CN114377094A - Traditional Chinese medicine composition and preparation as well as preparation method and application thereof - Google Patents

Abstract

The invention discloses a traditional Chinese medicine composition. The traditional Chinese medicine composition provided by the invention is prepared from the following traditional Chinese medicinal materials in parts by weight: 18 g of radix bupleuri, 12 g of radix scutellariae, 15 g of pinellia ternate, 10 g of radix codonopsis, 15 g of Chinese date, 10 g of ginger, 6 g of radix glycyrrhizae preparata, 15 g of rhizoma atractylodis macrocephalae, 15 g of poria cocos, 18 g of dried orange peel, 15 g of fructus aurantii immaturus, 10 g of fructus amomi, 12 g of angelica sinensis, 18 g of radix paeoniae alba, 12 g of ligusticum wallichii and 18 g of rhizoma alismatis. The invention also provides a traditional Chinese medicine preparation which is prepared from the traditional Chinese medicine composition. The invention also provides a preparation method of the traditional Chinese medicine preparation. The traditional Chinese medicine composition provided by the invention takes body resistance strengthening and constitution consolidating, spleen strengthening and liver soothing, blood circulation promoting and blood stasis removing, hardness softening and stagnation dissipating, and heat and toxic material clearing as main treatment principles, can relieve the adverse reaction of micro-vascular interventional therapy of liver cancer in middle and late stages, and obviously improve a series of adverse reactions caused by interventional therapy.

Description

Traditional Chinese medicine composition and preparation as well as preparation method and application thereof

Technical Field

The invention belongs to the field of traditional Chinese medicines, relates to a traditional Chinese medicine composition and a preparation thereof, and particularly relates to a traditional Chinese medicine composition for relieving adverse reactions of middle and late liver cancer microvascular intervention treatment and a traditional Chinese medicine preparation prepared from the traditional Chinese medicine composition.

Background

Liver cancer is malignant tumor derived from liver cells and hepatobiliary cells, is divided into primary and secondary types, and is one of common malignant tumors in China. Early liver cancer symptoms are not specific, the symptoms of middle and late liver cancer are more, and common clinical manifestations include liver region pain, abdominal distension, anorexia, hypodynamia, emaciation, progressive hepatomegaly or epigastric mass and the like; some patients have low fever, jaundice, diarrhea, upper gastrointestinal hemorrhage, etc. Surgical resection is the first choice for treating liver cancer, and the 5-year survival rate of patients suitable for surgical resection can exceed 50%, but only about 20% of patients are suitable for surgery because liver cancer is easy to have vascular infiltration or distant metastasis. For middle and late stage liver cancer patients who cannot be operated, radiotherapy, systemic chemotherapy, targeted drug therapy, immunotherapy, various minimally invasive ablation treatments including radio frequency, microwave, freezing, nano-knife and the like and the latest tumor micro-vessel interventional therapy can be adopted.

The tumor microvascular intervention therapy is characterized by that it adopts a special process, and makes several chemotherapeutic medicines into micrometer-grade microparticles, and under the condition of X-ray fluoroscopy and digital subtraction the catheter can be inserted into the tumor blood vessel, and the chemotherapeutic medicines can be injected into the tumor, at the same time the blood vessel of the tumor can be blocked. Such micro-particles of chemotherapeutic agents will selectively penetrate into tumor tissue and remain in high concentrations for extended periods of time. The principle is as follows: there are many gaps between tumor capillary endothelial cells, while normal capillary endothelial cells are tightly connected. Therefore, the chemotherapy drug micro-particles injected by the intervention method super-selection cannula penetrate into the tumor tissue gaps to cause the increase of tissue osmotic pressure and press the selective occlusion of tumor capillaries, so that the chemotherapy drug is retained in the tumor tissue for a long time and the tumor is killed to the maximum extent. For tumours that cannot be resected by surgery, palliative treatment can be achieved with this approach; or the tumor can be reduced by pouring anticancer drugs and then surgical excision is carried out; can also be used for the intra-arterial perfusion chemotherapy for preventing relapse of patients after tumor resection. One of the characteristics of the treatment is that the perfusion drug concentration is high, for example, the hepatic artery perfusion of the liver cancer is 100-fold higher than the drug concentration of the intravenous administration, and the high-concentration chemotherapy can play a role in killing a large number of tumor cells; the other is the blood vessel embolism effect, after the tumor blood vessel is blocked, the tumor tissue is degenerated and necrotized due to ischemia. The treatment is safe and reliable, has definite curative effect, but has certain adverse reactions and complications, mainly including nausea, vomiting, gastrectasia, anorexia, tiredness, hypodynamia, bitter taste, yellow urine and the like, and even influences the treatment effect of microvascular intervention.

