CN113813347A

CN113813347A - Preparation method and process of compound paclitaxel anti-tumor capsule tablet

Info

Publication number: CN113813347A
Application number: CN202111235270.7A
Authority: CN
Inventors: 庞中龙; 庞作仁; 杨忠荣; 刘�东
Original assignee: Individual
Current assignee: Individual
Priority date: 2021-10-22
Filing date: 2021-10-22
Publication date: 2021-12-21

Abstract

The invention discloses a preparation method and a process of compound paclitaxel anti-tumor capsule tablets, which comprises the following steps: step 1: drying the pulverized materials of white ginseng, selfheal, bletilla striata, liquorice, astragalus, pseudo-ginseng, radix stemonae, Chinese date, taxus chinensis extract, upturned skullcup, airpotato yam rhizome, fructus forsythiae and other Chinese herbal medicines, and pulverizing the dried Chinese herbal medicines into particles of 200 meshes and 300 meshes by an ultrafine pulverizer. Has the advantages that: the compound paclitaxel anti-tumor capsule tablet is prepared by repeatedly extracting and mixing the extractum, so that the medicinal materials for preparing the compound paclitaxel anti-tumor capsule tablet are fully utilized, the effective components of the medicinal materials are fully reserved, the therapeutic effect of the compound paclitaxel anti-tumor capsule tablet is improved, the medicinal materials are matched by a traditional Chinese medicine treatment mode, toxic components in the medicinal materials are effectively neutralized, and the safety of the compound paclitaxel anti-tumor capsule tablet during taking is ensured.

Description

Preparation method and process of compound paclitaxel anti-tumor capsule tablet

Technical Field

The invention relates to the field of tumor treatment, in particular to a preparation method and a process of compound paclitaxel anti-tumor capsule tablets.

Background

Surgery, radiotherapy and chemotherapy drug therapy are the main treatment means of malignant tumors, but the toxic and side effects are great. The present clinical antitumor chemicals have toxic side effect in different degrees, and they can kill tumor cell and normal tissue cell, especially blood and lymph tissue cell. Adverse reactions of anticancer drugs are classified into various types, and the adverse reactions mainly include blood toxicity, digestive tract toxicity, mucosal damage, hepatotoxicity, nephrotoxicity and the like according to the influence of the anticancer drugs on different systems of organisms. In the last sixties, American scientists found that Taxus chinensis extract paclitaxel has special effects of resisting tumor and cancer, so the Taxus chinensis extract is widely applied to anticancer drugs in Western medicine.

However, the existing medicine containing the taxus extract prepared by the western medicine method has large toxic and side effects, which causes pain of patients after taking the medicine, and other effective components in the prepared taxus chinensis are greatly wasted, which causes poor treatment effect of the antitumor medicine.

Disclosure of Invention

The invention aims to solve the problems and provide a preparation method and a process of compound paclitaxel anti-tumor capsule tablets.

The invention realizes the purpose through the following technical scheme:

the preparation process of compound taxol antitumor capsule tablet includes the following steps:

step 1: drying the weighed ground Chinese herbal medicine materials of white ginseng, selfheal, bletilla striata, liquorice, astragalus, pseudo-ginseng, radix stemonae, Chinese date, taxus chinensis extract, upturned skullcup, airpotato yam rhizome, forsythia and the like, and grinding the dried Chinese herbal medicine raw materials into particles of 200 meshes and 300 meshes by an ultrafine grinder;

step 2: adding 10-30 times of 70% ethanol into the above fine particles, mixing, extracting for 2-5 hr, standing at room temperature for 12-24 hr to obtain supernatant and residue;

and step 3: taking the dregs of the six particles in the step 2, adding 10-30 times of 60% ethanol, fully and uniformly mixing, extracting for 2-5 hours, standing for 12-24 hours at room temperature to respectively obtain supernatant extracting solution and dregs of the particles;

and 4, step 4: taking the residues of the six particles in the step 3, adding 10-30 times of 60% ethanol, mixing, extracting for 2-5 hr, standing at room temperature for 12-24 hr to obtain supernatant extractive solution and residues of the particles, respectively, and discarding the residues;

