CN102784226A - External Chinese medicine preparation for realizing postoperative analgesia and promoting wound healing and preparation method of external Chinese medicine preparation - Google Patents
External Chinese medicine preparation for realizing postoperative analgesia and promoting wound healing and preparation method of external Chinese medicine preparation Download PDFInfo
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Abstract
The invention belongs to the field of external Chinese medicine preparations, and particularly provides an external Chinese medicine preparation for realizing postoperative analgesia and promoting wound healing. The preparation comprises auxiliary materials including supercritical carbon dioxide corydalis tuber extract, supercritical carbon dioxide wild pepper extract, 50% of pseudo-ginseng ethanol extract, 95% of myrrh ethanol extract, polyethylene glycol 400, polyethylene glycol 4000 mixture, polysorbate-80, fatty acid sorbitan-80 and the like, and is obtained by means of extraction, concentration and formation in the modern preparation technology. The pain relieving effect and the healing promoting function of the external Chinese medicine preparation are obviously better than those of like products, and the external Chinese medicine preparation does not have relevant adverse reaction such as toxicity, irritation and anaphylaxis, is quite safe to use, is externally applied to postoperative analgesia and healing promotion for anorectal diseases, is innovative and is a new choice for postoperative therapy of the anorectal diseases.
Description
Technical field
The invention belongs to field of traditional Chinese, be specifically related to the preparation and the application of ointment in the Chinese medicine for external application field.
Technical background
The anorectal disease postoperative pain is the ubiquitous symptom of patient's postoperative, brings great misery for patient's body and mind, not only can cause many complication such as difficult defecation, urine retention; Can also produce a series of pathophysiological change, make the patient nervous, rapid breathing; Heart rate is accelerated, hypertension, serious caused cordis and cerebral accident; Directly have influence on the operation quality, especially the pain of anorectal disease postoperative such as anal fistula and the indolence of wound surface make the difficult peace of a lot of patient's sleeping and eating; Quality of life greatly reduces, and more lets a lot of patients hang back, and has delayed best occasion for the treatment.Big, the easy addiction property of existing analgesic toxic and side effects, the controlled analgesia price is more expensive, and application clinically receives certain restriction, and survey result shows, still has considerable patient's postoperative pain effectively not alleviated.
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 property of toxic and side effects and aboundresources also have the effect that significantly promotes wound healing.But receive the restriction of technical conditions in modern times in the clinical practice, fail to bring into play fully its advantage.
Existing external Chinese patent medicine though certain curative effect is arranged, all adopts conventional preparation process like jiuhua plaster, MAYINGLONG MUSK HEMORRHOID UNGUENTUM, Herba Tubocapsici Anomali cream etc., promptly extracts crude extract, adds substrate to process ointment, and active constituent content is lower, and the finished product outward appearance is coarse.Therefore utilize modern preparation new technique, the short more new product of Chinese medicine of analgesia that postgraduate's output is fit to anorectal disease postoperative characteristics seems extremely necessary.
Summary of the invention
The present invention is intended to have much room for improvement to the short effect more of existing Chinese medicine for external application pain relieving; And the lower present situation of active constituent content; The Chinese medicine for external application of a kind of postoperative analgesia and promotion wound healing is provided; Not only evident in efficacy, and related reactions such as avirulence, zest, anaphylaxis, medication is fool proof.