The traditional Chinese medicine theory holds that liver cancer generally refers to liver qi stagnation, qi stagnation and blood stasis caused by disorder of ascending and regulating of spleen and stomach due to exogenous dampness attacking spleen and stomach, and further liver-kidney yin deficiency and spleen-kidney yang deficiency, which are comprehensively expressed as qi-blood-phlegm-dampness stagnation. Therefore, when the main treatment principles of strengthening body resistance and banking up root, tonifying spleen and soothing liver, activating blood and dissolving stasis, softening hardness and dissipating stagnation, and clearing heat and detoxicating are taken, the medicinal materials are reasonably selected and matched for processing.

In order to obtain the best curative effect of the microvascular interventional therapy on the middle and late-stage liver cancer, the microvascular interventional therapy and a special traditional Chinese medicine formula preparation are combined, so that adverse reactions brought by the microvascular interventional therapy are relieved while the liver is conditioned, and the purpose of treating diseases and seeking the basis is achieved.

Disclosure of Invention

The invention aims to provide a traditional Chinese medicine composition for relieving adverse reactions of medium and late liver cancer microvascular interventional therapy.

In order to achieve the purpose, the invention adopts the following technical scheme:

the traditional Chinese medicine composition disclosed by the invention is prepared from the following traditional Chinese medicinal materials in parts by weight: 18 g of radix bupleuri, 12 g of radix scutellariae, 15 g of pinellia ternate, 10 g of radix codonopsis, 15 g of Chinese date, 10 g of ginger, 6 g of radix glycyrrhizae preparata, 15 g of rhizoma atractylodis macrocephalae, 15 g of poria cocos, 18 g of dried orange peel, 15 g of fructus aurantii immaturus, 10 g of fructus amomi, 12 g of angelica sinensis, 18 g of radix paeoniae alba, 12 g of ligusticum wallichii and 18 g of rhizoma alismatis.

The second purpose of the invention is to provide a Chinese traditional medicine preparation.

The traditional Chinese medicine preparation is prepared from the traditional Chinese medicine composition of claim 1.

The invention also provides a preparation method of the traditional Chinese medicine preparation.

The preparation method of the traditional Chinese medicine preparation comprises the following steps:

A. weighing the following raw materials by weight: 18 g of radix bupleuri, 12 g of radix scutellariae, 15 g of pinellia ternate, 10 g of radix codonopsis, 15 g of Chinese date, 10 g of ginger, 6 g of radix glycyrrhizae preparata, 15 g of rhizoma atractylodis macrocephalae, 15 g of poria cocos, 18 g of dried orange peel, 15 g of fructus aurantii immaturus, 10 g of fructus amomi, 12 g of angelica sinensis, 18 g of radix paeoniae alba, 12 g of ligusticum wallichii and 18 g of rhizoma alismatis;

B. placing the Chinese medicinal materials weighed in the step A into a marmite, mixing, adding water, soaking for 30-60 minutes, boiling with strong fire, boiling with slow fire for 20-30 minutes, and filtering to obtain a first filtrate;

C. placing the residue filtered in the step B in a casserole, adding water 8 times of the total weight of the raw materials, boiling with strong fire, decocting with slow fire for 20-30 min, and filtering to obtain a second filtrate;

D. and combining the first filtrate and the second filtrate, and uniformly mixing to obtain the traditional Chinese medicine preparation.

The invention also provides application of the traditional Chinese medicine composition in preparing a traditional Chinese medicine preparation for relieving adverse reactions of medium and late liver cancer microvascular interventional therapy.

The traditional Chinese medicine composition disclosed by the invention is excellent in prescription, has the purposes of strengthening body resistance and banking up root, tonifying spleen and soothing liver, activating blood and dissolving stasis, softening hardness and dissipating stagnation, and clearing heat and detoxicating, is used for conditioning liver and fu organs, is obvious in curative effect through clinical verification, and can relieve a series of adverse reactions caused by micro-vascular interventional therapy of liver cancer in middle and late stages.

