CN1931346A - Anticancer soft capsule and its prepn process - Google Patents

Anticancer soft capsule and its prepn process Download PDF

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Publication number
CN1931346A
CN1931346A CN 200510047219 CN200510047219A CN1931346A CN 1931346 A CN1931346 A CN 1931346A CN 200510047219 CN200510047219 CN 200510047219 CN 200510047219 A CN200510047219 A CN 200510047219A CN 1931346 A CN1931346 A CN 1931346A
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soft capsule
cancer
tumor
squalene
medicine
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CN100522237C (en
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石晓杰
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Abstract

The present invention relates to cancer treating medicine, and is especially one kind of anticancer Chinese medicine soft capsule and its preparation process. The anticancer Chinese medicine soft capsule is prepared with zedoary oil, cantharidin, squalene, soybean phospholipid, vitamin E and sesame oil in certain weight proportion. It has the functions of promoting qi circulation, removing blood stasis, eliminating stagnated qi, relieving pain, eliminating swelling, etc and is suitable for treating various kinds of cancers, including liver cancer, gastric cancer, intestinal cancer, etc. caused by qi stagnation, blood stasis and hypoimmunity.

Description

A kind of anticancer soft capsule and preparation method thereof
Technical field
The present invention relates to treat the herbal species of cancer, specifically a kind of anticancer soft capsule and preparation method thereof.
Background technology
Cancer is one of important diseases of harm people's life health because its course of disease is short, harm is big, popular wide.Still lack ideal medicine at present; According to the investigation of 29 provinces, cities and autonomous regions' populations more than 800,000,000, China has approximately greater than the hundreds of thousands people die from nine big common cancers every year; Mainly contain surgical operation, chemotherapy, radiotherapy, gene therapy, Chinese medicine and interventional therapy for treatment for cancer; But because cancer often merges severe complication or sends out in vivo, the excision rate only is about 5%, has lost the surgical engine meeting when nearly 95% patient makes a definite diagnosis, relies on Drug therapy mostly; So the medicine of developmental research treatment cancer has the meaning of particular importance.
According to The World Health Organization (WHO) statistics, the annual world has more than 1,000 ten thousand people to suffer from cancer, and the number of dying from cancer reaches more than 600 ten thousand, accounts for 12% of the dead sum in the whole world.The annual newly-increased cancer patient 2,000,000 of China, dead 1,400,000, just had 1.3 people to die from cancer in average per 3 minutes, and the sickness rate of cancer is rapid ascendant trend, and turns to the trend of becoming younger by aging with morbidity colony.The reason that cancer mortality is high mainly is that people are not enough to " high mortality risk phase " understanding of cancer " convalescence ".So-called cancer " convalescence " is exactly that patient is by operation with the period that puts, the state of an illness is eased and controls after the chemotherapy in fact.But experienced clinician thinks, compares with previous tretament, and be neoplasm metastasis, recurrence " dead high-risk period " this period.The cancer patient has 90% approximately nearly in being known as the life dawn of " convalescence ".The traditional treatment method for cancer was operation, radiotherapy, chemotherapy etc. in the past, all the cancerous cell of internal lesions can't be wiped up.Moreover, because body obtains the radiating irradiation (radiotherapy) and the chemotherapeutics treatment of overdose in a short time, make immunologic function, particularly hemopoietic function of bone marrow seriously is injured, thereby further promote the propagation of remaining cancerous cell madness, part patient lump occurs and once dwindled, quicken dead but body is depleted suddenly.Therefore, the understanding that medical circle is more and more clear-headed, traditional treatment means is to finish the historic mission of conquering cancer.
Motherland's medical science is very much remote to the understanding of cancer, " interior warp " record " vital QI in the body flowing normally; keeping a sound mind, sick peace are always ", " healthy energy internal memory; heresy can not be done ", " institute's its gas that gathers of heresy must be empty ", the rule that " strengthening the body resistance " dialectical opinions such as " supporting just long-pending from removing " is controlled.Ancient medicine proposes " six kinds of stagnation-syndromes is basis of Ji Ju mass in the abdomen "." QI and blood dash and, all kinds of diseases and ailments are not given birth to ", " one have looking angry strongly fragrant, here all kinds of diseases and ailments give birth to ", strongly fragrant person, sick knot does not loose also.Control Yu Zhifa, how many removing food stagnancy divides and controls it.
