CN105770474A - Lupus erythematosus resisting drug for combined immunization and preparing method and application thereof - Google Patents
Lupus erythematosus resisting drug for combined immunization and preparing method and application thereof Download PDFInfo
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Abstract
The invention discloses a lupus erythematosus resisting drug for combined immunization.The drug is prepared from walnut extract, folium artemisiae argyi extract, American ginseng extract and officinal dendrobium stem extract according to the weight ratio of 1: (0.5-2) : (1-5) : (1-10).The drug can inhibit and kill bacteria, improve organic immunity, quickly and effectively treat lupus erythematosus, regulate the body environment, recover the normal balance of the body and prevent relapse of lupus erythematosus.The drug is prepared by means of supercritical fluid and is safe and free of side effect, original plant bioactive components are not damaged during extraction, bioactive components are made into extracts with large specific surface areas, and in-vivo dissolution and body absorption can be achieved easily.
Description
Technical field
The invention belongs to drug world, more specifically, it relates to a kind of against erythema lupus combined immunization medicine and preparation method thereof, purposes.
Background technology
Lupus erythematosus (LupusErythematosus is called for short LE), sick for autoimmune connective tissue.Lupus erythematosus is divided into the hypotypes such as discoid lupus erythematosus (DLE), subacute cutaneous lupus erythematosus (SCLE), systemic lupus erythematosus (sle) (SLE), lupus erythematosus profundus (LEP), neonatal lupus erythematosus (NLE), Drug lupus erythematosus (DIL).At present the cause of disease of lupus erythematosus is not yet understood completely, but medical circle generally believes that the cause of disease of lupus erythematosus is likely to cause body's immunity disorder relevant with the many factors effect such as heredity, gonadal hormone, environment.In prior art, treatment lupus erythematosus mainly has western medicine and medical practitioners therapy, tcm therapy.Western medicine and medical practitioners treatment lupus erythematosus has certain effect, particularly outbreak period of disease or acute active stage, rapid symptom management is had positive role by the medicines such as the hormone of application heavy dose and cyclophosphamide, but widely apply these medicines for a long time, can have side effects, body is caused damage, even threat to life, simultaneously easy recurrent exerbation.Adopting Chinese traditional treatment lupus erythematosus, treatment cycle is longer, and the Various Tissues such as skin, internal organs and impaired organ are relatively wide, affect the confidence that patient cures, cause that its therapeutic effect is general.
Song Xiaoping etc. are in progress at the integrative therapy of lupus erythematosus,cutaneous and think deeply in (" Hainan medical science " the 21st volume the 21st phase in 2010), it is proposed that the integrative therapy method of lupus erythematosus,cutaneous.But the compatibility of Western medicine and Chinese medicine is also to be studied, and in, doctor trained in Western medicine combined therapy, mainly by the immunity strengthening patient, combined with westem reaches the purpose for the treatment of, this method can only strengthen patient's immunity during treating, and immune system destroyed before its treatment cannot be repaired, it is impossible to ensureing the immunity balance of organismic internal environment, this will cause that disease easily recurs；Easily interfere with each other between two kinds of treatments, it is easy to side reaction occurs.
How quick, effective, safe treatment lupus erythematosus, and prevent its recurrent exerbation, it has also become one of direction of primary study in industry.
Summary of the invention
For the deficiency that prior art exists, it is an object of the invention to provide a kind of energy bacteriostasis and sterilization, enhancing human body immunity power, fast and effectively treatment this disease of lupus erythematosus；Immunity of organisms can be further enhanced, regulate organismic internal environment, recover the normal equilibrium of body, the against erythema lupus combined immunization medicine of the recurrence of lupus erythematosus can be prevented.
For achieving the above object, the technical scheme is that
A kind of against erythema lupus combined immunization medicine, described against erythema lupus combined immunization medicine is raw material by Semen Juglandis extract, Artemisia argyi extract, Radix Panacis Quinquefolii extract, Herba Dendrobii extract；The weight proportion of described Semen Juglandis extract, Artemisia argyi extract, Radix Panacis Quinquefolii extract and Herba Dendrobii extract is 1: (0.5～2): (1～5): (1～10).
As preferably, described Semen Juglandis is black walnut, and Artemisia argyi is both A. absinthium, and Radix Panacis Quinquefolii is semi-wild Radix Panacis Quinquefolii, and Herba Dendrobii is wild Dendrodium.
Semen Juglandis, for juglandaceae plant Semen Juglandis JulansregiaL..The Semen Juglandis extract of the present invention is with North America black walnut (BlackWalnut, JuglansnigraL) endothelium extracts and makes, it contains juglone, Flavonoid substances, tannin, polysaccharide, gallic acid, volatile oil, mucilaginous gum, albumin, mineral, cellulose, linoleic acid, glyceride, linolenic acid, olein, riboflavin, carotene, Fructus Adinae D prime, casurin, Extract of Cimiei fruit, research finds that the ratio difference of its active component all can reach the purpose of the present invention, and the best results of the Semen Juglandis extract prepared by the preparation method of the present invention.
Artemisia argyi, has another name called Folium Artemisiae Argyi, Radix Artemisia ordosicae, Artemisia argyi Levl. et Van. var. argyi cv. Qiai or family Chinese mugwort, the dried leaves of the ArtemisiaargyiLevl.etVant. that ends for feverfew.It is pungent, bitter, temperature；Slightly poisonous, energy dispersing cold for relieving pain, warming the meridian for stopping bleeding.nullThe Artemisia argyi extract of the present invention is preferably with North America both A. absinthium (woormwood，Or Artemisiaabsinthium) herb extract make，It is mainly composed of volatile oil，Oil has terpinenol-4 (Terpinenol-4)、β-caryophyllene (β-Caryophyllene)、Artemisol (Artemisiaalcohol)、Linalool (Linalool)、Camphora (Camphorae)、Borneolum Syntheticum (Borneolum Syntheticum，Borneol)、Cineole (Cineol，And trans-carveol Eucalyptol)、α-terpinenol etc.，Again containing polysaccharose substance、Tannic acid、Absinthol、Phellandrene、Cupreol、5，7-dihydroxy-6，3 ' 4 '-trimethyl flavone，Research finds that the ratio difference of its active component all can reach the purpose of the present invention，And the best results of the Artemisia argyi extract prepared by the preparation method of the present invention.
