CN103263587B - Traditional Chinese medicine preparation for treating toxic and side effects of nasopharyngeal carcinoma after radiotherapy and preparation method thereof - Google Patents

Traditional Chinese medicine preparation for treating toxic and side effects of nasopharyngeal carcinoma after radiotherapy and preparation method thereof Download PDF

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CN103263587B
CN103263587B CN201310175645.4A CN201310175645A CN103263587B CN 103263587 B CN103263587 B CN 103263587B CN 201310175645 A CN201310175645 A CN 201310175645A CN 103263587 B CN103263587 B CN 103263587B
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radix
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李永团
迟晓艳
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Qingdao Municipal Hospital
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Abstract

The invention provides a traditional Chinese medicine preparation for treating toxic and side effects of nasopharyngeal carcinoma after radiotherapy and a preparation method thereof. The traditional Chinese medicine preparation comprises the following raw medicinal materials: radix codonopsitis, ophiopogon root, Schisandra chinensis, radix astragali, Caulis Spatholobi, blackberry lily, fructus jujubae, radix pseudostellariae, Eclipta, wolfberry fruit, glossy privet fruit, balloonflower, chrysanthemum, white atractylodes rhizome, Asparagus Cochinchinensis, radix adenophorae, saffron, liquorice, radix paeoniae alba, radix scrophulariae, dendrobe, Polygonatum, Pinellia ternata, dried rehamnnia root, peppermint, periostracum cicada and honeycombs. The traditional Chinese medicine preparation provided by the invention has the beneficial effects that the toxic and side effects generated when cancer cells are damaged by rays after the conventional simple chemotherapy are overcome by mainly strengthening body resistance and utilizing therapeutic principles of nourishing yin and promoting the secretion, reinforcing vital energy and nourishing blood and clearing away heat and toxic materials according to principles of syndrome differentiation and treatment, the whole body conditions can be improved, radiotherapy and chemotherapy reactions can be relieved, and treating effects can be improved as well; and the traditional Chinese medicine preparation has the advantages of small side effect, low cost and no drug resistance.

Description

A kind of Chinese medicine preparation and preparation method for the treatment of toxic and side effects after nasopharyngeal carcinoma radiotherapy
Technical field
The present invention relates to technical field of Chinese medicines, relate in particular to a kind of Chinese medicine preparation and preparation method for the treatment of toxic and side effects after nasopharyngeal carcinoma radiotherapy.
Background technology
Nasopharyngeal carcinoma (nasopharynega carcinoma, NPC) is a kind of common malignant tumor that is primary in rhinitis mucosa covering epithelium, relevant with viral infection, and has Family inherited inclination.Nasopharyngeal carcinoma is in south east asia and south China, and especially Guangdong Province's sickness rate is very high, and according to World Health Organization's statistics, the nasopharyngeal carcinoma of approximately 80% left and right occurs in China in the world, and therefore, the treatment of nasopharyngeal carcinoma is an important research direction of China's treatment of cancer.
At present, the mode for the treatment of nasopharyngeal carcinoma is mainly operation, radiation and chemotherapy.Because nasopharynx is positioned at head central authorities, be closely connected with basis cranii, vital tissue organ close relation with it, and nasopharyngeal carcinoma around has stronger aggressive, very easily invades structures surrounding, and rate of lymph-node metastasis is high, therefore adopts the mode of excision very difficult.Chemotherapy fails to improve overall survival, only can serve as the auxiliary treatment means of radiotherapy, and chemotherapeutics uses as cisplatin (DDP) and radiotherapy simultaneously, and energy loss is hindered human righteousness, makes toxic and side effects larger.
Nasopharyngeal carcinoma more than 90% for the lower squamous cell carcinoma of differentiation, more responsive to radiotherapy, therefore radiotherapy be nasopharyngeal carcinoma main be also the most effective treatment means.The prognosis of nasopharyngeal carcinoma is with by stages closely related, 5 years survival rates of nasopharyngeal carcinoma of radiation alone, I~IV phase is respectively 90%, 70%, 51% and 22%, current domestic III, the patient of IV phase have accounted for 2/3, and these patients exist high recurrence and high transfer case, advocate Comprehensive Treatment more, and chemotherapy still lacks individual scheme, chemotherapy can increase patient's body and mental burden simultaneously, and associated death increases, and seriously reduces life in patients.For early stage nasopharyngeal carcinoma, advocate radiation alone, unsuitable combined with chemotherapy.Therefore, how to improve early diagnosis, the early treatment of nasopharyngeal carcinoma, how to improve its survival rate and life quality, seem particularly important.
Radiotherapy is the first-selected Therapeutic Method of nasopharyngeal carcinoma, but ray is in damage cancerous cell, the normal structure wound that also can be partially damaged, generation toxicity.Clinical manifestation after damage can be divided into two kinds of acute reaction and late responses.Oral mucosa and skin injury are common toxicities, it is because ray is except coup injury mucosa and skin, and make the microvascular tube wall generation swelling in launched field, spasm, tube chamber narrows or stops up, make the bad and impact healing of damaged position blood supply, even ulcer, secondary infection etc., then there is pharyngalgia, drinking-water and feed difficulty, poor appetite, weak, dry skin dermatitis and moist reaction, severe patient is forced to suspend radiotherapy, need to strengthen suiting the medicine to the illness and the treatment such as support, so both reduced patient's life quality, extend again treatment time, patient's psychology and financial burden are increased, even reduce radiocurable effect.
Therefore, during Synchronous Radio chemotherapeutic treatment, prevent toxicity, the especially generation of oral mucosa reaction after underwent, can alleviate patient's misery, ensures to treat to carry out smoothly.Research shows, normal cell protective agent A meter Fu Ding (Amifostine) has obvious curative effect to alleviating during head and neck tumor chemoradiotherapy the toxicities such as oral mucosa reaction after underwent, has made some patients were be benefited after clinical use.But due to this drug price costliness, need repeatedly intravenously administrable, wide clinical application is restricted.
There is the tradition of utilizing treatment by Chinese herbs nasopharyngeal carcinoma in China, America and Europe also sets it as supplementary alternative medicine and studies, a large amount of scientific achievements show in recent years: Chinese medicine uses modern medicine treatment to have superiority with modern medicine combined treatment nasopharyngeal carcinoma than simple, and development prospect is wide.Chinese medicine can alleviate toxicity in nasopharyngeal carcinoma, suppresses the collagen fiber anabolic effect of radiotherapy district, alleviates sequela at a specified future date; Strengthen the sensitivity of tumor to chemicotherapy, suppress the existence of remaining cancerous cell, improve cure rate, the immunity of enhancing body, improves quality of life of patient, improve long term survival rate and late result etc., therefore the effect of Chinese medicine in treatment nasopharyngeal carcinoma is more and more noticeable.
Summary of the invention
Technical problem to be solved by this invention is, overcome ray toxicity that produces in damage cancerous cell after existing radiation alone, utilize the traditional theory of Chinese medical science of China, provide that a kind of side effect is little, good effect, cost is low, cure rate is high, have no drug resistance, improving the clinical efficacy of Nasopharyngeal Carcinoma Patients, quality of life, survival rate, especially toxic and side effects aspect has the Chinese medicine of greater advantage.
For solving the problems of the technologies described above, the invention provides a kind of Chinese medicine preparation for the treatment of toxic and side effects after nasopharyngeal carcinoma radiotherapy, comprise following raw medicinal material: Radix Codonopsis, Radix Ophiopogonis, Fructus Schisandrae Chinensis, the Radix Astragali, Caulis Spatholobi, Rhizoma Belamcandae, Fructus Jujubae, Radix Pseudostellariae, Herba Ecliptae, Fructus Lycii, Fructus Ligustri Lucidi, Radix Platycodonis, Flos Chrysanthemi, the Rhizoma Atractylodis Macrocephalae, Radix Asparagi, Radix Adenophorae (Radix Glehniae), Stigma Croci, Radix Glycyrrhizae, the Radix Paeoniae Alba, Radix Scrophulariae, Herba Dendrobii, Rhizoma Polygonati Odorati, the Rhizoma Pinelliae, Radix Rehmanniae, Herba Menthae, Periostracum Cicadae and Nidus Vespae.
