CN102078421A - Chinese medicine external preparation for postoperative analgesia and healing promotion and preparation method thereof - Google Patents

Chinese medicine external preparation for postoperative analgesia and healing promotion and preparation method thereof Download PDF

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CN102078421A
CN102078421A CN 201010579139 CN201010579139A CN102078421A CN 102078421 A CN102078421 A CN 102078421A CN 201010579139 CN201010579139 CN 201010579139 CN 201010579139 A CN201010579139 A CN 201010579139A CN 102078421 A CN102078421 A CN 102078421A
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chinese medicine
preparation
ointment
postoperative analgesia
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何永恒
刘丽兵
王晓燕
肖志国
徐焱尧
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Abstract

The invention belongs to the field of Chinese medicine external preparations and particularly provides a Chinese medicine external preparation for postoperative analgesia and healing promotion and a preparation method thereof. The ointment comprises a Chinese medicine preparation and a Carbomer ointment substrate, wherein a prescription of the Chinese medicine preparation comprises the following components in parts by weight: 22-26 parts of corydalis tuber, 10-14 parts of pepper, 10-14 parts of pseudo-ginseng and 4-8 parts of myrrh. Effective parts are extracted by applying the novel modern preparation preparing technology, the pain relieving effect and the healing promoting effect of the ointment are obviously better than those of a congeneric product, and the Chinese medicine external preparation is safe to apply. The research of the Chinese medicine external preparation for postoperative analgesia and healing promotion, which is externally used for anorectal disease postoperative analgesia and healing promotion, is an innovative point and is also novel choice in anorectal disease postoperative analgesia treatment.