and 5: respectively combining the liquid medicines obtained in the step 2 and the step 3, filtering to remove residual impurities to obtain clear supernate of the traditional Chinese medicine raw materials, respectively recovering ethanol from the clear supernate of the traditional Chinese medicine raw materials, respectively concentrating to obtain extractum with the relative density of 1.20-1.45, drying the extractum, crushing, sieving with a 60-80 mesh sieve to obtain dry extract powder, and uniformly mixing the dry extract powder;

step 6: mixing the above materials, filtering, and concentrating to obtain extract with relative density of 1.20-1.45;

and 7: and (4) uniformly mixing the extract obtained in the step (5) and the extract obtained in the step (6), adding auxiliary materials, and granulating, drying and sterilizing to obtain the capsule tablet for treating tumors.

Furthermore, the drying temperature of the extract in the step 5 is 60-80 ℃, and the active ingredients of the traditional Chinese medicinal materials in the extract can be retained to the maximum extent while the extract is dried by strictly controlling the drying temperature of the extract, so that the final curative effect of the medicinal materials is ensured.

Further, the drying temperature of the extract in the step 6 is 60-80 ℃.

Furthermore, the Chinese herbal medicines corresponding to the six particles extracted in step 2 are respectively white ginseng, astragalus root, pseudo-ginseng, radix stemonae, taxus chinensis extracts and zhangtian pots, so that the effective components in the Chinese herbal medicines can be fully extracted.

The invention has the beneficial effects that:

the compound paclitaxel anti-tumor capsule tablet is prepared by repeatedly extracting and mixing the extractum, so that the medicinal materials for preparing the compound paclitaxel anti-tumor capsule tablet are fully utilized, the effective components of the medicinal materials are fully reserved, the therapeutic effect of the compound paclitaxel anti-tumor capsule tablet is improved, the medicinal materials are matched in a traditional Chinese medicine treatment mode, toxic components in the medicinal materials are effectively neutralized, the safety of the compound paclitaxel anti-tumor capsule tablet during taking is ensured, and the compound paclitaxel anti-tumor capsule tablet can effectively inhibit the growth of tumor cells on a patient and relieve the pain of the patient after taking.

Detailed Description

In the embodiment, the drying temperature of the extract in the step 5 is 60-80 ℃, and the active ingredients of the traditional Chinese medicinal materials in the extract can be retained to the maximum extent while the extract is dried by strictly controlling the drying temperature of the extract, so that the final curative effect of the medicinal materials is ensured.

In this embodiment, the drying temperature of the extract in step 6 is 60-80 ℃.

In this embodiment, the Chinese herbal medicines corresponding to the six particles extracted in step 2 are respectively white ginseng, astragalus membranaceus, pseudo-ginseng, radix stemonae, and yew extract, and zhangtian pots, so that sufficient extraction of effective components in the Chinese herbal medicines can be ensured.

The treatment table of the invention is as follows:

case one: chen in Chen Shi, male and 66 years old, 2011-05-10 hospitalized, because of progressive lumbago, double lower limb paralysis, afternoon hectic fever and night sweat, CT examination in the municipal hospital shows: the bone destruction of the lumbar vertebra 1 and 2, considered as lumbar tuberculosis, is treated by operation due to weakness, and is treated by traditional Chinese medicine, and the diagnosis of chin after hospital admission: the pain and the face are pale, the color is dark, the back enters a ward, the speech is low and slight, the tongue is fat and large, the tongue coating is thin and white, the tongue root is stripped, and six veins are thready and rapid; traditional Chinese medicine diagnosis: after the bone tuberculosis is hospitalized, 0.5g of compound taxus chinensis extract is orally taken three times a day, and large dose of cephalotaxus fortunei, angelica sinensis, astragalus membranaceus, ginseng, prepared rhizome of rehmannia, Chinese yam, dogwood, hairyvein agrimony, semen brassicae, bletilla striata, radix rehmanniae, radix ophiopogonis, lalang grass rhizome, barbed skullcap herb, honey-fried licorice root, morinda officinalis, cinnamon, mahonia leaves, eucommia ulmoides, medicinal cyathula root, sargentgloryvine stem, salvia miltiorrhiza, stir-fried pangolin scales and spina gleditsiae are subjected to addition and subtraction treatment, after 20 days, symptoms of low heat and night sweat disappear, the patient can stand beside a bed, and the lumbago is slightly relieved; after the treatment is continued for 4 months, the patient can walk independently, stop taking the medicine after the treatment is consolidated for 8 months, and have self-care life, and after 1 year of follow-up visit, the bone morphological structure of the vertebral body is normal and completely cured;

