CN103933355B - Capsule of postoperative rigor incidence rate and preparation method thereof can be reduced - Google Patents

Abstract

The invention discloses a kind of preparation method that can reduce postoperative rigor incidence rate capsule, it is characterized in that preparation method includes: Herba Sarcandrae, Herba Changnieniae amoenae, Rhizoma Anemones Altaicae, Cortex Ponciri trifoliatae, Asarum forbesii Maxim, Cortex erythrinae coarse powder are extracted volatile oil with vapor distillation by (1) respectively, and collect mixing for standby use after volatile oil, medicinal residues are standby；(2) in Radix Satyrii nepalensis, Spina Gleditsiae, Rhizoma Cimicifugae, Sarcococca ruscifolia Stapf, Folium Salicis Babylonicae moss, Semen Aesculi and step 1, the mixing of gained medicinal residues adds 4 times of water yields, boiling 2 times, each 1 hour, and collecting decoction stands；Then toward the ethanol of the 95% of 3 ~ 4 times of medicinal liquids of addition in decocting liquid, stand 15 minutes, be then centrifuged 20 minutes with 3000rpm, extracting centrifugal liquid, concentrate, be spray-dried, draw just material；(3) material at the beginning of gained volatile oil sprays into step 2 gained in step 1 will mix, pulverize, cross 60 mesh sieves, encapsulated form.Clinical trial certificate: after the present invention prevents idiopathic general anesthesia, shiver with cold has good effect and the higher feature of safety, and clinic is applied clinically and popularized.

Description

Capsule of postoperative rigor incidence rate and preparation method thereof can be reduced

Technical field

The present invention relates to the field of Chinese medicines, be specifically related to a kind of capsule that can reduce postoperative rigor incidence rate and preparation method thereof.

Background technology

The mode using anesthesia can make sufferer carry out surgical operation under calm, painless comfort conditions, but anaesthetic is in addition to impact consciousness, change Pain Cognition degree, can also interfere with the normal physiological function of sufferer, such as heart beating, blood pressure, breathing etc..

Shiver with cold after idiopathic general anesthesia (postanesthesia Shivering, PS) incidence rate, previously document report, common surgical procedures is 5%～38%, and operation of opening cranium is 13%～65%.Shiver with cold after so-called idiopathic general anesthesia, also referred to as " penthiobarbital sample is tetanic ", belong to complication of anesthesia.Shiver with cold under physiological status is that body is to hypothermic compensation response, the heat production by skeletal muscle quick Rythmic contractions characteristic.Mechanism after Craniocerebral Surgery is then relevant with postoperative brain thermotaxic centre dysfunction, and blocks with the sympathetic nerve function under narcotism simultaneously, and heat redistribution regulation is not normal.

It is symptomatic treatment, the morphine receptor analeptic Pethidine that use, or maincenter respiratory stimulant medicine doxapram targetedly currently for the treatment of PS more.But shiver with cold i.e. can occur together while occurring, organism metabolism rate significantly raises the cardiopulmonary load caused increases；Even myocardial ischemia；The most also can damage platelet function, coagulation cascade response inhabitation, blood loss dramatically increases, and transfusion volume increases.Carry out effective prevention, the incidence rate of minimizing PS the most in the preoperative, and other post-operative complication will not be caused, be the new problem of research of neurosurgery operation of opening cranium.

Summary of the invention

The technical assignment of the present invention is for above the deficiencies in the prior art, it is provided that capsule that can reduce postoperative rigor incidence rate that a kind of curative effect is affirmed and side effect is little and preparation method thereof.

The present invention solves the technical scheme of its technical problem: a kind of capsule that can reduce postoperative rigor incidence rate and preparation method thereof, it is characterised in that be prepared from by the crude drug of following weight proportion: Radix Satyrii nepalensis 10 ~ 30 parts, Herba Changnieniae amoenae 6 ~ 12 parts, Spina Gleditsiae 3 ~ 10 parts, Rhizoma Cimicifugae 6 ~ 12 parts, Semen Aesculi 3 ~ 10 parts, Sarcococca ruscifolia Stapf 6 ~ 12 parts, Herba Sarcandrae 6 ~ 12 parts, Cortex Ponciri trifoliatae 6 ~ 12 parts, Rhizoma Anemones Altaicae 6 ~ 12 parts, Asarum forbesii Maxim 1 ~ 5 part, Folium Salicis Babylonicae moss 3 ~ 10 parts, Cortex erythrinae 10 ~ 25 parts.

