CN105853722A - Medicine composition for treating qi and yin deficiency syndrome after thyroid cancer operation - Google Patents

Medicine composition for treating qi and yin deficiency syndrome after thyroid cancer operation Download PDF

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CN105853722A
CN105853722A CN201610343664.7A CN201610343664A CN105853722A CN 105853722 A CN105853722 A CN 105853722A CN 201610343664 A CN201610343664 A CN 201610343664A CN 105853722 A CN105853722 A CN 105853722A
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radix
parts
yin
pharmaceutical composition
deficiency
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王传秀
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Qingdao Yuntian Biotechnology Co Ltd
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Abstract

The invention belongs to the field of traditional Chinese medicine and discloses a medicine composition for treating the qi and yin deficiency syndrome after the thyroid cancer operation and a preparing method thereof. The medicine composition is prepared from fructus ligustri lucidi, radix polygonati officinalis, panax pseudo-ginseng wsll. var, cynanchum mooreanum hemsl, carex siderosticta hance, textile screw pine seeds, oval kumquat seeds, hemsley rockvine roots, ampelopsis brevipedunculata trautv, uraria lagopodioides and euonymus porphyreus as medicinal raw materials. The medicinal materials are compatible and have the effects of tonifying qi, nourishing yin, reducing phlegm, resolving masses, removing dampness, clearing away turbidity, strengthening body resistance and eliminating evil, and can effectively improve clinical symptoms of qi and yin deficiency after the thyroid cancer operation, reduce the adverse reaction of endocrine therapy, reduce the serum thyroglobulin level after the operation so as to prevent recurrence and metastasis of cancer, improve the clinical symptom of patients and improve the life quality of the patients.

Description

A kind of pharmaceutical composition treating the postoperative syndrome of deficiency of both qi and yin of thyroid carcinoma
Technical field
The invention belongs to tcm field, be specifically related to a kind of pharmaceutical composition treating the postoperative syndrome of deficiency of both qi and yin of thyroid carcinoma and Preparation method.
Background technology
Thyroid carcinoma is a clinical common class neck malignant tumor, sickness rate in China just in the gesture of rising year by year.China at present The prevalence of crowd's thyroid nodule is 18.6%, and wherein Malignant Nodules (i.e. thyroid carcinoma) accounts for 5%～10%, and histological type is main It is divided into papillary carcinoma, filter blocking cancer, undifferentiated carcinoma, medullary carcinoma etc..In addition to except diagnostic techniques, prosperity is improved increasingly, improper diet, Excessive stress, lonizing radiation irradiation may be all predisposition thereto.
At present, operation is the Therapeutic Method that thyroid carcinoma is best.But the postoperative probability recurred at former operative site is the highest.And Thyroid carcinoma has lymphatic metastasis, particularly papillary adenocarcinoma mostly, and its regional lymph node metastasis rate is 44.7%.Folliculus sample cancer its Metastasis position is typically skeleton, can cause osteolytic lesion.And undifferentiated carcinoma cancerous protuberance in early days or do not find primary tumor it Before, so that it may see whole body metastasis.A lot of researchs show that thyroid cancer patients easily recurs after using operative treatment, and first shape Adenocarcinoma is postoperative, and Huan Zheqi, blood, body fluid consume wound in a large number, spiritlessness and weakness, spontaneous sweating, xerostomia, hoarseness, neck occurs more Portion distension is uncomfortable, two just symptoms such as imbalance.As can be seen here, even if the patient of thyroid carcinoma has carried out operative treatment, the most still there is portion Divide " pathogen " residual body, become the root of relapse and metastasis.
The traditional Chinese medical science thinks " healthy energy deposit in, heresy can not be done ", " being gathered of heresy, its gas must void ".Operation may result in patients blood and is subject to Damaging, positive QI-insufficiency, cause asthenia universalis, resistance declines, and easily causes post-operative complication, various clinical symptom occurs, right This Western medicine does not has active drug.At present, increasing evidence shows that middle thyroid cancer patients is the most actively aided with Chinese medicine and controls Treatment can make up the untoward reaction that operative treatment is not enough, alleviate endocrine therapy, reduce postoperative Serum Thyroglobulin from And prevent cancerous protuberance recurrence and transfer, improve patient clinical symptom, improve patients ' life quality.Therefore, Chinese medicine becomes first A requisite part in shape adenocarcinoma comprehensive therapeutic plan.
Summary of the invention
Inventor, according to oneself tcm clinical practice experience for many years, acts on the traditional Chinese medical science " Overall View " and " determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs ", and by dialectical with distinguish Sick combination, concentrates on studies and provides a kind of pharmaceutical composition treating the postoperative syndrome of deficiency of both qi and yin of thyroid carcinoma, can be effectively improved The clinical symptoms of the postoperative deficiency of both QI and YIN of thyroid carcinoma, alleviates the untoward reaction of endocrine therapy, reduces postoperative serum thyroid ball egg White level thus prevent cancerous protuberance recurrence and transfer, improve patient clinical symptom, improve patients ' life quality.
The present invention is achieved by the following technical solutions:
A kind of pharmaceutical composition treating the postoperative syndrome of deficiency of both qi and yin of thyroid carcinoma, its by Fructus Ligustri Lucidi, Rhizoma Polygonati Odorati, Rhizoma panacis majoris, Radix Tylophorae arenicolae, Radix caricis siderostictae, Fructus Pandani tectorii, Semen Fortunellae Margaritae, Radix Apioris Fortunei (Radix Lespedezae Buergeri), Radix ampelopsis brevipedunculatae, Herba Urariae Lagopodioidis, pale reddish brown winged euonymus are that medicinal raw material is made.
