CN108355052B - Medicine for treating leucopenia after radiotherapy and chemotherapy and preparation method and application thereof - Google Patents
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- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
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Abstract
The invention relates to a medicine for treating leucopenia after chemoradiotherapy and a preparation method thereof, in particular to a traditional Chinese medicine composition for treating leucopenia after chemoradiotherapy by oral administration of Chinese herbal medicines, which is prepared from the following raw materials in parts by weight: 0.60-0.75 of prepared rhizome of rehmannia, 0.20-0.25 of dwarf lilyturf tuber, 0.05-0.15 of tuckahoe and 0.05-0.10 of cinnamon. The medicine source of the medicine is sufficient, and the components are carried by pharmacopoeia. The medicine can treat leucopenia caused by radiotherapy and chemotherapy, can prevent leucopenia caused by radiotherapy and chemotherapy, is a medicine with homology of medicine and food, is safe to take, can greatly improve the inclusion of patients, has the effect of stopping vomiting, and can effectively improve appetite, thereby improving the life quality of the patients.
Description
Technical Field
The invention relates to the field of medicine and pharmacy, in particular to the field of tumor treatment, and more particularly relates to a traditional Chinese medicine composition which has higher safety and better compliance and can effectively reduce the side effect of leucopenia caused by radiotherapy and chemotherapy in tumor treatment.
Background
Tumor is also called cancer, which is a new organism formed by clonal abnormal hyperplasia caused by that a certain cell of local tissue loses normal regulation and control on the growth of the local tissue at the gene level under the action of various tumor-causing factors inside and outside the body, and generally expressed as local tumor mass. The number of new invasive cancer cases in our country is estimated to be 429.2 ten thousand in 2015, which is equivalent to 1.2 ten thousand new cancers per day on average; there are 281.4 ten thousand cancer deaths, corresponding to an average of 7500 deaths per day due to cancer. Almost 22% of new cancer cases worldwide occur in china and 27% of cancer deaths occur in china.
The existing treatment methods of tumors mainly comprise surgical operation, chemotherapy, radiotherapy and emerging gene therapy, but the latter has a long time from meaningful clinical treatment, and most tumors are mainly treated by radiotherapy and chemotherapy at present.
Radiotherapy and chemotherapy are the main treatment means for malignant tumors, and can kill a large number of tumor cells and also kill many normal bone marrow cells, so that direct damage of stem cells and structural or functional damage of bone marrow stromal cells or microcirculation are caused, and especially the influence on a granulocyte line is the greatest, so that bone marrow suppression occurs, and leucopenia and even pancytopenia are caused. Myelosuppression is a common complication of radiotherapy and chemotherapy, is a main cause of death of cancer patients, is a dose-limiting adverse reaction with the highest incidence rate, often interrupts or delays chemotherapy of patients, and has a great influence on treatment effect. Most chemotherapy drugs cause varying degrees of myelosuppression, usually with leukopenia followed by thrombocytopenia and, in severe cases, myeloregenerative dysfunction.
The number of leukocytes in peripheral blood is continuously lower than 4 × 109The percentage of neutrophils is lower than normal or slightly lower than normal, and is called leukopenia, for example, the total number of granulocytes is obviously reduced and is lower than 1.5 × 109Perliter, called granulocytopenia, when the total number of leukocytes in the peripheral blood is less than 2 × 109A/liter and an absolute value of neutrophils of less than 0.5 × 109The/liter, even the disappeared, becomes agranulocytosis, which often leads to infection of the patient, which is a clinical emergency.
The literature reports that treatment-related mortality associated with IV degree myelosuppression can reach 4% -12%, the majority of which are due to various refractory infections caused by severe myelosuppression and granulocyte deficiency. Between 25% and 40% of chemotherapy patients develop granulocytic deficiency, and 60% granulocytic deficiency is complicated by infection. Therefore, the treatment of increasing leukocytes is one of the most important research subjects in the field of adjuvant therapy of malignant tumors.
The inventor has conducted a summary of the therapeutic principles, methods and theories of granulocytopenia in modern medicine.
Modern medicine generally considers that the causes of granulocytopenia caused by anticancer therapeutic factors include:
1) radiotherapy such as X-ray, radioactive substance, etc. has strong negative effect on granulocyte production, especially when the irradiation area is large, the granulocyte production is strongly inhibited; various cytotoxic chemotherapeutic drugs can also inhibit the hematopoietic function of bone marrow to different degrees, thereby causing granulocytopenia, and a few chemotherapeutic drugs such as methylnitrosoureas drugs have the effect of delaying the myelotoxicity, and the granulocytopenia is more likely to occur when the drugs are taken in large dose.