Chinese medicine of the present invention can be prepared from as follows:

(1) with vapor distillation, Herba Sarcandrae, Herba Changnieniae amoenae, Rhizoma Anemones Altaicae, Cortex Ponciri trifoliatae, Asarum forbesii Maxim, Cortex erythrinae coarse powder being extracted volatile oil respectively, and collect mixing for standby use after volatile oil, medicinal residues are standby；

(2) in Radix Satyrii nepalensis, Spina Gleditsiae, Rhizoma Cimicifugae, Sarcococca ruscifolia Stapf, Folium Salicis Babylonicae moss, Semen Aesculi and step 1, the mixing of gained medicinal residues adds 4 times of water yields, boiling 2 times, each 1 hour, and collecting decoction stands；Then toward the ethanol of the 95% of 3 ~ 4 times of medicinal liquids of addition in decocting liquid, stand 15 minutes, be then centrifuged 20 minutes with 3000rpm, extracting centrifugal liquid, concentrate, be spray-dried, draw just material；

(3) material at the beginning of gained volatile oil sprays into step 2 gained in step 1 will mix, pulverize, cross 60 mesh sieves, encapsulated form.

Wherein said: Radix Satyrii nepalensis, for the orchid length tuber away from the blue Satyrium nepalense D. Don of bird foot.Nature and flavor are put down；Sweet.Return kidney；Heart channel.Merit can strengthening waist and nourishing kidney.

Herba Changnieniae amoenae, for the orchid family Herba Changnieniae amoenae Changuienia amoena Chien, is used as medicine with herb, root.Merit can heat clearing away, removing heat from blood, removing toxic substances.

Spina Gleditsiae, for the dry Spina jujubae of leguminous plant Fructus Gleditsia Gleditsia sinensis Lam..Nature and flavor are pungent, temperature.Return liver, stomach warp.Merit can be subsided a swelling poison holding, evacuation of pus, parasite killing.

Rhizoma Cimicifugae, for ranunculaceae plant C.heracleifolia Cimicifuga heracleifolia Kom., Cimicifuga Dahurica Cimicifuga dahurica (Turcz.) Maxim. or the dry rhizome of Rhizoma Cimicifugae Cimicifuga foetida L..Nature and flavor are pungent, micro-sweet, are slightly cold.Return lung, spleen, stomach, large intestine channel.Merit can deliver rash, heat-clearing and toxic substances removing, rises and lifts yang-energy.

Semen Aesculi, for Hippocastanaceae plant Aesculus chinensis Bunge Aesculus chinensis Bge., Radix Aesculi Aesculus chinensis Bge. var. chekiangensis (Hu et Fang) Fang or the dry mature seed of Aesculus Aesculus wilsonii Rehd..Nature and flavor are sweet, temperature.Return liver, stomach warp.Merit can regulating the flow of QI to ease the stomach, and stomach and alleviating pain.

Sarcococca ruscifolia Stapf, for Buxaceae Sarcococca plant fragrance osmanthus Sarcococca ruscifolia Stapf root.Nature and flavor are bitter, flat.Merit can regulating QI to relieve pain, dispelling, collateral-activating.

Herba Sarcandrae, for the dry Herb of Chloranthaceae plant plait Corallium Japonicum Kishinouye Sarcandra glabra (Thunb.) Nakai.Bitter, pungent, flat.GUIXIN, Liver Channel.Merit can clearing away heat and cooling blood, speckle removing of invigorating blood circulation, dispelling wind and removing obstruction in the collateral.

Cortex Ponciri trifoliatae, the bark for rutaceae Fructus Ponciri Trifoliatae (Fructus Ponciri Trifoliatae Immaturus) Poncirus tuifoliata (L.) Raf. is considered to be worth doing or peel bits.Nature and flavor are pungent；Temperature.Return liver；Kidney channel.Merit can endogenous wind stopping relieving convulsion；Eleminating phlegm and freeing channels.

Rhizoma Anemones Altaicae, for Ranunculaceae thimbleweed anemone altaica Anemone altaica Mey., it is used as medicine with root stock.Nature and flavor are pungent, temperature.Merit can causing resuscitation with aromatic drugs, reduce phlegm, calm the nerves.

Asarum forbesii Maxim, for the rhizome of aristolochiaceae plant Herba Asari Forbesii Asarum forbesii Maxim. and root or herb.Nature and flavor are pungent；Temperature.Return lung；Liver；Kidney；Bladder warp.Merit can expelling wind and cold；Expectorant diuretic；Promoting blood circulation and stopping pain.

Folium Salicis Babylonicae moss, for Amblystegiaceae Folium Salicis Babylonicae moss Amblystegium serpens(Hedw.) plant of B.S.G..Nature and flavor are puckery；Flat.Merit can astringing to arrest bleeding.