In we, indivedual flavour of a drug have effect of YIN nourishing, heat clearing away, eliminating stagnation, but do not have for treatment Complications Following Thyroid Caner Preferably curative effect, for make all medicines in formula organic assembling to realize functionally complementing each other heightening the effect of a treatment；Phase the most processed in the property of medicine Assistant lowers toxicity, and inventor further preferably goes out following scheme:
A kind of pharmaceutical composition treating the postoperative syndrome of deficiency of both qi and yin of thyroid carcinoma, it is characterised in that medicinal by following weight Raw material is made: Fructus Ligustri Lucidi 18-23 part, Rhizoma Polygonati Odorati 10-15 part, Rhizoma panacis majoris 20-25 part, Radix Tylophorae arenicolae 8-13 part, Radix caricis siderostictae 7-12 part, Fructus Pandani tectorii 10-15 part, Semen Fortunellae Margaritae 4-6 part, Radix Apioris Fortunei (Radix Lespedezae Buergeri) 10-15 part, Radix ampelopsis brevipedunculatae 7-12 part, Herba Urariae Lagopodioidis 10-15 part, pale reddish brown winged euonymus 6-9 part.
Further, a kind of pharmaceutical composition treating the postoperative syndrome of deficiency of both qi and yin of thyroid carcinoma, it is characterised in that by following weight portion The medicinal raw material of proportioning is made: Fructus Ligustri Lucidi 20 parts, Rhizoma Polygonati Odorati 10 parts, Rhizoma panacis majoris 20 parts, Radix Tylophorae arenicolae 10 parts, Radix caricis siderostictae 8 parts, big shield fishnet Son 12 parts, Semen Fortunellae Margaritae 4 parts, Radix Apioris Fortunei (Radix Lespedezae Buergeri) 12 parts, Radix ampelopsis brevipedunculatae 8 parts, Herba Urariae Lagopodioidis 12 parts, pale reddish brown winged euonymus 8 parts, or Fructus Ligustri Lucidi 20 Part, Rhizoma Polygonati Odorati 15 parts, Rhizoma panacis majoris 22 parts, Radix Tylophorae arenicolae 12 parts, Radix caricis siderostictae 12 parts, Fructus Pandani tectorii 10 parts, Semen Fortunellae Margaritae 5 parts, Radix Apioris Fortunei (Radix Lespedezae Buergeri) 15 Part, Radix ampelopsis brevipedunculatae 10 parts, Herba Urariae Lagopodioidis 10 parts, pale reddish brown winged euonymus 8 parts.
Fang Zhong: Fructus Ligustri Lucidi replenishing YIN to strengthen the kidney, QI invigorating soothing liver-QI；Rhizoma Polygonati Odorati nourishing YIN to relieve dryness, nourishes QI and blood, promoting the production of body fluid to quench thirst；Rhizoma panacis majoris heat clearing away Yin nourishing, dissipating blood stasis stops blooding, and reducing swelling and alleviating pain, three medicine 5 nourishing YIN and benefiting blood, supplementing QI for promoting the production of body fluid is monarch drug.Radix Apioris Fortunei (Radix Lespedezae Buergeri) heat-clearing and toxic substances removing, dispel the wind Reduce phlegm, promoting blood circulation and stopping pain；Radix ampelopsis brevipedunculatae heat-clearing and toxic substances removing, expelling wind and removing dampness, blood circulation promoting and dispersing pathogen accumulation；Herba Urariae Lagopodioidis heat-clearing and toxic substances removing, mass dissipating and swelling eliminating, Relieving stranguria by diuresis；Three medicine 5 heat-clearing and toxic substances removing, mass dissipating and swelling eliminating, blood circulation promoting and blood stasis dispelling, dampness removing is let out turbid for ministerial drug.Radix caricis siderostictae benefiting QI and nourishing blood, Promoting blood flow to regulate menstruation；Fructus Pandani tectorii spleen reinforcing benefit blood, promoting the circulation of QI to relieve pain, reduce phlegm dampness removing；Semen Fortunellae Margaritae dissipating phlegm and resolving masses, regulating QI to relieve pain；Radix Tylophorae arenicolae is clear Hot removing heat from blood, function of gallbladder promoting detoxifies；Pale reddish brown winged euonymus dissipating blood stasis for subsidence of swelling, heat-clearing and toxic substances removing, for adjuvant.All medicines phase 5, indispensable, useful Gas yin nourishing, dissipating phlegm and resolving masses, dampness removing let out turbid effect, and strengthening vital QI to eliminate pathogenic factors effect is notable.
Meridian distribution of property and flavor and the primary efficacy of each medicinal raw material used by the present invention are as follows.
Fructus Ligustri Lucidi: [nature and flavor] sweet, bitter, cold.[return through] returns liver, kidney channel.[function cures mainly] nourishing the liver and kidney, improving eyesight black hair. For vertigo and tinnitus, soreness of the waist and knees, early whitening of beard and hair, poor vision.
Rhizoma Polygonati Odorati: [nature and flavor] are sweet, are slightly cold.[return through] attaches to the lung and stomach meridians.[function cures mainly] nourishing YIN to relieve dryness, promoting the production of body fluid to quench thirst.For Lung stomach-Yin is hindered, and cough caused by dryness-heat, dry throat and mouth, interior-heat is quenched one's thirst.[usage and dosage] 6～12g.
Rhizoma panacis majoris: [nature and flavor] bitter in the mouth；Sweet；Cold in nature.[function cures mainly] clearing away heat and nourishing YIN；Dissipating blood stasis stops blooding；Reducing swelling and alleviating pain.Main heat Sick excessive thirst；Deficiency of YIN cough due to lung-heat；Hemoptysis；Spit blood；Epistaxis；Have blood in stool；Hematuria；Metrorrhagia；Traumatic hemorrhage；Traumatic injury wound is swollen；Wind Pain of dampness syndrome；Stomachache；Menoxenia；Acute toothache；Laryngopharynx swelling and pain；Sore and toxic.