2) The tumor invades bone marrow and infection factors can cause granulocytopenia.
Therefore, modern medicine is often based on the assumption that bone marrow hematopoietic function-stimulating drugs (adenine, berbamine, etc.) are used for patients with insufficient hematopoietic function, and granulocyte colony stimulating factor is used for patients with neutrophil destruction due to immune antibody formation. At present, various western medicines or biological medicines for treating leucopenia caused by radiotherapy and chemotherapy at home and abroad are available, and the traditional oral leucocyte increasing medicines comprise vitamin B4, batyl alcohol, inosine, deoxyribose 9 ribonucleic acid, linkejun tablets and the like, but have slow effect and unsatisfactory effect, and are difficult to adapt to the chemotherapy cycle rhythm. For example, adenine usually needs to be used 1 month later to achieve primary effect, and has potential conflict with many chemoradiotherapy means, and bone marrow growth factors such as granulocyte colony-stimulating factor (G-CSF) and granulocyte macrophage colony-stimulating factor (GM-CSF) have been used clinically, and are the main drugs for treating leucopenia of chemoradiotherapy at home and abroad at present, but the drugs such as G-CSF and GM-CSF have relatively ideal curative effect, fast effect, high price, unstable curative effect and no effect after being used for many times. After a large amount of the recombinant human granulocyte colony stimulating factors are used, bone marrow failure can be caused, bone metastasis is promoted, side reactions such as fever, bone pain, even acute lung injury, renal failure and the like can occur to patients with the recombinant human granulocyte colony stimulating factors, and the application still has limitation. This side effect allows some patients to refuse to receive either G-CSF or GM-CSF. The typical representative medicine of the medicine, filgrastim, belongs to contraindications for patients with partial serious liver and kidney dysfunction, is generally considered to be unsuitable for being combined with an anti-tumor medicine, and can be applied after a period of time after the radiotherapy and chemotherapy are finished. This all imposes a great limitation on its application.
The inventor also combines the traditional Chinese medicine to research while researching the modern medical treatment means and finding that the modern medical treatment means faces the limitation, and finds that a plurality of Chinese patent medicines for increasing the leucocyte have unobvious effect and slow effect, and some patients have stomatitis after taking the medicine, so that the compliance is poor. The main reason is that the traditional Chinese medicine has unclear Chinese medicine differentiation on the conventional components of blood (such as white blood cells, platelets and red blood cells) in the traditional Chinese medicine, and the medicine for increasing the white blood cells is mainly used for strengthening the spleen and tonifying the kidney and is also used for increasing the platelets and the red blood cells.
The applicant finds that the leucopenia caused by radiotherapy and chemotherapy is closely related to the deficiency of spleen and kidney, the deficiency of lung qi and the deficiency of defensive yang by combining a plurality of modern statistical means analysis of the traditional Chinese medical record. Weiyang is from the lower energizer and distributes the whole body through the lung to defend the invasion of exogenous pathogenic factors. If the congenital deficiency is caused by weak congenital factors, essence and blood deficiency, or impairment of seven emotions, malnutrition due to chronic diseases, internal injury due to overstrain, or damage of spleen and kidney due to radiotherapy and chemotherapy, the spleen and stomach will be damaged, and then food stagnation, qi and blood will not be generated, the essence will be deficient, and the essence will be transformed into the source of exhaustion. Therefore, the disease is most closely related to spleen, lung and kidney.
Disclosure of Invention
The invention aims to provide a traditional Chinese medicine composition which has higher safety and better compliance, can effectively stop vomiting and improve the appetite of patients, and can effectively reduce the side effect of leucopenia caused by radiotherapy and chemotherapy in tumor treatment. The invention also aims to provide a preparation method of the medicine, and the third aim of the invention is to provide the pharmaceutical application of the traditional Chinese medicine composition, namely the application of the traditional Chinese medicine composition in preparing medicines for reducing the side effect of leucopenia of patients with tumor radiotherapy and chemotherapy and effectively increasing leucocytes. The medicine overcomes the characteristics of slow and non-persistent increase of white blood cells of traditional Chinese medicines, has good curative effect on white blood cell reduction caused by most of tumor radiotherapy and chemotherapy, and is a medicine with homology of medicine and food. The traditional Chinese medicine composition has the advantages of quick response, good curative effect and no obvious toxic or side effect, in addition, the raw materials of the traditional Chinese medicine composition have high acceptability, the patient compliance is high, the effect of increasing the white blood cells is greatly improved from the side, and the life quality of the patient is greatly improved.
