CN107582969A - A kind of compound preparation for treating AITD and preparation method thereof - Google Patents

Abstract

The invention discloses a kind of compound preparation for treating AITD and preparation method thereof.Described compound preparation is prepared by the Chinese medicine of following mass percents：The Radix Astragali 10 15%, radix scrophulariae 10 15%, the tuber of pinellia 10 15%, selfheal 10 15%, fritillaria thunbergii 5 15%, Ligusticum wallichii 5 15%, dandelion 5 15%, radix scutellariae 10 15%, Rhizoma Sparganii 5 15%, root tuber of aromatic turmeric 5 15%, the mass percent summation of above Chinese medicine is 100%.Show through clinical research, invention formulation obtains satisfactory effect to type of deficiency of both QI and YIN AITD, symptom can be not only obviously improved, it is and obvious to the improvement result of lab index etc., it is long-term use of without any side effects, unique advantage of the traditional Chinese medicine in treatment AITD has been given full play to, has been had broad prospects.

Description

A kind of compound preparation for treating AITD and preparation method thereof

Technical field

The present invention relates to the field of Chinese medicines, and in particular to a kind of compound preparation for treating AITD and its Preparation method.

Background technology

As diagnosis of thyroid illness method is improved constantly, whole people's Universal salt iodization is come into effect within 1996, I The many areas of state are in iodine excess intake or super enough states, cause the detection increase of thyroid disease, spectrum of disease also to change Become.Show that the trend being gradually increasing also is presented in the incidence of disease of China's Autoimmune thyroid diseases according to epidemiology survey.This Outside, the recall rate of thyroid gland related auto-antibodies also has increase, it has been reported that China some areas crowd's thyroid peroxidase The recall rate of enzyme antibody and TGA is up to 7.9%-10.64%.And when Thyroid autoantibodies are positive, Subclinical thyroid dysfunction patient is more easy to develop into the abnormal thyroid function with clinical meaning.Most scholars think first The generation of shape gland disease mainly has with sex, age, environmental factor, iodine intake content and itself neurological susceptibility and inherent cause Close, and effect of the role of autoimmune factors in AITD morbidities is even more important.In terms of immunopathogenesis, it is one that most scholar, which accepts it, The autoimmune disease of the typical T cell mediation of kind, and characterized by the abnormal formation of thyroid gland endolymph folliculus.Itself exempts from Epidemic disease thyroid disease (AITD) is the most common thyroid disease in addition to IDD(Iodine deficiency disorders), while is also to cause parathyroid tissue The abnormal Etiological of 26S Proteasome Structure and Function, not only can cause hyperthyroidism, first to subtract, outside thyroid nodule, can also cause thyroid gland with Outer tissue, the infringement of organ, such as：Thyroid-related Ophthalmopathy, liver damage, muscle changes, female irregular menstruation etc..And according to system Meter Western medicine control thyroid disease can reach the effect of being satisfied with, but disease outside change for parathyroid tissue structure and thyroid gland Shape, then effect is undesirable.Therefore, the major project in International Medical field has been turned into this sick study on prevention.

But the treatment method of special efficacy is had no currently for the AITD causes of disease, the preferable treatment method for autoimmunity disease is Recover the poised state of immune system, and therapeutic alliance can be intervened immune system abnormality by many levels, finally lure Lead immune tolerance.The medicine of clinical treatment autoimmunity disease mainly based on suppressing immune, not only spend by immunosuppressive therapy Take high, have adverse reaction, and be invalid for many patients.And traditional Chinese medicine is the traditional medical treasure-house in China, recognize For AITD the cause of disease nothing more than feelings will internal injury, improper diet and overtiredness, the inappropriate, constitution of water and soil etc., cause liver to be lost Catharsis, the dysfunction of the spleen in transport, kidney qi disturbance in functioning of QI, the cause stagnation of the circulation of vital energy, phlegm are solidifying, blood stasis interaction is condensed in throat, and disease is then empty by causing in fact long, Asthenia in origin and asthenia in superficiality.Preventing and treating of the Chinese medicine to AITD have accumulated rich experience, and many experiments confirm that a variety of Chinese herbal medicines have well to AITD Curative effect, therefore there is vast potential for future development.