Radix Tylophorae arenicolae: the root disappeared for the plant bamboo spirit of trailing plants section or aerial parts.[nature and flavor] bitter in the mouth；Micro-pungent；Property flat.[return through] lung Warp.[function cures mainly] clearing away heat and cooling blood；Function of gallbladder promoting；Removing toxic substances.Main fever due to yin deficiency；Asthenia chronic cough；Spitting of blood；Distending pain over the hypochondrium；Vomiting and nausea； Dysentery；Puerperal fidgets due to deficiency；Scrofula；Innominate toxic swelling；Snakeworm；Mad dog is bitten.
Radix caricis siderostictae: [nature and flavor] sweet in the mouth；Pungent；Warm in nature.[return through] lung；Liver；Kidney channel.[function cures mainly] benefiting QI and nourishing blood； Promoting blood flow to regulate menstruation.Main deficient qi and blood；Lassitude；Palpitation and insomnia；Menoxenia；Amenorrhea [usage and dosage] takes orally: decoct soup, 9-12g。
Fructus Pandani tectorii: [source] medical material Ji Yuan: for the drupe of Pandanaceae plant Pandanus tectorius.[nature and flavor] acrid in the mouth；Light；Cool in nature. [return through] kidney；Spleen；Liver；Stomach warp.[function cures mainly] spleen reinforcing benefit blood；Promoting the circulation of QI to relieve pain；Reduce phlegm dampness removing；Improving eyesight.Main dysentery； Stomachache；Cough；Hernia；Orchitis；Hemorrhoid dysuria；The raw cataracta of mesh.[usage and dosage] takes orally: decoct soup, 10-30g； Infusing drugs in wine or leaching honey.
Semen Fortunellae Margaritae: [nature and flavor] are sour, pungent, flat.[return through] liver；Spleen；Stomach；Lung meridian.[function cures mainly] dissipating phlegm and resolving masses, regulates the flow of vital energy Pain relieving.Main sore throat；Scrofula tuberculosis；Hernia；Painful and swollen testis；Breast lumps；Mastitis.[usage and dosage] takes orally: decoct soup, 6-9g。
Radix Apioris Fortunei (Radix Lespedezae Buergeri): [nature and flavor] micro-hardship is flat.[function cures mainly] heat-clearing and toxic substances removing, dispelling pathogenic wind and eliminating phlegm, promoting blood circulation and stopping pain.Cure mainly: white Larynx, children with high fever induced convulsions, dysentery, hepatitis.Venom is controlled in external, tonsillitis, tuberculous lymphadenitis, cervicitis, Cellulitis, traumatic injury.[usage and dosage] 3～5 money；Suitable amount used externally, puts affected part on the skin with wine or water mill.
Radix ampelopsis brevipedunculatae: [nature and flavor] are pungent；Bitter；Cool.[return through] lung；Liver；Large intestine channel.[function cures mainly] heat-clearing and toxic substances removing；Dispel Wind dehumidifies；Blood circulation promoting and dispersing pathogen accumulation.Main pain in the lung vomiting pus；Pulmonary tuberculosis is spat blood；Rheumatic arthralgia；Traumatic injury；Carbuncle sore tumefacting virus；Scrofula；Cancer Swollen.[usage and dosage] takes orally: decoct soup, 15-30g, fresh goods times amount.External: appropriate, mashes or grinds into powder and dress.
Herba Urariae Lagopodioidis: [source] is the herb of leguminous plant rabbit tail grass.Summer, autumn take.Clean, give birth to or dry use.[property Taste] sweet in the mouth；Light；Property flat.[return through] liver；The heart；Spleen；Stomach warp.[function cures mainly] heat-clearing and toxic substances removing；Mass dissipating and swelling eliminating；Profit Water is treating stranguria.Main flu；Infantile pneumonia；Jaundice；Bellyache and diarrhea；Scrofula；Ulcerative carbuncle toxic swelling；Venom；Sand Stranguria hematuria；Women Middle impairment caused by overstrain.
Pale reddish brown winged euonymus: [source] medical material Ji Yuan: for root and the branch of the pale reddish brown winged euonymus of Celastraceae plant.[nature and flavor] are bitter；Cool.[function Cure mainly] eliminating stasis to stop pain；Heat-clearing and toxic substances removing.Main traumatic injury；Lymphoid tuberculosis；Furuncle swells malignant boil.[usage and dosage] takes orally: decoct soup, 6-10g.External: appropriate, smashes deposited；Or grind into powder and dress.
For the ease of using, the pharmaceutical composition of the present invention can be by Fructus Ligustri Lucidi, Rhizoma Polygonati Odorati, Rhizoma panacis majoris, Radix Tylophorae arenicolae, Radix caricis siderostictae, big shield Fishnet, Semen Fortunellae Margaritae, Radix Apioris Fortunei (Radix Lespedezae Buergeri), Radix ampelopsis brevipedunculatae, Herba Urariae Lagopodioidis, pale reddish brown winged euonymus or its water or its extractive with organic solvent are that activity becomes Point, make peroral dosage form according to galenic pharmacy routine techniques, such as: tablet, sugar coated tablet, film coated tablet, enteric coated tablet, Capsule, hard capsule, soft capsule, oral liquid, granule, electuary, pill, powder, suspensoid, powder.
Preferably, peroral dosage form described above is capsule, tablet, oral liquid, granule or pill.
Most preferably, peroral dosage form described above is capsule.
The preparation of the present invention determines usage and dosage according to the situation of patient in use.The preparation of the present invention is in use according to patient Situation determine usage and dosage, can take 1-3 time every day, each 1-20 agent, such as: 1-20 bag or grain or sheet etc..