Radix Panacis Quinquefolii, has another name called Radix Panacis Quinquefolii, Radix Panacis Quinquefolii, U.S.'s ginseng, and it is the root of Araliaceae Panax Radix Panacis Quinquefolii PanaxquinquefoliumLinn, and Radix Ginseng Panxginseng abounded with for Northeast China is equal belongs to together for it.It is cold in nature, has yin nourishing QI invigorating, blood pressure lowering and refrigeration function.Semi-wild Radix Panacis Quinquefolii is one of kind of American Ginseng of Radix Panacis Quinquefolii, and its main place of production is 25 states such as Wisconsin State, New York, the Kentucky State, and it is the seed of Radix Panacis Quinquefolii is placed on similar wild Environment cultivation obtain.The ginseng body of the Radix Panacis Quinquefolii extract semi-wild Radix Panacis Quinquefolii of the present invention extracts and makes, it is mainly composed of in ginsenoside, volatile oil, oils and fats fatty acid, organic acid, aminoacid, trace element, carbohydrate, pectin, sterol, and ginsenoside mainly has ginsenoside Ro, Rb1、Rb2、Rb3、Rc、Rd、Re、Rf、Rg1、Rg2、Rg3、Rh1、RAo, Radix Panacis Quinquefolii saponin R1, gypenoside XI, Herba Gynostemmatis glycosides XVII, Panax pseudoginseng Wall. saponin be mainly F11, Radix Ginseng soap F2、F3Deng, volatile oil mainly has β-farnesene, sesquiterpenoids, heerabolene, α-curcumene etc., research finds that the ratio difference of its active component all can reach the purpose of the present invention and the best results of the Radix Panacis Quinquefolii extract prepared by the preparation method of the present invention.
Herba Dendrobii, another name is bracketplant, Du Lan, and it is the stem of orchid Dendrobium nobile DendrobiumnobileLindl., Herba Dendrobii DendrobiumcandidumWall.exLindl. or Herba Dendrobii oculati DendrobiumfimbriatumHook.Var.oculatumHook and allied species thereof.It is sweet, is slightly cold, reinforcing stomach reg fluid, nourishing YIN and clearing away heat.The stem of the Herba Dendrobii extract wild Dendrodium of the present invention extracts and makes, it is containing multiple alkaloid, polysaccharide, aminoacid, phlegmatic temperament, starch, luxuriant and rich with fragrance class and bibenzyl etc., alkaloid includes dendrobine (Dendrobine), Herba Dendrobii pair alkali (Dendrine), Herba Dendrobii amine base (Dendramine), dendroxine (Dendroxine), 6-hydroxyl dendroxine (6-Hydroxy-dendroxine) etc., research finds that the ratio difference of its active component all can reach the purpose of the present invention, and the best results of the Herba Dendrobii extract prepared by the preparation method of the present invention.
Research finds, the against erythema lupus combined immunization medicine of the present invention, the weight proportion of its Semen Juglandis extract, Artemisia argyi extract, Radix Panacis Quinquefolii extract and Herba Dendrobii extract is 1: (0.5～2): (1～5): (1～10), and it combines potentiation:
(1) patients with SLE is played alleviate and improve the left and right of symptom, as alleviating pain, dispel pruritus, increase appetite, analgesia is enriched blood, hemopoietic, protect the liver, keep glucostasis；
(2) energy bacteriostasis and sterilization, antiviral, toxin expelling, antiinflammatory, has stronger non-oxidizability and Hydroxyl radical-scavenging ability, strengthens patients with SLE and resists the ability of other new diseases；
(3) other components in conjunction with its rich in polysaccharide make it have the effect of enhancing human body immunity power, to humoral immunity of organism function, the promotion of cellular immune function with induce cytokine profiles, lupus erythematosus can be treated fast and effectively；
(4) promote blood vigor, regulate nervus centralis, protect cardiovascular system; enhancing body functions of expelling toxin; energy enhancing human body immunity power and energy simultaneously; needed for body nutrition is provided; strengthen Cell-mediated Immunity; regulate organismic internal environment and repair former destroyed immune function, recovering normal physiological equilibrium, it is prevented that the recurrence of lupus erythematosus.
Research finds, it is preferable that the weight proportion of described Semen Juglandis extract, Artemisia argyi extract, Radix Panacis Quinquefolii extract and Herba Dendrobii extract is 1: 1: 5: 10.
As preferably, the preparation of described medicine is capsule.
It is administered with capsule, advantageously ensures that the against erythema lupus combined immunization medicine of the present invention can accurate, convenient be administered, be conducive to controlling.
The present invention also aims to the preparation method providing a kind of described against erythema lupus combined immunization medicine, described method includes the preparation of the preparation of Semen Juglandis extract capsule, the preparation of Artemisia argyi extract capsule, the preparation of Radix Panacis Quinquefolii extract capsule, Herba Dendrobii extract capsule；Described Semen Juglandis extract capsule, Artemisia argyi extract capsule, Radix Panacis Quinquefolii extract capsule, Herba Dendrobii extract capsule preparation all include:
S1, takes raw material and carries out screening and cleaning, by clean raw material by cold-maceration softening of reducing pressure；
The raw material of S2, the S1 that learns from else's experience step softening, supercritical fluid extraction, separate and be extracted liquid and residue；
S3, takes S2 and walks the residue obtained, by its attrition grinding；
S4, takes S2 and walks the extract obtained, and by its spray drying, adds the residue after the attrition grinding that S3 step obtains, obtain the raw material abstraction thing dried in the process of spray drying；
S5, the S4 taking formula ratio walks the raw material abstraction thing obtained, and fills to capsule shells, obtains capsule.
The present invention adopts decompression merceration tenderizer, and water is immediately wicked into by the effect by means of negative pressure, accelerates the softening of medical material, it is ensured that use water softening medical material at normal temperatures, shortens infiltrating time, reduces going mouldy of the loss of effective ingredient, destruction and medical material.
The present invention adopts supercritical liquid extraction technique to extract medicinal plants, the fluid of its supercritical fluid extraction is carbon dioxide, its extraction temperature is 30～40 DEG C, is avoided that volatilization wet goods composition volatilization in extraction process, can be maximally maintained the bioactive ingredients of medicinal plants；Simultaneously as inapplicable organic solvent, no solvent residue in process, it is ensured that the pure natural active of raw material, environmental protection, safety has no side effect.
