CN106389924A - Traditional Chinese medicine composition for curing sicca syndrome and application thereof - Google Patents

Traditional Chinese medicine composition for curing sicca syndrome and application thereof Download PDF

Info

Publication number
CN106389924A
CN106389924A CN201611046448.2A CN201611046448A CN106389924A CN 106389924 A CN106389924 A CN 106389924A CN 201611046448 A CN201611046448 A CN 201611046448A CN 106389924 A CN106389924 A CN 106389924A
Authority
CN
China
Prior art keywords
chinese medicine
parts
medicine composition
traditional chinese
sjogren syndrome
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN201611046448.2A
Other languages
Chinese (zh)
Inventor
苏晓
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Shanghai traditional chinese medicine hospital
Original Assignee
Shanghai traditional chinese medicine hospital
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Shanghai traditional chinese medicine hospital filed Critical Shanghai traditional chinese medicine hospital
Priority to CN201611046448.2A priority Critical patent/CN106389924A/en
Publication of CN106389924A publication Critical patent/CN106389924A/en
Pending legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/88Liliopsida (monocotyledons)
    • A61K36/899Poaceae or Gramineae (Grass family), e.g. bamboo, corn or sugar cane
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/23Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
    • A61K36/236Ligusticum (licorice-root)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/56Loganiaceae (Logania family), e.g. trumpetflower or pinkroot
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/57Magnoliaceae (Magnolia family)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/79Schisandraceae (Schisandra family)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/80Scrophulariaceae (Figwort family)
    • A61K36/804Rehmannia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/88Liliopsida (monocotyledons)
    • A61K36/898Orchidaceae (Orchid family)
    • A61K36/8984Dendrobium

Landscapes

  • Health & Medical Sciences (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Alternative & Traditional Medicine (AREA)
  • Biotechnology (AREA)
  • Botany (AREA)
  • Medical Informatics (AREA)
  • Medicinal Chemistry (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicines Containing Plant Substances (AREA)

Abstract

The invention relates to a traditional Chinese medicine composition for curing sicca syndrome, wherein the traditional Chinese medicine composition is prepared from the following traditional Chinese medicines in parts by weight: 25-35 parts of radix rehmanniae, 25-35 parts of dendrobe, 10-20 parts of schisandra chinensis, 8-16 parts of ligusticum wallichii, 8-16 parts of buddleja officinalis, and 25-35 parts of rhizoma imperatae. The invention further relates to an application of the traditional Chinese medicine composition in curing sicca syndrome. The traditional Chinese medicine composition has an obvious curative effect on the sicca syndrome, and a certain immunomodulatory effect is exerted while the clinical symptoms are improved. The traditional Chinese medicine composition and the application of the traditional Chinese medicine composition have certain development and innovation on curing sicca syndrome, prompt the development of the traditional Chinese medicine or combine traditional Chinese and western medicine on curing sicca syndrome, and are worthy of popularization and application.