In order to achieve the above object, technical scheme provided by the invention is:
Said postoperative analgesia and promote the Chinese medicine for external application of wound healing comprises the component of following weight portion:
Rhizoma Corydalis supercritical carbon dioxide extraction thing 780～820;
Pericarpium Zanthoxyli supercritical carbon dioxide extraction thing 400～500;
Radix Notoginseng 50% ethanol extract 800～1200;
Myrrha 95% ethanol extract 480～520;
Polysorbate-80 1500～1550;
The fatty acid Pyrusussuriensis is smooth-and 80 1100～1200;
PEG─4000?2000～2600；
PEG─400750～850；
Wherein, Said Rhizoma Corydalis supercritical carbon dioxide extraction thing prepares process and is: with pulverizing after the Rhizoma Corydalis hygroscopic desiccation; The Rhizoma Corydalis powder is added in the supercritical extraction unit; Ethanol with concentration expressed in percentage by volume 95% extracts as entrainer, and it is subsequent use to collect extract, and said extract is Rhizoma Corydalis supercritical carbon dioxide extraction thing; Wherein, the addition of entrainer is 4%～6% of a Rhizoma Corydalis grain weight amount, and extraction conditions is: extraction kettle pressure 17Mpa～20Mpa; Separate axe I pressure 8Mpa～10Mpa, separate axe II pressure 5Mpa～6Mpa, extraction temperature is 50 ℃～55 ℃; The extraction time is 2～4h, CO
2Flow is 23～27kg/hr;
Said Pericarpium Zanthoxyli supercritical carbon dioxide extraction thing prepares process and is: with pulverizing after the Pericarpium Zanthoxyli hygroscopic desiccation; Zanthoxyli Bungeani powder is added in the supercritical extraction unit; Ethanol with concentration expressed in percentage by volume 95% extracts as entrainer; The collection extract is subsequent use, and said extract is Pericarpium Zanthoxyli supercritical carbon dioxide extraction thing; Wherein, the addition of entrainer is 4%～6% of a Rhizoma Corydalis medicated powder weight, and extraction conditions is: extraction axe pressure 30Mpa～35Mpa, and extraction temperature is 40 ℃～45 ℃, the extraction time is 2～4h, CO
2Flow 38～42L/h.
Said Radix Notoginseng 50% ethanol extract is that Radix Notoginseng medicated powder is used concentration expressed in percentage by volume is the extractum that makes after 50% ethanol extraction and the drying;
Said Myrrha 95% ethanol extract will not have medicated powder with 95% ethanol extraction and the dry extractum that makes.Preferably, each ingredients weight parts of said Chinese medicine for external application is:
Rhizoma Corydalis supercritical carbon dioxide extraction thing 790～810;
Pericarpium Zanthoxyli supercritical carbon dioxide extraction thing 420～560;
Radix Notoginseng 50% ethanol extract 900～1100;
Myrrha 95% ethanol extract 490～510;
Polysorbate-80 (tween-80) 1520～1530;
The fatty acid Pyrusussuriensis is smooth-80 (span-80) 1130～1170;
PEG─4000?2200～2400；
PEG─400780～820。
Preferably, each ingredients weight parts of said Chinese medicine for external application is:
Rhizoma Corydalis supercritical carbon dioxide extraction thing 800;
Pericarpium Zanthoxyli supercritical carbon dioxide extraction thing 450;
Radix Notoginseng 50% ethanol extract 1000;
Myrrha 95% ethanol extract 500;
Polysorbate-80 1525;
The fatty acid Pyrusussuriensis is smooth-and 80 1150;
PEG─4000?2300；
PEG─400800。
Prepare the method for above-mentioned Chinese medicine for external application, comprise the steps:
(1) with pulverizing after the Rhizoma Corydalis hygroscopic desiccation, the Rhizoma Corydalis powder is added in the supercritical extraction unit, extract as entrainer with the ethanol of concentration expressed in percentage by volume 95%, it is subsequent use to collect extract; Wherein, the addition of entrainer is 4%～6% of a Rhizoma Corydalis grain weight amount, and extraction conditions is: extraction kettle pressure 17Mpa～20Mpa; Separate axe I pressure 8Mpa～10Mpa, separate axe II pressure 5Mpa～6Mpa, extraction temperature is 50 ℃～55 ℃; The extraction time is 2～4h, CO
2Flow is 23～27kg/hr;
(2 said Pericarpium Zanthoxyli supercritical carbon dioxide extraction things prepare process and are: with pulverizing after the Pericarpium Zanthoxyli hygroscopic desiccation, Zanthoxyli Bungeani powder is added in the supercritical extraction unit, extract as entrainer with the ethanol of concentration expressed in percentage by volume 95%, it is subsequent use to collect extract; Wherein, the addition of entrainer is 4%～6% of a Rhizoma Corydalis medicated powder weight, and extraction conditions is: extraction axe pressure 30Mpa～35Mpa, and extraction temperature is 40 ℃～45 ℃, the extraction time is 2～4h, CO
2Flow 38～42L/h.