The present invention adopts spray drying by the raw material abstraction liquid rapid draing of the present invention, and the product granularity obtained is tiny, uniform, good fluidity, adds its specific surface area, is conducive to its dissolution in body, is conducive to absorption of human body.Tiny particulate matter is obtained after raw material abstraction liquid is spray-dried, the material that the stickiness such as saccharide, protein, starch are bigger is contained due to it, the present invention adds the residue of its raw material in the process of raw material abstraction liquid spray drying, the residue of raw material can adsorb spray-dried raw material abstraction liquid, and spray-dried raw material abstraction liquid is relatively strong with the adhesion of the residue of raw material, can prevent it from the situation of viscous wall occurring；Make full use of crude drug simultaneously, be not added with other additional adjuvants, be conducive to preserving its pure-natural biological activity.
By the above-mentioned capsule prepared, safety has no side effect, and process of extracting is without destroying former plant biological active component, moreover it is possible to fully its bioactive ingredients is made the extract that specific surface area is big, is conducive to internal dissolution and absorption of human body；Use the method simultaneously, be avoided that in production process produce wall sticking phenomenon etc..
Research finds, it is preferable that in S1, the temperature of described decompression cold-maceration is 10～40 DEG C, and pressure is-0.1～-0.09MPa；
In S2, the fluid of described supercritical fluid extraction is carbon dioxide, and extraction temperature is 30～40 DEG C；
In S4, the temperature of described spray drying is 40～80 DEG C, and drying time is 3～60S；The granularity of described raw material abstraction thing is 10～60 μm；
In S5, described capsule shells is natural plants capsule shells.
The present invention also aims to the preparation method providing a kind of described against erythema lupus combined immunization medicine, described method includes the preparation of the preparation of Semen Juglandis extract capsule, the preparation of Artemisia argyi extract capsule, Radix Panacis Quinquefolii extract capsule and Herba Dendrobii extract capsule；
The preparation of described Semen Juglandis extract capsule includes:
S1, takes Semen Juglandis screening, cleans, by the endothelium of clean Semen Juglandis by cold-maceration softening of reducing pressure；The temperature of described decompression cold-maceration is 10～40 DEG C, and pressure is-0.1～-0.09MPa；
The Semen Juglandis of S2, the S1 that learns from else's experience step softening, supercritical fluid extraction, separate and obtain Semen Juglandis extract and Semen Juglandis residue；The fluid of described supercritical fluid extraction is carbon dioxide, and extraction temperature is 30～40 DEG C；
S3, takes S2 and walks the Semen Juglandis residue obtained, by its attrition grinding；
S4, takes S2 and walks the Semen Juglandis extract obtained, and by its spray drying, adds the Semen Juglandis residue after the attrition grinding that S3 step obtains, obtain the Semen Juglandis extract dried in the process of spray drying；The temperature of described spray drying is 40～80 DEG C, and drying time is 3～60S；The granularity of described Semen Juglandis extract is 10～60 μm；
S5, takes 1 part of S4 and walks the Semen Juglandis extract obtained, fill to natural plants capsule shells, obtain Semen Juglandis extract capsule；The preparation of described Artemisia argyi extract capsule includes:
S1, takes Artemisia argyi screening, cleans, by the herb of clean Artemisia argyi by cold-maceration softening of reducing pressure；The temperature of described decompression cold-maceration is 10～40 DEG C, and pressure is-0.1～-0.09MPa；
The Artemisia argyi of S2, the S1 that learns from else's experience step softening, supercritical fluid extraction, separate and obtain Artemisia argyi extract and Artemisia argyi residue；The fluid of described supercritical fluid extraction is carbon dioxide, and extraction temperature is 30～40 DEG C；
S3, takes S2 and walks the Artemisia argyi residue obtained, by its attrition grinding；
S4, takes S2 and walks the Artemisia argyi extract obtained, and by its spray drying, adds the Artemisia argyi residue after the attrition grinding that S3 step obtains, obtain the Artemisia argyi extract dried in the process of spray drying；The temperature of described spray drying is 40～80 DEG C, and drying time is 3～60S；The granularity of described Artemisia argyi extract is 10～60 μm；
S5, takes 54 parts of S4 and walks the Artemisia argyi extract obtained, fill to natural plants capsule shells, obtain Artemisia argyi extract capsule；The preparation of described Radix Panacis Quinquefolii extract capsule includes:
S1, takes Radix Panacis Quinquefolii screening, cleans, by the ginseng body of clean Radix Panacis Quinquefolii by cold-maceration softening of reducing pressure；The temperature of described decompression cold-maceration is 10～40 DEG C, and pressure is-0.1～-0.09MPa；
The Radix Panacis Quinquefolii of S2, the S1 that learns from else's experience step softening, supercritical fluid extraction, separate and obtain Radix Panacis Quinquefolii extract and Radix Panacis Quinquefolii residue；The fluid of described supercritical fluid extraction is carbon dioxide, and extraction temperature is 30～40 DEG C；
S3, takes S2 and walks the Radix Panacis Quinquefolii residue obtained, by its attrition grinding；
S4, takes S2 and walks the Radix Panacis Quinquefolii extract obtained, and by its spray drying, adds the Radix Panacis Quinquefolii residue after the attrition grinding that S3 step obtains, obtain the Radix Panacis Quinquefolii extract dried in the process of spray drying；The temperature of described spray drying is 40～80 DEG C, and drying time is 3～60S；The granularity of described Radix Panacis Quinquefolii extract is 10～60 μm；
S5, takes 1～5 part of S4 and walks the Radix Panacis Quinquefolii extract obtained, fill to natural plants capsule shells, obtain Radix Panacis Quinquefolii extract capsule；
The preparation of described Herba Dendrobii extract capsule includes:
S1, takes Herba Dendrobii screening, cleans, by clean Herba Dendrobii stem and leaf by cold-maceration softening of reducing pressure；The temperature of described decompression cold-maceration is 10～40 DEG C, and pressure is-0.1～-0.09MPa；
The Herba Dendrobii of S2, the S1 that learns from else's experience step softening, supercritical fluid extraction, separate and obtain Herba Dendrobii extract and Herba Dendrobii residue；The fluid of described supercritical fluid extraction is carbon dioxide, and extraction temperature is 30～40 DEG C；
S3, takes S2 and walks the Herba Dendrobii residue obtained, by its attrition grinding；
S4, takes S2 and walks the Herba Dendrobii extract obtained, and by its spray drying, adds the Herba Dendrobii residue after the attrition grinding that S3 step obtains, obtain the Herba Dendrobii extract dried in the process of spray drying；The temperature of described spray drying is 40～80 DEG C, and drying time is 3～60S；The granularity of described Herba Dendrobii extract is 10～60 μm；
S5, takes 1～10 part of S4 and walks the Herba Dendrobii extract obtained, fill to natural plants capsule shells, obtain Herba Dendrobii extract capsule；
Described Semen Juglandis is black walnut, and Artemisia argyi is both A. absinthium, and Radix Panacis Quinquefolii is semi-wild Radix Panacis Quinquefolii, and Herba Dendrobii is wild Dendrodium.