In addition, in order to overcome the problems that the existing western medicines are ineffective after repeated application and have obvious side effects, the traditional Chinese medicines cannot adapt to the chemotherapy cycle rhythm slowly and the effect is not ideal, the invention further provides a medicine-food homologous food, such as a biscuit, which can quickly and durably raise white blood cells and has no obvious side effects.
The medicine is characterized in that all the medicines are medicine-food homologous medicines.
The solution of the invention is based on the cognition of the traditional Chinese medicine on hemogram and the understanding of the applicant on leucocyte traditional Chinese medicine, the ancient formula is searched for all the time, the modern pharmacological research result is referred, the natural plant medicines for nourishing lung, spleen and kidney and generating qi and blood are screened from the traditional Chinese medicine treasury, and the essence is extracted according to the formula of the traditional Chinese medicine theory, so that the natural plant medicines play the roles of whitening, stopping vomiting, improving appetite and improving life quality.
The traditional Chinese medicine composition comprises the following raw materials in parts by weight: (amounts are in parts by weight)
Radix rehmanniae Preparata 0.60-0.75 and radix Ophiopogonis 0.20-0.25
Poria 0.05-0.15 and Cinnamomum cassia 0.05-0.10.
Preferably, the traditional Chinese medicine composition of the invention consists of the following raw material components: (amounts are in parts by weight)
Radix rehmanniae Preparata 0.65-0.72 radix Ophiopogonis 0.22-0.25
Poria 0.08-0.12 and Cinnamomum cassia 0.08-0.10.
Most preferably, the optimal weight (part) ratio of the medicine of the invention is as follows:
radix rehmanniae Preparata 0.90 and radix Ophiopogonis 0.30
Poria cocos wolf 0.15 and Cinnamomum cassia 0.10.
Rehmanniae radix [ REHMANNIAERADIX ] is fresh or dried root tuber of rehmannia glutinosa Libosch of Scrophulariaceae, such as Rehmann, iagtLLtinosa Libosch, sweet, bitter and cold. It enters heart, liver and kidney meridians.
Prepared rehmannia root, also known as prepared rehmannia root, belongs to tonifying medicines, particularly belongs to blood tonifying medicines, is prepared by processing root tuber of rehmannia root (Scrophulariaceae) into irregular pieces and fragments, and has black surface, luster, large viscosity, no odor and sweet taste, wherein the root tuber is prepared by steaming the rehmannia root with yellow rice wine or steaming the rehmannia root to black color and drying the rehmannia root in the sun. Mainly produced in Henan and Zhejiang provinces. The prepared rehmannia root contains rehmannia root polysaccharide, monosaccharide, amino acid, glycoside, organic acid, phosphoric acid, stigmasterol, campesterol and more than 20 trace elements such as potassium, calcium, magnesium, iron and the like, has the effects of nourishing yin and supplementing blood, replenishing vital essence and replenishing marrow and the like, belongs to the traditional blood-supplementing medicine, is sweet in nature and slightly warm, enters liver and kidney channels, and enriches the blood and nourishes yin. But because of sticky and greasy nature and obstructing digestion, it is not suitable for spleen deficiency, poor appetite, abdominal fullness and loose stool, and often combined with Chen Pi and stir-baked Sha ren to prevent stomach obstruction and affecting spleen and stomach.
Ophiopogonis sradix, also known as ophiopogon japonicus, Zostera religiosa and Ophiopogon japonicus, is a perennial herb of ophiopogon of Liliaceae, is a dried root tuber of Ophiopogon japonica (L.f) Ker-Gawl. of Ophiopogon japonicus of Liliaceae, is mainly produced in Ixi, Yuyao and Hangzhou in Zhejiang province, is called Chuan ophiopogon japonicus in Santai county of Sichuan province, and is filled to summer to harvest in the third year after cultivation; the Sichuan radix ophiopogonis is harvested from Qingming to grain rain in the next year of cultivation; cutting root tuber, cleaning, repeatedly solarizing, stacking until seven-eight dry, removing fibrous root, drying, making radix Ophiopogonis into spindle shape with two ends slightly pointed, length of 1.5-3 cm, and diameter of 0.3-0.6 cm. The surface is light yellow or gray yellow.