case two: the disease is characterized in that certain populus, women and 18 years old appear symptoms such as low fever, night sweat, nausea, headache and the like in 6 months of 2012, local treatment is ineffective, the symptoms are continuously aggravated, the disease returns to cities, the disease is diagnosed in general hospitals, tuberculous meningitis (early stage) is diagnosed, no obvious improvement is caused after one week of treatment, the patients are called by the hospital, when the patients are admitted, the patients suffer from pain and face, the face is flush, the nutrition is general, the head and five sense organs have no deformity, the patients talk and vomit naturally, the speech is fine, the tongue is ruddy, the tongue edge and tip are scattered at petechia points, the tongue fur is thin and white, and the pulse is fine and unsmooth; traditional Chinese medicine diagnosis: headache and cerebral stasis, 0.3g of Chinese yew extract is orally taken after the patient is hospitalized, the oral administration is carried out three times a day, the oral administration is carried out by combining with the traditional Chinese medicines of szechuan lovage rhizome, peach seed, safflower, red paeony root, Chinese angelica, membranous milkvetch root, ginseng, prepared rehmannia root, common yam rhizome, cephalotaxus fortunei, hairyvein agrimony, white mustard seed, bletilla striata, grassleaf sweelflag rhizome, gambir plant, danshen root, stir-fried pangolin scales, liquoric root, buffalo horn and musk for addition and subtraction treatment, the headache, low fever and night sweat are relieved after one week, the symptoms disappear after 1 month, the medicine with 3 months continues to treat because of heavy learning tasks, the follow-up visit after half a year, no discomfort reaction exists, and the liver and kidney functions are repeatedly checked for a plurality of times in the period have no obvious abnormality;

case three: zhangzhi, male, 22 years old, 2012 9 months because "cough, chest pain, short breath" come to hospital to diagnose and treat, diagnose to be tuberculous pleurisy, the equal amount hydrops in the right side thorax, hospitalize a week, it is not obvious to improve, see a doctor to my hospital, the time is complained: chest distress, shortness of breath, hypodynamia, night sweat and dizziness, and the diagnosis by the traditional Chinese medicines: after the patient is hospitalized, 0.2g of compound taxus chinensis extract is orally taken three times a day, the symptoms are improved to different degrees after three weeks by applying the formula medicines of red paeony root, Chinese angelica, astragalus, ginseng, prepared rehmannia root, Chinese yam, cephalotaxus fortunei, hairyvein agrimonia herb and bud, white mustard seed, bletilla striata, acorus gramineus, uncaria, salvia miltiorrhiza, stir-fried pangolin scales and liquorice, the pleural effusion is reduced by rechecking the chest tablets, the symptoms disappear after the chest tablets prompt that the pleural effusion is completely absorbed after 1.5 months of plus-minus treatment according to different reactions of each period of the patient, the pleural effusion is not obviously thickened, the treatment is continued for 3 months, and no abnormity appears after 1 year of follow-up;

case four: guo in a male, aged 32 years, hospitalized at 2010-08-10, suffering from both-lung infiltrative pulmonary tuberculosis, taking 4-combination antituberculosis drugs for 1 year, and rechecking that glutamic-pyruvic transaminase and glutamic-oxalacetic transaminase are obviously increased; the anti-tuberculosis medicine is not taken because of fear of influencing the body by continuously taking the medicine, the treatment is continuously carried out in our hospital, and the traditional Chinese medicine diagnosis is as follows: after the lung tuberculosis is subjected to qi and yin depletion, 0.8g of compound taxus chinensis extract is administered three times a day after the lung tuberculosis is placed in hospital and orally taken, and the prescription is added and subtracted for 1+ month after angelica sinensis, astragalus membranaceus, ginseng, prepared rehmannia root, Chinese yam, dogwood, fried bighead atractylodes rhizome, cephalotaxus fortunei, hairyvein agrimony, radix stemonae, bletilla striata, honey-processed loquat leaf, radix rehmanniae, radix ophiopogonis, dendrobium nobile, root of straight ladybell, houttuynia cordata, lalang grass rhizome, barbed skullcap herb and honey-fried licorice root are treated, so that not only is the symptom improved, but also the chest piece prompts the fibrosis of a pulmonary tuberculosis focus to be improved, and the liver and kidney functions are rechecked and recovered to be normal; after the medicine is taken for 4 months, tuberculosis focus disappears, the disease is cured, and the disease does not relapse after 1.5 years of follow-up visit;