Description

A kind of Chinese medicine composition treating sjogren syndrome and purposes
Technical field
The present invention relates to technical field of Chinese medicines, specifically, be a kind of Chinese medicine composition treating sjogren syndrome and Purposes.
Background technology
Sjogren syndrome (SS) is a kind of chronic inflammation itself based on the exocrine glands such as infringement salivary gland, lachrymal gland Immunological diseases.Patient often with obvious mouth xerophthalmia scheorma, the parotid gland enlargement of recurrent exerbation and arthralgia etc. as main clinical manifestation, Primary disease accounts for the 2nd in rheumatism in western countries' sickness rate, up to 0.5%, is only second to rheumatoid arthritis, this sufferer disease domestic Rate be 0.29%-0.77%, old people can be up to 3-4%, with 40-60 year middle and aged women be common.With diagnosis The continuous development of technology, the sickness rate of this disease is also significantly increased.Modern medicine is to the cause of disease of sjogren syndrome and mechanism Not yet it is fully apparent from, current research thinks that immunologic function disorder is the main foundation that its morbidity and pathological changes continue, and exempting from occurs in body Epidemic disease abnormal (cellular immunization, humoral immunization are abnormal, hypergammaglobulinemia etc.), the generation because of its own antibody often results in people The extensive immunologic injury of body, involves the multiple tract of whole body, causes extensive pathological changes, therefore increasingly closed by medical circle Note.In treatment, SS there is no reliable Therapeutic Method, and Main Means are symptomatic treatment and hormone and immunosuppressant, but curative effect is simultaneously Undesirable, the complication that life-time service is caused is also fatal sometimes.Chinese medicine has carried out beneficial spy in terms of SS treatment Rope, achieves some achievements.
Chinese patent 2012105241448, discloses a kind of Chinese medicine composition for treating dry syndrome, it is by such as The raw material of lower parts by weight prepares:Fructus Corni 20-30 part, Rhizoma Dioscoreae 20-30 part, Rhizoma Alismatis 10-20 part, Rhizoma Polygonati 15-25 part, company Stick up 15-25 part, Herba Cistanches 10-20 part, Radix Paeoniae Rubra 10-20 part, Radix Paeoniae Alba 10-20 part, Herba Dendrobii 10-20 part, Cortex Moutan 15-25 part, the Radix Rehmanniae 15-25 part, Poria 15-25 part, 30-50 part Radix Ophiopogonis, Cortex Eucommiae 15-25 part, Radix Cynanchi Paniculati 10-20 part, Radix Glycyrrhizae 10-20 part, by profit Lung fluid reaches the purpose for the treatment of dry syndrome.Chinese periodical《Chinese Chinese medicine academic periodical》The paper that 11 periodicals in 2009 are stepped on 《Nourishing yin and activating blood promotes the production of body fluid to rule by law and treats sjogren syndrome》, by clinical control, it is right from intending prescription " the nourishing yin and activating blood side of promoting the production of body fluid " to observe The impact of Patients with Sjogren Syndrome clinical symptoms and the adjustment effect to body immune system, wherein the nourishing yin and activating blood side of promoting the production of body fluid are basic Composition:Radix Rehmanniae 30g, Radix Scrophulariae 30g, Fructus Schisandrae Chinensis 15g, Rhizoma Chuanxiong 12g, Semen Celosiae (bag) 30g, Pollen Tyjphae (bag) 18g;Bright for xerostomia Aobvious person, plus Radix Adenophorae, Radix Glehniae, Radix Ophiopogonis;Eye is done with scorching hot pain person, plus Flos Chrysanthemi, Semen Cassiae (bag), Flos Buddlejae;Arthralgia very, Plus Rhizoma Et Radix Notopterygii, Cacumen Tamariciss, Herba Siegesbeckiae;Arthroncuss, plus Semen Lepidii (Semen Descurainiae), Semen Sinapis Albae;With soreness of the waist and knees, hectic fever person, plus Radix Cyathulae, bone Skin, Herba Artemisiae Annuae.But in prior art, with regard to the Chinese medicine composition of present invention treatment sjogren syndrome, yet there are no report.
Content of the invention
The purpose of the present invention is for deficiency of the prior art, provides a kind of Chinese medicine composition treating sjogren syndrome Thing.
Second object of the present invention is to provide the purposes of Chinese medicine composition as described above.
For achieving the above object, the present invention adopts the technical scheme that:
A kind of Chinese medicine composition treating sjogren syndrome, described Chinese medicine composition is by the Chinese medicine of weight portion as described below Raw material is made:Radix Rehmanniae 25-35 part, Herba Dendrobii 25-35 part, Fructus Schisandrae Chinensis 10-20 part, Rhizoma Chuanxiong 8-16 part, Flos Buddlejae 8-16 part, Rhizoma Imperatae 25-35 part.