Ophiopogon root, which is also a traditional tonic, is a yin-nourishing herb and can nourish yin fluid, and is sweet in taste, slightly bitter in taste and slightly cold in nature. It enters spleen, stomach, heart and lung meridians. Has the effects of clearing away heart-fire, relieving restlessness, tonifying stomach, promoting fluid production, nourishing yin and moistening lung, and is mainly used for treating diseases such as lung-stomach yin deficiency, inappetence, dry throat, thirst, dry cough due to lung dryness, vexation, insomnia, internal heat, diabetes, intestine dryness and constipation, and compared with adenophora stricta, the traditional Chinese medicine is better at tonifying stomach, promoting fluid production and slightly stronger in tonifying. Dwarf lilyturf tuber is cold, cool and greasy, and is not suitable for patients with weakness of the spleen and stomach, abdominal fullness and loose stool.
Poria is dry sclerotium of Wolf of Polyporaceae fungus Poria cocos oriacocos (Schw.), and the sclerotium is of different sizes and is mostly in the shape of sphere or fist. Rough surface, nodular protrusion, light grayish brown or black brown, pink section near the outer skin, and white inside. The fruiting body has no stalk, is flat on the surface of sclerotium, and has umbrella shape and diameter of 0.5-2 cm; the fungus tube mostly grows under the fruiting body, and the tube hole is polygonal to irregular.
Poria belongs to the drugs for inducing diuresis and eliminating dampness, specifically belongs to the drugs for inducing diuresis and relieving edema, has sweet, light and flat properties, enters heart, lung, spleen and bladder channels, induces diuresis and eliminates dampness, strengthens spleen and strengthens middle warmer, calms heart and tranquilizes mind, and is mainly used for treating dysuresia, edema and fullness, phlegm and fluid retention and cough, vomiting, spleen deficiency and anorexia, diarrhea, palpitation and uneasiness, insomnia and amnesia, spermatorrhea and whitish and turbid urine, taking the medicine for a long time and tranquilizing mind, and prolonging the life of muscles.
Poria is rich in polysaccharides: such as p-pachyman (p-pachyman), pachyman (pachyn.1a-ran), etc. Beta- (1 → 6) glucopyranose is beta- (1 → 3) glucosan of the branched chain, pachyman has no antitumor activity; its branched chain is cut into beta- (1 → 3) glucosan, i.e. pachyman (pachy-maran), and has antitumor activity. The diterpenoids: mainly comprises pachymic acid (pachymic acid), pinic acid (pmi ic acid), and temustic acid (tumu-losic acid); and organic acids, proteins, ergosterol, etc. However, there are some disadvantages of damaging yang qi and consuming yin fluid while inducing diuresis and excreting dampness.
Cinnamon (the scientific name of Latin: Cinnamomum cassia Presl), also called Yugui, Cinnamomum cassia, Jade Tree, Cinnamomum cassia, Pink Tree, Chinese cinnamon, is the dry bark of Cinnamomum cassia of Lauraceae. Cinnamon is a yang-warming medicine, and has the effects of tonifying primordial qi and yang, warming spleen and stomach, removing cold accumulation and promoting blood circulation. It is indicated for decline of vital gate fire, cold limbs and pulse, yang exhaustion and collapse, abdominal pain and diarrhea, cold hernia and dolphin, cold pain in waist and knee, amenorrhea, deep rooted carbuncle, abscess, and floating yang, upper heat and lower cold.