Wherein: the ratio of weight and number of the each raw medicinal material in described Chinese medicine preparation can be preferably, Radix Codonopsis 20~40 weight portions, Radix Ophiopogonis 15~25 weight portion, Fructus Schisandrae Chinensis 20~30 weight portions, the Radix Astragali 20~40 weight portions, Caulis Spatholobi 10~30 weight portions, Rhizoma Belamcandae 10~25 weight portions, Fructus Jujubae 20~35 weight portions, Radix Pseudostellariae 20~30 weight portions, Herba Ecliptae 16~28 weight portions, Fructus Lycii 20~35 weight portions, Fructus Ligustri Lucidi 10~16 weight portions, Radix Platycodonis 10~20 weight portions, Flos Chrysanthemi 20~40 weight portions, the Rhizoma Atractylodis Macrocephalae 15~30 weight portions, Radix Asparagi 20~30 weight portions, Radix Adenophorae (Radix Glehniae) 25~35 weight portions, Stigma Croci 15~25 weight portions, Radix Glycyrrhizae 10~20 weight portions, the Radix Paeoniae Alba 12~25 weight portions, Radix Scrophulariae 10~30 weight portions, Herba Dendrobii 15~26 weight portions, Rhizoma Polygonati Odorati 15~25 weight portions, the Rhizoma Pinelliae 20~36 weight portions, Radix Rehmanniae 10~25 weight portions, Herba Menthae 10~20 weight portions, Periostracum Cicadae 25~40 weight portions and Nidus Vespae 20~45 weight portions.
Wherein: the ratio of weight and number of the each raw medicinal material in described Chinese medicine preparation can also be preferably, Radix Codonopsis 20~30 weight portions, Radix Ophiopogonis 15~20 weight portion, Fructus Schisandrae Chinensis 20~25 weight portions, the Radix Astragali 20~30 weight portions, Caulis Spatholobi 10~20 weight portions, Rhizoma Belamcandae 15~25 weight portions, Fructus Jujubae 25~35 weight portions, Radix Pseudostellariae 25~30 weight portions, Herba Ecliptae 20~26 weight portions, Fructus Lycii gives 20~30 weight portions, Fructus Ligustri Lucidi 10~14 weight portions, Radix Platycodonis 16~20 weight portions, Flos Chrysanthemi 20~35 weight portions, the Rhizoma Atractylodis Macrocephalae 15~25 weight portions, Radix Asparagi 25~30 weight portions, Radix Adenophorae (Radix Glehniae) 25~30 weight portions, Stigma Croci 15~20 weight portions, Radix Glycyrrhizae 10~16 weight portions, the Radix Paeoniae Alba 12~20 weight portions, Radix Scrophulariae 10~20 weight portions, Herba Dendrobii 15~20 weight portions, Rhizoma Polygonati Odorati 20~25 weight portions, the Rhizoma Pinelliae 20~30 weight portions, Radix Rehmanniae 10~20 weight portions, Herba Menthae 15~20 weight portions, Periostracum Cicadae 25~35 weight portions and Nidus Vespae 30~45 weight portions.
Wherein: the ratio of weight and number of the each raw medicinal material in described Chinese medicine preparation has and can be preferably, Radix Codonopsis 25 weight portions, Radix Ophiopogonis 18 weight portion, Fructus Schisandrae Chinensis 22 weight portions, the Radix Astragali 25 weight portions, Caulis Spatholobi 16 weight portions, Rhizoma Belamcandae 17 weight portions, Fructus Jujubae 30 weight portions, Radix Pseudostellariae 28 weight portions, Herba Ecliptae 22 weight portions, Fructus Lycii 25 weight portions, Fructus Ligustri Lucidi 12 weight portions, Radix Platycodonis 18 weight portions, Flos Chrysanthemi 26 weight portions, the Rhizoma Atractylodis Macrocephalae 23 weight portions, Radix Asparagi 27 weight portions, Radix Adenophorae (Radix Glehniae) 28 weight portions, Stigma Croci 20 weight portions, Radix Glycyrrhizae 13 weight portions, the Radix Paeoniae Alba 14 weight portions, Radix Scrophulariae 16 weight portions, Herba Dendrobii 18 weight portions, Rhizoma Polygonati Odorati 22 weight portions, the Rhizoma Pinelliae 24 weight portions, Radix Rehmanniae 15 weight portions, Herba Menthae 16 weight portions, Periostracum Cicadae 30 weight portions and Nidus Vespae 35 weight portions.
For solving the problems of the technologies described above, the present invention also provides the preparation method of above-mentioned Chinese medicine preparation, and in the time that the dosage form of described Chinese medicine preparation is oral liquid, its preparation method comprises the following steps,
The first step, Radix Codonopsis, the Radix Astragali, Caulis Spatholobi, Rhizoma Belamcandae, Radix Pseudostellariae, Radix Asparagi, Radix Adenophorae (Radix Glehniae), Radix Scrophulariae, Herba Dendrobii, Rhizoma Polygonati Odorati, the Rhizoma Pinelliae, Periostracum Cicadae and Nidus Vespae are mixed, the alcohol reflux that to add with respect to 3 times~6 times, mixture amount determining alcohols be 75%~85% 2 times~4 times, each 2 hours~3 hours, filter, filtrate merges, and reclaims ethanol, the mastic that while being concentrated into 70 DEG C, relative density is 1.30~1.32, for subsequent use;
Second step, is mixed in proportion all the other raw medicinal materials, adds with respect to 4~8 times of water gagings of mixture, boils 2~4 hours, filters the mastic that while being concentrated into 70 DEG C, relative density is 1.27~1.29;
The 3rd step, the mastic that the first step, second step are obtained mixes, and 50 DEG C~65 DEG C reduced vacuum are dry, and powder gets dry extract;
The 4th step, will the 3rd add ethanol in the described dried cream powder that obtains of step, obtain containing alcohol mastic, and described is 65%~70% containing alcohol mastic containing alcohol amount; Carry out successively cold preservation processing, precipitation process, filtration treatment, recovery Ethanol Treatment by described containing alcohol mastic, obtain dealcoholysis mastic, wherein, the cold preservation processing time is 36~48 hours;
The 5th step, adds cane sugar powder and active carbon in the described dealcoholysis mastic that the 4th step is obtained, and carries out successively heat treated, filtration treatment, dilution process, obtains semi-finished product; The weight ratio of described dealcoholysis mastic and described cane sugar powder is 1: 0.2~0.4; The weight ratio of described dealcoholysis mastic and described active carbon is 1: 0.001~0.002; The described heat treated time is 30~60 minutes, and temperature is 100 DEG C~140 DEG C;
The 6th step, then semi-finished product are carried out to filtration treatment, embedding processing, sterilization treatment successively, obtain the oral liquid finished product of described Chinese medicine preparation.