Detailed description of the invention

The invention is further illustrated with reference to specific examples.

The traditional Chinese medicine composition disclosed by the invention is prepared from the following traditional Chinese medicinal materials in parts by weight: 18 g of radix bupleuri, 12 g of radix scutellariae, 15 g of pinellia ternate, 10 g of radix codonopsis, 15 g of Chinese date, 10 g of ginger, 6 g of radix glycyrrhizae preparata, 15 g of rhizoma atractylodis macrocephalae, 15 g of poria cocos, 18 g of dried orange peel, 15 g of fructus aurantii immaturus, 10 g of fructus amomi, 12 g of angelica sinensis, 18 g of radix paeoniae alba, 12 g of ligusticum wallichii and 18 g of rhizoma alismatis.

The traditional Chinese medicine composition disclosed by the invention comprises various traditional Chinese medicinal materials with the effects as follows:

bupleurum root: has bitter and mild flavor and no toxicity, and has the efficacies of relieving exterior syndrome, abating fever, soothing liver, relieving depression and lifting yang qi. The record of Shen nong Ben Cao Jing: "governing qi accumulation in the heart, abdomen, stomach and intestine, food accumulation, cold and heat pathogens, aging to cause novelty, taking lightly, improving eyesight and replenishing vital essence. Modern clinical application proves that the bupleurum has the effects of tranquilizing, calming, relieving pain, relieving fever, relieving cough and other extensive central inhibition effects. Bupleuri radix and its effective component saikoside have anti-inflammatory effect, and the anti-inflammatory effect is related to promoting adrenal cortex system function. Saikosaponin also has effect of reducing blood plasma cholesterol. Radix bupleuri has good effects of resisting fatty liver, resisting liver injury, promoting bile flow, reducing transaminase, exciting smooth muscle of intestine, inhibiting gastric acid secretion, resisting ulcer, inhibiting trypsin, etc. The bupleuri radix decoction has effect in inhibiting tubercle bacillus. In addition, bupleuri radix has effects of resisting common cold virus, increasing protein biosynthesis, resisting tumor, resisting radiation, and enhancing immunity.

Scutellaria baicalensis: bitter and mild, non-toxic, heat-clearing and dampness-drying, fire-purging and toxicity-removing, hemostasis and miscarriage prevention. The record of Shen nong Ben Cao Jing: it is mainly indicated for jaundice due to various heat, diarrhea and dysentery due to intestinal , edema, bleeding obstruction, sore, gangrene and ulcer. Modern clinical application proves that the scutellaria has the effects of relieving fever, reducing blood pressure, tranquilizing, protecting liver, benefiting gallbladder, inhibiting intestinal tract peristalsis, reducing blood fat, resisting oxidation, regulating cAMP level, resisting tumors and the like.

Pinellia ternata: pungent, mild and toxic, and has the actions of drying dampness, resolving phlegm, checking adverse rise of qi, relieving vomiting, relieving stuffiness, dissipating nodulation, and relieving swelling and pain for external use. Record of famous physicians bibliography: the recipe is used for treating heart, abdomen, chest and diaphragm phlegm-heat and fullness, cough and epigastric distention, urgent pain in the lower heart, mass and fullness, vomiting, carbuncle and swelling, abortion. Modern clinical application proves that pinellia ternate can inhibit vomiting center to arrest vomiting, and various processed products have obvious cough relieving effect on experimental animals. The diluted alcohol and water extract of rhizoma Pinelliae or its polysaccharide component and alkaloid have wide antitumor effect. The water infusion has obvious antagonistic action on experimental ventricular arrhythmia and ventricular premature beat; pinellia ternata has a remarkable gastric secretion inhibiting effect.

Codonopsis pilosula: sweet and mild, has no toxicity, and has the effects of invigorating spleen-stomach, replenishing qi, invigorating spleen and benefiting lung. The Chinese pharmacopoeia records: it is used for treating spleen and lung deficiency, short breath, palpitation, anorexia, loose stool, dyspnea due to deficiency, cough, internal heat, and diabetes. Modern clinical application proves that the codonopsis pilosula can slightly increase normal red blood cells and hemoglobin and has the function of enriching blood; it also has effects in increasing blood sugar and lowering blood pressure.