Description

Chinese medicine for external application of a kind of postoperative analgesia and promotion healing and preparation method thereof
Technical field:
The invention belongs to field of traditional Chinese, be specifically related to the preparation and the application of plaster in the Chinese medicine for external application field.
Technical background:
The anorectal disease postoperative is because operation coup injury channels, muscle arteries and veins, make local through vapour lock every, QI-blood circulation retardance, " stasis of blood is then obstructed ", " stagnation of QI and blood may bring about pain ", " general rule is not flourish ".Chinese medicine for external application blood circulation promoting and blood stasis dispelling, the promoting the circulation of QI to relieve pain of a kind of postoperative analgesia and promotion healing, external directly acts on patient's surgical wound surface, power reaches in interior by being administered to outer, make medicine go into space between skin and muscles from pore, stimulating the menstrual flow reaches network, with the removing blood stasis circulation of qi promoting, thereby stasis of blood resistance must remove, QI and blood is smooth, and through ruton, pain is alleviated.The capable then blood of gas is capable, and QI and blood is in harmonious proportion, and then the wound surface growth is vigorous.So this medicine has short promoting flow of QI and blood, the short merit more of pain relieving.
Big, the easy addiction of existing analgesic toxic and side effects, the controlled analgesia price is more expensive, and application clinically is subjected to certain restriction, and the survey result demonstration still has considerable patient's postoperative pain not obtain enough alleviations.The history in existing several thousand of Chinese medicine treatment pain card, powder for anethesia is exactly typical representative.Chinese medicine has demonstrated certain advantage in the analgesia therapy history in thousands of years: analgesic activity determined curative effect, less, the no addiction of toxic and side effects and aboundresources, but in modern clinical practice, do not given play to advantage.When Chinese medicine for external application can local be changed dressings, directly reaching the effect of short analgesic, avoid the loaded down with trivial details disadvantage of misery, therapeutic process of oral and muscle administration, is the step of must going of anal disease aftertreatment, has advantage simple to operate, effective.
Existing Chinese medicine for external application Chinese patent medicine though certain curative effect is arranged, all adopts traditional preparation technology to extract crude extract as jiuhua plaster, MAYINGLONG MUSK HEMORRHOID UNGUENTUM, Herba Tubocapsici Anomali cream etc., makes common ointment again, and active constituent content is very low, so poor effect.Therefore the analgesia new product of Chinese medicine that utilizes the particularly modern preparation technique research of modern science and technology to be fit to the anorectal disease characteristics seems extremely necessary.
Summary of the invention:
The Chinese medicine for external application active constituent content is low at having now, the defective of poor effect, and the Chinese medicine for external application that the invention provides a kind of postoperative analgesia and promote to heal can reach curative effect preferably.
Contain following effective ingredient in the Chinese medicine for external application finished product of a kind of postoperative analgesia of the present invention and promotion healing:
Rhizoma Corydalis total alkaloids 9-10 weight portion, Pericarpium Zanthoxyli volatile oil 23-25 weight portion,
Radix Notoginseng total arasaponins 70-80 weight portion, Myrrha volatile oil 8-10 weight portion,
Carbomer ointment base 870-890 weight portion.
Wherein effective ingredient is preferably:
Rhizoma Corydalis total alkaloids 9.6 weight portions, Pericarpium Zanthoxyli volatile oil 24 weight portions,
Radix Notoginseng total arasaponins 78 weight portions, Myrrha volatile oil 9 weight portions,
Carbomer ointment base 880 weight portions;
Wherein said carbomer ointment base is made up of the carbomer of 940.30 weight portions, the ethanol of 150 weight portions, the glycerol of 150 weight portions, the Polysorbate of 806 weight portions, the ethyl hydroxybenzoate of 3 weight portions, the sodium hydroxide of 12 weight portions and the distilled water of 529 weight portions.
The dosage form of the Chinese medicine for external application of a kind of postoperative analgesia of the present invention and promotion healing comprises ointment and suppository.
The Chinese medicine for external application of a kind of postoperative analgesia of the present invention and promotion healing is in the application of postoperative analgesia of preparation treatment anorectal disease and promotion healing medicine.
The foundation of the present invention prescription: the traditional Chinese medical science thinks that the main pathogenesis of anorectal disease postoperative pain is a qi and blood stagnation, controls when regulating the flow of vital energy removing blood stasis, and removing obstruction in the collateral to relieve pain removes blood stasis, and QI and blood is smooth, general rule not bitterly, general rule is not flourish.Rhizoma Corydalis function promoting the circulation of QI to relieve pain, blood circulation promoting and blood stasis dispelling are good at pain relieving especially in the side, and all pains inside and outside kind the controlling are the key medicine of pain relieving.And the stagnation of QI in the energy promoting the circulation of blood, stasis in the gas, a medicine two is controlled, and the gas promoting the circulation of blood is lived, and general rule plays a major role in the side not bitterly, so be monarch drug.Pericarpium Zanthoxyli, Xin Wen, the function warming middle-JIAO to relieve pain, the warm promoting blood circulation of energy removes blood stasis, and QI and blood is smooth, and through ruton, general rule matches with monarch drug not bitterly, strengthens the merit of Rhizoma Corydalis pain relieving, is ministerial drug.Radix Notoginseng, the sweetness and bitterness temperature, the function removing stasis to stop bleeding, subduing swelling and relieving pain, and