Further, described Chinese medicine composition is made up of the raw material of Chinese medicine of weight portion as described below:Radix Rehmanniae 28-32 part, stone Dry measure used in former times 28-32 part, Fructus Schisandrae Chinensis 13-17 part, Rhizoma Chuanxiong 10-14 part, Flos Buddlejae 10-14 part, Rhizoma Imperatae 28-32 part.
Further, described Chinese medicine composition is made up of the raw material of Chinese medicine of weight portion as described below:30 parts of the Radix Rehmanniae, Herba Dendrobii 30 Part, 15 parts of Fructus Schisandrae Chinensis, 12 parts of Rhizoma Chuanxiong, 12 parts of Flos Buddlejae, 30 parts of Rhizoma Imperatae.
For realizing above-mentioned second purpose, the present invention adopts the technical scheme that:
As above application in the medicine of preparation treatment sjogren syndrome for arbitrary described Chinese medicine composition.
Further, described sjogren syndrome differential diagnosis in tcm belongs to hepatic and renal YIN deficiency folder stasis of blood type.
Further, described medicine adds pharmaceutically acceptable carrier to be prepared into any pharmaceutical dosage form as needed.
Further, described medicine also includes the adjuvant pharmaceutically allowing.
Further, the dosage form of described medicine is capsule, granule, tablet, oral liquid, mixture or syrup.
Further, described pharmaceutically acceptable carrier includes but is not limited to:Mannitol, Sorbitol, sodium pyrosulfite, sulfurous Sour hydrogen sodium, sodium thiosulfate, Cysteine Hydrochloride, TGA, Methionine, injection Vitamin B_6 DTA disodium, Ethylenediaminetetraacetic Acid Calcium Salt, monovalence Alkali-metal carbonate, acetate, phosphate or its aqueous solution, hydrochloric acid, acetic acid, sulphuric acid, phosphoric acid, aminoacid, sodium chloride, chlorination Potassium, sodium lactate, xylitol, maltose, glucose, Fructose, dextran, glycine, starch, sucrose, Lactose, mannitol, Silicon derivative, cellulose and its derivates, alginate, gelatin, Polyvinylpyrrolidone, glycerol, POLYSORBATE 80, agar, Calcium Carbonate, Calcium bicarbonate, surfactant, Polyethylene Glycol, cyclodextrin, beta-schardinger dextrin-, phospholipid material, Kaolin, Pulvis Talci, stearic acid Calcium, magnesium stearate.
The invention has the advantages that:
1st, the Chinese medicine composition of the present invention, for sjogren syndrome determined curative effect, is improving clinical symptoms simultaneously, is having certain Immunoregulation effect.
2nd, the Chinese medicine composition of the present invention can effectively alleviate the clinical symptoms of Patients with Sjogren Syndrome, one group for the treatment of 6 of Chinese medicine After individual month, total effective rate is 90.0%.
3rd, the Chinese medicine composition of the present invention can reduce Immunoglobulin in Serum level, corrects hyperglobulinemia card, suppression Humoral immune function is hyperfunction.
4th, the proportioning of Chinese medicine composition of the present invention is to screen by many experiments to obtain, and has good effect, effect more aobvious The advantage writing.
Specific embodiment
With reference to specific embodiment, the present invention is expanded on further.It should be understood that these embodiments are merely to illustrate this Bright rather than limit the scope of the present invention.In addition, it is to be understood that after having read the content of present invention record, art technology Personnel can make various changes or modifications to the present invention, and these equivalent form of values equally fall within the application appended claims and limited Fixed scope.
Embodiment 1 treats the preparation () of the Chinese medicine composition of sjogren syndrome
30 parts of the Radix Rehmanniae, 30 parts of Herba Dendrobii, 15 parts of Fructus Schisandrae Chinensis, 12 parts of Rhizoma Chuanxiong, 12 parts of Flos Buddlejae, 30 parts of Rhizoma Imperatae, according to routine Method decocts.
Embodiment 2 treats the preparation (two) of the Chinese medicine composition of sjogren syndrome
25 parts of the Radix Rehmanniae, 35 parts of Herba Dendrobii, 10 parts of Fructus Schisandrae Chinensis, 16 parts of Rhizoma Chuanxiong, 8 parts of Flos Buddlejae, 35 parts of Rhizoma Imperatae, according to routine side Method decocts.
Embodiment 3 treats the preparation (three) of the Chinese medicine composition of sjogren syndrome
35 parts of the Radix Rehmanniae, 25 parts of Herba Dendrobii, 20 parts of Fructus Schisandrae Chinensis, 8 parts of Rhizoma Chuanxiong, 16 parts of Flos Buddlejae, 25 parts of Rhizoma Imperatae, according to routine side Method decocts.
Embodiment 4 treats the preparation (four) of the Chinese medicine composition of sjogren syndrome
35 parts of the Radix Rehmanniae, 35 parts of Herba Dendrobii, 20 parts of Fructus Schisandrae Chinensis, 8 parts of Rhizoma Chuanxiong, 8 parts of Flos Buddlejae, 25 parts of Rhizoma Imperatae, according to routine side Method decocts.
Embodiment 5 treats the preparation (five) of the Chinese medicine composition of sjogren syndrome