The content of the invention

It is an object of the invention to provide a kind of compound preparation for treating AITD and preparation method thereof, To treat type of deficiency of both QI and YIN AITD.

To reach above-mentioned purpose, the invention provides a kind of compound preparation for treating AITD, institute The compound preparation stated is prepared by the Chinese medicine of following mass percents：

Radix Astragali 10-15%, radix scrophulariae 10-15%, tuber of pinellia 10-15%, selfheal 10-15%, fritillaria thunbergii 5-15%, Ligusticum wallichii 5- 15%th, dandelion 5-15%, radix scutellariae 10-15%, Rhizoma Sparganii 5-15%, root tuber of aromatic turmeric 5-15%, the mass percent of above Chinese medicine are total With for 100%.

Wherein, Radix Astragali returns spleen lung two passes through, and has the function that tonifying Qi and lifting yang, benefit defend solid table, inducing diuresis for removing edema, radix scrophulariae return lung stomach kidney Through there is clearing heat and cooling blood, enriching yin removing toxic substances, two medicine phases are closed, play benefiting qi and nourishing yin, clearing heat and detoxicating altogether, be altogether monarch drug in a prescription；The tuber of pinellia, Fritillaria thunbergii resolving sputum dissolving lump and resolving mass, compatibility selfheal, dandelion clearing heat for detumescence dissipating bind, are altogether ministerial drug.The monarch and his subjects' phase 5, plays benefit jointly Gas yin-nourishing, softening and resolving hard mass, clearing heat and detoxicating effect；It is clearing heat and detoxicating with Ligusticum wallichii, root tuber of aromatic turmeric, Rhizoma Sparganii promoting flow of qi and blood circulation disperse accumulations, radix scutellariae again.It is all Medicine shares, and plays supplementing qi and nourishing yin, the goitre that disappears dissipating bind altogether, adjusts the effect of immune.

Preferably, described compound preparation is prepared by the Chinese medicine of following mass percents：

The Radix Astragali 10%, radix scrophulariae 10%, the tuber of pinellia 10%, selfheal 10%, fritillaria thunbergii 5%, Ligusticum wallichii 5%, dandelion 5%, Huang A kind of reed mentioned in ancient books 15%, Rhizoma Sparganii 15%, root tuber of aromatic turmeric 15%.

Preferably, described compound preparation is prepared by the Chinese medicine of following mass percents：

The Radix Astragali 15%, radix scrophulariae 15%, the tuber of pinellia 15%, selfheal 10%, fritillaria thunbergii 10%, Ligusticum wallichii 10%, dandelion 5%, Radix scutellariae 10%, Rhizoma Sparganii 5%, root tuber of aromatic turmeric 5%.

The compound preparation of above-mentioned treatment AITD, wherein, the formulation of the compound preparation has：Glue Wafer, granule, oral liquid, tablet, pill, decoction or powder.

Present invention also offers a kind of preparation method of the compound preparation of above-mentioned treatment AITD, bag Containing following steps：

Step S1, the Chinese medicine is soaked into 1-5 hours；

Step S2, water is added into the Chinese medicine after step S1 immersions, decoction is poured out after decocting 10-20min；

Step S3, water is added to the Chinese medicine after step S2 decoctions, decoction is poured out after decocting 30-60min；

Step S4, the decoction that combining step S2 and step S3 are poured out, compound preparation is made.

Preferably, the quality of the water added in step 2 and step 3 is 1-3 times of Chinese medicine quality.

Compound preparation joint Western medicine of the present invention is obvious to type of deficiency of both QI and YIN AITD curative effect, to improving Symptom, thyroid gland index of correlation etc. effect are obvious, have given full play to unique advantage of the Chinese medicine in treatment AITD.