In the against erythema lupus combined immunization medicine of the present invention, Semen Juglandis extract capsule, Artemisia argyi extract capsule, Radix Panacis Quinquefolii extract capsule and Herba Dendrobii extract capsule be preparation separately, Four Plants interfering in processing procedure can be avoided on the one hand, advantageously ensure that product quality；On the other hand when treatment, it is possible to be administered according to demand and flexibly, be suitable to different types of patient.
The present invention also aims to the purposes of the medicine providing a kind of described against erythema lupus combined immunization medicine in order to prepare prevention or treatment lupus erythematosus.
The against erythema lupus combined immunization medicine that the present invention also aims to provide a kind of described preparation method to prepare is in order to prepare the purposes of the medicine of prevention or treatment lupus erythematosus.
By adopting technique scheme, have the advantages that
1. the against erythema lupus combined immunization drug regimen potentiation of the present invention, on the one hand energy bacteriostasis and sterilization, enhancing human body immunity power, fast and effectively treatment this disease of lupus erythematosus；It can further enhance immunity of organisms on the other hand, regulates organismic internal environment and repairs former destroyed immune function, recovers the normal equilibrium of body, can prevent the recurrence of lupus erythematosus.
2. in the preparation process of the against erythema lupus combined immunization medicine of the present invention, do not use organic solvent and destructive condition, can farthest extract the bioactive ingredients of medicinal plants, safety has no side effect, its effective bioactive ingredients can also be made the particulate matter that specific surface area is big simultaneously, be conducive to absorption of human body.
3. in the preparation process of the against erythema lupus combined immunization medicine of the present invention, the process of raw material abstraction liquid spray drying adds the residue of its raw material, be conducive to and routine prevents the operation combined effect of viscous wall to solve the wall sticking phenomenon that raw material abstraction thing occurs in the process produced, crude drug can also be made full use of, keep pure natural property.
4. the against erythema lupus combined immunization medicine of the present invention adopts capsule form, and administration is accurate and convenient, is conducive to preserving, good stability.
Detailed description of the invention
In embodiment, Semen Juglandis is selected from North America black walnut (BlackWalnut has another name called JuglansnigraL).Artemisia argyi is selected from both A. absinthium (woormwood, or Artemisiaabsinthium).Radix Panacis Quinquefolii is selected from semi-wild Radix Panacis Quinquefolii.Herba Dendrobii is selected from wild Dendrodium.
Learn from else's experience screening, the endothelium of Semen Juglandis that cleans, by the decompression merceration softening under 10～40 DEG C and-0.1～-0.09MPa of the endothelium of clean Semen Juglandis.After the endothelium softening of Semen Juglandis, utilize CO 2 fluid to carry out supercritical fluid extraction at 30～40 DEG C, separate and obtain Semen Juglandis extract and Semen Juglandis residue.Take Semen Juglandis residue attrition grinding, cross 200-300 mesh sieve.Utilizing spray drying to be sprayed to by Semen Juglandis extract on the Semen Juglandis residue through sieving, the temperature of spray drying is 40～80 DEG C, and drying time is 3～60S, obtains the Semen Juglandis extract that granularity is 10～60 μm.Taking 1 part of Semen Juglandis extract, capsule fill method routinely is filled to natural plants capsule shells, obtains Semen Juglandis extract capsule.
Learn from else's experience screening, the herb of Artemisia argyi that cleans, by the decompression merceration softening under 10～40 DEG C and-0.1～-0.09MPa of the herb of clean Artemisia argyi.After Artemisia argyi softening, utilize CO 2 fluid to carry out supercritical fluid extraction at 30～40 DEG C, separate and obtain Artemisia argyi extract and Artemisia argyi residue.Take Artemisia argyi residue attrition grinding, cross 200-300 mesh sieve.Utilizing spray drying to be sprayed to by Artemisia argyi extract on the Artemisia argyi residue through sieving, the temperature of spray drying is 40～80 DEG C, and drying time is 3～60S, obtains the Artemisia argyi extract that granularity is 10～60 μm.Taking Artemisia argyi extract, capsule fill method routinely is filled to natural plants capsule shells, obtains Artemisia argyi extract capsule.
Learn from else's experience screening, the Radix Panacis Quinquefolii that cleans, by the decompression merceration softening under 10～40 DEG C and-0.1～-0.09MPa of the ginseng body of clean Radix Panacis Quinquefolii.After the ginseng body softening of Radix Panacis Quinquefolii, utilize CO 2 fluid to carry out supercritical fluid extraction at 30～40 DEG C, separate and obtain Radix Panacis Quinquefolii extract and Radix Panacis Quinquefolii residue.Take Radix Panacis Quinquefolii residue attrition grinding, cross 200-300 mesh sieve.Utilizing spray drying to be sprayed to by Radix Panacis Quinquefolii extract on the Radix Panacis Quinquefolii residue through sieving, the temperature of spray drying is 40～80 DEG C, and drying time is 3～60S, obtains the Radix Panacis Quinquefolii extract that granularity is 10～60 μm.Taking 1～5 part of Radix Panacis Quinquefolii extract, capsule fill method routinely is filled to natural plants capsule shells, obtains Radix Panacis Quinquefolii extract capsule.