25 parts of the Radix Rehmanniae, 25 parts of Herba Dendrobii, 10 parts of Fructus Schisandrae Chinensis, 16 parts of Rhizoma Chuanxiong, 16 parts of Flos Buddlejae, 35 parts of Rhizoma Imperatae, according to routine Method decocts.
Embodiment 6 treats the preparation (six) of the Chinese medicine composition of sjogren syndrome
35 parts of the Radix Rehmanniae, 35 parts of Herba Dendrobii, 10 parts of Fructus Schisandrae Chinensis, 8 parts of Rhizoma Chuanxiong, 16 parts of Flos Buddlejae, 35 parts of Rhizoma Imperatae, according to routine side Method decocts.
Embodiment 7 treats the preparation (seven) of the Chinese medicine composition of sjogren syndrome
25 parts of the Radix Rehmanniae, 25 parts of Herba Dendrobii, 20 parts of Fructus Schisandrae Chinensis, 16 parts of Rhizoma Chuanxiong, 8 parts of Flos Buddlejae, 25 parts of Rhizoma Imperatae, according to routine side Method decocts.
Embodiment 8 treats the preparation (eight) of the Chinese medicine composition of sjogren syndrome
32 parts of the Radix Rehmanniae, 28 parts of Herba Dendrobii, 17 parts of Fructus Schisandrae Chinensis, 10 parts of Rhizoma Chuanxiong, 14 parts of Flos Buddlejae, 28 parts of Rhizoma Imperatae, according to routine Method decocts.
Embodiment 9 treats the preparation (nine) of the Chinese medicine composition of sjogren syndrome
28 parts of the Radix Rehmanniae, 32 parts of Herba Dendrobii, 13 parts of Fructus Schisandrae Chinensis, 14 parts of Rhizoma Chuanxiong, 10 parts of Flos Buddlejae, 32 parts of Rhizoma Imperatae, according to routine Method decocts.
Embodiment 10 treats the preparation (ten) of the Chinese medicine composition of sjogren syndrome
28 parts of the Radix Rehmanniae, 28 parts of Herba Dendrobii, 13 parts of Fructus Schisandrae Chinensis, 14 parts of Rhizoma Chuanxiong, 14 parts of Flos Buddlejae, 32 parts of Rhizoma Imperatae, according to routine Method decocts.
Embodiment 11 treats the preparation (11) of the Chinese medicine composition of sjogren syndrome
32 parts of the Radix Rehmanniae, 32 parts of Herba Dendrobii, 17 parts of Fructus Schisandrae Chinensis, 10 parts of Rhizoma Chuanxiong, 10 parts of Flos Buddlejae, 28 parts of Rhizoma Imperatae, according to routine Method decocts.
It should be noted that it is the conventional manufacture method of Chinese medicine decoction that the conventional method described in embodiment 1-11 decocts, Crude drug that will be described adds water to cook into decoction.
Embodiment 12 treats the preparation of sjogren syndrome medicinal tablet/capsule
The arbitrary described medicine of Example 1-11, plus 8-12 times amount water, decoct 1-3 hour, leach medicine juice.Again plus 10 times Amount water, decocts 1.5-2.5 hour, leaches medicine juice, merges secondary decocting liquid, standing, leaching supernatant, concentrates, let cool, plus concentrated solution 2.5 times amount ethanol, stir precipitates overnight.Take supernatant, be concentrated into thick medicinal extract;Add pharmaceutical aids, vacuum drying, pulverize system Grain, tabletted or filling is encapsulated.
Embodiment 13 treats the preparation of sjogren syndrome drug particles
The arbitrary described medicine of Example 1-11, plus 8-10 times amount water, decoct 2.5-3.5 hour, leach medicine juice.Again plus 10 times amount water, decoct 2 hours, leach medicine juice, merge secondary decocting liquid, standing, leaching supernatant, concentrate, let cool, plus concentrated solution 2 Times amount ethanol, stirs precipitates overnight.Take supernatant, be concentrated into thick medicinal extract;Plus suitably pharmaceutical aids, granulation, it is dried, granulate, obtain 20g granule, subpackage 10g/ bag.
Embodiment 14 treats the preparation of sjogren syndrome drug mixture/oral liquid/syrup
The arbitrary described medicine of Example 1-11, plus 8-10 times amount water, decoct 3 hours, leach medicine juice.Again plus 8 times amount Water, decocts 2 hours, leaches medicine juice, merges secondary decocting liquid, standing, leaching supernatant, concentrates, let cool, plus concentrated solution 2 times amount wine Essence, stirs precipitates overnight.Take supernatant, be concentrated into thick medicinal extract;Plus suitable pharmaceutical aids, make mixture, oral liquid or syrup.
Embodiment 15 treats the clinical experiment of sjogren syndrome curative effect of medication
1 clinical data
1.1 case selection
Object of study must simultaneously meet following condition:(1) sjogren syndrome world diagnostic criteria (Europe diagnosis in 1992 Standard), differential diagnosis in tcm belongs to hepatic and renal YIN deficiency folder stasis of blood type;(2) not using immunosuppressant, Tripterygium Preparations, or disabled at least Half a year above person.
1.2 physical data