For solving the problems of the technologies described above, the present invention also provides the preparation method of above-mentioned Chinese medicine preparation, and in the time that the dosage form of described Chinese medicine preparation is tablet, its preparation method comprises the following steps,
The first step, Radix Codonopsis, the Radix Astragali, Caulis Spatholobi, Rhizoma Belamcandae, Radix Pseudostellariae, Radix Asparagi, Radix Adenophorae (Radix Glehniae), Radix Scrophulariae, Herba Dendrobii, Rhizoma Polygonati Odorati, the Rhizoma Pinelliae, Periostracum Cicadae and Nidus Vespae are mixed, the alcohol reflux that to add with respect to 3 times~6 times, mixture amount determining alcohols be 75%~85% 2 times~4 times, each 2 hours~3 hours, filter, filtrate merges, and reclaims ethanol, the mastic that while being concentrated into 70 DEG C, relative density is 1.30~1.32, for subsequent use;
Second step, is mixed in proportion all the other raw medicinal materials, adds with respect to 4~8 times of water gagings of mixture, boils 2~4 hours, filters the mastic that while being concentrated into 70 DEG C, relative density is 1.27~1.29;
The 3rd step, the mastic that the first step, second step are obtained mixes, and 50 DEG C~65 DEG C reduced vacuum are dry, and powder gets dry extract;
The 4th step, described dried cream powder and starch that the 3rd step is obtained mix processing, obtain mastic mixture; The weight ratio of described mastic and described starch is 1: 0.01~0.02; Described mastic mixture is carried out to pelletization treatment, dried, obtain mastic compound particles;
The 5th step, described mastic compound particles and Pulvis Talci, magnesium stearate that the 4th step is obtained mix processing, tabletting processing, Cotton seeds successively, obtain the tablet finished product of described Chinese medicine preparation; The weight ratio of described mastic compound particles, described Pulvis Talci, described magnesium stearate is 100: 1~3: 0.15~0.3.
Beneficial effect of the present invention:
Chinese medicine preparation provided by the invention, according to the principle of determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs, taking righting as main, with YIN nourishing and the production of body fluid promoting, benefiting QI and nourishing blood, enriching yin and nourishing kidney, heat-clearing and toxic substances removing etc. are Therapeutic Principle, overcome the toxicity that ray produces in damage cancerous cell after existing radiation alone, not only can improve systemic conditions, alleviate Radiotherapy chemotherapy reaction, and can improve curative effect, have advantages of that side effect is little, cost is low, have no drug resistance, improving the clinical efficacy of Nasopharyngeal Carcinoma Patients, quality of life, survival rate, especially toxic and side effects aspect has greater advantage.
Detailed description of the invention
In order to alleviate or to eliminate toxic and side effects after nasopharyngeal carcinoma radiotherapy, the invention provides a kind of mode of therapy of combining Chinese and Western medicine, in nasopharyngeal carcinoma process, take traditional Chinese medicine, the two combination, not only can improve systemic conditions simultaneously, alleviate Radiotherapy chemotherapy reaction, and can improve curative effect.According to the principle of determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs, taking righting as main, with YIN nourishing and the production of body fluid promoting, benefiting QI and nourishing blood, enriching yin and nourishing kidney, heat-clearing and toxic substances removing etc. are Therapeutic Principle, the invention provides a kind of Chinese medicine preparation for the treatment of toxic and side effects after nasopharyngeal carcinoma radiotherapy, comprise following raw medicinal material: Radix Codonopsis, Radix Ophiopogonis, Fructus Schisandrae Chinensis, the Radix Astragali, Caulis Spatholobi, Rhizoma Belamcandae, Fructus Jujubae, Radix Pseudostellariae, Herba Ecliptae, Fructus Lycii, Fructus Ligustri Lucidi, Radix Platycodonis, Flos Chrysanthemi, the Rhizoma Atractylodis Macrocephalae, Radix Asparagi, Radix Adenophorae (Radix Glehniae), Stigma Croci, Radix Glycyrrhizae, the Radix Paeoniae Alba, Radix Scrophulariae, Herba Dendrobii, Rhizoma Polygonati Odorati, the Rhizoma Pinelliae, Radix Rehmanniae, Herba Menthae, Periostracum Cicadae and Nidus Vespae.
Wherein, each raw medicinal material pharmacology is as follows:
Radix Codonopsis: sweet in the mouth, property is flat, enters lung, spleen channel, has QI invigorating strengthening the spleen, the effect of nourishing blood to promote the production of body fluid, be mainly used in deficiency of both the splenic and pulmonary QI or QI and blood deficiency fatigue and weakness, breathe hard, symptom such as cough spontaneous perspiration etc., Radix Codonopsis is longer than spleen reinforcing nourishing the stomach, adjust regulating the function of middle-JIAO, have the effect of nourishing blood concurrently, its property is flat, spleen invigorating fortune and not dry; Flavour is cloudy and not wet, can improve the immune state of body, improves resistance against diseases, facilitating digestion absorbs, and improves metabolism, promotes the absorption of intestinal to nutrient substance, Radix Codonopsis has certain antitumor assosting effect, can suppress the growth of gross tumor volume and weight, and reduces and shift.
Radix Ophiopogonis: sweet in the mouth, micro-hardship, cold nature.GUIXIN, lung, stomach warp.YIN nourishing and the production of body fluid promoting, lung moistening clears away heart-fire.For dryness of the lung dry cough.Chronic consumptive disease cough, Tianjin wound is thirsty, vexed insomnia, interior-heat is quenched one's thirst, dryness of the intestine constipation; Pharyngeal diphtheria.
Fructus Schisandrae Chinensis: sour in the mouth, sweet, warm in nature.Return lung, the heart, kidney channel.Restrain astringent or styptic treatment for spontaneous sweating, supplementing QI for promoting the production of body fluid, kidney calming.For chronic cough dyspnea due to deficiency, emission, enuresis frequent micturition, incessant chronic diarrhea, spontaneous perspiration, night sweat, Tianjin wound is thirsty, the deficient pulse of losing heart, interior-heat is quenched one's thirst, palpitation and insomnia.
The Radix Astragali: sweet in the mouth, warm in nature.Return lung, spleen channel.Invigorating QI to consolidate the body surface resistance, diuresis poison holding, evacuation of pus, expelling pus and promoting granulation.Weak for the deficiency of vital energy, anorexia and loose stool, sinking of QI of middle-JIAO, chronic diarrhea proctoptosis, the metrorrhagia of having blood in stool, exterior deficiency spontaneous perspiration, deficiency of vital energy edema, carbuncle is difficult bursts, and burst and do not hold back for a long time, blood deficiency dull yellowish colored skin, interior-heat is quenched one's thirst; Chronic nephritis proteinuria, diabetes.
Caulis Spatholobi: bitter in the mouth, sweet, warm in nature.Return liver, kidney channel.Enrich blood, invigorate blood circulation, dredging collateral.For menoxenia, blood deficiency and yellow complexion, paralysis and numbness, rheumatic arthralgia.
Rhizoma Belamcandae: bitter in the mouth, cold in nature.Return lung meridian.Heat-clearing and toxic substances removing, expectorant, sore-throat relieving.For the pent-up of pyretic toxicity phlegm-fire, laryngopharynx swelling and pain, accumulation and obstruction of sputum, cough and asthma.
Fructus Jujubae: sweet in the mouth, warm in nature.Return spleen, stomach warp.Invigorating the spleen and replenishing QI, nourishing blood to tranquillize the mind.For insufficiency of the spleen lack of appetite, weak loose stool, woman hysteria.
Radix Pseudostellariae: sweet in the mouth, micro-hardship, property is flat.Return spleen, lung meridian.Replenishing QI to invigorate the spleen, promoting the production of body fluid for nourishing the lung.Tired for insufficiency of the spleen body, inappetence, weak after being ill, deficiency of both vital energy and Yin, spontaneous perspiration is thirsty, dryness of the lung dry cough.
Herba Ecliptae: sweet in the mouth, acid, cold in nature.Return kidney, Liver Channel.Nourishing the liver and kidney, cooling blood for hemostasis.For odontoseisis, early whitening of beard and hair, vertigo and tinnitus, soreness of the waist and knees, YinXuXueRe, haematemesis, epistaxis, hematuria, dysentery, metrostaxis, traumatic hemorrhage.