On Chinese medicine, the pathogenesis that cancer forms, damaged by excess of seven emotions: stagnation of QI due to depression of the liver, blood flow are puckery with fixed attention.Qi depression to blood stasis Jie of a specified duration is a mass in the abdomen.Blood stasis is promptly of a specified duration, and gives birth to interior-heat.Control suitable: soothing the liver circulation of qi promoting, broken sedan-chair blood stasis dispelling is held concurrently and is set upright with tonify deficiency.In the side, Rhizoma Curcumae extract removing blood stasis, promoting the circulation of QI to relieve pain, Mylabris extract counteracting toxic substances feedback skin ulcer, removing blood stasis eliminating stagnation.The two removing blood stasis of working in coordination to be loosing abdominal mass, circulation of qi promoting Yi San Disorder, yet the product of removing blood stasis, and every meaning consumption is hindered healthy energy so use the Squalene strengthening by means of tonics.What make stasis is so incensed that diffusing, and healthy energy is not hindered, and all stasis must be loose and do not had sequel.
Now, what many recent studies ons were arranged controls cancer new method and medicine, but its drug effect is all not ideal enough, and also has some Chinese patent medicines to have certain side effect, is not suitable for all patients and uses.
Summary of the invention
The object of the present invention is to provide a kind of consolidate set upright, the anticancer soft capsule for the treatment of both the principal and secondary aspects of a disease, exact efficacy.
For achieving the above object, the technical solution used in the present invention is:
A kind of anticancer soft capsule, in per thousand, the weight proportion of its raw material is, Oleum Curcumae (being Rhizoma Curcumae extract) 3-15g, cantharidin (being Mylabris extract) 8-200mg, Squalene 100-500g, fabaceous lecithin (being soybean lecithin) 5-50g, vitamin E 1-5g, Oleum Sesami 1-5g.
Preferable prescription consists of, Oleum Curcumae 5-15g, cantharidin 8-80mg, Squalene 100-270g, bean squama fat 10-50g, vitamin E 1-5g, Oleum Sesami 1-5g.
Being prepared as follows of above-mentioned anticancer soft capsule: get it filled by described prescription, get Squalene and put in the enamelled vessel, be heated to 50-55 ℃, constant temperature adds fabaceous lecithin and stirs, treat that phospholipid dissolves after, the cooling of beginning nature; Add Oleum Sesami, vitamin E, Oleum Curcumae, cantharidin, stir and make it even, promptly get required medicine.
Prescription foundation, source:
Rhizoma Curcumae (extract) derives from the extract of Zhejiang temperature Rhizoma Curcumae.The extract of mylabris phalerata or yellow black mylabris cichorii is produced in the south of Mylabris (extract) source China.Squalene derives from the LEx that China's Zhoushan Islands produces the white shark of grand-mother.
Rhizoma Curcumae (extract) nature and flavor with return through: hot, bitter, warm, return liver, spleen channel, function with cure mainly: circulation of qi promoting removing blood stasis, removing food stagnancy pain relieving.Yong Yu mass in the abdomen mass in the abdomen, blood stasis amenorrhea, food stagnation distending pain.In the ancient books many records as: " it is pained to control woman's vim and vigour, broken mass beside the umbilicus cold air in famous traditional Chinese medical science man's Zhen Quan work Tang Dynasty " property of medicine opinion " record." " diet does not disappear for main cardiac and abdominal pain, attacked by pestiferous factors ... cholera, argument, acid regurgitation water, detoxifcation in Song dynasty " Kaibao Bencao " record.Wine grinds clothes, treats married woman's vim and vigour husband renal mass again." " the present doctor family controls and gathers all gas is most important medicine in the Su Song of Song dynasty work " book on Chinese herbal medicine warp " record." " Japan hanako materia medica " (without a date) according to Song dynasty palm Yu stannum: " this book is that state just opens in the treasured the four persons of good sense surname of not writing ... " put down in writing " must wine vinegar good, control all gas, appetite-stimulating indigestion-relieving, logical menstruation, repercussive blood, only pounce on and decrease pain, hematochezia and the interior stagnant blood etc. that decreases." our used Oleum Curcumae derives from the active component that Chinese medicine temperature Rhizoma Curcumae is carried with the modern technologies essence.
Mylabris (extract) nature and flavor with return through: hot, tremble with fear, return liver, stomach, kidney channel, function cures mainly the removing blood stasis eliminating mass, counteracting toxic substances food skin ulcer.Yong Yu mass in the abdomen cancerous protuberance, stubborn dermatitis etc. for many years.