Present invention also offers the preparation method of a kind of pharmaceutical composition described above, the present inventor finds under study for action, By optimizing preparation method, it is possible in the case of keeping active drug, go the removal of impurity or the part without drug effect, reduce impurity Interference to therapeutic effect so that this pharmaceutical composition is more efficient.
The preparation method of a kind of pharmaceutical composition treating the postoperative syndrome of deficiency of both qi and yin of thyroid carcinoma that the present invention provides, its feature exists In comprising the following steps:
(1) by prescription take Radix caricis siderostictae, Fructus Pandani tectorii, Semen Fortunellae Margaritae, Radix Apioris Fortunei (Radix Lespedezae Buergeri) pulverize, mixing, add described four Chinese medicine material weight portion 3～ The concentration of 8 times is the alcohol reflux 2 times of 40%-60% (preferably 50%), and the time being every time heated to reflux is 0.5～2 little Time, collect filtering residue after the ethanol extraction of Radix caricis siderostictae, Fructus Pandani tectorii, Semen Fortunellae Margaritae, Radix Apioris Fortunei (Radix Lespedezae Buergeri), united extraction liquid, filter, reduce pressure dense Shorten thick paste into；
(2) by prescription weigh Fructus Ligustri Lucidi, Rhizoma Polygonati Odorati, Rhizoma panacis majoris, Radix Tylophorae arenicolae, Radix ampelopsis brevipedunculatae, Herba Urariae Lagopodioidis, pale reddish brown winged euonymus and precipice Filtering residue mixing after palm fibre root, Fructus Pandani tectorii, Semen Fortunellae Margaritae, Radix Apioris Fortunei (Radix Lespedezae Buergeri) ethanol extraction, the water boiling and extraction of 2～10 times of weight portions of addition 2 times, Decocting time is 1～2 hour every time, united extraction liquid, filters, and stands, takes supernatant, and concentrating under reduced pressure becomes thick paste；
(3) the thick paste mixing (1) and (2) obtained, is ground into the fine powder of 200-400 mesh after lyophilization, thin with this Powder is as active component, and this active component individually or mixes with pharmaceutically acceptable carrier, by this area conventional formulation technique system Standby and get final product.
Pharmaceutically acceptable carrier described above can be: mannitol, sorbitol, sodium pyrosulfite, sodium sulfite, sulfur generation Sodium sulfate, cysteine hydrochloride, TGA, methionine, injection Vitamin B_6 DTA disodium, Ethylenediaminetetraacetic Acid Calcium Salt, monoacidic base gold Carbonate, acetate, phosphate or its aqueous solution, hydrochloric acid, acetic acid, sulphuric acid, phosphoric acid, aminoacid, sodium chloride, the chlorine belonged to Change 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, kaolinite Soil, Pulvis Talci, calcium stearate, magnesium stearate etc..
The present invention be inventor through repeatedly studying, progressively improve a kind of curative effect obtained preferably postoperative for treating thyroid carcinoma The medicine of syndrome of deficiency of both qi and yin, clinical effectiveness prompting, medication therapy groups therapeutic effect of the present invention is notable, and overall clinical efficacy rate is 95.2%, And matched group total effective rate is 76.2%, two groups of total effective rate comparing differences statistically significant (P ＜ 0.05), medicine of the present invention The total effective rate for the treatment of group is higher；Two groups of main diseases are (spiritlessness and weakness, inappetence, dry mouth and tougue, spontaneous sweating, vexed Insomnia) compare, the main disease integration of medication therapy groups of the present invention is significantly lower than matched group, and two groups of comparing differences have statistics to anticipate Justice (P ＜ 0.05)；After treatment, treatment group TG value is obviously reduced, comparing difference statistically significant (P ＜ 0.05) front with treatment, And matched group compares with before treatment, no significant difference, compares between two groups after treatment, statistically significant (the P ＜ of difference 0.05) what, treatment group TG value reduced becomes apparent from；Treatment group during observing, FT3、FT4And TSH there is no significant change, Illustrate that pharmaceutical composition is the least for the function effect of thyroid gland hormone, treatment group patient without any subjective uncomfortable, blood, urine, Stool routine examination and the heart, Liver and kidney function etc. check exception all do not occur.
In a word, compared with prior art, the present invention both have followed Chinese medical discrimination medicine law, has incorporated again modern pharmacology, legislation Comprehensively, according to the monarch rigorous prescription of principle compatibility, there is Mutiple Targets, too many levels, multi-level comprehensive regulation effect, be The rational drug of the treatment postoperative syndrome of deficiency of both qi and yin of thyroid carcinoma；Meanwhile, clinical efficacy is definite, can significantly reduce postoperative serum first shape Gland globulin levels thus prevent cancerous protuberance recurrence and transfer, patient compliance is preferable, taking convenience, can effectively alleviate patient and bear Load and misery, it is possible to reach the purpose for the treatment of both the principal and secondary aspects of a disease, wide popularization and application on clinic.
Detailed description of the invention
Further describing the present invention below by way of specific embodiment, the present invention is not limited only to following example.Model in the present invention Enclose interior or without departing from present disclosure, spirit and scope, change that the present invention is carried out, combine or replace, for It is apparent from for those skilled in the art, and is included within the scope of the present invention.
Embodiment 1 capsule
Prescription: Fructus Ligustri Lucidi 20 parts, Rhizoma Polygonati Odorati 10 parts, Rhizoma panacis majoris 20 parts, Radix Tylophorae arenicolae 10 parts, Radix caricis siderostictae 8 parts, Fructus Pandani tectorii 12 parts, gold Semen Citri Reticulatae 4 parts, Radix Apioris Fortunei (Radix Lespedezae Buergeri) 12 parts, Radix ampelopsis brevipedunculatae 8 parts, Herba Urariae Lagopodioidis 12 parts, pale reddish brown winged euonymus 8 parts.