Chinese date: sweet, warm and nontoxic, and has the effects of invigorating spleen and replenishing qi, nourishing blood and tranquillizing. The book of Ben Jing records: governing heart and abdomen pathogenic qi, pacifying spleen and assisting twelve meridians. Pacify stomach qi, unblock nine orifices, nourish qi and fluids, deficiency of body and middle energizer, severe convulsion, heaviness of limbs, and Bai Yao. Modern clinical application proves that the Chinese date can tonify qi and blood, promote sleep, and has the effects of invigorating stomach and brain and protecting liver.

Ginger: pungent, mild and nontoxic, and can be used for treating deficiency-cold of spleen and stomach, anorexia, nausea and emesis, or emesis due to phlegm-fluid retention and incoordination between stomach and qi. The record of "jin Kui Yao L ü e": pinellia ternate and ginger juice are good at relieving vomiting and are good for combining; it also has the actions of stimulating appetite and regulating the middle warmer. Can be used for treating incoordination between stomach-qi and vomiturition. Modern clinical application proves that the ginger can inhibit tumor; eating ginger can resist aging, and old people can remove senile plaque by eating ginger frequently; promoting appetite, invigorating spleen, and stimulating appetite; sterilizing, detoxicating, relieving swelling and alleviating pain. "

And (3) liquorice moxibustion: has mild nature, sweet taste and no toxicity, enters heart, lung, spleen and stomach channels, and has the effects of invigorating spleen-stomach, replenishing qi, clearing away heat and toxic materials, eliminating phlegm, relieving cough and asthma, relieving spasm and pain, and harmonizing the drugs. Prepared licorice root, radix Glycyrrhizae Praeparata has weak action of clearing heat and removing toxicity, and strong action of tonifying and neutralizing deficiency; can be used for treating spleen and stomach weakness, cardiopalmus, short breath, hysteria, cough, asthma, abdominal pain, spasm pain of limbs, superficial infection, pyocutaneous disease, sore throat, food poisoning, etc.; it can be combined with herbs with drastic property to relieve the drastic property.

White atractylodes rhizome: the nature and the temperature; sweet and bitter in taste; it enters spleen and stomach meridians. Has effects of invigorating spleen, invigorating qi, eliminating dampness, promoting diuresis, arresting sweating, and preventing miscarriage. Can be used for treating spleen deficiency, anorexia, abdominal distention, diarrhea, phlegm retention, dizziness, palpitation, edema, spontaneous perspiration, and threatened abortion. Record of "medical enlightenment": the traditional Chinese medicine composition has the effects of removing dampness and benefiting dryness, regulating the middle warmer and replenishing qi, warming the middle warmer, removing dampness in the spleen and stomach, removing stomach heat, strengthening the spleen and stomach, promoting appetite, quenching thirst and preventing miscarriage.

Tuckahoe, poria cocos: sweet and light taste, mild nature, no toxicity, and has effects of inducing diuresis to alleviate edema, eliminating dampness, invigorating spleen, and calming heart. The record of Shen nong Ben Cao Jing: "governing adverse qi in chest and hypochondrium, fear anger, fear and palpitation, pain in the lower part of the heart, chills and fever, restlessness, cough with dyspnea, dry mouth and tongue, and diuresis. Long-term administration of the product can relieve soul, nourish mind, prevent hunger, and prolong life. Modern clinical medicine proves that tuckahoe has an inhibiting effect on gastric ulcer and can reduce gastric secretion and free acid content; has protective effect on liver injury, obviously reduces the activity of glutamic-pyruvic transaminase, and prevents hepatocyte necrosis; the lymphocyte transformation rate is induced to be obviously increased, and the serum IgG content can be obviously increased, which indicates that the lymphocyte transformation rate has the function of promoting cellular immunity and humoral immunity. In addition, Poria has effects in lowering blood sugar, resisting tumor, resisting pathogenic microorganism, and promoting hematopoiesis.