Case is all in hospital and outpatient service 120 from Shanghai Chinese Medicine Hospital rheumatism immunity section totally, one group 30, Chinese medicine, Two groups 30, Chinese medicine, three groups 30, Chinese medicine and matched group 30.Wherein male 7, women 113, minimum 22 years old of age, maximum 75 years old, average 52 years old.The course of disease is the shortest 3 months, the longest 180 months, average 53 months.Sex, age, course of disease etc. between above four groups Data compares two-by-two, no significant difference (P>0.05), there is comparability.
2 Therapeutic Method
2.1 one group of Chinese medicines
Give the Chinese medicine composition prepared by embodiment 1, decocting to concentration is 0.18g/ml containing crude drug amount, morning and afternoon each 1 Secondary, take within 1 hour after meal.One time a day for meticortelone 5-10mg/.Methotrexate 7.5mg/ is 1 times a week.
2.2 two groups of Chinese medicines
Give the Chinese medicine composition prepared by embodiment 3, decocting to concentration is 0.18g/ml containing crude drug amount, morning and afternoon each 1 Secondary, take within 1 hour after meal.One time a day for meticortelone 5-10mg/.Methotrexate 7.5mg/ is 1 times a week.
2.3 three groups of Chinese medicines
Give the Chinese medicine composition of weight portion as described below:30 parts of the Radix Rehmanniae, 15 parts of Fructus Schisandrae Chinensis, 12 parts of Rhizoma Chuanxiong, Flos Buddlejae 12 Part, decocting to concentration is 0.18g/ml containing crude drug amount, each 1 time of morning and afternoon, takes within 1 hour after meal.Meticortelone 5-10mg/ is daily 1 time.Methotrexate 7.5mg/ is 1 times a week.
2.4 matched group
Give meticortelone 5-10mg, once a day, methotrexate 10mg, 1 times a week.
2.5 the course for the treatment of
In two 6 totally months stages of four groups of courses for the treatment of, during treatment, disable the relevant oral and external applied medicine of other treatment primary disease.
2.6 lab index
Before and after treatment each observed and recorded once, totally 3 times.
(1) safety indexes:Routine blood test, routine urinalysis, liver function, renal function.
(2) monitoring of immune indexes:Before and after treatment, immunoglobulin (IgG, IgM, IgA), erythrocyte sedimentation rate (ESR), treat simultaneously The change of CD cell subsets (CD3, CD4, CD8, NK cell) before and after group observation and treatment.
(3) Schirmer inspection, the sugary test of saliva.
Schirmer tests:Method is to take the graduated reagent paper of 5mm × 35mm, and one end opisthotonos 5mm gently puts into tested eye At the China and foreign countries 1/3 of lower conjunctival sac, after 5 minutes, take out filter paper, measure wet length, such as≤5mm/5min tests for Schirmer positive.
The sugary test of saliva:450mg Cube sugar is contained in back central authorities, and record is completely dissolved required time, with>It is within 15 minutes different Often.
3 observation of curative effect
3.1 statistical method
Set up data base, enumeration data X 2 test with Excel, all data are with mean ± standard deviationTable Show, carry out statistical procedures with SPSS13.0 statistical package, compare before and after treatment, two sample averages compare using t inspection, with P 0.05 is statistically significant.
3.2 efficacy assessment standard
Compile with reference to Ministry of Public Health《Study of tcm new drug guideline》(the 2nd volume).
(1) clinical remission:Cardinal symptom all disappears, and Shirmer ' s tests (left/right:-/-) and sugary test (450mg Cube sugar,<15min) normal;
(2) effective:Cardinal symptom is most of to disappear, and Shirmer ' s test (> 5mm) and sugary test are greatly improved (treatment surrounding time shortened more than 5 minutes);
(3) take a turn for the better:Cardinal symptom partial disappearance, or Shirmer ' s tests (≤5mm) and sugary test has certain improvement (time shortens≤5 minutes);
(4) invalid:Cardinal symptom and test no improve, or have on the basis of original and increase, Shirmer ' s test or sugary Result of the test is relatively treated front constant or is had and increase.
3.3 disease efficacy determination indexs
Evaluated by curative effect computing formula according to TCM syndrome integration:(nimodipine method) [(integration-treatment before treatment Integrate afterwards) the front integration of/treatment] × 100%
(1) clinical recovery:Tcm clinical practice symptom, sign disappear or basic disappearance, and syndrome integral reduces >=85%;
(2) effective:Tcm clinical practice symptom, sign substantially disappear, and syndrome integral reduces >=50%~84%;
(3) effective:Tcm clinical practice symptom, sign all take a favorable turn, and syndrome integral reduces >=20%~49%;
(4) invalid:Tcm clinical practice symptom, sign are not improved, or increase, and syndrome integral reduces<20%.
4 therapeutic outcomes
4.1 Schirmer ' s check, the sugary test of saliva