Embodiment

Below by way of specific embodiment, the invention will be further described, and these embodiments are merely to illustrate the present invention, It is not limiting the scope of the invention.

Embodiment one, clinical treatment Hashimoto's thyroiditis

1st, case selection and packet

1.1st, case selection：

1.1.1, Western medicine diagnostic criteria：Worked out by endocrine branch of Chinese Medical Association in 2008《Chinese thyroid gland diagnosis and treatment Guide》.

(1) there are typical clinical manifestations:Thyroid gland is in diffusivity, symmetry enlargement, or with tubercle；And thyroid gland peroxidating Enzyme antibody (TPOAb) or TGA (TGAb) are positive.(2) its atypical clinical manifestations, showed with hyperthyroidism, if high More than half a year persistently be present in titre TPOAb, TGAb antibody.(3) TPOAb, TGAb exceed normal range (NR), and ultrasound diagnosis shows and deposited In diffusivity infringement or goitre.(4) follicular epithelial cells polymorphy in fine-needle aspiration of thyroid nodules cytolgical examination, galandular epithelium Iuntercellular shows abundant lymphocyte and plasmocyte infiltrating, acidophilia follicular cells be present.Meet in above-mentioned 4 any 1 i.e. It can make a definite diagnosis.

1.1.2, TCM syndrome diagnostic criteria：Reference《New Chinese medicine guideline of clinical investigations (tentative)》Related content.

Primary symptom：Throat enlargement, lassitude hypodynamia, mesh is swollen more tears, feverishness in palms and soles, dry mouth and throat.Secondary disease：Palpitation and uneasiness, it is irritated Irritability, little sleep disturbed by dreams, finger are trembled, soreness and weakness of waist and knees, and more foods are become thin.Tongue vein：Tongue nature is partially red, and tongue is few or tire is thin white, thready rapid pulse without Power.Card type determines：Possess primary symptom 3, secondary disease 3 and more than, with reference to tongue vein feature, you can establish diagnose the card.

1.2nd, case is grouped：Treatment group and control group are randomly divided into by random table.

(1) treatment group's (taking levothyroxine sodium joint invention formulation)：33；

(2) control group (taking levothyroxine sodium)：31；

Two groups of patients are in terms of age, sex, the course of disease and disease severity without significant difference (P>0.05), having can Compare property.

2nd, observation and treatment method：

(1) observational technique：Observe 2 groups of pretherapy and post-treatment free triiodothyronines (FT3), free tetraiodo thyroid gland original Propylhomoserin (FT4), thyrotropic hormone (TSH), TPO antibody (TPOAb) and TGA (TGAb), thyrotrophin receptor antibody (TRAb), the course for the treatment of are analyzed after terminating using statistics software SPSS20.0.

(2) treatment method：Control group uses thyrotropic hormone (TSH)：Between 4-7mU/L, levothyroxine sodium is taken The μ g/d of piece (Euthyrox) 12.5.TSH：Between 7-10mU/L, the μ g/d of levothyroxine sodium tables (Euthyrox) 25 are taken, are within 3 months One course for the treatment of.Treatment group combines invention formulation on the basis of control group：By Shanghai City process of preparing specification nineteen ninety-five version medicine The material such as Radix Astragali, radix scrophulariae, the tuber of pinellia, selfheal etc..Compound preparation is prepared by the Chinese medicine of following mass percents：The Radix Astragali 10%th, radix scrophulariae 10%, the tuber of pinellia 10%, selfheal 10%, fritillaria thunbergii 5%, Ligusticum wallichii 5%, dandelion 5%, radix scutellariae 15%, Rhizoma Sparganii 15%th, root tuber of aromatic turmeric 15%.Its preparation method method is as follows：Step S1, the Chinese medicine is soaked 1 hour；Step S2, to through step S1 The water of 2 times of amount Chinese medicines is added in Chinese medicine after immersion, decoction is poured out after decocting 15min；Step S3, decocted to through step S2 Chinese medicine afterwards adds the water of 2 times of amount Chinese medicines, and decoction is poured out after decocting 30min；Step S4, combining step S2 and step S3 institutes The decoction poured out, splitting encapsulation, every bag of about 160ml or so.Each 160ml, twice daily, once in the morning and once at night orally, it is within 3 months One course for the treatment of.