According to the invention, aiming at the general deficiency of spleen, lung and kidney, susceptibility to exogenous pathogenic factors and other conditions of patients after radiotherapy and chemotherapy, the prepared rehmannia root and the dwarf lilyturf tuber are adopted to effectively supplement the deficiency, the prepared rehmannia root which is a nourishing holy drug is taken as a monarch drug, the effects of enriching the blood and nourishing yin can be achieved for most patients, the cold and cool dwarf lilyturf tuber is taken as a ministerial drug by combining the warm property of the prepared rehmannia root, the effects of nourishing yin and promoting the secretion of the body fluid and harmonizing the sexual and flavor are enhanced, in addition, aiming at the defect that the prepared rehmannia root is sticky and greasy in nature and has the effect of obstructing. In addition, the characteristics of sticky and greasy radix rehmanniae preparata and radix ophiopogonis and the defects of little damage to yang qi and yin consumption of poria cocos are combined, cinnamon is pertinently introduced to serve as an adjuvant drug, the effects of warming and activating blood vessels, tonifying fire and supporting yang are achieved, the effect of inducing fire to return to original elements is equivalent, yang qi is warmed and transformed, qi and blood are encouraged to generate, and therefore yang qi is efficiently supplemented, the blood replenishing effect is effectively achieved, the number of white blood cells is rapidly increased, and the immunity of a patient is improved. The combination of the medicines effectively realizes the synergistic effects of tonifying lung and kidney, tonifying yin liquid, promoting yang qi, compensating qi and blood deficiency, helping to dissolve cereal, improving inclusion and the like, avoids the respective medication defects of the rehmannia glutinosa, the radix ophiopogonis, the cinnamon and the poria cocos, expands the adapted crowds, improves the compliance and greatly improves the patient acceptance by virtue of an organic formula. In addition, aiming at the conditions of poor general tolerance and low compliance of patients with radiotherapy and chemotherapy, the combination of the medicines avoids the negative influence of the medicines on the compliance of the patients, and after the combination, the four medicines are organically combined, so that the compliance of the patients is not deteriorated, the incorporation of the patients is improved, the vomiting stopping effect is achieved, the appetite can be effectively improved, and the life quality of the patients is improved.
In addition, the Chinese traditional medicine is made of the precisely known medicinal materials, and the medicines produced in specific areas are generally considered and proved to have better quality and curative effect and more stable quality. Therefore, from the perspective of genuine medicinal materials, the prepared rhizome of rehmannia of the invention selects the traditional genuine Huai medicine, the ophiopogon root selects the traditional genuine Chuan medicine, the tuckahoe selects the genuine Yunyun medicine, and the cinnamon selects the genuine Guangdong medicine. Proved by verification, the radix rehmanniae preparata, the radix ophiopogonis, the poria cocos and the cinnamon bark which are the traditional Chinese medicines are selected, so that the traditional Chinese medicine has better curative effect than the same medicinal materials in other areas.
Hangzhou ophiopogon root, especially Zhejiang Cixi ophiopogon root, is generally regarded as the traditional genuine medicinal material, and Chuan ophiopogon root is regarded as slightly inferior to Zhejiang ophiopogon root, but the inventor finds that the Sichuan Mianyang ophiopogon root has better curative effect only in terms of treating leucopenia of tumor patients.
Therefore, the traditional Chinese medicine composition comprises the following main raw materials: (amounts are in parts by weight)
0.60-0.75 of radix ophiopogonis from Sichuan of Henan, radix rehmanniae preparata, 0.20-0.25
0.05-0.15 of Yunnan tuckahoe, 0.05-0.10 of Guangdong cinnamon.
Preferably, the traditional Chinese medicine composition of the invention consists of the following raw material components: (amounts are in parts by weight)
0.65-0.72 of Henan radix rehmanniae Preparata and 0.22-0.25 of Sichuan radix Ophiopogonis
0.08-0.12 part of Yunnan tuckahoe, 0.08-0.10 part of Guangdong cinnamon.
Most preferably, the optimal weight (part) ratio of the traditional Chinese medicine composition is as follows:
henan radix rehmanniae Preparata 0.90 radix Ophiopogonis 0.30
Yunnan Poria 0.15 Guangdong cortex Cinnamomi 0.10.
More preferably, the prepared rehmannia root in the raw materials of the traditional Chinese medicine composition is scorched and prepared rehmannia root or warm county prepared rehmannia root is more preferably selected, the dwarf lilyturf tuber is preferably Sichuan three-platform dwarf lilyturf tuber, the poria cocos is preferably Yunnan Kunming, Chuang Xionggan or Qujing white poria cocos, the Kunming white poria cocos is most preferably selected, and the cinnamon is preferably Guangdong Gaokou cinnamon.
The invention provides application of the traditional Chinese medicine composition in preparing a medicine for effectively reducing leucopenia side effects caused by tumor radiotherapy and chemotherapy and increasing leucocytes.
The invention provides application of the traditional Chinese medicine composition in preparing a medicine for stopping vomiting and/or improving anorexia after radiotherapy and chemotherapy.
The invention relates to a medicament containing the traditional Chinese medicine composition and capable of effectively reducing leucopenia side effects caused by radiotherapy and chemotherapy for tumor radiotherapy and chemotherapy, which belongs to the protection scope of the invention.