Before treatment, Schirmer ' s test and saliva sugary test Chinese medicine group and matched group are statistically analyzed, P>0.05, There was no significant difference.Schirmer ' s one group of Chinese medicine of test after treatment 3 months be improved significantly, extend with treatment time, Therapeutic effect is more obvious;Matched group has no improvement.One group of saliva sugary test Chinese medicine must be that time of occurrence is bright after treating 3 months Aobvious shortening (P<0.05), and the prolongation effect with treatment time is more notable, matched group has no and is clearly better.After treatment end, in Compared with matched group, difference has significance (P to one group of medicine<0.05).
Before and after table 1 treatment, Schirmer ' s checks, compares before and after the sugary test of cure of saliva
Note:Compare #P with before treatment<0.05;Compare * P with matched group<0.05.
4.2 clinical efficacy evaluation results
After treatment 3 months, one group of clinical remission of Chinese medicine 3, effective 8, takes a turn for the better 9, invalid 10, total effective rate is 66.7%.Matched group no clinical remission, no effective case, takes a turn for the better 10, invalid 20, total effective rate is 33.3%.Chinese medicine one Group is compared with matched group, and one group of total effective rate of Chinese medicine is better than matched group, and difference has significance.
2 four groups of Clinical Global comparitive study of table (after treatment 3 months)
After treatment June, one group of clinical remission of Chinese medicine 5, effective 15, takes a turn for the better 7, invalid 3, total effective rate is 90.0%.Matched group no clinical remission, no effective case, takes a turn for the better 13, invalid 17, total effective rate is 43.3%.Chinese medicine one Group is compared with matched group, and one group of total effective rate of Chinese medicine is better than matched group, and difference has significance.
3 four groups of Clinical Global comparitive study of table (after treatment 6 months)
4.3 TCM syndrome integrations
It is obviously improved (P before all relatively treating after four groups of TCM syndrome integration treatments<0.05);After one group for the treatment of of Chinese medicine 3 months Total effective rate is 60.0%, and after 6 months, all patients all have alleviation;After two groups of Chinese medicine is treated 3 months, total effective rate is 40.0%, After 6 months, total effective rate is 93.3%;After three groups of Chinese medicine is treated 3 months, total effective rate is 23.3%, and after 6 months, total effective rate is 73.3%;Treatment of control group after 3 months total effective rate be 10.0%, after 6 months total effective rate be 20.0%.During treatment end One group of medicine is compared with matched group, and one group of total effective rate of Chinese medicine is better than matched group, and difference has significance.
4 four groups of TCM syndrome integrations of table improve comparative example
4.4 lab index
4.4.1 ESR、IgG、IgA、IgM
One group of Chinese medicine and matched group erythrocyte sedimentation rate and the equal P of immunoglobulin index statistical analysis before treatment>0.05, two groups are compared There was no significant difference.Erythrocyte sedimentation rate in two groups, after treatment, compare with before treatment, all has significant difference (P by March, June<0.05), control Treatment terminates to compare between rear group and has no notable difference (P>0.05);IgG, IgA, compare (P with after treatment before treatment group's treatment< 0.05), one group of IgG of Chinese medicine improves substantially, and after treatment end, one group of Chinese medicine is better than matched group (P<0.05) it is seen that with treatment The prolongation of time, Chinese medicine onset is obvious.One group of IgA of Chinese medicine as time went on, the more notable (P of effect<0.05);One group of Chinese medicine After IgM treatment, there is improvement (P in June<0.05), matched group no significant change.
Compare before and after table 5 ESR, IgG, IgA, IgM treatment
Note:Compare #P with before treatment<0.05;Compare * P with matched group<0.05.
5 conclusions
(1) Chinese medicine composition of the present invention, for sjogren syndrome determined curative effect, is improving clinical symptoms simultaneously, is having certain Immunoregulation effect.
(2) Chinese medicine composition of the present invention can effectively alleviate the clinical symptoms of Patients with Sjogren Syndrome, one group for the treatment of 6 of Chinese medicine After individual month, total effective rate is 90.0%.
(3) Chinese medicine composition of the present invention can reduce Immunoglobulin in Serum level, corrects hyperglobulinemia card, suppression Humoral immune function is hyperfunction.
The above is only the preferred embodiment of the present invention it is noted that ordinary skill people for the art Member, on the premise of without departing from the inventive method, can also make some improvement and supplement, these improve and supplement also should be regarded as Protection scope of the present invention.