3rd, criterion of therapeutical effect：With reference to《Practical thyroid disease》

(1) clinical recovery：Thyroid gland recovers normal, and clinical symptoms are wholly absent with sign, and related physical and chemical inspection recovers Normally；

(2) it is effective：Clinical symptoms significantly improve, and goitre significantly diminishes, and TPOAb, TGAb turn out cloudy or titre declines> 30%；

(3) effectively：Clinical symptoms make moderate progress, and goitre softens, and TPOAb, TGAb titre decline<30%, and> 10%；

(4) it is invalid：Clinical symptoms do not improve, and TPOAb, TGAb titre decline<10%；

It is total be effectively recovery from illness, effective, effective sum.

4th, treatment results and analysis

(1) treatment group 33：Clinical recovery 4, effective 13, effective 14, invalid 2, total effective rate is 93.94%；

(2) control group 31：Clinical recovery 1, effective 3, there are a 23 effect examples, invalid 4, total effective rate 87.09%；

Treatment group is compared with control group, and the total effective rate for the treatment of group patient is substantially higher than control group patient, and difference is obvious, has Statistical significance (P<0.05).Not statistically significant (the P of the horizontal comparing difference of TRAb, TPOAb, TGAb before two groups of treatments>0.05), These parameters level significantly reduces (P after treatment<0.05), and treatment group is substantially less than control group (P<0.05).

Embodiment two, clinical treatment graves disease (Graves diseases)

1st, case selection and packet

1.1st, case selection：

1.1.1, Western medicine diagnostic criteria：Worked out by endocrine branch of Chinese Medical Association in 2008《Chinese thyroid gland diagnosis and treatment Guide》.

(1) sings and symptoms of hypermetabolism；(2) palpation and ultrasound diagnosis diffusivity Thyroid Gland Swell (small number of patients can without)； (3) serum total thyroxine (TT4), free thyroxine (FT4) reduce, thyroid-stimulating hormone (TSH) rise；(4) exophthalmos Levied with other wellability eyes；(5) pretibial myxedema；(6) thyrotropin receptor (TRAb), thyroid-stimulating antibody (TSAb), Peroxidase Antibody (TPOAb) is positive.(1)-(3) item is diagnosis necessary requirement above, and (4)-(6) item is diagnosis Subsidiary conditions.

1.1.2, TCM syndrome diagnostic criteria：Reference《New Chinese medicine guideline of clinical investigations (tentative) related content.

Primary symptom：Throat enlargement, lassitude hypodynamia, mesh is swollen more tears, feverishness in palms and soles, dry mouth and throat.Secondary disease：Palpitation and uneasiness, it is irritated Irritability, little sleep disturbed by dreams, finger are trembled, soreness and weakness of waist and knees, and more foods are become thin.Tongue vein：Tongue nature is partially red, and tongue is few or tire is thin white, thready rapid pulse without Power.Card type determines：Possess primary symptom 3, secondary disease 3 and more than, with reference to tongue vein feature, you can establish diagnose the card

1.2nd, case is grouped：Treatment group and control group are randomly divided into by random table.

(1) treatment group's (taking invention formulation joint methimazole)：33；

(2) control group (methimazole)：36；

Two groups of patients are in terms of age, sex, the course of disease and disease severity without significant difference (P>0.05), having can Compare property.

2nd, observation and treatment method

(1) observational technique：The FT3 of pretherapy and post-treatment experimental group and control group, FT4, TSH, TRAb, TGAb are observed, TPOAb refers to Mark situation of change.