case five: in the case of a certain populus, a female is 31 years old, and is admitted to a hospital at 2010-05-10, 4-combined antituberculosis drug is taken for treatment, after 6+ months, the weight is obviously reduced, the fatigue, the appetite is reduced, the liver and kidney dysfunction (glutamic-pyruvic transaminase and glutamic-oxalacetic transaminase are obviously increased), the antituberculosis drug is discontinued, and the traditional Chinese medicine treatment is carried out in the hospital, so that the admission condition is as follows: quiet face, dry skin, poor elasticity, natural walking, clear speech, soft voice, red tongue with thin and white coating and red tongue edge and tip; the six pulses are thin and numerous, the respiratory sounds of the two parties are thick, the dry and wet rales can be reached, and the traditional Chinese medicine diagnosis is as follows: tuberculosis: depletion of qi and yin; after the patient is hospitalized, 1.2g of compound taxus chinensis extract is orally taken three times a day, the traditional Chinese medicines such as angelica sinensis, astragalus membranaceus, ginseng, dogwood, bighead atractylodes rhizome, cephalotaxus fortunei, hairyvein agrimony, radix stemonae, bletilla striata, honey-processed loquat leaf, radix rehmanniae, radix ophiopogonis, dendrobium nobile, radix adenophorae and lalang grass rhizome are added and reduced for treatment, the weight is increased by 1Kg after 1+ month, symptoms such as hypodynamia and the like disappear, and the diet is recovered to be normal; after 5+ month, the tuberculosis focus is fibrous and calcified, and no abnormality exists in follow-up visit for 6+ month;

case six: old male, 19 years old, has 4-up antitubercular drugs for 7+ months, weight loss, debilitation and liver function damage due to left infiltrative pulmonary tuberculosis with left supraclavicular lymphadenectasis (left supraclavicular lymphadenectasis, 3 x 2cm for those with large lymph nodes); stopping taking antituberculosis drugs, performing dialectical treatment according to goiter and tumor in traditional Chinese medicine, orally taking 1.0g of Chinese yew extract three times a day, adding or subtracting decoction of Chinese angelica, astragalus, ginseng, bighead atractylodes rhizome, cephalotaxus fortunei, hairyvein agrimony, bletilla striata, honey-processed loquat leaf, lalang grass rhizome, seaweed, stir-fried pangolin scales, selfheal, curcuma zedoary and the like for treatment, eliminating hypodynamia symptom after one month, increasing the weight by 2Kg, rechecking after 6 months of medication, eliminating phthisis focus, eliminating swelling on left clavicle, rechecking that liver and kidney lymph nodes have normal functions, and having no rebound after 3+ month follow-up;

case seven: in Zhongzhi, the male is difficult to walk for 1+ month due to progressive right hip pain, accompanied with hectic fever, night sweat and hypodynamia, suspected to have tuberculosis to the examination of the hospital of the people in the market, right hip CT prompts the thickening of the synovial membrane, the joint tuberculosis is considered, antituberculosis and traction (brake) treatment are proposed, the patient is unwilling to go to the hospital and see a doctor, 1.5g of compound taxus chinensis extract is given to take orally three times a day after the hospital is admitted, cephalotaxus fortunei is taken as the monarch, liver and kidney tonifying, muscle and bone strengthening and tuberculosis resisting insecticidal traditional Chinese medicines are assisted, the pain is relieved after 15 days of treatment, the male can walk independently after 1+ month, the function of liver and kidney is rechecked without obvious influence, the pain is completely disappeared after 2+ months of continuous treatment, the male walks freely, and the right hip CT prompts: normal hip joint structural manifestations; the follow-up visit is 6 months without any abnormality;