Learn from else's experience screening, the Herba Dendrobii that cleans, by the decompression merceration softening under 10～40 DEG C and-0.1～-0.09MPa of the stem of clean Herba Dendrobii.After the stem softening of Herba Dendrobii, utilize CO 2 fluid to carry out supercritical fluid extraction at 30～40 DEG C, separate and obtain Herba Dendrobii extract and Herba Dendrobii residue.Take Herba Dendrobii residue attrition grinding, cross 200-300 mesh sieve.Utilizing spray drying to be sprayed to by Herba Dendrobii extract on the Herba Dendrobii residue through sieving, the temperature of spray drying is 40～80 DEG C, and drying time is 3～60S, obtains the Herba Dendrobii extract that granularity is 10～60 μm.Taking 1～10 part of Herba Dendrobii extract, capsule fill method routinely is filled to natural plants capsule shells, obtains Herba Dendrobii extract capsule.
When using the against erythema lupus combined immunization medicine of the present invention, Semen Juglandis extract capsule, Artemisia argyi extract capsule, Radix Panacis Quinquefolii extract capsule and Herba Dendrobii extract capsule are administered by a certain percentage simultaneously.
The against erythema lupus combined immunization medicine of table 1 present invention
Comparative example one toxicology test
Tested material: Semen Juglandis extract, Artemisia argyi extract, Radix Panacis Quinquefolii extract, Herba Dendrobii extract are prepared by embodiment one.Take Semen Juglandis extract, Artemisia argyi extract, Radix Panacis Quinquefolii extract, Herba Dendrobii extract respectively, respectively after 70 DEG C of water-baths 1 hour, immersion 12 hours, concentration, be for experiment.
2, experimental animal:
Select the Kunming kind healthy mice that Nat'l Pharmaceutical & Biological Products Control Institute's Experimental Animal Center provides.
3, mice bone marrow micronucleus
24hr twice per os administration by gavage in interval is adopted to test.With body weight 25-30 gram of white mice 50, it is randomly divided into 5 groups by body weight, is randomly divided into 5 groups by body weight, often group 10, male and female half and half.With the cyclophosphamide (cp) of 50mg/kg bw dosage for positive control, distilled water is negative control, the dosage of the against erythema lupus combined immunization medicine of the present invention respectively 2.00,4.00,6.00g/kg bw, be assigned to desired concn with distilled water.Last is to 6hr after the against erythema lupus combined immunization medicine of the present invention, and cervical dislocation puts to death animal, takes bone marrow of sternum calf serum and dilutes smear, and methanol is fixed, and Giemsa dyes.Under an optical microscope, every animal 1000 polychromatic erythrocytes (PRC) of counting, the incidence rate of micronucleus is in the PRC permillage containing micronucleus, and carries out statistical disposition.The result of the impact of Micronuclei In The Mouse Bone Marrow incidence rate is added up in Table 2 by the against erythema lupus combined immunization medicine of the present invention.
The result statistics of table 2 mice bone marrow micronucleus
* pole significance (P < 0.01) is had with negative control group comparing difference.
From table 2; each dosage group micronuclear rates of against erythema lupus combined immunization medicine of the little present invention; each dosage group and negative control group comparing difference are without significance, and cyclophosphamide group and negative control group comparing difference have pole significance (P < 0.01).PCEMNR micronuclear rates is produced impact by the against erythema lupus combined immunization medicine having no the present invention.
4, mouse inbred strain
With the sexual maturity male mice 50 of body weight 30-35 gram, it is randomly divided into 5 groups.With the cyclophosphamide of 40mg/kg bw dosage for positive control, distilled water is negative control, the against erythema lupus combined immunization drug dose of the present invention is 2.00,4.00,6.OOg/kg bw, be assigned to desired concn with distilled water.Every day gavage once, continuous 5 days, after last gavage 30 days put to death animal, take epididymis film-making, eosin stains, often 5 animals of group counting, the sperm of every animal 1000 structural integrities of counting, calculates distortion spermatogenesis rate (with percentage), and carries out statistical disposition.The result of the impact of Sperm Abnormalities of Mice is added up in Table 3 by the against erythema lupus combined immunization medicine of the present invention.
The result statistics of table 3 mouse inbred strain
| Dosage (g/kg.bw) | Number of animals (only) | By inspection sperm count (individual) | Sperm deformity number (individual) | Rate of teratosperm (%) |
| 0.00 | 5 | 5000 | 81 | 1.62 |
| 2.00 | 5 | 5000 | 94 | 1.88 |
| 4.00 | 5 | 5000 | 76 | 1.52 |
| 6.00 | 5 | 5000 | 87 | 1.74 |
| 40mg/kg.bw(cp) | 5 | 5000 | 480 | 9.6* |
* pole significance (P < 0.01) is had with negative control group comparing difference
From table 3, Sperm Abnormalities of Mice is not produced obvious change by the against erythema lupus combined immunization medicine of the present invention, each dosage group and negative control group comparing difference are without significance, and cyclophosphamide positive controls comparing difference has pole significance (P < 0.01).Therefore, mouse sperm deformity is produced impact by the against erythema lupus combined immunization medicine of the present invention.
The against erythema lupus combined immunization medicine of the present invention of embodiment two to embodiment seven preparation is also carried out similar toxicology test, and its result is identical with the result of the against erythema lupus combined immunization medicine of the present invention prepared by embodiment one.
Comparative example two immunoregulation effect is tested
1, tested material: Semen Juglandis extract capsule, Artemisia argyi extract capsule, Radix Panacis Quinquefolii extract capsule, Herba Dendrobii extract capsule are prepared by embodiment one.Human oral's recommended amounts is 3.4g/ days, calculates (each one of each kind) with everyone 60kg body weight, is equivalent to 0.057g/kg bw.The dose,equivalent of mice is equivalent to 10 times of human body recommended amounts, i.e. 0.57 approved product every day/kg bw (middle dosage).Upper and lower respectively set a dosage group: 1.70g approved product/kg bw (high dose) and 0.057g approved product/kg bw (low dosage).The sample water preparation to have sterilized, matched group replaces with the water sterilized.Continuous gavage surveyed every immune indexes after 30 days.Because Semen Juglandis extract capsule, Artemisia argyi extract capsule, Radix Panacis Quinquefolii extract capsule, Herba Dendrobii extract capsule are all water insoluble, divide 3 times with the hot water (70-80 DEG C) of 10 times of recommended amounts, within each 1 hour, soak, then become 30 times of recommended dose concentration in Rotary Evaporators (50-60 DEG C) evaporation and concentration, then dilution carries out gavage in proportion.