Shark liver (extract Squalene) nature and flavor with return through sweet flat, nontoxic, tonifying five ZANG-organs.Extract in the shark liver of Squalene source, and the medicinal beginning of shark liver extract see with the many drug effects of beam Dai Taohong scape Collective Notes to the Canon of Materia medica in many doctor's nationalitys of China no matter record record in " Treatise on Dietetic Therapy " (Meng Tang Dynasty): ' tonifying five ZANG-organs ', " medical center bun will " record: detumescence blood stasis dispelling.Shark liver extract (Main Ingredients and Appearance Squalene) tool strengthening by means of tonics, make eye bright, the function of bone strengthening.
The adaptation population: early, middle and late phase tumor patient is taken, and can effectively suppress tumor growth, transfer or diffusion, by destruction of cancer cells and transfer patient active immune function, reaches the purpose of dispersing tumor.
Take before the operation: the development of may command focus, energy direct killing cancerous cell suppresses tumor growth, dwindle the tumor body, prevent that tumor from increasing and metastasis, and obvious enhancing human body immunity power, create good condition for the enforcement operation of success, guarantee carrying out smoothly of operation.
Take after the operation: can prevent the recurrence and the transfer of tumor, behind the tumor resection, small lesion residual in the body can't thoroughly be eliminated with the cancerous cell that is scattered in the blood.Patient takes this medicine after operation immediately, can eliminate remaining cancerous cell and minimal disease in the body, effectively prevents the recurrence and the transfer of cancer, quickens patient's rehabilitation and rebuilds one's physical constitution as early as possible.
Put, take in the chemotherapy: can play the effect of efficacy enhancing and toxicity reducing, compose that your caring soft capsule can effectively suppress to put, the toxic and side effects of chemotherapy.Emesis is arranged, and stimulating appetite improves sleep, health invigorating, rising leukocyte, effects such as hepatoprotective.
Late period or patient with severe symptoms: anxious, heavy, patient with advanced cancer or can not undergo surgery, put, the serious symptom tumor patient of chemotherapy takes this medicine and can suppress tumor propagation, the transfer of control tumor.Stablize the state of an illness and prolong life, improve end-stage patients' cachexia: diseases such as fever, pain, ascites pleural fluid, hypoproteinemia, organ failure, jaundice, improve life quality, prolong life time.Operation is put, the treatment of the continuation after the chemotherapy (convalescence) is taken and can be improved patient's immunity monitoring function.Eliminate residual cancer cell in the body targetedly, effectively control tumor recurrence.
The present invention has following advantage:
The present invention's (composing that caring soft capsule) is made up of Rhizoma Curcumae extract, Mylabris extract, Squalene, fabaceous lecithin, vitamin E, Oleum Sesami etc.; The present invention follow just " duty is asked old maxim, learns wildly from other's strong points " dialectical look because of, the active component of screening Chinese medicine screens active component from marine animal from terrestrial plant, insecticide, form to compose your caring soft capsule.Rhizoma Curcumae in the side (extract), the hot hardship of loosing let out that temperature is current to stagnate, can removing blood stasis, promoting the circulation of QI to relieve pain are arranged again.Cantharidin, energy removing blood stasis eliminating stagnation, removing blood stasis is with ventilation, eliminating stagnation De Xiao Disorder.Squalene: sweet flat, nontoxic, tonifying five ZANG-organs; Strengthening by means of tonics, make eye bright, bone strengthening.
The present invention is year over thousands of routine patient surplus ten, obtains ideal effect.In order to obtain better therapeutic, the applicant follows the principle of " duty is asked old maxim, widely collects crowd side ", sums up the new results of modern medicine development again, and screening is formed the present invention and composed your caring soft capsule; Tax that caring soft capsule is through pharmacodynamics and the experiment of prolongation animal survival phase, and the result shows that tax that health is 48.77%, 57.14% to suppression ratio 2.5g, the 5.0g/kg of sarcoma S180, is 32.92%, 54.74% to liver H22 suppression ratio 2.5g, 5.0g/kg; To ehrlich carcinoma life extended period experimental result, can obviously prolong white mice life cycle.