Fructus Lycii: sweet in the mouth, property are flat, enter liver, kidney channel, have liver and kidney tonifying, nourish blood enrich blood, the effect of replenishing vital essence to improve eyesight, nourishing the lung to arrest cough, be mainly used in soreness of the waist and knees, dizziness and tinnitus, seminal emission tinnitus, the unconsciously sweat and tire of Liver and kidney two void, asthenia of essence and blood; The sexual impotence of insufficiency of kidney-YANG, sterile; The cards such as the dim-sighted and deficiency of YIN chronic cough of the eyes of deficiency of YIN-essence, deficiency of liver-blood, Fructus Lycii can promote liver cell regeneration, the effect of enhancing non-specific immunity function.
Fructus Ligustri Lucidi: sweet in the mouth, hardship, cool in nature.Return liver, kidney channel.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.
Radix Platycodonis: bitter in the mouth, pungent, property is flat.Return lung meridian.Lung qi dispersing, sore-throat relieving, eliminates the phlegm, evacuation of pus.For cough with copious phlegm, uncomfortable in chest not smooth, pharyngalgia, hoarseness, lung abscess vomiting pus, skin infection difficulty in discharging of pus.
Flos Chrysanthemi: sweet in the mouth, hardship, cold nature.Return lung, Liver Channel.Loose wind heat clearing away, suppressing the hyperactive liver improving eyesight.For anemopyretic cold, have a headache dizzy, conjunctival congestion and swelling pain, eyes is dim-sighted.
The Rhizoma Atractylodis Macrocephalae: bitter in the mouth, sweet, warm in nature.Return spleen, stomach warp.Invigorating the spleen and benefiting QI, dampness diuretic, hidroschesis, antiabortive.For insufficiency of the spleen lack of appetite, abdominal distention is had loose bowels, phlegm retention vertigo and palpitation, edema, spontaneous perspiration, frequent fetal movement.Rhizoma Atractylodis Macrocephalae spleen invigorating, stomach function regulating, antiabortive.For insufficiency of the spleen lack of appetite, the loose stool of having loose bowels, frequent fetal movement.The Rhizoma Atractylodis Macrocephalae also has the effects such as antioxidation, slow down aging, blood sugar lowering, anticoagulation, antitumor, the Rhizoma Atractylodis Macrocephalae can improve the immunologic function of body, increase quantity of leucocyte, the special active immunity of new-added item cancer cell antigen antibody, by reducing the rate of increase of oncocyte, lower the aggressive of tumor tissue, improve body antitumor respond and the cytotoxic effect to oncocyte, thereby suppress tumor.
Radix Asparagi: sweet in the mouth, hardship, cold in nature.Return lung, kidney channel.Nourishing YIN to relieve dryness, lung heat clearing is promoted the production of body fluid.For dryness of the lung dry cough, pertussis expectorant is glutinous, dry throat and mouth, dryness of the intestine constipation.
Radix Adenophorae (Radix Glehniae): sweet in the mouth, micro-hardship, cold nature.Return lung; Stomach warp.Replenishing YIN and removing heat; Moistening the lung and resolving phlegm; Reinforcing stomach reg fluid.Main deficiency of YIN chronic cough; The consumptive disease expectorant blood of coughing; Cough caused by dryness expectorant is few; Deficiency-heat sore throat; Tianjin wound is thirsty
Stigma Croci: sweet in the mouth, property is flat.Enter the heart, Liver Channel.Blood circulation promoting and blood stasis dispelling, dispersing stagnation and relieving accumulation of pathogens.Control troubled thoughts pent-up, chest and diaphragm painful abdominal mass is vexed, spits blood, and typhoid fever is gone mad, frightened fear in a trance, women's amenorrhea, postnatal blood stasis stomachache, tumbling and swelling.
Radix Glycyrrhizae: sweet in the mouth, property is flat.GUIXIN, lung, spleen, stomach warp.Invigorating the spleen and replenishing QI, heat-clearing and toxic substances removing, expelling phlegm for arresting cough, relieving spasm to stop pain, coordinating the actions of various ingredients in a prescription.For weakness of the spleen and stomach, fatigue and weakness, shortness of breath and palpitation, cough with copious phlegm, gastral cavity abdomen, the anxious pain of extremity contraction, carbuncle sore tumefacting virus, cushion toxicity, strong.
The Radix Paeoniae Alba: bitter in the mouth, acid, cold nature.Return liver, spleen channel.Suppressing the hyperactive liver pain relieving, nourishing blood for regulating menstruation, astringing YIN to stop sweating.Be used for having a headache dizzy, hypochondriac pain, stomachache, limb pain twin, blood deficiency and yellow complexion, menoxenia, spontaneous perspiration, night sweat.
Radix Scrophulariae: sweet in the mouth, hardship, one-tenth, cold nature, enters lung, stomach, kidney channel, have clearing away heat and cooling blood, nourishing YIN to lower pathogenic fire, effect of detoxicating and resolving stagnation of pathogens, for the warm febrile disease blood of joining the army, consumption of YIN caused by febrile disease, impairment of body fluid constipation, hectic fever due to YIN-deficiency phthisical cough, conjunctival congestion redness, pain after giving as security, the cards such as carbuncle sore tumefacting virus, have remarkable inhibitory action to staphylococcus aureus, diphtheria corynebacterium, Bacillus typhi etc., also have effect of antiinflammatory.
Herba Dendrobii: cold nature, sweet in the mouth, enters stomach, kidney channel, has reinforcing stomach reg fluid, nourishing YIN and clearing away heat, effect of lung moistening kidney tonifying, for consumption of body fluid by heat, low grade fever excessive thirst, the few tongue of red tongue; Deficiency of stomach-Yin, thirsty and dry pharynx, vomiting is eaten less, vague epigastralgia, the few tongue of tongue light; Deficiency of kidney yin, the cards such as blurring of vision.
Rhizoma Polygonati Odorati: sweet in the mouth, cold nature.Attach to the lung and stomach meridians.Nourishing YIN to relieve dryness, promoting the production of body fluid to quench thirst.For lung stomach-Yin wound, cough caused by dryness-heat, dry throat and mouth, interior-heat is quenched one's thirst.
The Rhizoma Pinelliae: acrid in the mouth, warm in nature; Poisonous.Return spleen, stomach, lung meridian.Drying dampness to eliminate phlegm, stopping nausea and vomiting by lowering the adverse flow of QI, dissolving lump and resolving mass.For abundant expectoration cough with asthma, phlegm retention vertigo and palpitation, dizziness due to wind-phlegm, syncope due to accumulation of phlegm headache, vomiting regurgitation, breast gastral cavity painful abdominal mass is vexed, globus hystericus; Raw with external treatment carbuncle sucutaneous nodule.Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) is used for stopping nausea and vomiting by lowering the adverse flow of QI.
Radix Rehmanniae: sweet in the mouth, cold in nature.GUIXIN, liver, kidney channel.Clearing away heat and cooling blood, yin nourishing, promotes the production of body fluid.For calentura crimson tongue excessive thirst, yin asthenia generating intrinsic heat, hectic fever due to YIN-deficiency consumptive fever, interior-heat is quenched one's thirst, and spits blood, and epistaxis, sends out speckle dermexanthesis.
Herba Menthae: acrid in the mouth, cool in nature.Return lung, Liver Channel.Dispelling wind-heat.Refresh oneself, rash.For anemopyretic cold, pathogenic wind-warm from the beginning of, headache, conjunctival congestion, sore throat, aphtha, rubella, measles, breast side of body feeling of distension and oppression.
Periostracum Cicadae: sweet in the mouth, cold in nature.Return lung, Liver Channel.Loose wind heat extraction, sore-throat relieving, rash, nebula removing, spasmolytic.For anemopyretic cold, pharyngalgia, hoarseness, measles without adequate eruption, rubella pruritus, conjunctival congestion cataracta, convulsion with spasms, tetanus.