Cortex erythrinae, for bark or the root bark of pulse family Erythrinae Arborescentis Erythrina indica Lam..Nature and flavor are bitter, flat.Return liver, kidney channel.Merit can wind-damp dispelling, channels sootheing and network vessel quickening.Wind-damp dispelling, the meridian dredging, parasite killing.

Composition principle: shiver with cold after idiopathic general anesthesia (PS) is different from other shiver with colds, not only without secondary high heat, is also embodied by central body temperature simultaneously and declines.In wind and cold disease, the reason of shiver with cold heating is that cold-evil visitor defends point in flesh table, and PS to be anaesthetic cause inside and outside the negative and positive of physiological status can not traffic, lie prostrate in being embodied in Yuanyang in Shao Yin, yang-energy is hindered, defend gas not with flourish split-phase and, seek the gas defended and can not thoroughly reach caused by flesh table.Wind and cold disease, but if PS uses relieving the exterior syndrome with drugs of pungent in flavor and warm in nature medicine, the most lunar unit YANG deficiency, counter is let out when hiding with except shiver with cold with relieving exterior syndrome and dispelling cold medicine divergence cold-evil, or becomes his disease raw.Therefore its prevention, should with inside and outside traffic, resolving mass and removing the obstruction of the collateral, consolidate heat clearing away and go forward side by side.

Compared with prior art, the invention have the characteristics that:

1, prescription is unique: take Radix Satyrii nepalensis in Fang, Spina Gleditsiae is monarch, and described Radix Satyrii nepalensis, Spina Gleditsiae coordinate, and for PS, the few cloudy Yuanyang of the Radix Satyrii nepalensis temperature dim glow of the setting sun, Spina Gleditsiae follows Liver Channel Xin Wentuo and dissipates；Radix Satyrii nepalensis is different from other training tonic thing, and its negative and positive are gentle, and nature and flavor are put down sweet, and without the anxiety of derivative endogenous fire, but the feature of Radix Satyrii nepalensis is to keep and do not walk, and clinic is used for strengthening waist and nourishing kidney, but coordinates Spina Gleditsiae to lift yang-energy, and the gas of Yuanyang can walk in shaoyin channel network.Radix Satyrii nepalensis, Spina Gleditsiae 1:3 ratio decocting liquid gavage, rat serum prostaglandin E l level can be improved, and in amount-effect linear relationship trend, and single Radix Satyrii nepalensis and single Spina Gleditsiae decocting liquid compare not statistically significant for the impact of blood prostaglandin E l level with blank group.

2, take Herba Changnieniae amoenae in side, Rhizoma Cimicifugae, Semen Aesculi, Sarcococca ruscifolia Stapf, Herba Sarcandrae are minister: Herba Changnieniae amoenae, Herba Sarcandrae have the merit of removing summer-heat, can be effectively prevented yang-energy and excessively lax brought intenseness of heat, and Rhizoma Cimicifugae, Sarcococca ruscifolia Stapf rise lifts yang-energy, and auxiliary Spina Gleditsiae lifts yang-energy；Semen Aesculi promoting of the circulation of QI and removing the obstruction in the collaterals is the most overbearing.Wherein, Sarcococca ruscifolia Stapf is apt to walk head's nine orifices, and its gas floats gently, uses so being particularly suited for neurosurgery operation of opening cranium preoperative the intervention.

3, supplementary drug thing is fewer but better, Cortex Ponciri trifoliatae endogenous wind stopping dredging collateral；Rhizoma Anemones Altaicae is had one's ideas straightened out and calms the nerves；The pungent temperature of Asarum forbesii Maxim is wandered away, and has effect of promoting blood circulation and stopping pain, is suitable for Postoperative relief pain；Cortex erythrinae dredging collateral.

4, the part in neurosurgery operation of opening cranium is cerebral hemorrhage sufferer, and in order to prevent, the medicine in prescription is the most pungent to be dissipated, and makes so adding by Folium Salicis Babylonicae moss assistant, and Folium Salicis Babylonicae moss is puckery flat, has the effect of convergence, unsmooth battalion will not defend mechanism of qi again.

5, medicine material consumption of the present invention is groped to sum up to draw through inventor in a large number, and each raw material dosage is for all to have preferable curative effect in following weight parts scope.

Detailed description of the invention

Below in conjunction with practical situation, the detailed description of the invention of the present invention is elaborated.