Preparation method: (1) takes Radix caricis siderostictae, Fructus Pandani tectorii, Semen Fortunellae Margaritae, Radix Apioris Fortunei (Radix Lespedezae Buergeri) pulverizing, mixing by prescription, adds described four Chinese medicine The concentration that material weight portion is 5 times is the alcohol reflux 2 times of 50%, and the time being every time heated to reflux is 0.5～2 hour, collects precipice Palm fibre root, Fructus Pandani tectorii, Semen Fortunellae Margaritae, Radix Apioris Fortunei (Radix Lespedezae Buergeri) ethanol extraction after filtering residue, united extraction liquid, filter, concentrating under reduced pressure becomes thick paste；
(2) by prescription weigh Fructus Ligustri Lucidi, Rhizoma Polygonati Odorati, Rhizoma panacis majoris, Radix Tylophorae arenicolae, Radix ampelopsis brevipedunculatae, Herba Urariae Lagopodioidis, pale reddish brown winged euonymus and precipice Filtering residue mixing after palm fibre root, Fructus Pandani tectorii, Semen Fortunellae Margaritae, Radix Apioris Fortunei (Radix Lespedezae Buergeri) ethanol extraction, the water boiling and extraction of 5 times of weight portions of addition 2 times, often Secondary decocting time is 1～2 hour, united extraction liquid, filters, and stands, takes supernatant, and concentrating under reduced pressure becomes thick paste；
(3) the thick paste mixing (1) and (2) obtained, is ground into the fine powder of 200-400 mesh after lyophilization, thin with this Powder, as active constituents of medicine, is prepared by this area conventional formulation technique and be get final product.The present embodiment capsule, every loading amount 0.4g, Be equivalent to crude drug 1.24g.
Embodiment 2 capsule
Prescription: Fructus Ligustri Lucidi 20 parts, Rhizoma Polygonati Odorati 15 parts, Rhizoma panacis majoris 22 parts, Radix Tylophorae arenicolae 12 parts, Radix caricis siderostictae 12 parts, Fructus Pandani tectorii 10 parts, Semen Fortunellae Margaritae 5 parts, Radix Apioris Fortunei (Radix Lespedezae Buergeri) 15 parts, Radix ampelopsis brevipedunculatae 10 parts, Herba Urariae Lagopodioidis 10 parts, pale reddish brown winged euonymus 8 parts.
Preparation method: (1) takes Radix caricis siderostictae, Fructus Pandani tectorii, Semen Fortunellae Margaritae, Radix Apioris Fortunei (Radix Lespedezae Buergeri) pulverizing, mixing by prescription, adds described four Chinese medicine The concentration that material weight portion is 5 times is the alcohol reflux 2 times of 55%, and the time being every time heated to reflux is 0.5～2 hour, collects precipice palm fibre Root, Fructus Pandani tectorii, Semen Fortunellae Margaritae, Radix Apioris Fortunei (Radix Lespedezae Buergeri) ethanol extraction after filtering residue, united extraction liquid, filter, concentrating under reduced pressure becomes thick paste；
(2) by prescription weigh Fructus Ligustri Lucidi, Rhizoma Polygonati Odorati, Rhizoma panacis majoris, Radix Tylophorae arenicolae, Radix ampelopsis brevipedunculatae, Herba Urariae Lagopodioidis, pale reddish brown winged euonymus and precipice Filtering residue mixing after palm fibre root, Fructus Pandani tectorii, Semen Fortunellae Margaritae, Radix Apioris Fortunei (Radix Lespedezae Buergeri) ethanol extraction, the water boiling and extraction of 6 times of weight portions of addition 2 times, often Secondary decocting time is 1～2 hour, united extraction liquid, filters, and stands, takes supernatant, and concentrating under reduced pressure becomes thick paste；
(3) the thick paste mixing (1) and (2) obtained, is ground into the fine powder of 200-400 mesh after lyophilization, thin with this Powder, as active constituents of medicine, is prepared by this area conventional formulation technique and be get final product.
Embodiment 3 capsule
Prescription: Fructus Ligustri Lucidi 18 parts, Rhizoma Polygonati Odorati 15 parts, Rhizoma panacis majoris 20 parts, Radix Tylophorae arenicolae 10 parts, Radix caricis siderostictae 10 parts, Fructus Pandani tectorii 10 parts, Semen Fortunellae Margaritae 6 parts, Radix Apioris Fortunei (Radix Lespedezae Buergeri) 12 parts, Radix ampelopsis brevipedunculatae 8 parts, Herba Urariae Lagopodioidis 12 parts, pale reddish brown winged euonymus 6 parts.
Preparation method:
(1) take Radix caricis siderostictae, Fructus Pandani tectorii, Semen Fortunellae Margaritae, Radix Apioris Fortunei (Radix Lespedezae Buergeri) pulverizing, mixing by prescription, add described four Chinese medicine material weight portion 7 The alcohol reflux that concentration is 45% (preferably 50%) again 2 times, the time being every time heated to reflux is 0.5～2 hour, receives Collecting filtering residue after the ethanol extraction of Radix caricis siderostictae, Fructus Pandani tectorii, Semen Fortunellae Margaritae, Radix Apioris Fortunei (Radix Lespedezae Buergeri), united extraction liquid, filter, concentrating under reduced pressure becomes thick Cream；
(2) by prescription weigh Fructus Ligustri Lucidi, Rhizoma Polygonati Odorati, Rhizoma panacis majoris, Radix Tylophorae arenicolae, Radix ampelopsis brevipedunculatae, Herba Urariae Lagopodioidis, pale reddish brown winged euonymus and precipice Filtering residue mixing after palm fibre root, Fructus Pandani tectorii, Semen Fortunellae Margaritae, Radix Apioris Fortunei (Radix Lespedezae Buergeri) ethanol extraction, the water boiling and extraction of 8 times of weight portions of addition 2 times, often Secondary decocting time is 1～2 hour, united extraction liquid, filters, and stands, takes supernatant, and concentrating under reduced pressure becomes thick paste；
(3) the thick paste mixing (1) and (2) obtained, is ground into the fine powder of 200-400 mesh after lyophilization, thin with this Powder, as active constituents of medicine, is prepared by this area conventional formulation technique and be get final product.