(2) treatment method：The control group methimazole 10mg is oral, and 3 times a day, March is a course for the treatment of.Medicine for treatment Meanwhile giving diet to illustrate instruction (avoiding iodine, high heat, high protein, homovitamin diet), treatment group is in control group On the basis of combine invention formulation：By Shanghai City process of preparing specification nineteen ninety-five version the medicinal material such as Radix Astragali, radix scrophulariae, the tuber of pinellia, selfheal Deng.Compound preparation is prepared by the Chinese medicine of following mass percents：The Radix Astragali 15%, radix scrophulariae 15%, the tuber of pinellia 15%, selfheal 10%th, fritillaria thunbergii 10%, Ligusticum wallichii 10%, dandelion 5%, radix scutellariae 10%, Rhizoma Sparganii 5%, root tuber of aromatic turmeric 5%.Its preparation method method is as follows： Step S1, the Chinese medicine is soaked 1 hour；Step S2,2 times of amount Chinese medicines are added into the Chinese medicine after step S1 immersions Water, decoct 15min after pour out decoction；Step S3, the water of 2 times of amount Chinese medicines is added to the Chinese medicine after step S2 decoctions, Decoction is poured out after decocting 30min；Step S4, the decoction that combining step S2 and step S3 are poured out, splitting encapsulation, every bag about 160ml or so.Each 160ml, twice daily, once in the morning and once at night orally, 3 months are a course for the treatment of.The course for the treatment of uses system after terminating Meter is learned software SPSS20.0 and analyzed.

3rd, criterion of therapeutical effect：Reference《New Chinese medicine treats the guideline of clinical investigations of hyperthyroidism》.

(1) clinic control：Symptom disappears, and weight increase, pulse frequency is normal, and region thyreoidea trembles and vascular murmur disappears, Goitre and expophthalmos sign mitigate, and every laboratory examination project recovers normal.

(2) it is effective：Cardinal symptom disappears, and weight increase, pulse frequency is normal, and region thyreoidea trembles and vascular murmur disappears Lose, goitre and expophthalmos sign mitigate, and every laboratory examination project is normal；

(3) effectively：Symptom takes a turn for the better, decreased heart rate, and thyroid gland reduces, and vascular murmur mitigates, every laboratory examination project It is substantially normal.

(4) it is invalid：Symptom, sign, laboratory examination are not improved.

4th, treatment results and analysis：

(1) treatment group 33：Clinic control 4, effective 10, effective 17, invalid 2, total effective rate is 93.94%；

(2) control group 36：Clinical recovery 1, effective 10, effective 19, invalid 6, total effective rate is 83.33%；

Compared with control group, two groups of differences have conspicuousness (P for treatment group<0.05).TRAb, TPOAb before two groups of treatments, Not statistically significant (the p of the horizontal comparing differences of TGAb>0.05) index level, is appealed after treatment significantly reduces (p<0.05), and control Treatment group is substantially less than control group (p<0.05).In summary, invention formulation combines Western medicine to type of deficiency of both QI and YIN LADA Obvious (the P of thyroid disease curative effect<0.01) it is, obvious to improving symptom, thyroid gland index of correlation etc. effect, give full play to Unique advantage of the Chinese medicine in treatment AITD.

In summary, compound preparation of the present invention has carried out AITD clinical research：

(1) Hashimoto's thyroiditis Clinical practice, the prompting of clinical practice result：Treatment group efficient is 93.94%, and right Compare according to group, there is significant difference (P<0.05).During medication, two groups of cases in doing blood thyroglobulin before and after treatment Antibody (TGAb), ATPO (TPOAb) check that treatment group is significantly improved it except thyroid gland associated antibodies (P outside<0.05), remaining all Non Apparent Abnormalities (P>0.05) obvious (P before, control group thyroid gland associated antibodies are relatively treated<0.05) it is, remaining Change without exception.After medication, there is significant difference (P compared with control group to Thyreoidine associated antibodies treatment group<0.05).Two groups equal Without adverse reactions such as liver and kidney dysfunctions.