2, experimental animal:
Selecting the Kunming kind healthy male mice 75 that Nat'l Pharmaceutical & Biological Products Control Institute's Experimental Animal Center provides, body weight 18-22g, be divided into 4 groups, dosage group often organizes 15, matched group 30, carries out delayed allergy and antibody-producting cell detection.
Selecting the Kunming kind Healthy female mice 75 that Nat'l Pharmaceutical & Biological Products Control Institute's Experimental Animal Center provides, body weight 18-22g, be divided into 4 groups, dosage group often organizes 15, matched group 30, carries out carbon clearance test.
3, delayed allergy detection (DTH) (the foot sole of the foot thickens method)
Mice, through the SRBC (the every Mus of 0.2mL/) of lumbar injection 2% (v/v, with normal saline), after sensitization 4 days, measures foot sole of the foot portion, left and right thickness, and same position is measured three times, averages.Then at the SRBC (the 20 every Mus of μ L/) of measuring point subcutaneous injection 20% (v/v, with normal saline), within latter 24 hours, measuring sole of the foot portion, left and right thickness in injection, same position is measured three times, averages.The degree of DTH is represented with the difference (swelling degree of the paw) of foot sole of the foot thickness before and after injecting.The result of the impact of mice delayed allergy (DTH) is added up in Table 4 by the against erythema lupus combined immunization medicine of the present invention.
The result statistics of table 4 delayed allergy detection (DTH)
| Group | Number of animals (only) | Swelling degree of the paw (mm) |
| Comparison | 30 | 0.573±0.109 |
| Low dosage | 15 | 0.663±0.106 |
| Middle dosage | 15 | 0.712±0.105 |
| High dose | 15 | 0.700±0.102 |
From table 4, per os gives the against erythema lupus combined immunization medicine 30 days of the present invention of mice various dose, through statistical procedures, its swelling degree of the paw all has pole significant difference (P < 0.01) in basic, normal, high dosage group with comparing between matched group, and namely the against erythema lupus combined immunization medicine of the present invention can be remarkably reinforced the delayed allergy of mice.
4, antibody-producting cell detection (Jerne improves slide method)
Mice carries out immunity through the SRBC (the every Mus of 0.2mL/) of lumbar injection 0.2mL2% (v/v, with normal saline).After 5 days, by sacrifice, take spleen, tear up gently, make cell suspension with Hank ' s liquid, wash, be centrifuged 2 times, by cell suspension on 5mLHank ' s liquid.After top layer culture medium (agarose) heating for dissolving, mix with the double Hank ' s liquid of equivalent, subpackage small test tube, often manage O.5mL, 50 μ L10% (v/v are added again in pipe, with SA liquid prepare) SRBC, splenocyte suspension 20 μ L, rapidly after mixing, it is poured on the slide of own brush agarose thin layer, after agar solidification, slide level being buckled is placed on horse, puts incubation 1.5hr in CO2 gas incubator, is then added in slide frame groove with the complement (1:10) of SA buffer dilution, after continuing incubation 1.5hr, count hemolysis plaque number.The result of the impact of the against erythema lupus combined immunization medicine antagonist cellulation number of the present invention is added up in Table 5.
The result statistics of table 5 antibody-producting cell detection
| Group | Number of animals (only) | Hemolysis plaque number (× 103/ full spleen) |
| Comparison | 22 | 115.9±50.5 |
| Low dosage | 11 | 108.2±43.6 |
| Middle dosage | 13 | 141.6±51.3 |
| High dose | 12 | 129.6±101.3 |
From table 5, per os gives the against erythema lupus combined immunization medicine 30 days of the present invention of mice various dose, through statistical procedures, its swelling degree of the paw basic, normal, high dosage group with compare all electrodeless significant difference (P > 0.05) between matched group, namely the against erythema lupus combined immunization medicine of the present invention on the antibody-producting cell number of mice without impact.
5, mice carbonic clearance experiment test
Mouse tail vein injection is with the india ink of normal saline dilution 4 times, every 10g body weight injection 0.1mL, timing immediately after prepared Chinese ink injection.Inject after prepared Chinese ink 2,10min, take blood 20 μ L from angular vein clump respectively, be added to 2mL0.1%Na2CO3In solution, shake up.With 0.1%Na2CO3Solution makes blank, with 721 spectrophotometers at 600nm wavelength place densitometric value (OD).By sacrifice, taking liver, spleen, weighing, (body weight is m, and liver is heavily m1, spleen is heavily m2), it is calculated as follows phagocytic index a:
The result of the impact on mouse monokaryon-macrophage phagocytic function is added up in Table 6 by the against erythema lupus combined immunization medicine of the present invention.
The result statistics of table 6 mice carbonic clearance experiment test
| Group | Number of animals (only) | Phagocytic index |
| Comparison | 25 | 6.01±0.52 |
| Low dosage | 15 | 6.33±0.40 |
| Middle dosage | 14 | 5.89±0.48 |
| High dose | 14 | 5.77±0.43 |
From table 6, per os gives the against erythema lupus combined immunization medicine 30 days of the present invention of mice various dose, through statistical procedures, its swelling degree of the paw basic, normal, high dosage group with compare all electrodeless significant difference (P > 0.05) between matched group, namely the against erythema lupus combined immunization medicine of the present invention on mouse monokaryon-macrophage carbonic clearance function without impact.
From table 4 to table 6, per os gives the against erythema lupus combined immunization medicine 30 days of the present invention of mice various dose, the delayed allergy of mice can be remarkably reinforced, on the antibody-producting cell number of mice and mouse monokaryon-macrophage carbonic clearance function without impact.As can be seen here, the against erythema lupus combined immunization medicine of the present invention has the effect strengthening cellular immune function.
The against erythema lupus combined immunization medicine of the present invention of embodiment two to embodiment seven preparation is also carried out similar immunoregulation effect test, and its result is identical with the result of the against erythema lupus combined immunization medicine of the present invention prepared by embodiment one.
