parts, Folium Ilicis Purpureae 30 parts, Herba Kalimeridis 26 parts, Rhizoma Stahlianthi Involucrati 20 parts, water body floral leaf 22 parts.
Gel formula: Chinese medicine extract 12%, Acritamer 940 2.5%, polyvinylpyrrolidone k301.6%, glycerol 5.5%, Polysorbate 0.8%, triethanolamine 2.0%, ethyl hydroxybenzoate 0.35%, azone 1.5%, surplus are water;
Preparation method: will add 8-10 times of water gaging through the finished Radix Kadsurae longipedunculatae of micronizing, Rhizoma Stahlianthi Involucrati, soaks 2-5h, adopts extraction by steam distillation total volatile oil; Take lecithin, cholesterol (mass ratio of lecithin and cholesterol is 5.5:1), be placed in round-bottomed flask, add ether to make it to dissolve, ether is removed under reduced pressure at 55 DEG C, add appropriate distilled water (making the concentration of phospholipid be 6.5mg/ml), in 55 DEG C of hatching 20-30min, homogenizing is carried out with high speed dispersion homogenizer, add Radix Kadsurae longipedunculatae, Rhizoma Stahlianthi Involucrati total volatile oil (mass ratio of volatile oil and lecithin is 1:0.25), carry out homogenizing with high speed dispersion homogenizer, the liposome of Radix Kadsurae longipedunculatae, Rhizoma Stahlianthi Involucrati volatile oil must be contained;
Get Folium Ilicis Purpureae, Herba Kalimeridis, water body floral leaf, add 6-10 times amount water soaking 1-5h, add Radix Kadsurae longipedunculatae again, Rhizoma Stahlianthi Involucrati extracts remaining medicinal residues after volatile oil, decoct with water secondary, collecting decoction, filter, filtrate reduced in volume to relative density is 1.15 (60 DEG C of surveys), adding ethanol makes the volumn concentration of ethanol reach 65%, and precipitate with ethanol leaves standstill 12h; Get supernatant and reclaim ethanol, and to be concentrated into relative density be 1.12 (60 DEG C record), Chinese medicine clear paste;
Using stand-by as matrix solution for Acritamer 940 swelling a few hours in distilled water; Get Polysorbate, glycerol, polyvinylpyrrolidone k30, add suitable quantity of water in 50-60 DEG C of heated and stirred solution, add while hot in carbomer solution to stir and make substrate; Then add in substrate by above-mentioned Chinese medicine clear paste and stearopten plastid, mixing stirs evenly, and adds ethyl hydroxybenzoate, azone, and finally add triethanolamine and adjust PH to 6.7, adding distil water supplies weight, obtains Chinese medicine gel of the present invention.
Embodiment 2
Chinese medicine extract forms: Radix Kadsurae longipedunculatae 12 parts, Folium Ilicis Purpureae 30 parts, Herba Kalimeridis 26 parts, Rhizoma Stahlianthi Involucrati 20 parts, water body floral leaf 22 parts.
Gel formula: Chinese medicine extract 15%, Acritamer 940 2.8%, polyvinylpyrrolidone k301.8%, glycerol 6.5%, Polysorbate 0.9%, triethanolamine 3.0%, ethyl hydroxybenzoate 0.4%, azone 1.5%, surplus are water;
Preparation method: will add 8-10 times of water gaging through the finished Radix Kadsurae longipedunculatae of micronizing, Rhizoma Stahlianthi Involucrati, soaks 2-5h, adopts extraction by steam distillation total volatile oil; Take lecithin, cholesterol (mass ratio of lecithin and cholesterol is 6.5:1), be placed in round-bottomed flask, add ether to make it to dissolve, ether is removed under reduced pressure at 50 DEG C, add appropriate distilled water (making the concentration of phospholipid be 5.5mg/ml), in 55 DEG C of hatching 20-30min, homogenizing is carried out with high speed dispersion homogenizer, add Radix Kadsurae longipedunculatae, Rhizoma Stahlianthi Involucrati total volatile oil (mass ratio of volatile oil and lecithin is 1:0.26), carry out homogenizing with high speed dispersion homogenizer, the liposome of Radix Kadsurae longipedunculatae, Rhizoma Stahlianthi Involucrati volatile oil must be contained;
Get Folium Ilicis Purpureae, Herba Kalimeridis, water body floral leaf, add 6-10 times amount water soaking 1-5h, add Radix Kadsurae longipedunculatae again, Rhizoma Stahlianthi Involucrati extracts remaining medicinal residues after volatile oil, decoct with water secondary, collecting decoction, filter, filtrate reduced in volume to relative density is 1.12 (60 DEG C of surveys), adding ethanol makes the volumn concentration of ethanol reach 65%, and precipitate with ethanol leaves standstill 12h; Get supernatant and reclaim ethanol, and to be concentrated into relative density be 1.10 (60 DEG C record), Chinese medicine clear paste;
Using stand-by as matrix solution for Acritamer 940 swelling a few hours in distilled water; Get Polysorbate, glycerol, polyvinylpyrrolidone k30, add suitable quantity of water in 50-60 DEG C of heated and stirred solution, add while hot in carbomer solution to stir and make substrate; Then add in substrate by above-mentioned Chinese medicine clear paste and stearopten plastid, mixing stirs evenly, and adds ethyl hydroxybenzoate, azone, and finally add triethanolamine and adjust PH to 6.7, adding distil water supplies weight, obtains Chinese medicine gel of the present invention.