(3) Radix Notoginseng medicated powder being added concentration expressed in percentage by volume is to soak 30min～60min in 50% the ethanol; And to use concentration expressed in percentage by volume be twice of 50% ethanol water-bath reflux, extract; Filter, merge the filtrating of extracted twice, 50 ℃～60 ℃ (0.1Mpa) are reclaimed ethanol to there not being the alcohol flavor on the rotating thin film evaporimeter; In water-bath, be condensed into thick extractum again, it is subsequent use that last drying under reduced pressure is processed dry extract; Wherein, for the first time during the water-bath reflux, extract,, add alcoholic acid volume and be 10～12 times of Radix Notoginseng powder weight, extraction time is 1.0～1.5h; For the second time during the water-bath reflux, extract,, add alcoholic acid volume and be 8～10 times of Radix Notoginseng powder weight, extraction time is 0.5～1.0h;
(4) will not having medicated powder to add concentration expressed in percentage by volume is to soak 30min～60min in 95% the ethanol; And to use concentration expressed in percentage by volume be twice of 50% ethanol water-bath reflux, extract; Filter, merge the filtrating of extracted twice, put and concentrate (recovery ethanol) on the rotating thin film evaporimeter and do not steam (or be concentrated into no ethanol distinguish the flavor of) to there being distillate; Concentrated solution is poured in the evaporating dish; Continue to be condensed into thick extractum in 85 ℃～90 ℃ water-baths, drying under reduced pressure is processed dry extract subsequent use (Myrrha volatile oil is dissolved in 95% ethanol, so dry extract contains volatile oil) again; Wherein, for the first time during the water-bath reflux, extract,, add alcoholic acid volume and be 10～12 times of Myrrha grain weight amount, extraction time is 2.0～2.5h; For the second time during the water-bath reflux, extract,, add alcoholic acid volume and be 8～10 times of Myrrha grain weight amount, extraction time is 1.5～2.0h;
(5) the Rhizoma Corydalis supercritical carbon dioxide extraction thing for preparing than preparation process (1) to (4) by aforesaid set of dispense; Pericarpium Zanthoxyli supercritical carbon dioxide extraction thing; Radix Notoginseng 50% ethanol extract, Myrrha 95% ethanol extract, Polysorbate-80; The fatty acid Pyrusussuriensis is smooth-and 80, PEG-4000 and PEG-400;
(6) mix with the PEG4000 heating for dissolving and with PEG400 the insulation subsequent use;
(7) Myrrha 95% ethanol extract and the grinding of Radix Notoginseng 50% ethanol extract are made its uniform mixing;
(8) grind-80 and span-80 with adding tween in the Pericarpium Zanthoxyli supercritical carbon dioxide extraction thing; Add Rhizoma Corydalis supercritical carbon dioxide extraction thing then; Grind, add Radix Notoginseng 50% ethanol extract of step (7) preparation and the mixture of Myrrha 95% ethanol extract again, mixing; Add the PEG4000 of step (6) preparation and the mixture of PEG400 at last, grind evenly;
(9) decompression method emptying gas is adopted in fill, the sterilization of γShe Xianmiejun method during fill.
Wherein, the volume unit described in the above-mentioned steps is ml, and unit of weight is g.
The foundation of the present invention's prescription: the traditional Chinese medical science thinks that the anorectal disease operation is that golden sword is hindered, damage passages through which vital energy circulates blood network in the art, and the local stagnation of QI is difficult to walk, and the postoperative retention of blood stasis does not go, and QI-blood circulation is not smooth, qi depression to blood stasis, stagnation of QI and blood may bring about pain.Ancient literature causes pain to wound and discusses and to have: "guide to clinical practice with medical record" is pointed out: " the long-pending wound goes into network, and QI and blood is the stasis of blood all, then popular mistake department; so-called bitterly then also obstructed "; " Shengji Zonglu traumatic fracture door " also pointed out: " if folding due to wound, interior influencing meridian network, the road that blood is capable must not be declared logical; the stasis of blood is long-pending does not loose, and then is pain for swollen." about the wound treatment of pain, it is a lot of that ancient literature is discussed, and says like " abstracts of classic of internal medicine ": " general rule not bitterly, pain is then obstructed "; "guide to clinical practice with medical record" is said: " ... So-called logical its QI and blood then is not bitterly yet ... Qi stagnation hemagglutination; Logical its gas its blood that looses is then healed ", " element ask the most pure virginity will discuss greatly " said again: " disease caused by accumulations of pathogen should be treated with therapy of dispersion ", clearly propose with logical be main; logical its QI and blood, its stasis of blood of loosing is stagnant, to reach not bitterly purpose of general rule.The pathogenesis of anorectal disease postoperative pain is that passages through which vital energy circulates is impaired, local qi and blood stagnation, and stagnation of QI and blood may bring about pain is controlled 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, and general rule is not bitterly.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 are the key medicine of pain relieving inside and outside kind the controlling, and the stagnation of QI in the ability promoting the circulation of blood, stasis in the gas, and 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 ability 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 the stasis of blood, 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 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 promoting flow of QI and blood, the short merit more of pain relieving.