Comparative example three, preparation hygiene inspection
With reference to GB4789-94 and GB4789.15-94, the against erythema lupus combined immunization medicine of the present invention of embodiment one preparation is carried out the detection of coliform, total plate count, pathogenic bacterium, mycete, yeast counts.Respectively to one group of sample of harsh product with place one group of sample after 3 years under 25 DEG C/60%RH and detect, and two groups of samples are the sample of same production batch.Often sample is all parallel takes 10 samples for group.Its hygiene inspection is the results detailed in Table 7.
Table 7 hygiene inspection result is added up
From table 7, against erythema lupus combined immunization medicine after manufacture and is placed 3 years under 25 DEG C/60%RH, and its hygiene inspection is qualified.
The against erythema lupus combined immunization medicine of the present invention of embodiment two to embodiment seven preparation is also carried out similar hygiene inspection, and its result is identical with the result of the against erythema lupus combined immunization medicine of the present invention prepared by embodiment one.
Comparative example four, clinical trial
Taking patients with SLE case and carry out clinical trial, case inclusion criteria is: all confirm diagnosis through pathology or cytology.Wherein, below 11 standards meet 4 and above person, namely diagnosable for systemic lupus erythematosus (sle): (1) Face and cheek butterfly erythema；(2) plate-like erythema；(3) daylight；(4) oral ulcer；(5) not aggressive；(6) pleuritis, pericarditis；(7) albuminuria every day more than 0.5 gram；(8) nervous system abnormality: twitch or psychosis；(9) hematological abnormality, hemolytic, or leukocyte are less than 4 × 109/ liters, or lymphocyte is less than 1.5 × 109/ liters, or platelet is less than 100 × 109/ liters；(10) crucial immunological abnormality, lupus cell is positive, and anti-dsdna Antibodies is positive or Anti-sm antibody is positive, or serum test false positive；(11) immunofluorescence antinuclear antibody is positive.Its detection methods includes blood routine examination (including hematochrome, erythrocyte, leukocyte, platelet), routine urianlysis and blood biochemistry checking.
Take Patients with SLE 200 example altogether, wherein male 30 examples, female 170 example, age 20-60 year, 30 years old mean age.
Therapeutic Method: the against erythema lupus combined immunization medicine of the present invention of full group case all oral embodiment one preparation every day, each one of each every kind of capsule, evening every day is each once, 6 months is a course for the treatment of.
After treatment, that cured completely in 2 months has 25 examples, and that cured completely in 2-4 month has 44 examples, and that cured completely in 4-6 month has 61 examples.After taking a course for the treatment of, in 130 examples cured, there are 106 examples that the situation of recurrence did not all occur in 2 years, and during all the other 24 example recurrences, symptom is lighter relatively before.When this 24 example recurs, continuing to take one course for the treatment of of against erythema lupus combined immunization medicine of the present invention, it all cured completely in 2 months.
Toxicity is observed: full group case is the untoward reaction observing the heart, Liver and kidney function etc., peripheral hemogram no abnormality seen during treating.Do not observe that the allergic phenomenas such as erythra occur.
The above is only the preferred embodiment of the present invention, and protection scope of the present invention is not limited merely to above-described embodiment, and all technical schemes belonged under thinking of the present invention belong to protection scope of the present invention.It should be pointed out that, for those skilled in the art, some improvements and modifications without departing from the principles of the present invention, these improvements and modifications also should be regarded as protection scope of the present invention.
Claims (9)
1. an against erythema lupus combined immunization medicine, it is characterised in that described against erythema lupus combined immunization medicine is raw material by Semen Juglandis extract, Artemisia argyi extract, Radix Panacis Quinquefolii extract, Herba Dendrobii extract；The weight proportion of described Semen Juglandis extract, Artemisia argyi extract, Radix Panacis Quinquefolii extract and Herba Dendrobii extract is 1: (0.5～2): (1～5): (1～10).
2. against erythema lupus combined immunization medicine according to claim 1, it is characterised in that described Semen Juglandis is black walnut, and Artemisia argyi is both A. absinthium, and Radix Panacis Quinquefolii is semi-wild Radix Panacis Quinquefolii, and Herba Dendrobii is wild Dendrodium.
3. against erythema lupus combined immunization medicine according to claim 1, it is characterised in that the weight proportion of described Semen Juglandis extract, Artemisia argyi extract, Radix Panacis Quinquefolii extract and Herba Dendrobii extract is 1: 1: 5: 10.
4. the against erythema lupus combined immunization medicine according to claim 1 or 2 or 3, it is characterised in that the preparation of described medicine is capsule.
5. the preparation method of an against erythema lupus combined immunization medicine as claimed in claim 4, it is characterized in that, described method includes the preparation of the preparation of Semen Juglandis extract capsule, the preparation of Artemisia argyi extract capsule, the preparation of Radix Panacis Quinquefolii extract capsule, Herba Dendrobii extract capsule；Described Semen Juglandis extract capsule, Artemisia argyi extract capsule, Radix Panacis Quinquefolii extract capsule, Herba Dendrobii extract capsule preparation all include:
S1, takes raw material and carries out screening and cleaning, by clean raw material by cold-maceration softening of reducing pressure；
The raw material of S2, the S1 that learns from else's experience step softening, supercritical fluid extraction, separate and be extracted liquid and residue；
S3, takes S2 and walks the residue obtained, by its attrition grinding；
S4, takes S2 and walks the extract obtained, and by its spray drying, adds the residue after the attrition grinding that S3 step obtains, obtain the raw material abstraction thing dried in the process of spray drying；
S5, the S4 taking formula ratio walks the raw material abstraction thing obtained, and fills to capsule shells, obtains capsule.
6. the preparation method of against erythema lupus combined immunization medicine according to claim 5, it is characterised in that
In S1, the temperature of described decompression cold-maceration is 10～40 DEG C, and pressure is-0.1～-0.09MPa；
In S2, the fluid of described supercritical fluid extraction is carbon dioxide, and extraction temperature is 30～40 DEG C；
In S4, the temperature of described spray drying is 40～80 DEG C, and drying time is 3～60S；The granularity of described raw material abstraction thing is 10～60 μm；
In S5, described capsule shells is natural plants capsule shells.