The production method for preparing the medicine of the invention by the components comprises the following steps:
1) cleaning the genuine medicinal materials such as Sichuan radix Ophiopogonis, Guangdong cortex Cinnamomi, etc., and removing impurities;
2) firstly, taking prepared rehmannia glutinosa Libosch, freeze drying and crushing at-15 ℃, and sieving with 200 meshes of fine powder;
3) air drying radix Ophiopogonis, Poria, and cortex Cinnamomi, and pulverizing into 200 mesh fine powder;
4) decocting the above four materials in water, mixing, sterilizing, and packaging. Thus obtaining the medicine for treating leucopenia caused by chemoradiotherapy.
Preferably, the production method for preparing the medicine of the invention by the components comprises the following steps:
1) cleaning the genuine medicinal materials such as Sichuan radix Ophiopogonis, Guangdong cortex Cinnamomi, etc., and removing impurities;
2) firstly, taking prepared rehmannia glutinosa Libosch, freeze drying and crushing at-15 ℃, and sieving with 200 meshes of fine powder;
3) air drying radix Ophiopogonis, Poria, and cortex Cinnamomi, and pulverizing into 200 mesh fine powder;
4) decocting the above four materials in water, mixing, sterilizing, and packaging. Thus obtaining the medicine for treating leucopenia caused by chemoradiotherapy.
The product obtained by the invention is proved by clinical trial results to have the following characteristics:
1. the invention selects common Chinese herbal medicines, and each component accords with the regulation of the drug administration law. The comprehensive effects of the traditional Chinese medicines are utilized to treat leucopenia caused by radiotherapy and chemotherapy. The medicine source is sufficient, and the components are carried by pharmacopoeia.
2. The medicine of the invention can treat leucopenia caused by radiotherapy and chemotherapy and prevent leucopenia caused by radiotherapy and chemotherapy.
3. The medicine has the homology of medicine and food, and is safe to take.
4. The medicine can be used for treating patients with severe granulocyte inhibition, and has improved effect.
5. The medicine provided by the invention combines the monarch, minister, assistant and guide theory of traditional Chinese medicine, combines the statistical analysis of patients with radiotherapy and chemotherapy, and combines the four medicines, so that the synergistic effects of tonifying lung and kidney, tonifying yin liquid, assisting in generating yang qi, compensating qi and blood deficiency, helping to dissolve cereals, improving incorporation and the like are effectively realized.
6. The medicine disclosed by the invention has an organic formula, avoids the respective administration defects of the rehmannia glutinosa, the radix ophiopogonis, the cinnamon and the poria cocos, expands the adaptive population, improves the compliance and greatly improves the patient acceptance.
7. The combination of the four medicines avoids the negative influence of the four medicines on the compliance of patients, and after the combination, the four medicines are organically combined, so that the inclusion of the patients is greatly improved, the antiemetic effect is achieved, and the appetite can be effectively improved, so that the life quality of the patients is improved.
Detailed Description
The following examples further illustrate the present invention but are not to be construed as limiting the invention. Modifications or substitutions to methods, procedures, or conditions of the invention may be made without departing from the spirit and scope of the invention.
Unless otherwise specified, the technical means used in the examples are conventional means well known to those skilled in the art.
Example 1 preparation of granules of the invention
Weighing the raw material particles (kilogram) according to the following proportion
Prepared rehmannia glutinosa Libosch 70, radix Ophiopogonis Sichuan 20, Poria cocos wolf 15, Cinnamomum cassia Presl 10.
The production method comprises the following steps: cleaning the raw medicinal materials and removing impurities; freeze drying radix rehmanniae Preparata at-15 deg.C, pulverizing, and sieving with 200 mesh fine powder; air drying radix Ophiopogonis, Poria and cortex Cinnamomi, and pulverizing into 200 mesh fine powder; collecting the above four materials, mixing, keeping at 110 deg.C for 10 min, cooling to 105 deg.C for 5 min, cooling to 100 deg.C for 15 min, aging, and sterilizing to obtain granule. The medicine is taken orally with warm boiled water 10 g each time, 2 times a day.
Example 2 preparation of granules of the invention
Weighing the granules (kilogram) according to the following proportion
Henan radix rehmanniae Preparata 72, Sichuan radix Ophiopogonis 23, Yunnan Poria 12, Guangdong cortex Cinnamomi 8
The production process is as in example 1.