Embodiment 1, crude drug weight proportion: Radix Satyrii nepalensis 20 parts, Herba Changnieniae amoenae 10 parts, Spina Gleditsiae 6 parts, Rhizoma Cimicifugae 10 parts, Semen Aesculi 6 parts, Sarcococca ruscifolia Stapf 10 parts, Herba Sarcandrae 10 parts, Cortex Ponciri trifoliatae 10 parts, Rhizoma Anemones Altaicae 10 parts, Asarum forbesii Maxim 2 parts, Folium Salicis Babylonicae moss 6 parts, Cortex erythrinae 20 parts.

The preparation method of embodiment 1 is: Radix Satyrii nepalensis, Herba Changnieniae amoenae, Spina Gleditsiae, Rhizoma Cimicifugae, Semen Aesculi, Sarcococca ruscifolia Stapf, Herba Sarcandrae, Cortex Ponciri trifoliatae, Rhizoma Anemones Altaicae, Asarum forbesii Maxim, Folium Salicis Babylonicae moss, Cortex erythrinae mixing and water adding are decocted, filtrate is taken after 30 minutes, medicinal residues add water after continuation decocts 20 minutes and take filtrate, twice filtrate merges, and is divided into two parts and sooner or later takes.

Embodiment 2, crude drug weight proportion: Radix Satyrii nepalensis 10 parts, Herba Changnieniae amoenae 6 parts, Spina Gleditsiae 3 parts, Rhizoma Cimicifugae 6 parts, Semen Aesculi 3 parts, Sarcococca ruscifolia Stapf 6 parts, Herba Sarcandrae 6 parts, Cortex Ponciri trifoliatae 6 parts, Rhizoma Anemones Altaicae 6 parts, Asarum forbesii Maxim 1 part, Folium Salicis Babylonicae moss 3 parts, Cortex erythrinae 10 parts.

Embodiment 3, crude drug weight proportion: Radix Satyrii nepalensis 20 parts, Herba Changnieniae amoenae 10 parts, Spina Gleditsiae 6 parts, Rhizoma Cimicifugae 10 parts, Semen Aesculi 6 parts, Sarcococca ruscifolia Stapf 10 parts, Herba Sarcandrae 10 parts, Cortex Ponciri trifoliatae 10 parts, Rhizoma Anemones Altaicae 10 parts, Asarum forbesii Maxim 2 parts, Folium Salicis Babylonicae moss 6 parts, Cortex erythrinae 20 parts.

Embodiment 4, crude drug weight proportion: Radix Satyrii nepalensis 30 parts, Herba Changnieniae amoenae 12 parts, Spina Gleditsiae 10 parts, Rhizoma Cimicifugae 12 parts, Semen Aesculi 10 parts, Sarcococca ruscifolia Stapf 12 parts, Herba Sarcandrae 12 parts, Cortex Ponciri trifoliatae 12 parts, Rhizoma Anemones Altaicae 12 parts, Asarum forbesii Maxim 5 parts, Folium Salicis Babylonicae moss 10 parts, Cortex erythrinae 25 parts.

The Chinese medicine of embodiment 2 ~ 4 can be prepared from as follows:

(1) with vapor distillation, Herba Sarcandrae, Herba Changnieniae amoenae, Rhizoma Anemones Altaicae, Cortex Ponciri trifoliatae, Sarcococca ruscifolia Stapf, Asarum forbesii Maxim, Cortex erythrinae coarse powder being extracted volatile oil respectively, and collect mixing for standby use after volatile oil, medicinal residues are standby；

(2) in Radix Satyrii nepalensis, Spina Gleditsiae, Rhizoma Cimicifugae, Folium Salicis Babylonicae moss, Semen Aesculi and step 1, the mixing of gained medicinal residues adds 4 times of water yields, boiling 2 times, each 1 hour, and collecting decoction stands；Then toward the ethanol of the 95% of 3 ~ 4 times of medicinal liquids of addition in decocting liquid, stand 15 minutes, be then centrifuged 20 minutes with 3000rpm, extracting centrifugal liquid, concentrate, be spray-dried, draw just material；

(3) material at the beginning of gained volatile oil sprays into step 2 gained in step 1 will mix, pulverize, cross 60 mesh sieves, encapsulated form.

Every seed lac capsule can be set as 0.5g.

The efficient combination of said medicine, coordinates mutually, and traffic is inside and outside, resolving mass and removing the obstruction of the collateral, consolidate heat clearing away, effectively reaches to prevent the purpose of PS, and side effect is less.The above results is that clinical data fully proves, relevant information is as follows.

1 object and method.

1.1 object.