Embodiment 3
Chinese medicine extract forms: Radix Kadsurae longipedunculatae 12 parts, Folium Ilicis Purpureae 30 parts, Herba Kalimeridis 26 parts, Rhizoma Stahlianthi Involucrati 20 parts, water body floral leaf 22 parts.
Gel formula: Chinese medicine extract 17%, Acritamer 940 3.5%, polyvinylpyrrolidone k301.5%, glycerol 6.5%, Polysorbate 1.1%, triethanolamine 3.4%, ethyl hydroxybenzoate 0.35%, azone 2.5%, surplus are water;
Preparation method: will add 8-10 times of water gaging through the finished Radix Kadsurae longipedunculatae of micronizing, Rhizoma Stahlianthi Involucrati, soaks 2-5h, adopts extraction by steam distillation total volatile oil; Take lecithin, cholesterol (mass ratio of lecithin and cholesterol is 7:1), be placed in round-bottomed flask, add ether to make it to dissolve, ether is removed under reduced pressure at 60 DEG C, add appropriate distilled water (making the concentration of phospholipid be 7.0mg/ml), in 58 DEG C of hatching 20-30min, homogenizing is carried out with high speed dispersion homogenizer, add Radix Kadsurae longipedunculatae, Rhizoma Stahlianthi Involucrati total volatile oil (mass ratio of volatile oil and lecithin is 1:0.30), carry out homogenizing with high speed dispersion homogenizer, the liposome of Radix Kadsurae longipedunculatae, Rhizoma Stahlianthi Involucrati volatile oil must be contained;
Get Folium Ilicis Purpureae, Herba Kalimeridis, water body floral leaf, add 6-10 times amount water soaking 1-5h, add Radix Kadsurae longipedunculatae again, Rhizoma Stahlianthi Involucrati extracts remaining medicinal residues after volatile oil, decoct with water secondary, collecting decoction, filter, filtrate reduced in volume to relative density is 1.18 (60 DEG C of surveys), adding ethanol makes the volumn concentration of ethanol reach 67%, and precipitate with ethanol leaves standstill 12h; Get supernatant and reclaim ethanol, and to be concentrated into relative density be 1.14 (60 DEG C record), Chinese medicine clear paste;
Using stand-by as matrix solution for Acritamer 940 swelling a few hours in distilled water; Get Polysorbate, glycerol, polyvinylpyrrolidone k30, add suitable quantity of water in 58 DEG C of heated and stirred solution, add while hot in carbomer solution to stir and make substrate; Then add in substrate by above-mentioned Chinese medicine clear paste and stearopten plastid, mixing stirs evenly, and adds ethyl hydroxybenzoate, azone, and finally add triethanolamine and adjust PH to 6.7, adding distil water supplies weight, obtains Chinese medicine gel of the present invention.
Embodiment 4
Chinese medicine extract forms: Radix Kadsurae longipedunculatae 15 parts, Folium Ilicis Purpureae 30 parts, Herba Kalimeridis 30 parts, Rhizoma Stahlianthi Involucrati 23 parts, water body floral leaf 20 parts.