Nidus Vespae: sweet in the mouth, property is flat.Return stomach warp.Dispel the wind, merit poison, parasite killing, pain relieving.For toothache due to dental caries, sore swollen toxin, acute mastitis, scrofula, skin stubborn dermatitis, fungal infection of hand and foot.
Wherein: the ratio of weight and number of the each raw medicinal material in described Chinese medicine preparation can be preferably, Radix Codonopsis 20~40 weight portions, Radix Ophiopogonis 15~25 weight portion, Fructus Schisandrae Chinensis 20~30 weight portions, the Radix Astragali 20~40 weight portions, Caulis Spatholobi 10~30 weight portions, Rhizoma Belamcandae 10~25 weight portions, Fructus Jujubae 20~35 weight portions, Radix Pseudostellariae 20~30 weight portions, Herba Ecliptae 16~28 weight portions, Fructus Lycii 20~35 weight portions, Fructus Ligustri Lucidi 10~16 weight portions, Radix Platycodonis 10~20 weight portions, Flos Chrysanthemi 20~40 weight portions, the Rhizoma Atractylodis Macrocephalae 15~30 weight portions, Radix Asparagi 20~30 weight portions, Radix Adenophorae (Radix Glehniae) 25~35 weight portions, Stigma Croci 15~25 weight portions, Radix Glycyrrhizae 10~20 weight portions, the Radix Paeoniae Alba 12~25 weight portions, Radix Scrophulariae 10~30 weight portions, Herba Dendrobii 15~26 weight portions, Rhizoma Polygonati Odorati 15~25 weight portions, the Rhizoma Pinelliae 20~36 weight portions, Radix Rehmanniae 10~25 weight portions, Herba Menthae 10~20 weight portions, Periostracum Cicadae 25~40 weight portions and Nidus Vespae 20~45 weight portions.
Wherein: the ratio of weight and number of the each raw medicinal material in described Chinese medicine preparation can also be preferably, Radix Codonopsis 20~30 weight portions, Radix Ophiopogonis 15~20 weight portion, Fructus Schisandrae Chinensis 20~25 weight portions, the Radix Astragali 20~30 weight portions, Caulis Spatholobi 10~20 weight portions, Rhizoma Belamcandae 15~25 weight portions, Fructus Jujubae 25~35 weight portions, Radix Pseudostellariae 25~30 weight portions, Herba Ecliptae 20~26 weight portions, Fructus Lycii 20~30 weight portions, Fructus Ligustri Lucidi 10~14 weight portions, Radix Platycodonis 16~20 weight portions, Flos Chrysanthemi 20~35 weight portions, the Rhizoma Atractylodis Macrocephalae 15~25 weight portions, Radix Asparagi 25~30 weight portions, Radix Adenophorae (Radix Glehniae) 25~30 weight portions, Stigma Croci 15~20 weight portions, Radix Glycyrrhizae 10~16 weight portions, the Radix Paeoniae Alba 12~20 weight portions, Radix Scrophulariae 10~20 weight portions, Herba Dendrobii 15~20 weight portions, Rhizoma Polygonati Odorati 20~25 weight portions, the Rhizoma Pinelliae 20~30 weight portions, Radix Rehmanniae 10~20 weight portions, Herba Menthae 15~20 weight portions, Periostracum Cicadae 25~35 weight portions and Nidus Vespae 30~45 weight portions.
Wherein: the ratio of weight and number of the each raw medicinal material in described Chinese medicine preparation has and can be preferably, Radix Codonopsis 25 weight portions, Radix Ophiopogonis 18 weight portion, Fructus Schisandrae Chinensis 22 weight portions, the Radix Astragali 25 weight portions, Caulis Spatholobi 16 weight portions, Rhizoma Belamcandae 17 weight portions, Fructus Jujubae 30 weight portions, Radix Pseudostellariae 28 weight portions, Herba Ecliptae 22 weight portions, Fructus Lycii 25 weight portions, Fructus Ligustri Lucidi 12 weight portions, Radix Platycodonis 18 weight portions, Flos Chrysanthemi 26 weight portions, the Rhizoma Atractylodis Macrocephalae 23 weight portions, Radix Asparagi 27 weight portions, Radix Adenophorae (Radix Glehniae) 28 weight portions, Stigma Croci 20 weight portions, Radix Glycyrrhizae 13 weight portions, the Radix Paeoniae Alba 14 weight portions, Radix Scrophulariae 16 weight portions, Herba Dendrobii 18 weight portions, Rhizoma Polygonati Odorati 22 weight portions, the Rhizoma Pinelliae 24 weight portions, Radix Rehmanniae 15 weight portions, Herba Menthae 16 weight portions, Periostracum Cicadae 30 weight portions and Nidus Vespae 35 weight portions.
For solving the problems of the technologies described above, the present invention also provides the preparation method of above-mentioned Chinese medicine preparation, and in the time that the dosage form of described Chinese medicine preparation is oral liquid, its preparation method comprises the following steps,
The first step, Radix Codonopsis, the Radix Astragali, Caulis Spatholobi, Rhizoma Belamcandae, Radix Pseudostellariae, Radix Asparagi, Radix Adenophorae (Radix Glehniae), Radix Scrophulariae, Herba Dendrobii, Rhizoma Polygonati Odorati, the Rhizoma Pinelliae, Periostracum Cicadae and Nidus Vespae are mixed, the alcohol reflux that to add with respect to 3 times~6 times, mixture amount determining alcohols be 75%~85% 2 times~4 times, each 2 hours~3 hours, filter, filtrate merges, and reclaims ethanol, the mastic that while being concentrated into 70 DEG C, relative density is 1.30~1.32, for subsequent use;
Second step, is mixed in proportion all the other raw medicinal materials, adds with respect to 4~8 times of water gagings of mixture, boils 2~4 hours, filters the mastic that while being concentrated into 70 DEG C, relative density is 1.27~1.29;
The 3rd step, the mastic that the first step, second step are obtained mixes, and 50 DEG C~65 DEG C reduced vacuum are dry, and powder gets dry extract;
The 4th step, will the 3rd add ethanol in the described dried cream powder that obtains of step, obtain containing alcohol mastic, and described is 65%~70% containing alcohol mastic containing alcohol amount; Carry out successively cold preservation processing, precipitation process, filtration treatment, recovery Ethanol Treatment by described containing alcohol mastic, obtain dealcoholysis mastic, wherein, the cold preservation processing time is 36~48 hours;
The 5th step, adds cane sugar powder and active carbon in the described dealcoholysis mastic that the 4th step is obtained, and carries out successively heat treated, filtration treatment, dilution process, obtains semi-finished product; The weight ratio of described dealcoholysis mastic and described cane sugar powder is 1: 0.2~0.4; The weight ratio of described dealcoholysis mastic and described active carbon is 1: 0.001~0.002; The described heat treated time is 30~60 minutes, and temperature is 100 DEG C~140 DEG C;
The 6th step, then semi-finished product are carried out to filtration treatment, embedding processing, sterilization treatment successively, obtain the oral liquid finished product of described Chinese medicine preparation.