Example 3
In order to show the treatment effect of the medicine on leucopenia caused by radiotherapy and chemotherapy, from 10 months in 2009 to 2 months in 2011, the oral administration (20 examples) of the medicine prepared by applying the embodiment 1 of the invention and the treatment (20 examples) by using the hematogenous pill (produced by Tianjin Dantang Jingwanhong pharmaceutical industry Co., Ltd., consisting of pilose antler, amur corktree bark, Chinese yam, fried bighead atractylodes rhizome, mulberry twig, fried white hyacinth bean, rice sprout and human placenta) are compared and observed, and the level of venous blood leucocyte is checked to be (2.0-4.0) × 10 within 1 week after chemotherapy9L, or neutrophil at (1.0-2.0) × 109And L. The chemotherapy does not contain carboplatin, anthracyclines and other medicines which can cause late myelosuppression. The two groups were comparable in disease species (lung, breast, stomach, intestine, ovarian), age, sex and chemotherapy regimen.
When the traditional Chinese medicine of the invention example 1 is used for treating I degree-II degree leucopenia caused by chemotherapy (hereinafter referred to as observation group), 20 patients with the traditional Chinese medicine oral administration are observed randomly and parallelly, and the average value of the leucocytes of the observation group after 3 days of treatment is (4.83 +/-1.39) × 10 compared with the patient using the hematogenesis pill group (20 patients)9The average value of the leucocytes on 7 days is (6.21 +/-1.52) × 109The blood-generating pill groups are respectively (3.85 +/-1.19) × 109/L、(4.85±1.38)×109the/L shows that the observed group is superior to the hematogenesis pills in increasing the white blood cells.
After stopping the administration, the monitoring indicated that the mean value of the leukocytes in the observation group was (6.13. + -. 1.50) × 10 at 10 days after the treatment9The leucocyte mean value of the hematogenesis pill group is (4.61 +/-1.32) × 109L, two group comparison, statistical differences (P)<0.05), which shows that the invention has a predominant level of leucocytes within one week of drug withdrawal and has certain maintenance capability.
In addition, statistically, the number of cases in which the normal level of leukocytes was restored within 3 days was 40% (8/20) in the observation group and 20% (4/20) in the hematogenous pill group, indicating that the restoration rate was high in the observation group within 3 days. Statistically, the observed group was 85% (17/20) and the hematogenous pill group was 60% (12/20) in the number of cases where normal levels of leukocytes were restored within 7 days, indicating that the restoration rate was still high in the observed group within 7 days. Statistically, the observed group was 85% (17/20) and the hematopoietic pill group was 72% (13/18) in the number of cases in which the normal level of leukocytes was restored within 14 days, indicating that the overall recovery rate of the observed group was still higher than that of the hematopoietic pill group after the withdrawal of the drug.
As can be seen from Table 1, the mean leukocyte values of the group observed 3 days after the treatment were (4.83. + -. 1.39) × 109The leucocyte mean value of the hematogenesis pill group is (3.85 +/-1.19) × 109L, two groups were significantly different from those before treatment (t 7.83, P)<0.05); statistical differences (P) were present in the two groups compared 3 days after treatment<0.05). The medicine of the embodiment 1 of the invention can improve the speed of high leucocyte cells faster than that of the hematogenesis pill group.
TABLE 1 mean and statistical leukocyte values at different times for two groups of patients (× 10)9/L)
The mean value of the white blood cells of the invention is (6.21 +/-1.52) × 10 after 7 days of treatment9The leucocyte mean value of the hematogenesis pill group is (4.85 +/-1.38) × 109L, two groups showed significant differences (P) than 3 days after treatment<0.05), indicating that both groups of leukocytes are significantly elevated within 3 to 7 days. Two groups compared 7 days after treatment, there was a statistical difference (P)<0.05). Show that as the treatment progresses, twoThe group method can further increase the number of the white blood cells, and the observation group is more remarkably improved. Both leukocyte levels peaked at day 7 during the observation period.
The analysis data shows that the two groups of lifting amplitudes within 3 days are respectively (1.82 +/-1.04) × 109/L、(0.87±0.87)×109Per L, there is a statistical difference (P)<0.05), indicating that the observed group administered with the drug of example 1 had a higher amplitude of elevation within 3 days, and that the two groups had (3.21. + -. 1.21) × 10 amplitudes within 7 days9/L、(1.87±1.01)×109Per L, there is a statistical difference (P)<0.05), indicating that the observed group boost amplitude is still high within 7 days.
The data in table 2 show that: statistically, the number of cases in which the leukocytes recovered to normal levels within 3 days was 40% (8/20) in the observation group and 20% (4/20) in the hematogenous pill group, indicating that the recovery rate was high in the observation group within 3 days. Statistically, the observed group was 85% (17/20) and the hematogenous pill group was 60% (12/20) in the number of cases where normal levels of leukocytes were restored within 7 days, indicating that the restoration rate was still high in the observed group within 7 days.