Embodiment 4 capsule
Prescription: Fructus Ligustri Lucidi 22 parts, Rhizoma Polygonati Odorati 12 parts, Rhizoma panacis majoris 20 parts, Radix Tylophorae arenicolae 8 parts, Radix caricis siderostictae 12 parts, Fructus Pandani tectorii 10 parts, gold Semen Citri Reticulatae 5 parts, Radix Apioris Fortunei (Radix Lespedezae Buergeri) 15 parts, Radix ampelopsis brevipedunculatae 8 parts, Herba Urariae Lagopodioidis 10 parts, pale reddish brown winged euonymus 6 parts.
Preparation method: the operation with reference to embodiment 1-3 is carried out.
Embodiment 5 capsule
Prescription: Fructus Ligustri Lucidi 18 parts, Rhizoma Polygonati Odorati 15 parts, Rhizoma panacis majoris 22 parts, Radix Tylophorae arenicolae 13 parts, Radix caricis siderostictae 8 parts, Fructus Pandani tectorii 10 parts, gold Semen Citri Reticulatae 5 parts, Radix Apioris Fortunei (Radix Lespedezae Buergeri) 15 parts, Radix ampelopsis brevipedunculatae 7 parts, Herba Urariae Lagopodioidis 15 parts, pale reddish brown winged euonymus 8 parts.
Preparation method: the operation with reference to embodiment 1-3 is carried out.
Embodiment 6 capsule
Prescription: Fructus Ligustri Lucidi 20 parts, Rhizoma Polygonati Odorati 15 parts, Rhizoma panacis majoris 20 parts, Radix Tylophorae arenicolae 13 parts, Radix caricis siderostictae 10 parts, Fructus Pandani tectorii 10 parts, Semen Fortunellae Margaritae 4 parts, Radix Apioris Fortunei (Radix Lespedezae Buergeri) 10 parts, Radix ampelopsis brevipedunculatae 12 parts, Herba Urariae Lagopodioidis 12 parts, pale reddish brown winged euonymus 9 parts.
Preparation method: the operation with reference to embodiment 1-3 is carried out.
Embodiment 7 capsule
Prescription: Fructus Ligustri Lucidi 22 parts, Rhizoma Polygonati Odorati 13 parts, Rhizoma panacis majoris 22 parts, Radix Tylophorae arenicolae 13 parts, Radix caricis siderostictae 7 parts, Fructus Pandani tectorii 15 parts, gold Semen Citri Reticulatae 6 parts, Radix Apioris Fortunei (Radix Lespedezae Buergeri) 12 parts, Radix ampelopsis brevipedunculatae 10 parts, Herba Urariae Lagopodioidis 10 parts, pale reddish brown winged euonymus 8 parts.
Preparation method: the operation with reference to embodiment 1-3 is carried out.
Embodiment 8 capsule
Prescription: Fructus Ligustri Lucidi 18 parts, Rhizoma Polygonati Odorati 12 parts, Rhizoma panacis majoris 20 parts, Radix Tylophorae arenicolae 12 parts, Radix caricis siderostictae 7 parts, Fructus Pandani tectorii 13 parts, gold Semen Citri Reticulatae 5 parts, Radix Apioris Fortunei (Radix Lespedezae Buergeri) 10 parts, Radix ampelopsis brevipedunculatae 10 parts, Herba Urariae Lagopodioidis 10 parts, pale reddish brown winged euonymus 8 parts.
Preparation method: the operation with reference to embodiment 1-3 is carried out.
The clinical observation of thyroid carcinoma postoperative patient is tested by embodiment 9 pharmaceutical composition of the present invention
1 data and method
1.1 physical data: choose Operation of Thyroid Carcinoma patient 84 example that in January, 2010 in December ,-2013 is the most medical in the court, Man's 29 examples, female 55 example；Age 24～57 years old；Art formula includes Ipsilateral gland leaf excision+isthmus excision+central lymph node dissection art 36 Example, bilateral gland lobectomy+Functional Neck Dissection 48 example.All cases is made a definite diagnosis by histology or pathological examination, Wherein papillary carcinoma 72 example, filter blocking cancer 12 example.
Random digits table is used to be randomly divided into treatment group and matched group, each 42 examples.Treatment group, male 15 examples, female 27 example；Mean age 34.6 ± 8.4 years old；Matched group man's 14 examples, female 28 example；33.8 ± 8.1 years old mean age；Estimate life cycle for two groups to be all higher than 6 months, Two groups, at the no significant difference (P ＞ 0.05) of the aspects such as sex, age, pathology, have comparability.
1.2 diagnostic criterias:
1.2.1 diagnosis of thyroid cancer standard: make a definite diagnosis through preoperative B ultrasonic, thyroid radioisotope scanning or needle biopsy, and warp Verified by postoperative pathology is diagnosed as thyroid carcinoma；Accompany or without abnormal thyroid function.