Claims (8)

1. a kind of Chinese medicine composition treating sjogren syndrome is it is characterised in that described Chinese medicine composition is by as described below heavy The raw material of Chinese medicine of amount part is made:Radix Rehmanniae 25-35 part, Herba Dendrobii 25-35 part, Fructus Schisandrae Chinensis 10-20 part, Rhizoma Chuanxiong 8-16 part, Flos Buddlejae 8- 16 parts, Rhizoma Imperatae 25-35 part.
2. treat the Chinese medicine composition of sjogren syndrome according to claim 1 it is characterised in that described Chinese medicine composition is It is made up of the raw material of Chinese medicine of weight portion as described below:Radix Rehmanniae 28-32 part, Herba Dendrobii 28-32 part, Fructus Schisandrae Chinensis 13-17 part, Rhizoma Chuanxiong 10- 14 parts, Flos Buddlejae 10-14 part, Rhizoma Imperatae 28-32 part.
3. treat the Chinese medicine composition of sjogren syndrome according to claim 1 it is characterised in that described Chinese medicine composition is It is made up of the raw material of Chinese medicine of weight portion as described below:30 parts of the Radix Rehmanniae, 30 parts of Herba Dendrobii, 15 parts of Fructus Schisandrae Chinensis, 12 parts of Rhizoma Chuanxiong, Flos Buddlejae 12 Part, 30 parts of Rhizoma Imperatae.
4. the purposes of the arbitrary described Chinese medicine composition of claim 1-3 it is characterised in that treat the medicine of sjogren syndrome in preparation Application in thing.
5. purposes according to claim 4 is it is characterised in that described sjogren syndrome differential diagnosis in tcm belongs to the hepatic and renal YIN deficiency folder stasis of blood Type.
6. purposes according to claim 4 is it is characterised in that described medicine adds pharmaceutically acceptable carrier as needed It is prepared into any pharmaceutical dosage form.
7. purposes according to claim 4 is it is characterised in that described medicine also includes the adjuvant pharmaceutically allowing.
8. purposes according to claim 4 is it is characterised in that the dosage form of described medicine is capsule, granule, tablet, is administered orally Liquid, mixture or syrup.
CN201611046448.2A 2016-11-23 2016-11-23 Traditional Chinese medicine composition for curing sicca syndrome and application thereof Pending CN106389924A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN201611046448.2A CN106389924A (en) 2016-11-23 2016-11-23 Traditional Chinese medicine composition for curing sicca syndrome and application thereof