The dosage form of the Chinese medicine for external application of postoperative analgesia of the present invention and promotion wound healing is ointment and similar dosage form thereof.
The Chinese medicine for external application of postoperative analgesia of the present invention and promotion wound healing belongs in preparation and treats the application that the anorectal disease postoperative eases pain and promotes wound healing medicine and similar medicine thereof.
Compared with prior art, beneficial effect of the present invention is:
1, the Chinese medicine externally-applied soft ointment of postoperative analgesia of the present invention and promotion wound healing; Can be when changing dressings in the part; Directly reach the effect of analgesia, promotion wound healing; Avoid the misery and the loaded down with trivial details disadvantage of therapeutic process of oral and administered intramuscular, have advantage simple to operate, effective.
2, the Chinese medicine externally-applied soft ointment of postoperative analgesia of the present invention and promotion wound healing; Use modern preparation new technique to extract the effective site of medicine; Adopt the high extract of active constituent content to be used as medicine; The utilization surfactant makes oil phase (supercritical carbon dioxide extraction thing) and water (polyethylene glycols substrate) disperse mutually to process ointment, thereby helps medicine performance optimum curative effect.
3, the Chinese medicine externally-applied soft ointment of postoperative analgesia of the present invention and promotion wound healing, analgesic effect is superior to the tetracaine hydrochloride rubber cement, obviously is superior to Herba Tubocapsici Anomali ointment; Short more effect is superior to Herba Tubocapsici Anomali ointment, obviously is superior to the tetracaine hydrochloride rubber cement; And in the medication process, be safe, for the clinical treatment postoperative pain provides a kind of safe and effective external used medicine ointment.
Preparation technology's of the present invention innovative point is:
1, old technology extracts the Rhizoma Corydalis effective ingredient; Must be with the refining purification of chloroform; The chloroform consumption is very big during mass production, must public security bureau prove that old friend's technology can't be developed and buy chloroform; The present invention uses supercritical carbon dioxide extraction method instead and extracts the Rhizoma Corydalis effective ingredient; Not only must not use chloroform, and greatly reduce production cost, shortened the production cycle, practice thrift medical material, tetrahydropalmatine content height, mouldability, drug effect and be superior to former technology, be particularly suitable for industrialized great production (carbon dioxide can recycling use).
2, Pericarpium Zanthoxyli supercritical carbon dioxide extraction thing, layering when Myrrha 95% ethanol extract mixes with PEG400 and PEG4000 ointment base; Can't disperse ,-80 is smooth with the fatty acid Pyrusussuriensis-80 processed O/W Emulsion as emulsifying agent (surfactant) so adopt Polysorbate, helps Pericarpium Zanthoxyli supercritical carbon dioxide extraction thing first, Myrrha 95% ethanol extract is dispersed in PEG400 and the PEG4000 ointment base; Second strengthen wound surface local analgesia effect; Because of the O/W breast can penetrate to the skin or mucosa in, can get into blood circulation again, both brought into play the central analgesia effect; Bring into play skin or the effect of mucosa targeted therapy again, three have increased stability of formulation.
3, process using Polyethylene Glycol substrate of the present invention; Reason is the foreign minister that PEG400 both can be used as Pericarpium Zanthoxyli supercritical carbon dioxide extraction thing, Myrrha 95% ethanol extract O/W breast; Can be used as the part of ointment base again, and mouldability, electrolyte-resistant property, stability, drug loading all are superior to other ointment bases: like carbomer substrate.
In a word, the Chinese medicine for external application of postoperative analgesia of the present invention and promotion wound healing has promoting flow of QI and blood, the short effect more of pain relieving; External directly acts on patient's surgical wound surface, and power reaches in interior through being administered to outer, stimulates the menstrual flow to reach network; With the removing blood stasis circulation of qi promoting, the stasis of blood hinders to such an extent that remove, and QI and blood is smooth; Through ruton, pain is able to alleviate; The capable then blood of gas is capable, and QI and blood is in harmonious proportion, and then the wound surface growth is vigorous.This preparation uses modern preparation new technique to extract the effective site of medicine, adopts the high extract of active constituent content to be used as medicine, and drug loading is high, so curative effect of medication is remarkable.