For solving the problems of the technologies described above, the present invention also provides the preparation method of above-mentioned Chinese medicine preparation, and in the time that the dosage form of described Chinese medicine preparation is tablet, its preparation method comprises the following steps,
The first step, Radix Codonopsis, the Radix Astragali, Caulis Spatholobi, Rhizoma Belamcandae, Radix Pseudostellariae, Radix Asparagi, Radix Adenophorae (Radix Glehniae), Radix Scrophulariae, Herba Dendrobii, Rhizoma Polygonati Odorati, the Rhizoma Pinelliae, Periostracum Cicadae and Nidus Vespae are mixed, the alcohol reflux that to add with respect to 3 times~6 times, mixture amount determining alcohols be 75%~85% 2 times~4 times, each 2 hours~3 hours, filter, filtrate merges, and reclaims ethanol, the mastic that while being concentrated into 70 DEG C, relative density is 1.30~1.32, for subsequent use;
Second step, is mixed in proportion all the other raw medicinal materials, adds with respect to 4~8 times of water gagings of mixture, boils 2~4 hours, filters the mastic that while being concentrated into 70 DEG C, relative density is 1.27~1.29;
The 3rd step, the mastic that the first step, second step are obtained mixes, and 50 DEG C~65 DEG C reduced vacuum are dry, and powder gets dry extract;
The 4th step, described dried cream powder and starch that the 3rd step is obtained mix processing, obtain mastic mixture; The weight ratio of described mastic and described starch is 1: 0.01~0.02; Described mastic mixture is carried out to pelletization treatment, dried, obtain mastic compound particles;
The 5th step, described mastic compound particles and Pulvis Talci, magnesium stearate that the 4th step is obtained mix processing, tabletting processing, Cotton seeds successively, obtain the tablet finished product of described Chinese medicine preparation; The weight ratio of described mastic compound particles, described Pulvis Talci, described magnesium stearate is 100: 1~3: 0.15~0.3.
Below adopt embodiment to describe embodiments of the present invention in detail, to the present invention, how application technology means solve technical problem whereby, and the implementation procedure of reaching technique effect can fully understand and implement according to this.
Embodiment 1: oral solutions prepared by the present invention
Radix Codonopsis 250g, Radix Ophiopogonis 180g, Fructus Schisandrae Chinensis 220g, Radix Astragali 250g, Caulis Spatholobi 160g, Rhizoma Belamcandae 170g, Fructus Jujubae 300g, Radix Pseudostellariae 280g, Herba Ecliptae 220g, Fructus Lycii 250g, Fructus Ligustri Lucidi 120g, Radix Platycodonis 180g, Flos Chrysanthemi 260g, Rhizoma Atractylodis Macrocephalae 230g, Radix Asparagi 270g, Radix Adenophorae (Radix Glehniae) 280g, Stigma Croci 200g, Radix Glycyrrhizae 130g, Radix Paeoniae Alba 140g, Radix Scrophulariae 160g, Herba Dendrobii 180g, Rhizoma Polygonati Odorati 220g, Rhizoma Pinelliae 240g, Radix Rehmanniae 150g, Herba Menthae 160g, Periostracum Cicadae 300g and Nidus Vespae 350g.
Its preparation method comprises the following steps,
The first step, Radix Codonopsis, the Radix Astragali, Caulis Spatholobi, Rhizoma Belamcandae, Radix Pseudostellariae, Radix Asparagi, Radix Adenophorae (Radix Glehniae), Radix Scrophulariae, Herba Dendrobii, Rhizoma Polygonati Odorati, the Rhizoma Pinelliae, Periostracum Cicadae and Nidus Vespae are mixed, the alcohol reflux that to add with respect to 5 times, mixture amount determining alcohols be 80% 4 times, each 2 hours, filter, filtrate merges, and reclaims ethanol, the mastic that while being concentrated into 70 DEG C, relative density is 1.30, for subsequent use;
Second step, is mixed in proportion all the other raw medicinal materials, adds with respect to 6 times of water gagings of mixture, boils 3 hours, filters the mastic that while being concentrated into 70 DEG C, relative density is 1.29;
The 3rd step, the mastic that the first step, second step are obtained mixes, and 60 DEG C of reduced vacuum are dry, and powder gets dry extract;
The 4th step, adds ethanol in the dried cream powder that the 3rd step is obtained, and obtains containing alcohol mastic, and is 65% containing alcohol mastic containing alcohol amount; To carry out successively cold preservation processing, precipitation process, filtration treatment, recovery Ethanol Treatment containing alcohol mastic, and obtain dealcoholysis mastic, wherein, the cold preservation processing time is 48 hours;
The 5th step, adds cane sugar powder and active carbon in the dealcoholysis mastic that the 4th step is obtained, and carries out successively heat treated, filtration treatment, dilution process, obtains semi-finished product; The weight ratio of dealcoholysis mastic and cane sugar powder is 1: 0.3; The weight ratio of dealcoholysis mastic and active carbon is 1: 0.001; The heat treated time is 60 minutes, and temperature is 120 DEG C;
The 6th step, then semi-finished product are carried out to filtration treatment, embedding processing, sterilization treatment successively, obtain the oral liquid finished product of Chinese medicine preparation.
Embodiment 2: tablet prepared by the present invention
Radix Codonopsis 280g, Radix Ophiopogonis 160g, Fructus Schisandrae Chinensis 240g, Radix Astragali 220g, Caulis Spatholobi 120g, Rhizoma Belamcandae 220g, Fructus Jujubae 260g, Radix Pseudostellariae 260g, Herba Ecliptae 200g, Fructus Lycii 220g, Fructus Ligustri Lucidi 130g, Radix Platycodonis 160g, Flos Chrysanthemi 280g, Rhizoma Atractylodis Macrocephalae 180g, Radix Asparagi 250g, Radix Adenophorae (Radix Glehniae) 260g, Stigma Croci 160g, Radix Glycyrrhizae 110g, Radix Paeoniae Alba 160g, Radix Scrophulariae 110g, Herba Dendrobii 150g, Rhizoma Polygonati Odorati 240g, Rhizoma Pinelliae 250g, Radix Rehmanniae 120g, Herba Menthae 170g, Periostracum Cicadae 320g and Nidus Vespae 380g.
Its preparation method comprises the following steps,
The first step, Radix Codonopsis, the Radix Astragali, Caulis Spatholobi, Rhizoma Belamcandae, Radix Pseudostellariae, Radix Asparagi, Radix Adenophorae (Radix Glehniae), Radix Scrophulariae, Herba Dendrobii, Rhizoma Polygonati Odorati, the Rhizoma Pinelliae, Periostracum Cicadae and Nidus Vespae are mixed, the alcohol reflux that to add with respect to 6 times, mixture amount determining alcohols be 85% 3 times, each 3 hours, filter, filtrate merges, and reclaims ethanol, the mastic that while being concentrated into 70 DEG C, relative density is 1.31, for subsequent use;
Second step, is mixed in proportion all the other raw medicinal materials, adds with respect to 8 times of water gagings of mixture, boils 4 hours, filters the mastic that while being concentrated into 70 DEG C, relative density is 1.28;
The 3rd step, the mastic that the first step, second step are obtained mixes, and 65 DEG C of reduced vacuum are dry, and powder gets dry extract;
The 4th step, dried cream powder and starch that the 3rd step is obtained mix processing, obtain mastic mixture; The weight ratio of mastic and starch is 1: 0.02; Mastic mixture is carried out to pelletization treatment, dried, obtain mastic compound particles;
The 5th step, mastic compound particles and Pulvis Talci, magnesium stearate that the 4th step is obtained mix processing, tabletting processing, Cotton seeds successively, obtain the tablet finished product of Chinese medicine preparation; The weight ratio of mastic compound particles, Pulvis Talci, magnesium stearate is 100: 3: 0.25.
Toxicity test:
Acute toxicity test
Tablet prepared by the oral solutions of preparing with the embodiment of the present invention 1 and embodiment 2, tablet dissolved, in distilled water, is given respectively 2 groups of white mice feedings dispensings with 160 times of clinical consumption per day and 220 times, observes 7; The all white mice of result are strong deposits, and its activity, diet, hair, Excreta are no abnormal, have no toxic reaction.Irritation test is carried out in white mouse oral cavity and damaged skin, there are no irritative response and other untoward reaction.