Dried orange peel: warming; pungent and bitter; it enters spleen and lung meridians. Has effects of warming stomach, dispelling cold, regulating qi-flowing, and invigorating spleen, and is suitable for people with symptoms of stomach distention, dyspepsia, anorexia, cough, excessive phlegm, etc. Modern researches show that the dried orange peel contains a large amount of volatile oil, hesperidin and other components, and the volatile oil contained in the dried orange peel has a mild stimulation effect on gastrointestinal tracts, can promote secretion of digestive juice, eliminate pneumatosis in intestinal tracts and increase appetite.

Immature bitter orange: bitter; pungent taste; is cold. Invigorating spleen; the stomach; liver; the heart meridian. Break qi and remove food retention, resolve phlegm and disperse distention and fullness. Can be used for treating stagnation, abdominal distention, pain, dysentery, constipation, phlegm stagnation, qi obstruction of chest, and thoracic obstruction; gastroptosis, rectocele, uterine prolapse.

Amomum fruit: warm in nature and pungent in taste, has effects of activating qi-flowing, regulating middle warmer, regulating stomach function and activating spleen, and can be used for treating damp turbidity obstruction in middle warmer, abdominal pain and distention, anorexia, emesis, diarrhea, pernicious vomiting, threatened abortion, etc.

Chinese angelica: sweet and pungent, warm. Tonify blood and regulate blood, regulate menstruation and relieve pain, moisten dryness and smooth intestines. Treating menoxenia, amenorrhea, abdominal pain, abdominal mass, metrorrhagia and metrostaxis; headache due to blood deficiency, vertigo, flaccidity arthralgia; intestinal dryness, difficulty in defecation, and severe dysentery; carbuncle, deep-rooted carbuncle, sore, traumatic injury. The book of entry records: warming the middle energizer to relieve pain, removing obstruction in the blood, relieving spasm of the middle energizer, failing to perspire, damp arthralgia, aversion to qi, deficiency cold, nourishing five reservoirs, and growing muscle. "

White peony root: bitter, sour, slightly cold; it enters liver and spleen meridians. Pacify liver and alleviate pain, nourish blood and regulate menstruation, astringe yin and check sweating. Can be used for treating headache, vertigo, hypochondriac pain, abdominal pain, limb spasm and pain, blood deficiency, sallow complexion, menoxenia, spontaneous perspiration, and night sweat. The book of entry records: promoting blood circulation, relieving epigastric distention, dispersing blood stasis, expelling blood stasis, removing water and qi, benefiting bladder, large intestine and small intestine, and eliminating carbuncle and swelling. "

Ligusticum wallichii: pungent and warm; it enters liver, gallbladder and pericardium meridians. Move qi and relieve depression, treat wind-damp, activate blood and alleviate pain. It is indicated for wind-cold headache, dizziness, hypochondriac pain, abdominal pain, cold arthralgia, spasm of tendons, amenorrhea, dystocia, postpartum pain due to blood stasis, carbuncle, cellulitis, sore and ulcer. Can be used for treating menoxenia, amenorrhea, dysmenorrhea, abdominal pain, pricking pain in chest and hypochondrium, traumatic injury, swelling and pain, headache, and rheumatalgia. The book of entry records: ' removing cold in brain, wind on face coming, eye tears, nasal mucus, sudden and sudden like drunk, all cold qi, heart and abdomen hard pain, aversion to cold, sudden swelling and pain, hypochondriac pain, warming middle-jiao and interior cold. "

Rhizoma alismatis: sweet and cold; meridian tropism enters kidney and bladder meridians. Induce diuresis, drain dampness and purge heat. It is used to treat dysuria, edema, emesis, dysentery, phlegm-fluid retention, tinea pedis, gonorrhea, and hematuria. The book of entry records: to tonify deficiency and impair five internal organs, remove fullness and fullness of five internal organs, activate yin qi, stop diarrhea, quench thirst, drain dribbling, expel bladder and triple energizer and stop water. "

A Chinese medicinal preparation is prepared from the Chinese medicinal composition according to the following steps:

A. weighing the following raw materials by weight: 18 g of radix bupleuri, 12 g of radix scutellariae, 15 g of pinellia ternate, 10 g of radix codonopsis, 15 g of Chinese date, 10 g of ginger, 6 g of radix glycyrrhizae preparata, 15 g of rhizoma atractylodis macrocephalae, 15 g of poria cocos, 18 g of dried orange peel, 15 g of fructus aurantii immaturus, 10 g of fructus amomi, 12 g of angelica sinensis, 18 g of radix paeoniae alba, 12 g of ligusticum wallichii and 18 g of rhizoma alismatis;