Gel formula: Chinese medicine extract 13%, Acritamer 940 1.5%, polyvinylpyrrolidone k302.5%, glycerol 5.5%, Polysorbate 1.0%, triethanolamine 1.4%, ethyl hydroxybenzoate 0.4%, azone 2.0%, surplus are water;
Preparation method: with reference to the operation of embodiment 1-3, the mass ratio unlike lecithin and cholesterol is 6.0:1; The mass ratio of Radix Kadsurae longipedunculatae, Rhizoma Stahlianthi Involucrati total volatile oil and lecithin is 1:0.28.
Embodiment 5
Chinese medicine extract forms: Radix Kadsurae longipedunculatae 10 parts, Folium Ilicis Purpureae 25 parts, Herba Kalimeridis 25 parts, Rhizoma Stahlianthi Involucrati 18 parts, water body floral leaf 20 parts.
Gel formula: Chinese medicine extract 10%, Acritamer 940 1.2%, polyvinylpyrrolidone k301.0%, glycerol 5%, Polysorbate 0.8%, triethanolamine 1.1%, ethyl hydroxybenzoate 0.45%, azone 2.5%, surplus are water;
Preparation method: with reference to the operation of embodiment 1-3, the mass ratio unlike lecithin and cholesterol is 5.5:1; The mass ratio of Radix Kadsurae longipedunculatae, Rhizoma Stahlianthi Involucrati total volatile oil and lecithin is 1:0.23.
Embodiment 6
Chinese medicine extract forms: Radix Kadsurae longipedunculatae 15 parts, Folium Ilicis Purpureae 25 parts, Herba Kalimeridis 35 parts, Rhizoma Stahlianthi Involucrati 20 parts, water body floral leaf 25 parts.
Gel formula: Chinese medicine extract 12%, Acritamer 940 3.5%, polyvinylpyrrolidone k300.5%, glycerol 8%, Polysorbate 0.8%, triethanolamine 3.3%, ethyl hydroxybenzoate 0.35%, azone 2.5%, surplus are water;
Preparation method: with reference to the operation of embodiment 1-3, the mass ratio unlike lecithin and cholesterol is 5.5:1; The mass ratio of Radix Kadsurae longipedunculatae, Rhizoma Stahlianthi Involucrati total volatile oil and lecithin is 1:0.25.
Embodiment 7
Chinese medicine extract forms: Radix Kadsurae longipedunculatae 10 parts, Folium Ilicis Purpureae 35 parts, Herba Kalimeridis 20 parts, Rhizoma Stahlianthi Involucrati 25 parts, water body floral leaf 30 parts.
Gel formula: Chinese medicine extract 15%, Acritamer 940 2.5%, polyvinylpyrrolidone k301.5%, glycerol 7.5%, Polysorbate 1.0%, triethanolamine 2.5%, ethyl hydroxybenzoate 0.3%, azone 2.8%, surplus are water;
Preparation method: with reference to the operation of embodiment 1-3, the mass ratio unlike lecithin and cholesterol is 6.5:1; The mass ratio of Radix Kadsurae longipedunculatae, Rhizoma Stahlianthi Involucrati total volatile oil and lecithin is 1:0.275.
Embodiment 8
Chinese medicine extract forms: Radix Kadsurae longipedunculatae 12 parts, Folium Ilicis Purpureae 30 parts, Herba Kalimeridis 26 parts, Rhizoma Stahlianthi Involucrati 20 parts, water body floral leaf 22 parts.
Gel formula: Chinese medicine extract 14%, Acritamer 940 3.5%, polyvinylpyrrolidone k300.8%, glycerol 7.0%, Polysorbate 0.85%, triethanolamine 3.4%, ethyl hydroxybenzoate 0.3%, azone 3.0%, surplus are water;
Preparation method: with reference to the operation of embodiment 1-3, the mass ratio unlike lecithin and cholesterol is 7.0:1; The mass ratio of Radix Kadsurae longipedunculatae, Rhizoma Stahlianthi Involucrati total volatile oil and lecithin is 1:0.225.
Claims (8)
1. one kind promotes the Chinese medicine gel of lateral episiotomy wound healing, it is characterized in that being prepared from primarily of following raw material: by weight percentage, Chinese medicine extract 10% ~ 20%, Acritamer 940 0.5% ~ 4.5%, polyvinylpyrrolidone k300.5-3.5%, glycerol 3-10%, Polysorbate 0.5-1.3%, triethanolamine 0% ~ 10%, ethyl hydroxybenzoate 0.3-0.5%, azone 0.5-5%, surplus are water;
Described Chinese medicine extract is made up of following raw material: Radix Kadsurae longipedunculatae, Folium Ilicis Purpureae, Herba Kalimeridis, Rhizoma Stahlianthi Involucrati, water body floral leaf.