1.2.2 Chinese medical discrimination is customized to syndrome of deficiency of both qi and yin, clinical table with reference to " new Chinese medicine guideline of clinical investigations " such as Zheng Xiao cornels Being now spiritlessness and weakness, deficiency of QI with disinclination to talk, hoarseness, dryness of the mouth and throat, being irritable and getting angry easily, sensation of oppression over the chest with shortness of breath, To Be Protected from Heat hyperhidrosis, body disappears Thin, light red tongue point is red, few tongue, thready pulse without strength.Tcm symptom is marked: asymptomatic meter 0 point, slight meter 1 point, moderate meter 2 points, Severe meter 3 points.
1.3 case exclusion standards: gestation, women breast-feeding their children, abnormal liver function person；It is associated with cardiovascular, liver, kidney and hemopoietic The severe primary diseases such as system, psychotic；Accept other Chinese medicines, glucocorticoid and other immunosuppressant treatment person.
1.4 Therapeutic Method:
Matched group: give levothyroxine sodium tables treatment, adjust dosage according to thyroid function.Treatment group: in treatment of control group On the basis of add with the embodiment of the present invention 1 preparation capsule for treating, twice on the one, each 4-6 grain.Two groups all being January 1 course for the treatment of, 3 courses for the treatment of carry out observation of curative effect after terminating.
1.5 observation index: measure Elityran TG before and after treatment；Observe spiritlessness and weakness, inappetence, dry mouth and tougue, The change of the qi-yin deficiency syndromes such as spontaneous sweating, vexed insomnia, tongue fur pulse condition, the syndrome before record treatment and after treatment is commented respectively Point.
1.6 efficacy assessment standards: comprehensive therapeutic effect criterion: computing formula: before (integration after integration-treatment before treatment)/treatment Integration, is expressed as a percentage.Recovery from illness: symptom and sign disappears substantially, integration is more than or equal to 90%；Effective: symptom and sign is bright Aobvious improvement, integration is more than or equal to 75%；Effective: symptom and sign take a favorable turn, integration is more than or equal to 35%；Invalid: symptom Sign is not improved, even increase the weight of, integration is less than 35%.
1.7 statistical analysis use spss16.0 statistical software to be analyzed, and the comparison of enumeration data two sample rate uses X2Inspection, Measurement data withRepresenting, comparing before and after treatment with paired t-test, compare employing t inspection between group, P ＜ 0.05 represents that difference has Statistical significance.
2 results
Two groups of patient clinical comparitive study after 2.1 treatments: after 3 courses for the treatment of, treatment group cures 14 examples, effective 19 examples, effective 7 examples, Invalid 2 examples, total effective rate 95.2%；And matched group cures 6 examples, effective 9 examples, effective 17 examples, invalid 10 examples, total effective rate 76.2%, The therapeutic effect for the treatment of group is substantially better than matched group, difference statistically significant (P ＜ 0.01).It is shown in Table 1.
Two groups of patient clinical comparitive study after table 1 treatment, example (%)
Note: matched group compares, * P ＜ 0.01.
Before and after 2.2 liang of group treatments, syndrome total mark compares, and is shown in Table 2.After two groups of treatments, syndrome integral all significantly improves, before treatment Comparing difference all has significant (P ＜ 0.05, P ＜ 0.01)；Comparing between two groups after treatment, difference also has statistics meaning (P ＜ 0.05).
2 liang of table group treatment before and after disease total mark compare (Point)
Note: compare with treatment, * P ＜ 0.05, * * P ＜ 0.01；Compare between group,#P ＜ 0.05.
Main syndromes integral contrast before and after 2.3 liang of group treatments, is shown in Table 3.After two groups of treatments, syndrome integral all significantly improves, with treatment Front comparison, difference all has significant (P ＜ 0.05, P ＜ 0.01)；Comparing after two groups of treatments, difference also has significant (P ＜ 0.05).
Main disease integral contrast before and after the group treatment of 3 liang of table (Point)
Note: compare with before group treatment, * P ＜ 0.05, * * P ＜ 0.01；Compare between group after treatment,#P ＜ 0.05.
The change of TG value before and after 2.4 liang of group treatments: TG value comparing difference not statistically significant before two groups of treatments, has comparability. After treatment, treatment group TG value is obviously reduced, comparing difference statistically significant (P ＜ 0.05) front with treatment, matched group and treatment Front comparison, no significant difference, compares between two groups after treatment, difference statistically significant (P ＜ 0.05), treatment group TG What value reduced becomes apparent from.It is shown in Table 4.
The change of TG value before and after the group treatment of 4 liang of table, (ug/L)
Note: compare with treatment, * P ＜ 0.05；Compare between group,#P ＜ 0.05.
2.5 untoward reaction and safety detection: treatment group during observing, FT3、FT4And TSH there is no significant change, medicine is described Compositions is the least for the function effect of thyroid gland hormone, and treatment group patient, without any subjective uncomfortable, blood, urinate, defecates Conventional and the heart, Liver and kidney function etc. check exception all do not occur.
This result of study shows, the present invention medication combined levothyroxine sodium treatment thyroid carcinoma is postoperative is alleviating clinical symptoms, fall The aspects such as low blood serum TG content, minimizing TCM syndrome integration are respectively provided with positive effect, and clinic is worthy to be popularized.

Claims (10)

1. the pharmaceutical composition treating the postoperative syndrome of deficiency of both qi and yin of thyroid carcinoma, it is characterised in that by Fructus Ligustri Lucidi, Rhizoma Polygonati Odorati, bead Ginseng, Radix Tylophorae arenicolae, Radix caricis siderostictae, Fructus Pandani tectorii, Semen Fortunellae Margaritae, Radix Apioris Fortunei (Radix Lespedezae Buergeri), Radix ampelopsis brevipedunculatae, Herba Urariae Lagopodioidis, pale reddish brown winged euonymus are medicinal raw material Elaborate.