Long term toxicity test
Oral solutions prepared by the embodiment of the present invention 1 to two groups of mices by 8.15g crude drug/kg and 18.34g crude drug/kg, tablet prepared by the embodiment of the present invention 2 to two groups of mices by 19.25g crude drug/kg and 40.34g crude drug/kg, 4 groups of mices are distinguished to continuous uses 12 weeks, every day 2 times, and drug withdrawal is after 4 weeks, result shows: the hair of Chinese medicine of the present invention to 4 groups of test mices, behavior, defecation, body weight, organ weights, hemogram, hepatic and renal function, blood glucose, the indexs such as blood fat all have no significant effect, internal organs naked eyes do not find that difference changes and histological examination result shows, medication 12 weeks and drug withdrawal are after 4 weeks, Organs of Mice is all without obviously changing.Illustrate that toxicity is little after Chinese medicine of the present invention is to mice long-term prescription, after drug withdrawal, also there is no difference reaction, application safety.
Clinical experiment:
1.1 case groupings
Nasopharyngeal carcinoma case 242 examples are included in this research altogether in, all derive from February, 2009~2012, the court inpatient in year October.Male 140 examples in all cases, female's 102 examples, the age, the mean age was 48.2 years old from 21 years old~70 years old, Karnofky scoring is all greater than 70 points; Before all patient's radiotherapies, all confirm through pathology, and all have CT/MRI to check for clinical 92 by stages, before chemotherapy, all do before chemotherapy and check and confirm without chemicotherapy contraindication by clinical criteria, all patients are all without transition nasopharyngeal carcinoma (M0).Case is divided into two groups at random, treatment group 122 examples, male 72 examples, female's 50 examples, matched group 120 examples, male 68 examples, female's 52 examples, two groups of clinical datas have comparability, in table 1.
Table 1 liang group patient clinical data comparison
Note: *pathology WHO classification: World Health Organization (WHO) (WHO) is divided into the pathomorphology of nasopharyngeal carcinoma: (1) WHO I type, the keratinizing squamous cell carcinoma of breaking up good and medium differentiation; (2) WHO II type, the cancer that differentiation is poor; (3) WHOIII type, undifferentiated carcinoma or lymphepithelioma. clinical stages: I phase-T1N0M0; II phase-T2N0M0, T0~T2N1M0; III phase-T3N0~N2M0, T0~T3N2M0; IVa phase-T4N0~N3M0, T0~T4N3M0; IVb phase-any T, any N, any M1.
1.2 Therapeutic Method
Two groups of cases all adopt thermoplastic facial film to fix, and locate under CT or x-ray analog machine, 6MV-X roentgenization, and neck tangential field all adopts 60Co-r roentgenization.(1) the plumbous technology of two dimension gear: patient's normal bit of lying on the back, dehisce containing plug, at digitized x-ray simulated positioner (He Tong company) picked-up spacer, and delineate face neck and combine open country and the front little open country of face ear, after completing, manufacture gear lead stamp tool, determine and establish wild border respectively according to CT, lower neck tangential field is determined the upper bound according to spacer and calculating penumbra.Dose fractionation adopts hyperfractionated method, and 120cGy/ time, BID/ days, nasopharynx accumulated dose is 72~76.8Gy/60~64 time, face neck is combined the open country of contracting on spacer after wild nasopharynx part dosage reaches 43.2Gy/36 time/24 days.Full neck tangent line preventive dose reaches 50Gy/25 time/5 weeks, and cervical region positive region adopts electric wire according to lymph nodes size benefit amount 16~26Gy, conventional gradation, 200cGy/ time.(2) intensive modulated radiotherapy technology (IMRT): patient adopts head and neck pendulum position fixture, and supine body position obtains treatment plan designed image under CT, and part patient adopts MRI image co-registration, GTV:72~78Gy, 2.2~2.4Gy/ time; CTV1:66~68Gy, 2.1~2.2Gy/ time; CTV2:56~62Gy, 2Gy/ time; GTVN:66~78Gy, 2.2~2.4Gy/ time; CTVN:52~55Gy, 1.6~1.8Gy/ time; All patients all calculate with PTV, and 95% for describing dosage.Some patients were adopts dosage dynamic I MRT (2~3 CT/MRI).
Two groups of equal concurrent chemotherapies, chemotherapy adopts DF scheme: cis-diaminedichloroplatinum (CDDP) is 80mg/m 2, d1,5-fluorouracil (5-FU) is 500mg/m 2, d1-3.Every 3 weeks repeat chemotherapy 1 time, amount to 2 cycles.
On the basis of the radiotherapy for the treatment of group cancer, chemotherapy, coordinate the extract oral liquor of the embodiment of the present invention 1, each 2 doses, every day three times, every mouthful of frequent decoction being taken warmly repeatedly, slowly swallows, until chemicotherapy general plan finishes.
1.3 observation index and method
(1) in treatment, check weekly whole blood routine 1 time.Every 2 weekly check 1 liver, renal function and electrocardiogram.The toxicity grade scale that observation caliber: RTOG (radiation oncology treatment cooperative groups), WHO formulate.Mucosa reaction: 0 grade, normal; I level, erythema, has mild pain, does not need analgesic; II level, mottled mucositis, companion's serosity is oozed out, medium degree pain; III level, slabbing cellulose mucositis, sharp ache, needs analgesic; IV level, hemorrhage, ulcer, necrosis.
(2) short term effect: according to WHO treatment malignant tumor evaluation criteria evaluation curative effect, point alleviation (CR) completely: all visible pathological changes disappeared at least 4 weeks completely; Partial rcsponse (PR): tumor size is estimated dwindle >=50% at least 4 week; Unchanged (NC): without at least 4 weeks of significant change, comprise that pathological changes is stable, tumor size is estimated to expand less than 25%, dwindles less than 50%; Pathological changes expansion (PD); New focus occurs or original pathological changes estimates to expand 25%4 ranking nasopharynx part primary tumors of > and Cervical Lymph Node Metastasis kitchen range gross tumor volume changes.
1.4 statistical method
Meeting rank test, paired t-test and independent sample t with statistical package SPSS1010 Wileoxon checks.
1.5 result
1.5.1 two groups of acute reaction comparisons, the results are shown in Table 2, and treatment group is obviously better than matched group to alleviating of oral mucosa and gastrointestinal reaction, statistically have significant difference (P < 0.05).
Table 2 liang group acute reaction
Note: two index comparisons between two groups, p < 0.05.
1.5.2 two groups of hematological index comparisons
In experimental group blood system reaction, leukocyte (WBC), erythrocyte (RBC), hemoglobin (Hb) decline and obviously alleviate compared with matched group, statistically have a significant difference (P < 0.05).In table 3.
Table 3 liang group blood system toxicity
Note: *p < 0.05, p > 0.05.
1.5.3 the comparison of hepatic and renal function before and after two groups of treatments
As seen from Table 4: alanine aminotransferase after experimental group chemicotherapy (ALT), blood urea nitrogen (UN), blood creatinine (CR), gamma glutamyltransferase (GGT) value significantly reduce, tool statistical significance (P < 0.05); And control group A LT, UN, CR value compared with chemicotherapy before without significant change (P > 0.05).
Before and after the treatment of table 4 hepatic and renal function, compare
1.5.4 two groups of short term effect comparisons, in table 5.
Group CR PR NC PD Effective percentage (%)
Treatment group 68 39 15 0 87.7
Matched group 35 40 44 1 62.5
All above-mentioned these intellectual properties of primary enforcement, do not set restriction this new product of other forms of enforcement and/or new method.Those skilled in the art will utilize this important information, and foregoing amendment, to realize similar implementation status.But all modifications or transformation belong to the right of reservation based on new product of the present invention.