Description of drawings
Fig. 1 is Chinese medicine for external application pilot process of the present invention and online detection quality control sketch map.
The specific embodiment
Below in conjunction with chart and embodiment the present invention is described further.
One. recipe quantity
Rhizoma Corydalis (vinegar system) 10000g
Pericarpium Zanthoxyli 5000g
Radix Notoginseng (fine powder) 5000g
Myrrha (fine powder) 2500g
Two. processing step (the volume unit described in the following steps is ml, and unit of weight is g)
1. Rhizoma Corydalis supercritical carbon dioxide extraction technology
With the powder that is ground into No. 2 sieves (24 mesh sieve) after the Rhizoma Corydalis hygroscopic desiccation, take by weighing the Rhizoma Corydalis powder and add in the extraction axe, the ethanol with 95% is as entrainer; The volume that adds entrainer is 5% of a medical material weight, and extraction axe pressure is 17Mpa, and separating axe I pressure is 10Mpa; Separating axe II pressure is 5Mpa; Extraction temperature is 50 ℃, and the extraction time is 2 hours, CO
2Flow 25kg/hr collects the extract refrigerator and preserves subsequent use.
2. Pericarpium Zanthoxyli supercritical carbon dioxide extraction technology
With the powder that is ground into 40 mesh sieves～60 mesh sieves after the Pericarpium Zanthoxyli hygroscopic desiccation, take by weighing Zanthoxyli Bungeani powder and add in the extraction axe, the ethanol with 95% is as entrainer, and addition is 5% of a medical material amount, and extraction axe pressure is 30Mpa, and extraction temperature is 40 ℃, the extraction time is 2 hours, CO
2Flow 40L/h collects the extract refrigerator and preserves subsequent use.
3. Radix Notoginseng alcohol extraction concentrate drying technology
Get the pseudo-ginseng fine powder, add 50% soak with ethanol 30min, add for the first time alcoholic acid volume and be 10 times of medical material weight; Add for the second time alcoholic acid volume and be 8 times of medical material weight; The reflux extracting time of water-bath for the first time is 1.0 hours, and the reflux extracting time of water-bath for the second time is 0.5 hour, filters; Filtrate on the rotating thin film evaporimeter 50 ℃～60 ℃ and (0.1Mpa) reclaim ethanol to there not being the alcohol flavor; Pour in the evaporating dish again, in water-bath, be condensed into thick extractum, last drying under reduced pressure is processed dry extract.
4. the bisabolol concentration drying process that contracts
Because of the Myrrha bought is 60 orders～80 purpose fine powders, do not have medicated powder to add 95% soak with ethanol 30 minutes so get, water-bath reflux, extract, 2 times; The volume that first and second time adds alcohol is respectively 10 times, 8 times of Myrrha grain weight amount, and reflux extracting time was respectively 2.0,1.5 hours, filters; Merge secondary filtrating; Put on the rotating thin film evaporimeter and to concentrate (recovery ethanol) and do not steam (or be concentrated into no ethanol distinguish the flavor of), concentrated solution is poured in the evaporating dish, continue to be condensed into thick extractum in 85 ℃ of water-baths to there being distillate; Drying under reduced pressure is processed dry extract (Myrrha volatile oil is dissolved in 95% ethanol, so dry extract contains volatile oil) again.