In a word, according to curing mainly relevant pharmacodynamics test and clinical case checking with function, the present invention has the circulation of qi promoting removing blood stasis, removing food stagnancy pain relieving, detumescence blood stasis dispelling, strengthening by means of tonics; Be applicable to qi depression to blood stasis and the various cancers that immunologic hypofunction caused; Be treatment hepatocarcinoma, gastric cancer, intestinal cancer, the esophageal carcinoma, pulmonary carcinoma, malignant lymphoma, the comparatively ideal first-use drug of gynecologic malignant tumor geometric ratio of high-efficiency low-toxicity, medicine of the present invention obviously is better than operation and chemotherapy.
The specific embodiment
Capsule of the present invention (promptly composing that caring soft capsule) is a compound Chinese medicinal preparation; Used medical material is one one of 2005 editions Pharmacopoeia of the People's Republic of China and records product.Prescription by theory of Chinese medical science for the basis monarch, minister, help, make compatibility, select the physicochemical property of representative medicine, as quality control standard; Monarch drug: Oleum Curcumae is warm Rhizoma Curcumae extract; Ministerial drug: Mylabris (insecticide) extract; Adjuvant: Squalene (the white shark of grand-mother) extract.
Embodiment 1
Prescription is formed: Rhizoma Curcumae extract 10g, Mylabris extract 80mg, Squalene 270g, fabaceous lecithin 17g, vitamin E 1.5g, Oleum Sesami 1.5g.Amount to 300g, make 1000.
Method for making: get Squalene 270g, put in the container, add bean squama fat 17g again, heat 50-55 ℃ and stirred 30 minutes, treat that phospholipid dissolves, cooling adds Oleum Sesami 1.5g, vitamin E 1.5g successively naturally, Oleum Curcumae 10g, cantharidin 80mg stirred 15 minutes, prepares ball.
Get the jelly powder adding distil water and soak expand back adding glycerol, arabic gum, stirred 15 minutes, make it even; The glue plate, get be heated to 90 ℃ of evaporation moisture content on the glue horizontalization steel plate after, become offset plate, prepare ball.
Character: this product is orange-yellow oval soft capsule.
The technological process explanation:
1. after bean squama fat decomposes fully, can add other medical materials.
2. the course of dissolution temperature is not beneficial too high, strict control (50-55 ℃).
3. add other medical materials after beginning to lower the temperature, stirred 15 minutes.
4. rubber powder soaks and expands, and check whether expansion evenly or not has foreign body, pinpoints the problems and in time handles.
Embodiment 2
Prescription is formed: Rhizoma Curcumae extract 15g, Mylabris extract 200mg, Squalene 450g, fabaceous lecithin 30g, vitamin E 2.5g, Oleum Sesami 2.5g; Amount to 500g, make 1000.
Method for making: get Squalene 450g and put in the enamelled vessel, be heated to 50-55 ℃ of constant temperature and add fabaceous lecithin 30g and stirred 30 minutes, treat that phospholipid dissolves after, the cooling of beginning nature.Adding Oleum Sesami 2.5g, vitamin E 2.5g, Oleum Curcumae 15g, cantharidin 200mg stirred 20 minutes, made it even.
Character: this product is orange-yellow oval soft capsule.
Embodiment 3
Prescription is formed: Rhizoma Curcumae extract 3g, Mylabris extract 8mg, Squalene 100g, fabaceous lecithin 5g, vitamin E 1g, Oleum Sesami 1g.Amount to 110g, make 1000.
Method for making: get Squalene 100g and put in the enamelled vessel, be heated to 50-55 ℃ of constant temperature and add fabaceous lecithin 5g and stirred 20 minutes, treat that phospholipid dissolves after, the cooling of beginning nature.Adding Oleum Sesami 1g, vitamin E 1g, Oleum Curcumae 3g, cantharidin 8mg stirred 10 minutes, made it even.
Character: this product is orange-yellow oval soft capsule.
Embodiment 4
Prescription is formed: Rhizoma Curcumae extract 10g, Mylabris extract 100mg, Squalene 500g, fabaceous lecithin 30g, vitamin E 5g, Oleum Sesami 5g.Amount to 550g, make 1000.
Method for making: get Squalene 500g and put in the enamelled vessel, be heated to 50-55 ℃ of constant temperature and add fabaceous lecithin 30g and stirred 25 minutes, treat that phospholipid dissolves after, the cooling of beginning nature.Adding Oleum Sesami 5g, vitamin E 5g, Oleum Curcumae 10g, cantharidin 100mg stirred 12 minutes, made it even.