case eight: after the patient is known in detail, 0.3g of compound taxus chinensis extract is given (packaged into capsules) and is matched with a tonifying soup (the medicine comprises angelica sinensis, astragalus membranaceus, bighead atractylodes rhizome, cephalotaxus fortunei, hairyvein agrimony, stemona root, bletilla striata, honey-processed loquat leaf, radix rehmanniae, radix ophiopogonis, dendrobium nobile, root of straight ladybell, lalang grass rhizome and the like), the cough is obviously relieved after 3 weeks, the liver and kidney function is checked to be free from any abnormality, the tuberculosis focus is rechecked after 3 months, partial calcification is completely disappeared, and the treatment is consolidated for 2 months; the follow-up 1.5 years has no recurrence;

case nine: zhao somewhat, women, 26 years old, 9 months of 2012 were admitted to the hospital for treatment due to illness, and the diagnosis is tuberculous pleurisy, and the equal amount of hydrops in the right thorax, a small amount of hydrops in the left thorax, hospitalization for one week, the improvement is not obvious, complain when arriving our hospital to see a doctor: chest distress, shortness of breath, debilitation, night sweat and dizziness, the compound Chinese yew extract is used for treating with Chinese herbal medicines for tonifying lung qi, benefiting qi and tonifying kidney, the symptoms are improved in different degrees after three weeks, the reduction of pleural effusion is prompted by rechecking the chest tablet, after the treatment is continued for 1.5 months by adjusting according to different reactions of each period of the patient, the symptoms disappear, the pleural effusion is prompted to be completely absorbed by the chest tablet, and the pleural thickening is not obvious; no abnormal discomfort reaction after 6 months of follow-up;

case ten: when Luo-Shi, male and 11 years old are admitted to hospital at 2012-11-06, the patient is unwilling to receive anti-tuberculosis drug treatment due to various reasons because of finding the left pulmonary tuberculosis during physical examination, and after admission, 0.3g of compound taxus chinensis extract is orally taken and handed over to nutritional and high-protein diet of families, and after one month, the liver and kidney function is checked to be free of any abnormality, and the pulmonary tuberculosis focus is not diffused; after 3 months, rechecking that tuberculosis focus completely disappears, and curing for 2 months; no recurrence after 1 year follow-up;

case eleven: the patient Marwei, male and 20 years old is admitted to the hospital in 2011-11-20 due to the fact that the patient suffers from lumbago accompanied by numbness of the two lower limbs for 1+ month, the patient suffers from lumbago for more than one month, and the lumbago gradually worsens, and the examination of a municipal hospital indicates that the lumbar 1 vertebral bone structure is damaged and the paravertebral tissue is swollen; considering the lumbar tuberculosis, the patient is unwilling to receive surgical treatment due to various reasons, and then the patient goes to our hospital to receive traditional Chinese medicine treatment and geniotherapy: quiet face, ruddy face, walking into ward, extensive tenderness of lumbar vertebra spinous process and paravertebral tissue, no discomfort such as pain of both lower limbs and the like; the muscle strength of both lower limbs is 4+ grade, no obvious muscular atrophy, no local red swelling, plaque and the like, the tongue is fat and large, the tongue coating is thick and greasy, the pulse is thin, and the diagnosis by the traditional Chinese medicine is as follows: bone tuberculosis with liver and kidney deficiency; after admission, 1.2g of compound yew extract is taken orally three times a day; after the prescription is added and reduced for treating lumbago, numbness and abnormal sensation of both lower limbs after one month, the symptoms basically disappear after 3 months, and the lumbar vertebra bone destruction absorption and edge hardening are rechecked;