The above, be only preferred embodiment of the present invention, is not the restriction of the present invention being made to other form, and any those skilled in the art may utilize the technology contents of above-mentioned announcement to be changed or be modified as the equivalent embodiment of equivalent variations.But every technical solution of the present invention content that do not depart from, any simple modification, equivalent variations and the remodeling above embodiment done according to technical spirit of the present invention, still belong to the protection domain of technical solution of the present invention.

Claims (3)

1. treat the Chinese medicine preparation of toxic and side effects after nasopharyngeal carcinoma radiotherapy for one kind, it is characterized in that: the ratio of weight and number of the each raw medicinal material in described Chinese medicine preparation is, Radix Codonopsis 20~40 weight portions, Radix Ophiopogonis 15~25 weight portion, Fructus Schisandrae Chinensis 20~30 weight portions, the Radix Astragali 20~40 weight portions, Caulis Spatholobi 10~30 weight portions, Rhizoma Belamcandae 10~25 weight portions, Fructus Jujubae 20~35 weight portions, Radix Pseudostellariae 20~30 weight portions, Herba Ecliptae 16~28 weight portions, Fructus Lycii 20~35 weight portions, Fructus Ligustri Lucidi 10~16 weight portions, Radix Platycodonis 10~20 weight portions, Flos Chrysanthemi 20~40 weight portions, the Rhizoma Atractylodis Macrocephalae 15~30 weight portions, Radix Asparagi 20~30 weight portions, Radix Adenophorae (Radix Glehniae) 25~35 weight portions, Stigma Croci 15~25 weight portions, Radix Glycyrrhizae 10~20 weight portions, the Radix Paeoniae Alba 12~25 weight portions, Radix Scrophulariae 10~30 weight portions, Herba Dendrobii 15~26 weight portions, Rhizoma Polygonati Odorati 15~25 weight portions, the Rhizoma Pinelliae 20~36 weight portions, Radix Rehmanniae 10~25 weight portions, Herba Menthae 10~20 weight portions, Periostracum Cicadae 25~40 weight portions and Nidus Vespae 20~45 weight portions,
The dosage form of described Chinese medicine preparation is oral liquid, and its preparation method comprises the following steps,
The first step, Radix Codonopsis, the Radix Astragali, Caulis Spatholobi, Rhizoma Belamcandae, Radix Pseudostellariae, Radix Asparagi, Radix Adenophorae (Radix Glehniae), Radix Scrophulariae, Herba Dendrobii, Rhizoma Polygonati Odorati, the Rhizoma Pinelliae, Periostracum Cicadae and Nidus Vespae are mixed, the alcohol reflux that to add with respect to 3 times~6 times, mixture amount determining alcohols be 75%~85% 2 times~4 times, each 2 hours~3 hours, filter, filtrate merges, and reclaims ethanol, the mastic that while being concentrated into 70 DEG C, relative density is 1.30~1.32, for subsequent use;
Second step, is mixed in proportion all the other raw medicinal materials, adds with respect to 4~8 times of water gagings of mixture, boils 2~4 hours, filters the mastic that while being concentrated into 70 DEG C, relative density is 1.27~1.29;
The 3rd step, the mastic that the first step, second step are obtained mixes, and 50 DEG C~65 DEG C reduced vacuum are dry, and powder gets dry extract;
The 4th step, will the 3rd add ethanol in the described dried cream powder that obtains of step, obtain containing alcohol mastic, and described is 65%~70% containing alcohol mastic containing alcohol amount; Carry out successively cold preservation processing, precipitation process, filtration treatment, recovery Ethanol Treatment by described containing alcohol mastic, obtain dealcoholysis mastic, wherein, the cold preservation processing time is 36~48 hours;
The 5th step, adds cane sugar powder and active carbon in the described dealcoholysis mastic that the 4th step is obtained, and carries out successively heat treated, filtration treatment, dilution process, obtains semi-finished product; The weight ratio of described dealcoholysis mastic and described cane sugar powder is 1: 0.2~0.4; The weight ratio of described dealcoholysis mastic and described active carbon is 1: 0.001~0.002; The described heat treated time is 30~60 minutes, and temperature is 100 DEG C~140 DEG C;
The 6th step, then semi-finished product are carried out to filtration treatment, embedding processing, sterilization treatment successively, obtain the oral liquid finished product of described Chinese medicine preparation.
2. Chinese medicine preparation as claimed in claim 1, it is characterized in that: the ratio of weight and number of the each raw medicinal material in described Chinese medicine preparation is, Radix Codonopsis 20~30 weight portions, Radix Ophiopogonis 15~20 weight portion, Fructus Schisandrae Chinensis 20~25 weight portions, the Radix Astragali 20~30 weight portions, Caulis Spatholobi 10~20 weight portions, Rhizoma Belamcandae 15~25 weight portions, Fructus Jujubae 25~35 weight portions, Radix Pseudostellariae 25~30 weight portions, Herba Ecliptae 20~26 weight portions, Fructus Lycii 20~30 weight portions, Fructus Ligustri Lucidi 10~14 weight portions, Radix Platycodonis 16~20 weight portions, Flos Chrysanthemi 20~35 weight portions, the Rhizoma Atractylodis Macrocephalae 15~25 weight portions, Radix Asparagi 25~30 weight portions, Radix Adenophorae (Radix Glehniae) 25~30 weight portions, Stigma Croci 15~20 weight portions, Radix Glycyrrhizae 10~16 weight portions, the Radix Paeoniae Alba 12~20 weight portions, Radix Scrophulariae 10~20 weight portions, Herba Dendrobii 15~20 weight portions, Rhizoma Polygonati Odorati 20~25 weight portions, the Rhizoma Pinelliae 20~30 weight portions, Radix Rehmanniae 10~20 weight portions, Herba Menthae 15~20 weight portions, Periostracum Cicadae 25~35 weight portions and Nidus Vespae 30~45 weight portions.
3. Chinese medicine preparation as claimed in claim 1, it is characterized in that: the ratio of weight and number of the each raw medicinal material in described Chinese medicine preparation is, Radix Codonopsis 25 weight portions, Radix Ophiopogonis 18 weight portion, Fructus Schisandrae Chinensis 22 weight portions, the Radix Astragali 25 weight portions, Caulis Spatholobi 16 weight portions, Rhizoma Belamcandae 17 weight portions, Fructus Jujubae 30 weight portions, Radix Pseudostellariae 28 weight portions, Herba Ecliptae 22 weight portions, Fructus Lycii 25 weight portions, Fructus Ligustri Lucidi 12 weight portions, Radix Platycodonis 18 weight portions, Flos Chrysanthemi 26 weight portions, the Rhizoma Atractylodis Macrocephalae 23 weight portions, Radix Asparagi 27 weight portions, Radix Adenophorae (Radix Glehniae) 28 weight portions, Stigma Croci 20 weight portions, Radix Glycyrrhizae 13 weight portions, the Radix Paeoniae Alba 14 weight portions, Radix Scrophulariae 16 weight portions, Herba Dendrobii 18 weight portions, Rhizoma Polygonati Odorati 22 weight portions, the Rhizoma Pinelliae 24 weight portions, Radix Rehmanniae 15 weight portions, Herba Menthae 16 weight portions, Periostracum Cicadae 30 weight portions and Nidus Vespae 35 weight portions.
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CN103550719B (en) * 2013-11-18 2015-09-09 青岛市中心医院 A kind of Chinese medicine composition for the treatment of nasopharyngeal carcinoma
CN104800692A (en) * 2015-04-27 2015-07-29 陶俊荣 Chinese material medicine preparation for alleviating side effects from radiation therapy and preparation method
CN105194341B (en) * 2015-10-20 2019-07-05 阚士锋 The drug for treating xerostomia after head and neck neoplasm radiotherapy
CN105148039A (en) * 2015-10-28 2015-12-16 冷宁 Traditional Chinese medicine pill used for relieving tumor postradiotherapy reaction and preparation method

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