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN201611046448.2A CN106389924A (en) 2016-11-23 2016-11-23 Traditional Chinese medicine composition for curing sicca syndrome and application thereof

Publications (1)

Publication Number Publication Date
CN106389924A true CN106389924A (en) 2017-02-15

Family

ID=58082597

Family Applications (1)

Application Number Title Priority Date Filing Date
CN201611046448.2A Pending CN106389924A (en) 2016-11-23 2016-11-23 Traditional Chinese medicine composition for curing sicca syndrome and application thereof

Country Status (1)

Country Link
CN (1) CN106389924A (en)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115040617A (en) * 2022-08-15 2022-09-13 中日友好医院(中日友好临床医学研究所) Traditional Chinese medicine composition for treating dampness-eliminating and junction type primary sicca syndrome and preparation method and application thereof

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102579945A (en) * 2011-01-14 2012-07-18 天津市中宝制药有限公司 Traditional Chinese medicinal composition for treating sicca syndrome
CN103585504A (en) * 2013-11-16 2014-02-19 崔新明 Traditional Chinese medicine composition for treating sjogren syndrome and application
CN104547502A (en) * 2015-01-31 2015-04-29 河南中医学院 Traditional Chinese medicine composition for treating sicca syndrome
CN105169036A (en) * 2015-09-10 2015-12-23 丽水市中心医院 Traditional Chinese medicinal composition for treating sicca syndrome

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102579945A (en) * 2011-01-14 2012-07-18 天津市中宝制药有限公司 Traditional Chinese medicinal composition for treating sicca syndrome
CN103585504A (en) * 2013-11-16 2014-02-19 崔新明 Traditional Chinese medicine composition for treating sjogren syndrome and application
CN104547502A (en) * 2015-01-31 2015-04-29 河南中医学院 Traditional Chinese medicine composition for treating sicca syndrome
CN105169036A (en) * 2015-09-10 2015-12-23 丽水市中心医院 Traditional Chinese medicinal composition for treating sicca syndrome

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
赵宇捷: "商宪敏教授治疗干燥综合征的临床经验", 《现代中医临床》 *

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115040617A (en) * 2022-08-15 2022-09-13 中日友好医院(中日友好临床医学研究所) Traditional Chinese medicine composition for treating dampness-eliminating and junction type primary sicca syndrome and preparation method and application thereof

Similar Documents

Publication Publication Date Title
CN110787233A (en) Liver-protecting traditional Chinese medicine composition, extract and pharmaceutical application thereof
CN101982193A (en) Traditional Chinese medicine composition for treating pulmonary tuberculosis, preparation method and application thereof
CN102133271A (en) Medicinal tea for curing gout
CN111643634A (en) Chinese medicinal formula for treating asymptomatic nucleic acid positive coronavirus pneumonia
CN103191298A (en) Traditional Chinese medicinal composition for treating blood group incompatibility haemolytic disease and preparation method thereof
CN103006989B (en) Medical composition for treating diabetic nephropathy
CN116036202B (en) Traditional Chinese medicine composition for clearing heat and detoxicating, and preparation method and application thereof
CN102657736B (en) Medicament composition for treating rheumatoid arthritis and preparation method of medicament composition
CN102861199A (en) Traditional Chinese medicine composition for treating gastroesophageal reflux disease and preparation method
CN105126030B (en) A kind of strong drug composition assisting anti-lung cancer
CN106237268A (en) One treats schizoid pharmaceutical composition and application thereof
CN106389924A (en) Traditional Chinese medicine composition for curing sicca syndrome and application thereof
CN104721256A (en) Anwei Yang extract as well as preparation method and medical application thereof
CN108514627B (en) Traditional Chinese medicine composition for treating chronic urticaria
CN1947767B (en) Medicine for treating and preventing infantile mental retardation, and its preparation method
CN103191293B (en) Sub-health-preventive drug composition and preparation method thereof
CN105982906A (en) Application of 20(R)-ginsenoside Rg3 in preparing medicines or health products capable of alleviating or/and treating rheumatoid diseases and medicines
CN101683421B (en) Applications of traditional Chinese medicine composition in preparation of medicament for treating repetitive respiratory tract infection
CN104606596B (en) A kind of Chinese patent drug for treating behcet disease and preparation method thereof
CN109091645A (en) A kind of pharmaceutical composition with treatment inhibition of HIV
CN115869375B (en) Traditional Chinese medicine composition for clearing heat and dispelling wind as well as preparation method and application thereof
CN102805795B (en) Chinese medicinal composition for treating acute soft tissue injury of chest and hypochondrium and application thereof
CN116251141B (en) Traditional Chinese medicine composition for dispelling wind-cold and preparation method and application thereof
CN115814047B (en) Traditional Chinese medicine composition for preventing and treating asthma in stable period and application thereof
CN1814193B (en) Chinese medicine composition for treating nephritis dropsy and preparation method thereof

Legal Events

Date Code Title Description
C06 Publication
PB01 Publication
C10 Entry into substantive examination
SE01 Entry into force of request for substantive examination
RJ01 Rejection of invention patent application after publication

Application publication date: 20170215

RJ01 Rejection of invention patent application after publication