case twelve: the patient is simple and certain, women, 33 years old, the disabled arrives at my hospital in 2014, 23 months, complains of repeated breathlessness, cough at night for 6+ months, no discomfort such as fever, aversion to cold, chest pain and the like, the cough is obvious at night, the daytime is slightly improved, the patient can take medicine for treatment (not detailed) by self, no obvious improvement is caused, the cough is gradually aggravated, the patient can spit a small amount of foam-like phlegm, the patient can feel hypodynamia, chest distress and breathlessness after long-time running and labor work, but can still endure, the patient can still endure without systematic diagnosis and treatment due to economic reasons, the breathlessness is obvious after the patient walks in the near term, X-ray examination is carried out in a water-steel hospital, and the conditions of right pleurisy, small amount of hydrops in right chest and admission are prompted: pale complexion, low mood, whispering, low and distant breath sound on the right side, and considering the characteristics of early treatment and weak constitution, the diagnosis is planned: for consumptive of qi and yin of pulmonary tuberculosis, angelica, astragalus, ginseng, fried white paeony root, prepared rehmannia root, Chinese yam, dogwood, fried bighead atractylodes rhizome, cephalotaxus fortunei, hairyvein agrimony, stemona root, bletilla striata, honey-processed loquat leaf, dried rehmannia root, dwarf lilyturf tuber, dendrobium, adenophora stricta, heartleaf houttuynia herb, lalang grass rhizome, honey-fried licorice root and other prescription drugs are added or subtracted for treating more than one month, the weight of a patient is increased by 2.5kg, the complexion is ruddy, the mood is improved, the shortness of breath and the hypodynamia are eliminated, the labor capacity is obviously improved, and the imaging examination: right pleural effusion, currently under treatment;

case thirteen: tanshi, male, 21 years old, hospitalized because "the patient finds 15+ days of left upper pulmonary tuberculosis during physical examination" hospitalized at 16 days of 2014 05, no abnormal discomfort such as low fever, night sweat, cough, expectoration, chest pain and the like at night, no obvious discomfort exists in learning, labor and the like, the re-examination confirms that the diagnosis of pulmonary tuberculosis is established, and the doctor opinion and the treatment of antituberculosis drugs (isoniazid, rifampicin, pyrazinamide, vitamin and the like) are followed, the drug is stopped due to large gastrointestinal tract reaction after the administration, the patient is diagnosed with traditional Chinese medicine in our hospital, and the genisis is diagnosed: quiet face, normal nutrition, natural walking, normal five sense organs without deformity, clear speech and good luck, no cough, expectoration, red tongue, thin and yellow fur, and thready and rapid pulse, and is diagnosed by the traditional Chinese medicine: tuberculosis with lung yin deficiency; administering 12 pills of anti-tuberculosis pill three times daily for oral administration, and adjuvant treating with radix Angelicae sinensis, radix astragali, Ginseng radix, radix Paeoniae alba preparata, Poria, Cephalotaxus fortunei, herba et Gemma Agrimoniae, radix Stemonae, rhizoma Bletillae, rhizoma Dioscoreae, radix Ophiopogonis, radix Glycyrrhizae Preparata, herba Scutellariae Barbatae, and radix Adenophorae; after 42 days, the left upper pulmonary tuberculosis focus is calcified, and the medicine is continuously taken for consolidation treatment.

The combination of the cases proves that the capsule tablet prepared by the process can effectively treat malignant tumor and inhibit cancer prevention, and can greatly reduce the pain of patients after taking the medicine.

The above description is only for the purpose of illustrating the preferred embodiments of the present invention and is not to be construed as limiting the invention, and any modifications, equivalents, improvements and the like that fall within the spirit and principle of the present invention are intended to be included therein.

Claims

1. The preparation method and the process of the compound paclitaxel anti-tumor capsule tablet are characterized in that: it comprises the following steps:

2. The preparation method and process of the compound paclitaxel anti-tumor capsule tablet according to claim 1 are characterized in that: the drying temperature of the extract in the step 5 is 60-80 ℃.

3. The preparation method and process of the compound paclitaxel anti-tumor capsule tablet according to claim 1 are characterized in that: the drying temperature of the extract in the step 6 is 60-80 ℃.

4. The preparation method and process of the compound paclitaxel anti-tumor capsule tablet according to claim 1 are characterized in that: the Chinese herbal medicines corresponding to the six particles extracted in the step 2 are respectively white ginseng, astragalus, pseudo-ginseng, radix stemonae, taxus chinensis extracts and Korean ginseng cans.