5, Chinese medicine for external application prescription of the present invention
(1) medicinal substances extract prescription
Rhizoma Corydalis supercritical carbon dioxide extraction thing 800g
Pericarpium Zanthoxyli supercritical carbon dioxide extraction liquid 450g
Radix Notoginseng 50% alcohol-extracted extract powder 1000g
Myrrha 95% alcohol-extracted extract powder 500g
(2) adjuvant (substrate) and dispersant prescription
Polysorbate-80 (Tween 80) 1525g
The fatty acid Pyrusussuriensis is smooth-80 (sorbester p17) 1150g
PEG─40002300g
PEG─400?800g
Total amount 8525g
(3) note
1. Pericarpium Zanthoxyli supercritical carbon dioxide extraction thing yield 9% (promptly 100 gram medical materials get SFE extract 9 gram)
2. Rhizoma Corydalis supercritical carbon dioxide extraction thing yield 8% (promptly 100 gram medical materials get SFE extract 8 gram)
6. ointment preparation
Get the PEG4000 heating for dissolving and mix insulation with PEG400 subsequent use; In addition Myrrha 95% ethanol extract (100 order dry extract) and Radix Notoginseng 50% ethanol extract (100 order dry extract) are ground in mortar and make its uniform mixing; Pericarpium Zanthoxyli supercritical carbon dioxide extraction thing is liquid, puts in another mortar, adds tween-80 and span-80 fully grinds and makes it homodisperse, adds Rhizoma Corydalis SFE CO by the equivalent incremental method
2Extract fully grinds and makes it homodisperse, adds the mixed powder of Radix Notoginseng 50% ethanol extract and Myrrha 95% ethanol extract equally by the equivalent incremental method; 80 ratio makes homodisperse to adjustment tween-80 and span-; The mixed liquor that adds PEG4000 and PEG400 at last fully grinds and makes it homodisperse, and milling time lasts till and naturally cooled to after the room temperature 20 minutes～30 minutes; Up to the smooth exquisiteness of ointment, mouldability reaches the end product quality requirement, and can to adorn box subsequent use.
7. sterilization: adopt the sterilization of γShe Xianmiejun method.
8. points for attention: adopt decompression method emptying gas during fill.
Three. Chinese medicine for external application--the Comparison of therapeutic demonstration test of ointment of a kind of postoperative analgesia of the present invention and promotion wound healing
Anus anorectal disease patient's 180 examples that will meet the standard of including in are divided into groups by sick the kind earlier, and 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
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
Can know that by table 11 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 property, nausea and vomiting, toxicities such as hyperhidrosis is drowsiness, sensualness incontinence.
2, hepatic and renal function compares before and after the Chinese medicine for external application group medication of a kind of postoperative analgesia and promotion healing
Hepatic and renal function relatively before and after the medication of table 2 ointment formulation group of the present invention
Can know that by table 2 ointment formulation group of the present invention does not have hepatic and renal function injure.
3, in three groups of patient's postoperatives 48 hours 4 observe the time point analgesic effects relatively
Observe time point analgesic effects relatively (branch) for 4 in three groups of patient's postoperatives of table 3 48 hours
[5]
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.
Can know by table 3, observe the time point analgesic effects and obviously be superior to Herba Tubocapsici Anomali ointment group for 4 in the ointment formulation group postoperative of the present invention 48 hours, also be superior to tetracaine hydrochloride rubber cement group.
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)
[5]
Annotate: ointment formulation group of the present invention and Herba Tubocapsici Anomali ointment group ratio: < 0.05, * * P < 0.01 for * P; Compare with tetracaine hydrochloride rubber cement group: ☆ P 0.05, ☆ ☆ P < 0.01.
Can know that by 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 superior to Herba Tubocapsici Anomali ointment group, also is superior to tetracaine hydrochloride rubber cement group.
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.
Can know that by 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.
6, three groups of patient's wound healing times relatively
Three groups of patient's wound healing times comparisons of table 6 (my god)
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.
Can know that by table 6 ointment formulation group of the present invention shortens wound healing time and is superior to Herba Tubocapsici Anomali ointment group, obviously is superior to tetracaine hydrochloride rubber cement group.
7, three groups of patient's wound healing rates relatively
Three groups of patient's wound healings of table 7 rate is (%) relatively
[6]
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.
Can know that by table 7 ointment formulation group of the present invention improves the wound healing rate and is superior to Herba Tubocapsici Anomali ointment group, obviously is superior to tetracaine hydrochloride rubber cement group.
In sum: the Chinese medicine for external application of a kind of postoperative analgesia of the present invention and promotion wound healing, analgesic effect is superior to the tetracaine hydrochloride rubber cement, obviously is superior to Herba Tubocapsici Anomali ointment; Short more effect is superior to Herba Tubocapsici Anomali ointment, obviously is superior to the tetracaine hydrochloride rubber cement; And in the medication process, be safe.