(2) Graves diseases Clinical practice, treatment group carry out observation of curative effect and FT3, FT4, TSH, TRAb with control group, TGAb, TPOAb compare.As a result show：The total effective rate for the treatment of group is 93.94%, and the effective percentage of control group is 83.33%, two Group compares, and has significant difference (P<0.05).Thyroid gland associated antibodies improve there were significant differences property (P before and after treatment group< 0.05), the pretherapy and post-treatment thyroid gland associated antibodies no significant difference (P of control group>0.05).It is related to Thyreoidine after medication Antybody therapy group has significant difference (P compared with control group<0.05).Two groups without adverse reactions such as liver and kidney dysfunctions.

Show through clinical research, invention formulation obtains to type of deficiency of both QI and YIN AITD and is satisfied with treatment Effect, can not only be obviously improved symptom, and obvious to the improvement result of lab index etc., and long-term use is without any poison Side effect, unique advantage of the traditional Chinese medicine in treatment AITD is given full play to, has been had broad prospects.

Although present disclosure is discussed in detail by above preferred embodiment, but it should be appreciated that above-mentioned Description is not considered as limitation of the present invention.After those skilled in the art have read the above, for the present invention's A variety of modifications and substitutions all will be apparent.Therefore, protection scope of the present invention should be limited to the appended claims.

Claims (6)

1. a kind of compound preparation for treating AITD, it is characterised in that described compound preparation is by following The Chinese medicine of mass percent is prepared：

Radix Astragali 10-15%, radix scrophulariae 10-15%, tuber of pinellia 10-15%, selfheal 10-15%, fritillaria thunbergii 5-15%, Ligusticum wallichii 5- 15%th, dandelion 5-15%, radix scutellariae 10-15%, Rhizoma Sparganii 5-15%, root tuber of aromatic turmeric 5-15%, the mass percent of above Chinese medicine are total With for 100%.

2. the compound preparation for the treatment of AITD as claimed in claim 1, it is characterised in that described answers Square preparation is prepared by the Chinese medicine of following mass percents：

The Radix Astragali 10%, radix scrophulariae 10%, the tuber of pinellia 10%, selfheal 10%, fritillaria thunbergii 5%, Ligusticum wallichii 5%, dandelion 5%, radix scutellariae 15%th, Rhizoma Sparganii 15%, root tuber of aromatic turmeric 15%.

3. the compound preparation for the treatment of AITD as claimed in claim 1, it is characterised in that described answers Square preparation is prepared by the Chinese medicine of following mass percents：

The Radix Astragali 15%, radix scrophulariae 15%, the tuber of pinellia 15%, selfheal 10%, fritillaria thunbergii 10%, Ligusticum wallichii 10%, dandelion 5%, radix scutellariae 10%th, Rhizoma Sparganii 5%, root tuber of aromatic turmeric 5%.

4. the compound preparation for the treatment of AITD as claimed in claim 1, it is characterised in that the compound The formulation of preparation has：Capsule, granule, oral liquid, tablet, pill, decoction or powder.

A kind of 5. system of the compound preparation of the treatment AITD in 1-4 such as claim as described in any one Preparation Method, it is characterised in that comprise the steps of：

Step S1, the Chinese medicine is soaked into 1-5 hours；

Step S2, water is added into the Chinese medicine after step S1 immersions, decoction is poured out after decocting 10-20min；

Step S3, water is added to the Chinese medicine after step S2 decoctions, decoction is poured out after decocting 30-60min；

Step S4, the decoction that combining step S2 and step S3 are poured out, compound preparation is made.

6. the preparation method of the compound preparation for the treatment of AITD, its feature exist as claimed in claim 5 In the quality of the water added in step 2 and step 3 is 1-3 times of Chinese medicine quality.