2. the pharmaceutical composition treating the postoperative syndrome of deficiency of both qi and yin of thyroid carcinoma as claimed in claim 1, it is characterised in that by following The medicinal raw material of weight is made: Fructus Ligustri Lucidi 18-23 part, Rhizoma Polygonati Odorati 10-15 part, Rhizoma panacis majoris 20-25 part, Radix Tylophorae arenicolae 8-13 part, Radix caricis siderostictae 7-12 part, Fructus Pandani tectorii 10-15 part, Semen Fortunellae Margaritae 4-6 part, Radix Apioris Fortunei (Radix Lespedezae Buergeri) 10-15 part, Radix ampelopsis brevipedunculatae 7-12 part, Herba Urariae Lagopodioidis 10-15 Part, pale reddish brown winged euonymus 6-9 part.
3. the pharmaceutical composition treating the postoperative syndrome of deficiency of both qi and yin of thyroid carcinoma as claimed in claim 2, it is characterised in that by following The medicinal raw material of preferred weight part proportioning is made: Fructus Ligustri Lucidi 20 parts, Rhizoma Polygonati Odorati 10 parts, Rhizoma panacis majoris 20 parts, Radix Tylophorae arenicolae 10 parts, precipice palm fibre Root 8 parts, Fructus Pandani tectorii 12 parts, Semen Fortunellae Margaritae 4 parts, Radix Apioris Fortunei (Radix Lespedezae Buergeri) 12 parts, Radix ampelopsis brevipedunculatae 8 parts, Herba Urariae Lagopodioidis 12 parts, pale reddish brown winged euonymus 8 parts.
4. the pharmaceutical composition treating the postoperative syndrome of deficiency of both qi and yin of thyroid carcinoma as claimed in claim 2, it is characterised in that by following The medicinal raw material of preferred weight part proportioning is made: Fructus Ligustri Lucidi 20 parts, Rhizoma Polygonati Odorati 15 parts, Rhizoma panacis majoris 22 parts, Radix Tylophorae arenicolae 12 parts, precipice palm fibre Root 12 parts, Fructus Pandani tectorii 10 parts, Semen Fortunellae Margaritae 5 parts, Radix Apioris Fortunei (Radix Lespedezae Buergeri) 15 parts, Radix ampelopsis brevipedunculatae 10 parts, Herba Urariae Lagopodioidis 10 parts, pale reddish brown winged euonymus 8 parts.
5. the pharmaceutical composition of the postoperative syndrome of deficiency of both qi and yin for the treatment of thyroid carcinoma as described in claim 1-4 is arbitrary, its feature is described Pharmaceutical composition is preferably made as peroral dosage form.
6. the pharmaceutical composition treating the postoperative syndrome of deficiency of both qi and yin of thyroid carcinoma as claimed in claim 5, its feature is described oral Dosage form is preferably tablet, sugar coated tablet, film coated tablet, enteric coated tablet, capsule, hard capsule, soft capsule, mouth Take liquid, granule, electuary, pill, powder, suspensoid, powder, etc..
7. the pharmaceutical composition treating the postoperative syndrome of deficiency of both qi and yin of thyroid carcinoma as claimed in claim 6, its feature is described oral Dosage form is preferably tablet, capsule, tablet, oral liquid, granule or pill.
8. the pharmaceutical composition treating the postoperative syndrome of deficiency of both qi and yin of thyroid carcinoma as claimed in claim 7, its feature is described oral Dosage form is preferably capsule.
9. the pharmaceutical composition of the postoperative syndrome of deficiency of both qi and yin for the treatment of thyroid carcinoma as described in claim 1-8 is arbitrary, its feature is described The preparation method of pharmaceutical composition comprises the following steps:
(1) take Radix caricis siderostictae by prescription, Fructus Pandani tectorii, Semen Fortunellae Margaritae, Radix Apioris Fortunei (Radix Lespedezae Buergeri) are pulverized, mixing, add the dense of medical material weight portion 3～8 times The alcohol reflux that degree is 40%-60% (preferably 50%) 2 times, the time being every time heated to reflux is 0.5～2 hour, collects Radix caricis siderostictae, Fructus Pandani tectorii, Semen Fortunellae Margaritae, Radix Apioris Fortunei (Radix Lespedezae Buergeri) ethanol extraction after filtering residue, united extraction liquid, filter, concentrating under reduced pressure becomes thick paste；
(2) Fructus Ligustri Lucidi, Rhizoma Polygonati Odorati, Rhizoma panacis majoris, Radix Tylophorae arenicolae, Radix ampelopsis brevipedunculatae, Herba Urariae Lagopodioidis, pale reddish brown winged euonymus and precipice palm fibre are weighed by prescription Filtering residue mixing after root, Fructus Pandani tectorii, Semen Fortunellae Margaritae, Radix Apioris Fortunei (Radix Lespedezae Buergeri) ethanol extraction, the water boiling and extraction of 2～10 times of weight portions of addition 2 times, Decocting time is 1～2 hour every time, united extraction liquid, filters, and stands, takes supernatant, and concentrating under reduced pressure becomes thick paste；
(3) thick paste mixing step (1) and step (2) obtained, is ground into the fine powder of 200-400 mesh after lyophilization, With this fine powder as active constituents of medicine, this active constituents of medicine individually or mixes, by this area with pharmaceutically acceptable carrier Conventional formulation technique is prepared and get final product.
10. claim 1-9 arbitrary described pharmaceutical composition use in preparation treatment thyroid carcinoma postoperative syndrome of deficiency of both qi and yin medicine On the way.
CN201610343664.7A 2016-05-20 2016-05-20 Medicine composition for treating qi and yin deficiency syndrome after thyroid cancer operation Withdrawn CN105853722A (en)

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Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
谷言芳等: "《谷铭三治疗肿瘤经验集》", 28 February 2002, 上海科学技术出版社 *

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Application publication date: 20160817