have hemostasis not stay blood stasis, new advantage is not hindered in promoting the circulation of blood, is the key medicine of clinical hemostasis and pain-relieving; The Myrrha bitter in the mouth is flat, the function promoting blood circulation and stopping pain, and detumescence and promoting granulation is the key medicine of ventilation meridian.Two medicines match, and can strengthen the merit of the promoting blood circulation and stopping pain of monarch-minister drug, are adjuvant drug altogether.More than all medicines be harmonious, can reach current QI and blood, the merit of blood-activating analgetic is gone stasis of blood resistance, QI and blood is smooth, general rule is not bitterly, and is capable with the capable then blood of seasonal epidemic pathogens, QI and blood is in harmonious proportion, then the wound surface growth is vigorous.So this medicine has short promoting flow of QI and blood, the short merit more of pain relieving.
The invention has the beneficial effects as follows:
1, the Chinese medicine for external application of a kind of postoperative analgesia of the present invention and promotion healing can be when changing dressings in the part, directly reach the effect of analgesia, promotion healing, avoid the misery and the loaded down with trivial details disadvantage of therapeutic process of oral and muscle administration, be the step of to go of anal disease aftertreatment, have advantage simple to operate, effective.
2, the Chinese medicine for external application of a kind of postoperative analgesia of the present invention and promotion healing uses modern preparation new technique to extract effective site, as: supercritical carbon dioxide extraction method extracts Pericarpium Zanthoxyli, volatilization wet goods liposoluble constituent in the Myrrha, HPD-100 type macroporous adsorbent resin separates Radix Notoginseng total arasaponins, Rhizoma Corydalis is extracted, separate, refining, purification obtains having the Rhizoma Corydalis total alkaloids of analgesic activity, all adopt effective site to be used as medicine, adopting nanotechnology that oleaginous effective site is made nanoparticle enables to be scattered in water solublity or the hydrophilic ointment base, with drug release rate fast emulsion-type substrate or water-soluble base (comprising gel-type vehicle) preparation ointment, therapeutic effect is remarkable.
3, the Chinese medicine for external application analgesic effect of a kind of postoperative analgesia and promotion healing is better than the tetracaine hydrochloride rubber cement, obviously is better than Herba Tubocapsici Anomali ointment; Short more effect is better than Herba Tubocapsici Anomali ointment, obviously is better than the tetracaine hydrochloride rubber cement; And in the medication process, be safe.
The specific embodiment
The invention will be further described below in conjunction with chart and embodiment.
1. write out a prescription:
Pericarpium Zanthoxyli 20g Rhizoma Corydalis 40g Radix Notoginseng 20g Myrrha 10g
The about 15g of PEG substrate
2. Rhizoma Corydalis extraction separation process for purification:
2.1 Rhizoma Corydalis alcohol extraction:
Volumetric concentration is that 75% alcoholic solution extracts 2 times: the alcoholic solution that adds with respect to 6 times of amounts of medical material for the 1st time, soak 0.5h, and reflux, extract, 1.5h adds with respect to 4 times of amounts of medical material alcoholic solution, reflux, extract, 1.5h for the 2nd time.Filter, reclaim ethanol and concentrate, get the Rhizoma Corydalis dry extract.
2.2 the thick total alkaloids of Rhizoma Corydalis is refining:
100ml 1% dilute hydrochloric acid solution is added in the Rhizoma Corydalis alcohol-extracted extract, fully grind after-filtration, the gained precipitation continues to add 1% dilute hydrochloric acid solution and filters.Merge filtrate twice, ammonia is transferred about filtrate pH=9, and equal-volume chloroform extraction 3 times gets chloroform solution, and the reclaim under reduced pressure chloroform promptly gets the thick total alkaloids of Rhizoma Corydalis.Extraction ratio is about 0.4%.
3. Radix Notoginseng extraction separation process for purification:
3.1 the alcohol extraction of Radix Notoginseng total arasaponins
It is 30% alcoholic solution that Radix Notoginseng medicated powder adds with respect to 13 times of volumetric concentrations of medical material, extracts 70 ℃ of temperature, and extraction time 40min extracts twice with method.
3.2HPD100 the preparation of type macroporous adsorptive resins:
It is an amount of to get HPD-100 type macroporous adsorbent resin, is 95% alcohol solution dipping with volumetric concentration, consumption: with 95% ethanol submergence macroporous adsorbent resin, decide according to the consumption of macroporous adsorbent resin.(1.5cm * 20cm), wash with water to there not being the alcohol flavor can use wet method dress post.
3.3 Radix Notoginseng total arasaponins is refining:
Adopt HPD 100 type macroporous adsorbent resins, the extracting solution that contains the 0.4g pseudo-ginseng with every ml is a upper prop liquid, and upper column quantity is 1.5 times of column volumes, and passes through resin column with the speed of 1 column volume/h.After finishing on the medicinal liquid, wash post with water to there being the molish reaction.With volumetric concentration is that 75% alcoholic solution is an eluant, and the consumption of eluant is 5~6 times of column volumes, the speed eluting of 2~3 times of column volume/h, and being eluted to does not have color in the eluent, and determines terminal point with TLC.Extraction ratio is about 6.5%.
4. the extraction of Pericarpium Zanthoxyli, Myrrha volatile oil:
Pericarpium Zanthoxyli is put in the round-bottomed flask, added the water with respect to 6 times of amounts of medical material, steam distillation extracts volatile oil.Oil pump capacity is: by volume concentration is calculated Pericarpium Zanthoxyli 2%, Myrrha 1.5%.
5. substrate preparation:
[prescription] PEG4000 8g PEG400 12g
[method for making] takes by weighing two kinds of Polyethylene Glycol, is heated to 65 ℃ in water-bath, and be to fusion, standby.
6. postoperative analgesia and promote the method for making of the Chinese medicine for external application ointment of healing:
Rhizoma Corydalis 0.16g, Radix Notoginseng extract 1.4g are ground in mortar, cross 120 mesh sieves, add to and grind in the fused 15gPEG substrate evenly, when treating that temperature is reduced to room temperature, the mixed solution that adds Pericarpium Zanthoxyli 0.25mL, Myrrha 0.0675mL volatile oil and 95% ethanol 0.3175mL, stir to condensation, promptly get ointment.Also can and promote the Chinese medicine external of healing to be made into the form of suppository or the form of pad pasting with a kind of postoperative analgesia of the present invention.
7. the Chinese medicine for external application ointment Comparison of therapeutic demonstration test of postoperative analgesia of the present invention and promotion healing:
Anus anorectal disease patient's 180 examples that will meet the standard of including in, divide into groups by sick the kind earlier, every group comprises mixed hemorrhoid 15 examples, old anal fissure 15 examples, anal fistula 15 examples, perianal abscess 15 examples, random assortment is to Chinese medicine for external application group, Herba Tubocapsici Anomali ointment group and the tetracaine hydrochloride rubber cement group of a kind of postoperative analgesia and promotion healing, every group of equal 60 examples are treated respectively.A situation arises and the situation of change of the hepatic and renal function variation of medication front and back, wound surface analgesic effect, wound healing time and healing rate is observed in the untoward reaction of selection medicine
7.1 after three groups of patient's medications untoward reaction a situation arises relatively
After three groups of patient's medications of table 1 untoward reaction a situation arises relatively
Figure BDA0000036906130000041
As shown in Table 1,1 routine erythra and pruritus appears in ointment formulation group of the present invention in the medication process, die away after the drug withdrawal, but do not have addiction, nausea and vomiting, toxicities such as hyperhidrosis is drowsiness, sensualness incontinence.
7.2 postoperative analgesia and promote the Chinese medicine for external application group medication of healing before and after hepatic and renal function relatively
Hepatic and renal function relatively before and after the medication of table 2 ointment formulation group of the present invention
Figure BDA0000036906130000042
As shown in Table 2, ointment formulation group of the present invention does not have hepatic and renal function injure.
7.3 observe the time point analgesic effects relatively for 4 in three groups of patient's postoperatives 48 hours
Observe time point analgesic effects relatively (branch) for 4 in three groups of patient's postoperatives of table 3 48 hours
Figure BDA0000036906130000043
Annotate: ointment formulation group of the present invention and Herba Tubocapsici Anomali ointment group compare: * P<0.05, * * P<0.01; Compare with tetracaine hydrochloride rubber cement group: ☆ P<0.05, ☆ ☆ P<0.01.
As shown in Table 3, observe the time point analgesic effects and obviously be better than Herba Tubocapsici Anomali ointment group for 4 in the ointment formulation group postoperative of the present invention 48 hours, also be better than tetracaine hydrochloride rubber cement group.
7.4 three groups of first three times of patient are changed dressings and are finished back 0.5 hour time point analgesic effect relatively
First three inferior back 0.5 hour time point analgesic effect of end of changing dressings of three groups of patients of table 4 compares (example)
Figure BDA0000036906130000051
Annotate: ointment formulation group of the present invention and Herba Tubocapsici Anomali ointment group ratio: * P<0.05, * * P<0.01; Compare with tetracaine hydrochloride rubber cement group: ☆ P<0.05, ☆ ☆ P<0.01.
As shown in Table 4, first three inferior back 0.5 hour time point analgesic effect of end of changing dressings of ointment formulation group of the present invention obviously is better than Herba Tubocapsici Anomali ointment group, also is better than tetracaine hydrochloride rubber cement group.
7.5 three groups of patients ask for the analgesics situation relatively in 48 hours
Three groups of patient's postoperatives of table 5 are asked for analgesics situation relatively (example) in 48 hours
Annotate: the Chinese medicine for external application group and the Herba Tubocapsici Anomali ointment group of a kind of postoperative analgesia and promotion healing compare: * P<0.05, * * P<0.01; Compare with tetracaine hydrochloride rubber cement group: ☆ P<0.05, ☆ ☆ P<0.01.
As shown in Table 5, ointment formulation group postoperative of the present invention is asked for analgesics in 48 hours and obviously is less than Herba Tubocapsici Anomali ointment group, also is less than tetracaine hydrochloride rubber cement group.
7.6 three groups of patient's wound healing times relatively
Three groups of patient's wound healing times comparisons of table 6 (my god)
Figure BDA0000036906130000053
Annotate: ointment formulation group of the present invention and Herba Tubocapsici Anomali ointment group compare: * P<0.05, * * P<0.01; Compare with tetracaine hydrochloride rubber cement group: ☆ P<0.05, ☆ ☆ P<0.01.
As shown in Table 6, ointment formulation group of the present invention shortens wound healing time and is better than Herba Tubocapsici Anomali ointment group, obviously is better than tetracaine hydrochloride rubber cement group.
7.7 three groups of patient's wound healing rates relatively
Three groups of patient's wound healings of table 7 rate is (%) relatively
Figure BDA0000036906130000061
Annotate: ointment formulation group of the present invention and Herba Tubocapsici Anomali ointment group compare: * P<0.05, * * P<0.01; Compare with tetracaine hydrochloride rubber cement group: ☆ P<0.05, ☆ ☆ P<0.01.
As shown in Table 7, ointment formulation group of the present invention improves the wound healing rate and is better than Herba Tubocapsici Anomali ointment group, obviously is better than tetracaine hydrochloride rubber cement group.
In sum: the Chinese medicine for external application analgesic effect of a kind of postoperative analgesia of the present invention and promotion healing is better than the tetracaine hydrochloride rubber cement, obviously is better than Herba Tubocapsici Anomali ointment; Short more effect is better than Herba Tubocapsici Anomali ointment, obviously is better than the tetracaine hydrochloride rubber cement; And in the medication process, be safe.