1.1.1 Case selection: do not use the medicine of the treatment shiver with colds such as ondansetron, tramadol, clonidine under in February, 2013～general anesthesia in February, 2014 in Selective neurosurgery patient 121 example, and preoperative 3 days.Operation reason includes: intracranial tumour 51 example, pituitary tumor 23 example, cerebrovascular 19 example, epilepsy surgery 2 example, other operation such as hydrocephalus, skull repairing etc. 26 examples.Age between 7～70 years old, 43.6 ± 9.4 years old mean age, wherein: age<14 years old 20 example, age>60 years old 18 example；Male patient 69 example, female patient 52 example.

1.1.2 Packet: patient is randomly divided into matched group 40 example, decoction group 40 example and Capsules group 41 example.Compare on sex, age, the state of an illness, anesthesia method before three groups of patient treatments, no significant difference (P > 0.05), there is comparability.

1.2 method.

1.2.1 interference method: matched group routine preoperative and postoperative is administered, and is incubated by skin.Decoction group and Capsules group, on the basis of matched group, from the beginning of preoperative three days, respectively with gained decoction in the embodiment of the present invention 1, with gained capsule oral in the embodiment of the present invention 3,2 times/d, add up to three days.

1.2.2 statistical analysis: SPSS 13.0 carries out statistical analysis.Enumeration data χ²Inspection.

2 results.

2.1 three groups of PS incidence rates in postoperative 5 hours are respectively as follows: matched group 27.50%(11/40), decoction group 10.00%(4/40), Capsules group 9.76%(4/41).Decoction group and Capsules group shiver with cold incidence rate are significantly lower than matched group (χ²=4.02, P < 0.05；χ²=4.22, P < 0.05).

2.2 3 groups of patient's other recovery rooms (PACU) complication compare: see table,

	Number of cases	Cardiovascular related complication	Digestive complication	Spirit complication	Respiratory complication	Delayed recovery
							Matched group	40	12	5	9	1	1
Decoction group	40	14	5	6	1	1
							Capsules group	41	11	4	6	1	2

Matched group, decoction group, Capsules group be no significant difference (P > 0.05) in terms of cardiovascular related complication, Digestive complication, spirit complication, respiratory complication, Delayed recovery.

2.3 adverse reaction rates compare: obvious medicine related reactions do not occur in decoction group, Capsules group.

3. conclusion.

This result of study shows, decoction group and the Capsules group PS incidence rate of taking the present invention are significantly lower than matched group, and the PACU complication not resulting in other increases, illustrate that pharmaceutical composition prepared by the inventive method has the advantage that untoward reaction is relatively light, safety is higher in terms of prevention of postoperative PS.

Claims (1)

1. the preparation method that can reduce postoperative rigor incidence rate capsule, it is characterized in that, being prepared from by the crude drug of following weight proportion: Radix Satyrii nepalensis 10 ~ 30 parts, Herba Changnieniae amoenae 6 ~ 12 parts, Spina Gleditsiae 3 ~ 10 parts, Rhizoma Cimicifugae 6 ~ 12 parts, Semen Aesculi 3 ~ 10 parts, Sarcococca ruscifolia Stapf 6 ~ 12 parts, Herba Sarcandrae 6 ~ 12 parts, Cortex Ponciri trifoliatae 6 ~ 12 parts, Rhizoma Anemones Altaicae 6 ~ 12 parts, Asarum forbesii Maxim 1 ~ 5 part, Folium Salicis Babylonicae moss 3 ~ 10 parts, Cortex erythrinae 10 ~ 25 parts, preparation process is:

(1) with vapor distillation, Herba Sarcandrae, Herba Changnieniae amoenae, Rhizoma Anemones Altaicae, Cortex Ponciri trifoliatae, Asarum forbesii Maxim, Cortex erythrinae coarse powder being extracted volatile oil respectively, and collect mixing for standby use after volatile oil, medicinal residues are standby；

(2) in Radix Satyrii nepalensis, Spina Gleditsiae, Rhizoma Cimicifugae, Sarcococca ruscifolia Stapf, Folium Salicis Babylonicae moss, Semen Aesculi and step 1, the mixing of gained medicinal residues adds 4 times of water yields, boiling 2 times, each 1 hour, and collecting decoction stands；Then toward the ethanol of the 95% of 3 ~ 4 times of medicinal liquids of addition in decocting liquid, stand 15 minutes, be then centrifuged 20 minutes with 3000rpm, extracting centrifugal liquid, concentrate, be spray-dried, draw just material；

(3) material at the beginning of gained volatile oil sprays into step 2 gained in step 1 will mix, pulverize, cross 60 mesh sieves, encapsulated form.