7. the preparation method of an against erythema lupus combined immunization medicine as claimed in claim 2, it is characterized in that, described method includes the preparation of the preparation of Semen Juglandis extract capsule, the preparation of Artemisia argyi extract capsule, Radix Panacis Quinquefolii extract capsule and Herba Dendrobii extract capsule；
The preparation of described Semen Juglandis extract capsule includes:
S1, takes Semen Juglandis screening, cleans, by the endothelium of clean Semen Juglandis by cold-maceration softening of reducing pressure；The temperature of described decompression cold-maceration is 10～40 DEG C, and pressure is-0.1～-0.09MPa；
The Semen Juglandis of S2, the S1 that learns from else's experience step softening, supercritical fluid extraction, separate and obtain Semen Juglandis extract and Semen Juglandis residue；The fluid of described supercritical fluid extraction is carbon dioxide, and extraction temperature is 30～40 DEG C；
S3, takes S2 and walks the Semen Juglandis residue obtained, by its attrition grinding；
S4, takes S2 and walks the Semen Juglandis extract obtained, and by its spray drying, adds the Semen Juglandis residue after the attrition grinding that S3 step obtains, obtain the Semen Juglandis extract dried in the process of spray drying；The temperature of described spray drying is 40～80 DEG C, and drying time is 3～60S；The granularity of described Semen Juglandis extract is 10～60 μm；
S5, takes 1 part of S4 and walks the Semen Juglandis extract obtained, fill to natural plants capsule shells, obtain Semen Juglandis extract capsule；
The preparation of described Artemisia argyi extract capsule includes:
S1, takes Artemisia argyi screening, cleans, by the herb of clean Artemisia argyi by cold-maceration softening of reducing pressure；The temperature of described decompression cold-maceration is 10～40 DEG C, and pressure is-0.1～-0.09MPa；
The Artemisia argyi of S2, the S1 that learns from else's experience step softening, supercritical fluid extraction, separate and obtain Artemisia argyi extract and Artemisia argyi residue；The fluid of described supercritical fluid extraction is carbon dioxide, and extraction temperature is 30～40 DEG C；
S3, takes S2 and walks the Artemisia argyi residue obtained, by its attrition grinding；
S4, takes S2 and walks the Artemisia argyi extract obtained, and by its spray drying, adds the Artemisia argyi residue after the attrition grinding that S3 step obtains, obtain the Artemisia argyi extract dried in the process of spray drying；The temperature of described spray drying is 40～80 DEG C, and drying time is 3～60S；The granularity of described Artemisia argyi extract is 10～60 μm；
S5, takes 54 parts of S4 and walks the Artemisia argyi extract obtained, fill to natural plants capsule shells, obtain Artemisia argyi extract capsule；
The preparation of described Radix Panacis Quinquefolii extract capsule includes:
S1, takes Radix Panacis Quinquefolii screening, cleans, by the ginseng body of clean Radix Panacis Quinquefolii by cold-maceration softening of reducing pressure；The temperature of described decompression cold-maceration is 10～40 DEG C, and pressure is-0.1～-0.09MPa；
The Radix Panacis Quinquefolii of S2, the S1 that learns from else's experience step softening, supercritical fluid extraction, separate and obtain Radix Panacis Quinquefolii extract and Radix Panacis Quinquefolii residue；The fluid of described supercritical fluid extraction is carbon dioxide, and extraction temperature is 30～40 DEG C；
S3, takes S2 and walks the Radix Panacis Quinquefolii residue obtained, by its attrition grinding；
S4, takes S2 and walks the Radix Panacis Quinquefolii extract obtained, and by its spray drying, adds the Radix Panacis Quinquefolii residue after the attrition grinding that S3 step obtains, obtain the Radix Panacis Quinquefolii extract dried in the process of spray drying；The temperature of described spray drying is 40～80 DEG C, and drying time is 3～60S；The granularity of described Radix Panacis Quinquefolii extract is 10～60 μm；
S5, takes 1～5 part of S4 and walks the Radix Panacis Quinquefolii extract obtained, fill to natural plants capsule shells, obtain Radix Panacis Quinquefolii extract capsule；
The preparation of described Herba Dendrobii extract capsule includes:
S1, takes Herba Dendrobii screening, cleans, by clean Herba Dendrobii stem and leaf by cold-maceration softening of reducing pressure；The temperature of described decompression cold-maceration is 10～40 DEG C, and pressure is-0.1～-0.09MPa；
The Herba Dendrobii of S2, the S1 that learns from else's experience step softening, supercritical fluid extraction, separate and obtain Herba Dendrobii extract and Herba Dendrobii residue；The fluid of described supercritical fluid extraction is carbon dioxide, and extraction temperature is 30～40 DEG C；
S3, takes S2 and walks the Herba Dendrobii residue obtained, by its attrition grinding；
S4, takes S2 and walks the Herba Dendrobii extract obtained, and by its spray drying, adds the Herba Dendrobii residue after the attrition grinding that S3 step obtains, obtain the Herba Dendrobii extract dried in the process of spray drying；The temperature of described spray drying is 40～80 DEG C, and drying time is 3～60S；The granularity of described Herba Dendrobii extract is 10～60 μm；
S5, takes 1～10 part of S4 and walks the Herba Dendrobii extract obtained, fill to natural plants capsule shells, obtain Herba Dendrobii extract capsule；
Described Semen Juglandis is black walnut, and Artemisia argyi is both A. absinthium, and Radix Panacis Quinquefolii is semi-wild Radix Panacis Quinquefolii, and Herba Dendrobii is wild Dendrodium.
8. an against erythema lupus combined immunization medicine as claimed in claim 1 is in order to prepare the purposes of the medicine of prevention or treatment lupus erythematosus.
9. the against erythema lupus combined immunization medicine that the preparation method as described in any one of claim 5-7 prepares is in order to prepare the purposes of the medicine of prevention or treatment lupus erythematosus.
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| WO2017173609A1 (en) * | 2016-04-07 | 2017-10-12 | 北京路德凯奇商贸有限责任公司 | Pharmaceutical product for treating lupus erythematosus and combined immune defect, and preparation and application thereof |
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| WO2017173609A1 (en) * | 2016-04-07 | 2017-10-12 | 北京路德凯奇商贸有限责任公司 | Pharmaceutical product for treating lupus erythematosus and combined immune defect, and preparation and application thereof |
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Application publication date: 20160720 |