TABLE 2 Normal cases and statistics of leukocyte recovery in two groups of patients at different times
Table 3 the results suggest: statistically, the number of cases in which the granulocytes were restored to the normal level within 3 days was 35% (7/20) in the observation group and 20% (4/20) in the hematogenous pill group, indicating that the recovery rate was high in the observation group within 3 days. Statistically, the observation group was 85% (17/20) and the hematogenous pill group was 65% (13/20) in the number of cases in which the granulocytes returned to normal levels within 7 days, indicating that the recovery rate was still high in the observation group within 7 days.
TABLE 3 Normal cases and statistics of neutrophil recovery in two groups of patients at different times
The results in Table 4 demonstrate that the Chinese medicine of example 1 of the present application can improve the survival quality of patients after chemotherapy.
TABLE 4 KPS score mean and statistic values before and after treatment for two groups of patients
Table 5 shows that the observation group has advantages in improving the leukocyte level of patients with I-II degree leukopenia after chemotherapy compared with the hematogenous pill group in terms of total effective rate and significant efficiency.
TABLE 5 two groups of statistics for efficacy
Table 6 shows that the drug prepared in example 1 of the present invention has the effects of stopping vomiting, improving anorexia to some extent, and alleviating nausea symptoms, compared with the hematopoietic pill group.
TABLE 6 statistics of the two groups of therapeutic effects
Compared with the hematogenesis pill group, the medicine prepared in the embodiment 1 of the application also has the effects of stopping vomiting, improving anorexia to a certain extent and relieving nausea symptoms.
The prepared rehmannia root, the tuckahoe, the dwarf lilyturf tuber and the cinnamon are both medicinal and edible, have higher safety, belong to Chinese medicinal materials approved by the national ministry of health and drug administration and can be used for health care food or common food to a certain extent, and have stronger safety. In addition, combined with the clinical application of nearly 7 years, the medicine of the invention does not affect the cardiac function, the liver and kidney function, the hematuria and the defecation convention and the like of patients during the treatment period, and has better safety.
Claims (10)
1. A traditional Chinese medicine composition for treating leucopenia after chemoradiotherapy is characterized by being prepared from the following raw materials in parts by weight:
radix rehmanniae Preparata 0.60-0.75 and radix Ophiopogonis 0.20-0.25
Poria 0.05-0.15 and Cinnamomum cassia 0.05-0.10.
2. The traditional Chinese medicine composition of claim 1, which is prepared from the following raw materials in parts by weight:
radix rehmanniae Preparata 0.65-0.72 radix Ophiopogonis 0.22-0.25
Poria 0.08-0.12 and Cinnamomum cassia 0.08-0.10.
3. The traditional Chinese medicine composition of claim 1 or 2, wherein the prepared rhizome of rehmannia is prepared from rehmannia glutinosa Libosch.
4. The traditional Chinese medicine composition of claim 1 or 2, wherein the radix ophiopogonis is radix ophiopogonis.
5. The traditional Chinese medicine composition of claim 1 or 2, wherein the poria cocos is Yunnan poria cocos.
6. The traditional Chinese medicine composition of claim 1 or 2, wherein the cinnamon is cinnamon from Guangdong.
7. The use of the Chinese medicinal composition of any one of claims 1-6 in the preparation of a medicament for effectively reducing the side effects of leukopenia caused by tumor radiotherapy and chemotherapy and increasing leukocytes.
8. Use of the Chinese medicinal composition of any one of claims 1-6 in the preparation of a medicament for stopping vomiting and/or improving anorexia after radiotherapy and chemotherapy.
9. A medicament for effectively reducing the side effect of leukopenia caused by radiotherapy and chemotherapy for tumor, which is characterized by comprising the traditional Chinese medicine composition of any one of claims 1 to 6.
10. The preparation method of the traditional Chinese medicine composition of any one of claims 1 to 6, which is characterized by comprising the following steps:
1) cleaning the raw medicinal materials and removing impurities;
2) freeze drying radix rehmanniae Preparata at-15 deg.C, pulverizing, and sieving with 200 mesh fine powder;
3) air drying radix Ophiopogonis, Poria, and cortex Cinnamomi, and pulverizing into 200 mesh fine powder;
4) decocting the above four materials in water, mixing, and sterilizing.
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