B. placing the Chinese medicinal materials weighed in the step A into a marmite, mixing, adding water, soaking for 30-60 minutes, boiling with strong fire, boiling with slow fire for 20-30 minutes, and filtering to obtain a first filtrate;

C. placing the residue filtered in the step B in a casserole, adding water 8 times of the total weight of the raw materials, boiling with strong fire, decocting with slow fire for 20-30 min, and filtering to obtain a second filtrate;

D. and combining the first filtrate and the second filtrate, and uniformly mixing to obtain the traditional Chinese medicine preparation.

The Chinese medicinal preparation is used for carrying out curative effect experiments.

Subject: 50 patients with adverse reactions after the middle-and late-stage liver cancer microvascular interventional therapy are randomly divided into 2 groups of 25 patients.

Adverse reaction symptoms: nausea, vomiting, stomach distention, poor appetite, fatigue, lassitude, bitter taste in the mouth, yellow urine.

Experimental methods and times: the control group is treated by using a conventional medicament, and the experimental group uses the traditional Chinese medicine preparation disclosed by the invention, and the recording time is 1 month.

The taking method of the traditional Chinese medicine preparation comprises the following steps: the product is taken one hour after meal, 2 times daily, 100 ml each time, and one treatment course each month.

And (4) judging the standard:

the effect is shown: adverse reactions disappear, and no linkage adverse reactions occur;

the method has the following advantages: the adverse reaction is improved;

and (4) invalidation: adverse reactions were unchanged or worsened;

the results are shown in Table 1:

	show effect	Is effective	Invalidation
				Control group	3	14	8
Experimental group	12	9	4

The clinical experiment results show that the traditional Chinese medicine formula disclosed by the invention is remarkable in efficacy and capable of effectively relieving adverse reactions generated after microvascular interventional therapy of middle and late liver cancer.

Claims (4)

1. A traditional Chinese medicine composition is characterized by comprising the following raw materials by weight: 18 g of radix bupleuri, 12 g of radix scutellariae, 15 g of pinellia ternate, 10 g of radix codonopsis, 15 g of Chinese date, 10 g of ginger, 6 g of radix glycyrrhizae preparata, 15 g of rhizoma atractylodis macrocephalae, 15 g of poria cocos, 18 g of dried orange peel, 15 g of fructus aurantii immaturus, 10 g of fructus amomi, 12 g of angelica sinensis, 18 g of radix paeoniae alba, 12 g of ligusticum wallichii and 18 g of rhizoma alismatis.

2. A traditional Chinese medicine preparation is characterized in that: is prepared from the traditional Chinese medicine composition of claim 1.

3. The method for preparing a Chinese medicinal preparation according to claim 2, comprising the steps of:

A. weighing the following raw materials by weight: 18 g of radix bupleuri, 12 g of radix scutellariae, 15 g of pinellia ternate, 10 g of radix codonopsis, 15 g of Chinese date, 10 g of ginger, 6 g of radix glycyrrhizae preparata, 15 g of rhizoma atractylodis macrocephalae, 15 g of poria cocos, 18 g of dried orange peel, 15 g of fructus aurantii immaturus, 10 g of fructus amomi, 12 g of angelica sinensis, 18 g of radix paeoniae alba, 12 g of ligusticum wallichii and 18 g of rhizoma alismatis;

B. placing the Chinese medicinal materials weighed in the step A into a marmite, mixing, adding water, soaking for 30-60 minutes, boiling with strong fire, boiling with slow fire for 20-30 minutes, and filtering to obtain a first filtrate;

C. placing the residue filtered in the step B in a casserole, adding water 8 times of the total weight of the raw materials, boiling with strong fire, decocting with slow fire for 20-30 min, and filtering to obtain a second filtrate;

D. and combining the first filtrate and the second filtrate, and uniformly mixing to obtain the traditional Chinese medicine preparation.

4. The use of the Chinese medicinal composition of claim 1 in the preparation of a Chinese medicinal preparation for relieving adverse reactions of microvascular interventional therapy of middle and late stage liver cancer.