Claims (7)
1. postoperative analgesia and promote the Chinese medicine for external application of wound healing comprises the component of following weight portion:
Rhizoma Corydalis supercritical carbon dioxide extraction thing 780～820;
Pericarpium Zanthoxyli supercritical carbon dioxide extraction thing 400～500;
Radix Notoginseng 50% ethanol extract 800～1200;
Myrrha 95% ethanol extract 480～520;
Polysorbate-80 1500～1550;
The fatty acid Pyrusussuriensis is smooth-and 80 1100～1200;
PEG─4000?2000～2600；
PEG─400750～850；
Wherein, said Rhizoma Corydalis supercritical carbon dioxide extraction thing prepares process and is: Rhizoma Corydalis is pulverized, added in the supercritical extraction unit, extract as entrainer with the ethanol of concentration expressed in percentage by volume 95%, it is subsequent use to collect extract; Wherein, the addition of entrainer is 4%～6% of a Rhizoma Corydalis grain weight amount, and extraction conditions is: extraction kettle pressure 17Mpa～20Mpa; Separate axe I pressure 8Mpa～10Mpa, separate axe II pressure 5Mpa～6Mpa, extraction temperature is 50 ℃～55 ℃; The extraction time is 2～4h, CO
2Flow is 23～27kg/hr;
Said Pericarpium Zanthoxyli supercritical carbon dioxide extraction thing prepares process and is: Pericarpium Zanthoxyli is pulverized, added in the supercritical extraction unit, extract as entrainer with the ethanol of concentration expressed in percentage by volume 95%, it is subsequent use to collect extract; Wherein, the addition of entrainer is 4%～6% of a Rhizoma Corydalis medicated powder weight, and extraction conditions is: extraction axe pressure 30Mpa～35Mpa, and extraction temperature is 40 ℃～45 ℃, the extraction time is 2～4h, CO
2Flow 38～42L/h.
Said Radix Notoginseng 50% ethanol extract is that Radix Notoginseng medicated powder is used concentration expressed in percentage by volume is the extractum that makes after 50% ethanol extraction and the drying;
Said Myrrha 95% ethanol extract will not have medicated powder with 95% ethanol extraction and the dry extractum that makes;
Wherein, the volume unit described in the above-mentioned preparation process is ml, and unit of weight is g.
2. Chinese medicine for external application as claimed in claim 1 is characterized in that, each ingredients weight parts of said Chinese medicine for external application is:
Rhizoma Corydalis supercritical carbon dioxide extraction thing 790～810;
Pericarpium Zanthoxyli supercritical carbon dioxide extraction thing 420～560;
Radix Notoginseng 50% ethanol extract 900～1100;
Myrrha 95% ethanol extract 490～510;
Polysorbate-80 1520～1530;
The fatty acid Pyrusussuriensis is smooth-and 80 1130～1170;
PEG─40002?200～2400；
PEG─400?780～820。
3. Chinese medicine for external application as claimed in claim 1 is characterized in that, each ingredients weight parts of said Chinese medicine for external application is:
Rhizoma Corydalis supercritical carbon dioxide extraction thing 800;
Pericarpium Zanthoxyli supercritical carbon dioxide extraction thing 450;
Radix Notoginseng 50% ethanol extract 1000;
Myrrha 95% ethanol extract 500;
Polysorbate-80 1525;
The fatty acid Pyrusussuriensis is smooth-and 80 1150;
PEG─4000?2300；
PEG─400800。
4. a method for preparing each described Chinese medicine for external application of claim 1 to 3 comprises the steps:
(1) Rhizoma Corydalis is pulverized, the Rhizoma Corydalis powder is added in the supercritical extraction unit, extract as entrainer with the ethanol of concentration expressed in percentage by volume 95%, it is subsequent use to collect extract; Wherein, the addition of entrainer is 4%～6% of a Rhizoma Corydalis grain weight amount, and extraction conditions is: extraction kettle pressure 17Mpa～20Mpa; Separate axe I pressure 8Mpa～10Mpa, separate axe II pressure 5Mpa～6Mpa, extraction temperature is 50 ℃～55 ℃; The extraction time is 2～4h, CO
2Flow is 23～27kg/hr;
(2) said Pericarpium Zanthoxyli supercritical carbon dioxide extraction thing prepares process and is: Pericarpium Zanthoxyli is pulverized, Zanthoxyli Bungeani powder is added in the supercritical extraction unit, extract as entrainer with the ethanol of concentration expressed in percentage by volume 95%, it is subsequent use to collect extract; Wherein, the addition of entrainer is 4%～6% of a Rhizoma Corydalis medicated powder weight, and extraction conditions is: extraction axe pressure 30Mpa～35Mpa, and extraction temperature is 40 ℃～45 ℃, the extraction time is 2～4h, CO
2Flow 38～42L/h.