Claims (4)

1. the Chinese medicine for external application that postoperative eases pain and promotes to heal is characterized in that, contains following effective ingredient in the said preparation finished product:
Rhizoma Corydalis total alkaloids 9-10 weight portion, Pericarpium Zanthoxyli volatile oil 23-25 weight portion,
Radix Notoginseng total arasaponins 70-80 weight portion, Myrrha volatile oil 8-10 weight portion,
Carbomer ointment base 870-890 weight portion.
2. the Chinese medicine for external application of a kind of postoperative analgesia according to claim 1 and promotion healing is characterized in that, contains following effective ingredient in the said preparation finished product:
Rhizoma Corydalis total alkaloids 9.6 weight portions, Pericarpium Zanthoxyli volatile oil 24 weight portions,
Radix Notoginseng total arasaponins 78 weight portions, Myrrha volatile oil 9 weight portions,
Carbomer ointment base 880 weight portions.
3. the Chinese medicine for external application of a kind of postoperative analgesia according to claim 1 and promotion healing is characterized in that the dosage form of said preparation comprises ointment, suppository and pad pasting.
4. according to the Chinese medicine for external application of described a kind of postoperative analgesia of one of claim 1-3 and promotion healing, it is characterized in that described preparation is in the application of postoperative analgesia of preparation treatment anorectal disease and promotion healing medicine.
CN 201010579139 2010-12-08 2010-12-08 Chinese medicine external preparation for postoperative analgesia and healing promotion and preparation method thereof Pending CN102078421A (en)

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CN102784226A (en) * 2012-08-23 2012-11-21 何永恒 External Chinese medicine preparation for realizing postoperative analgesia and promoting wound healing and preparation method of external Chinese medicine preparation
CN102793787A (en) * 2012-08-23 2012-11-28 何永恒 Traditional Chinese medicine ointment for postoperative analgesia and wound healing promotion, and preparation method thereof
CN104547584A (en) * 2015-01-13 2015-04-29 陈琦 Traditional Chinese medicine spray capable of promoting healing of incision after cesarean section surgery and preparation method of traditional Chinese medicine spray

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CN102784226A (en) * 2012-08-23 2012-11-21 何永恒 External Chinese medicine preparation for realizing postoperative analgesia and promoting wound healing and preparation method of external Chinese medicine preparation
CN102793787A (en) * 2012-08-23 2012-11-28 何永恒 Traditional Chinese medicine ointment for postoperative analgesia and wound healing promotion, and preparation method thereof
CN102793787B (en) * 2012-08-23 2014-10-29 何永恒 Traditional Chinese medicine ointment for postoperative analgesia and wound healing promotion, and preparation method thereof
CN104547584A (en) * 2015-01-13 2015-04-29 陈琦 Traditional Chinese medicine spray capable of promoting healing of incision after cesarean section surgery and preparation method of traditional Chinese medicine spray

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Application publication date: 20110601