2. Chinese medicine gel as claimed in claim 1, is characterized in that described Chinese medicine extract is made up of the raw material of following weight portion: Radix Kadsurae longipedunculatae 9-19 part, Folium Ilicis Purpureae 15-35 part, Herba Kalimeridis 20-40 part, Rhizoma Stahlianthi Involucrati 15-30 part, water body floral leaf 15-30 part.
3. Chinese medicine gel as claimed in claim 2, is characterized in that described Chinese medicine extract is made up of the raw material of following weight portion: Radix Kadsurae longipedunculatae 12-15 part, Folium Ilicis Purpureae 28-33 part, Herba Kalimeridis 25-30 part, Rhizoma Stahlianthi Involucrati 18-23 part, water body floral leaf 20-25 part.
4. Chinese medicine gel as claimed in claim 3, is characterized in that described Chinese medicine extract is made up of the raw material of following weight portion: Radix Kadsurae longipedunculatae 12 parts, Folium Ilicis Purpureae 30 parts, Herba Kalimeridis 26 parts, Rhizoma Stahlianthi Involucrati 20 parts, water body floral leaf 22 parts.
5. Chinese medicine gel as claimed in claim 1, is characterized in that also containing lecithin, cholesterol.
6. the Chinese medicine gel as described in claim 1-5, is characterized in that preparation method comprises the following steps:
8-10 times of water gaging will be added through the finished Radix Kadsurae longipedunculatae of micronizing, Rhizoma Stahlianthi Involucrati, soak 2-5h, adopt extraction by steam distillation total volatile oil; Take lecithin, cholesterol, add ether to make it to dissolve, ether is removed under reduced pressure at 50-60 DEG C, add appropriate distilled water, in 50-60 DEG C of hatching 20-30min, carry out homogenizing with high speed dispersion homogenizer, add Radix Kadsurae longipedunculatae, Rhizoma Stahlianthi Involucrati total volatile oil, carry out homogenizing with high speed dispersion homogenizer, the liposome of Radix Kadsurae longipedunculatae, Rhizoma Stahlianthi Involucrati volatile oil must be contained;
Get Folium Ilicis Purpureae, Herba Kalimeridis, water body floral leaf, add 6-10 times amount water soaking 1-5h, add Radix Kadsurae longipedunculatae again, Rhizoma Stahlianthi Involucrati extracts remaining medicinal residues after volatile oil, decoct with water secondary, collecting decoction, filter, filtrate reduced in volume to relative density is 1.10-1.20 (60 DEG C of survey), adding ethanol makes the volumn concentration of ethanol reach 60% ~ 70% (preferably 65%), and precipitate with ethanol leaves standstill 12h; Get supernatant and reclaim ethanol, and to be concentrated into relative density be 1.10 ~ 1.15 (60 DEG C record), Chinese medicine clear paste;
Using stand-by as matrix solution for Acritamer 940 swelling a few hours in distilled water; Get Polysorbate, glycerol, polyvinylpyrrolidone k30, add suitable quantity of water in 50-60 DEG C of heated and stirred solution, add while hot in carbomer solution to stir and make substrate; Then add in substrate by above-mentioned Chinese medicine clear paste and stearopten plastid, mixing stirs evenly, and adds ethyl hydroxybenzoate, azone, and finally add triethanolamine and adjust PH to 6.5 ~ 7.0, adding distil water supplies weight, obtains Chinese medicine gel of the present invention.
7. Chinese medicine gel as claimed in claim 6, is characterized in that the mass ratio of described lecithin and cholesterol is 3-8:1; The mass ratio of volatile oil and lecithin is 1:0.2-0.35.
8. Chinese medicine gel as claimed in claim 7, is characterized in that the mass ratio of described lecithin and cholesterol is 5.5:1; The mass ratio of volatile oil and lecithin is 1:0.25.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN107625920A (en) * | 2017-10-11 | 2018-01-26 | 付金龙 | Gynaecology's gel and preparation method thereof |
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