(3) Radix Notoginseng medicated powder being added concentration expressed in percentage by volume is to soak 30min～60min in 50% the ethanol; And to use concentration expressed in percentage by volume be twice of 50% ethanol water-bath reflux, extract; Filter, merge the filtrating of extracted twice, evaporation is reclaimed ethanol to there not being the alcohol flavor; Reconcentration becomes thick extractum, and it is subsequent use that final drying is processed dry extract; Wherein, for the first time during the water-bath reflux, extract,, add alcoholic acid volume and be 10～12 times of Radix Notoginseng powder weight, extraction time is 1.0～1.5h; For the second time during the water-bath reflux, extract,, add alcoholic acid volume and be 8～10 times of Radix Notoginseng powder weight, extraction time is 0.5～1.0h;
(4) will not having medicated powder to add concentration expressed in percentage by volume is to soak 30min～60min in 95% the ethanol; And to use concentration expressed in percentage by volume be twice of 50% ethanol water-bath reflux, extract; Filter, merge the filtrating of extracted twice, evaporation is reclaimed ethanol and is not steamed to having the alcohol flavor or being evaporated to no distillate; Reconcentration becomes thick extractum, and it is subsequent use that final drying is processed dry extract; Wherein, for the first time during the water-bath reflux, extract,, add alcoholic acid volume and be 10～12 times of Myrrha grain weight amount, extraction time is 2.0～2.5h; For the second time during the water-bath reflux, extract,, add alcoholic acid volume and be 8～10 times of Myrrha grain weight amount, extraction time is 1.5～2.0h;
(5) the Rhizoma Corydalis supercritical carbon dioxide extraction thing for preparing than preparation process (1) to (4) by the described set of dispense of claim 1; Pericarpium Zanthoxyli supercritical carbon dioxide extraction thing; Radix Notoginseng 50% ethanol extract, Myrrha 95% ethanol extract, Polysorbate-80; The fatty acid Pyrusussuriensis is smooth-and 80, PEG-4000 and PEG-400;
(6) mix with the PEG4000 heating for dissolving and with PEG400 the insulation subsequent use;
(7) Myrrha 95% ethanol extract and the grinding of Radix Notoginseng 50% ethanol extract are made its uniform mixing;
(8) grind-80 and span-80 with adding tween in the Pericarpium Zanthoxyli supercritical carbon dioxide extraction thing; Add Rhizoma Corydalis supercritical carbon dioxide extraction thing then; Grind, add Radix Notoginseng 50% ethanol extract of step (7) preparation and the mixture of Myrrha 95% ethanol extract again, mixing; Add the PEG4000 of step (6) preparation and the mixture of PEG400 at last, grind evenly.
Wherein, the volume unit described in the above-mentioned steps is ml, and unit of weight is g.
5. method as claimed in claim 4 is characterized in that, said Rhizoma Corydalis medicated powder is 24～60 orders; Said Zanthoxyli Bungeani powder is 40～60 orders.
6. method as claimed in claim 4 is characterized in that, said method step also comprises the product fill behind step (8) mixing, sterilization.
7. method as claimed in claim 6 is characterized in that, said sterilization is to sterilize with the γShe Xianmiejun method.
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN105288016A (en) * | 2015-12-03 | 2016-02-03 | 广东省第二中医院 | Externally-applied traditional Chinese medicine emulsion for prevention and treatment of knee osteoarthritis and preparation method thereof |
| CN106924311A (en) * | 2017-03-27 | 2017-07-07 | 四川森迪科技发展股份有限公司 | It is a kind of to promote Idesia polycarpa flower compound essential oil of wound healing and preparation method thereof |
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| CN102078421A (en) * | 2010-12-08 | 2011-06-01 | 何永恒 | Chinese medicine external preparation for postoperative analgesia and healing promotion and preparation method thereof |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105288016A (en) * | 2015-12-03 | 2016-02-03 | 广东省第二中医院 | Externally-applied traditional Chinese medicine emulsion for prevention and treatment of knee osteoarthritis and preparation method thereof |
| CN105288016B (en) * | 2015-12-03 | 2020-02-18 | 广东省第二中医院 | External traditional Chinese medicine emulsion for preventing and treating knee osteoarthritis and preparation method thereof |
| CN106924311A (en) * | 2017-03-27 | 2017-07-07 | 四川森迪科技发展股份有限公司 | It is a kind of to promote Idesia polycarpa flower compound essential oil of wound healing and preparation method thereof |
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Application publication date: 20121121 |