Character: this product is orange-yellow oval soft capsule.
Application examples 1
1. laboratory animal: 170 of female Kunming kind white mice, body weight 20 ± 2 grams (providing) by Shenyang Pharmaceutical University's Experimental Animal Center.
2. animal model for tumour:
Get 75 of white mice, right front oxter subcutaneous vaccination sarcoma S180 cell suspension (1 * 10 7Individual/ml) 0.2ml only is divided into 5 groups at random;
Get 40 of white mice, right front oxter subcutaneous vaccination hepatocarcinoma H22 cell suspension (1 * 10 7Individual/ml) 0.2ml only is divided into 4 groups at random;
Get 50 of white mice, the abdominal cavity connects middle ehrlich ascites cell suspension (1 * 10 7Individual/ml) 0.2ml only is divided into 5 groups at random.
3. dosage and medication
(1) experimental group: the white mice dosage is 2.5g/kg/d, 5.0g/kg/d, 10.0g/kg/d, gets the content that the present invention composes your caring soft capsule (embodiment 1), irritates stomach, continuous 10 days next day in connecing tumor.
(2) positive controls (chemotherapy group): cyclophosphamide (CTX, permanent auspicious Pharma Inc.) lot number 02070721; 5-fluorouracil (5-FU, Hai Pu pharmaceutcal corporation, Ltd) lot number 02041275, respectively with 20mg/kg/d, lumbar injection; Continuous 5 days.
4. animal grouping
(1) sarcoma S180: (in connecing tumor administration on the 3rd), 10.0g/kg/d behind matched group and experimental group 2.5g/kg/d, 5.0g/kg/d elder generation (in connecing tumor administration on the same day), the 5.0g/kg/d, each 15.
(2) hepatocarcinoma H22 matched group and positive controls (5-FU), experimental group 2.5g/kg/d, 5.0g/kg/d, each 10.
(3) ehrlich carcinoma: the next day of matched group and positive controls (CTX), experimental group 2.5g/kg/d, 5.0g/kg/d (after inoculation begins to irritate stomach, 1 time again/next day, totally 5 times), each 10.
5. result
(1) tumor weight and the weight of animals
The 15th day execution animal weighed after the administration, claims tumor heavy after the excision tumor, presses following formula calculating tumour inhibiting rate:
Heavy (g) * 100% of the average tumor of heavy (the g)/matched group of the average tumor of heavy (the g)-matched group of the average tumor of tumour inhibiting rate=experimental group
The average tumor of each experimental group of S180 heavy (g) compares with matched group (2.03 ± 0.44), is p<0.01
Each experimental group average weight (g) of S180 compares with matched group (23.10 ± 0.17), is p<0.05
Table 1 is composed your caring soft capsule to the inhibitory action of white mice sarcoma S180 (X ± S)
Group Number of animals (n) Body weight (g) Tumor heavy (g) Tumour inhibiting rate (%)
Beginning The end
Matched group 15 22.78±0.11 23.10±0.17 2.03±0.44 ----
2.5g/kg/d group 15 22.19±0.14 22.71±0.20 1.04±0.19 * 48.77
5.0g/kg/d organize earlier 15 22.24±0.10 22.62±0.12 0.87±0.21 * 57.14
5.0g/kg/d back group 15 21.83±0.13 23.00±0.11 0.92±0.22 * 54.68
10.0g/kg/d group 15 21.97±0.12 19.10±0.16 0.80±0.19 * 60.59
Annotate: *Compare p<0.01 with matched group
The average tumor of each experimental group of hepatocarcinoma H22 heavy (g) compares with matched group (1.97 ± 0.59), is p<0.05
The average tumor of each experimental group of hepatocarcinoma H22 heavy (g) compares with matched group (26.40 ± 0.14), is p<0.05
Table 2 is composed your caring soft capsule to the inhibitory action of white mice sarcoma H22 (X ± S)
Group Number of animals (n) Body weight (g) Tumor heavy (g) Tumour inhibiting rate (%)
Beginning 7 days The end
Matched group 10 21.04±0.12 23.38±0.11 26.40±0.14 1.97±0.59 ----
Chemotherapy group (5-FU) 10 20.99±0.10 19.93±0.16 21.83±0.20 1.01±0.25 * 48.03
2.5g/kg/d group 10 20.79±0.09 22.69±0.13 24.08±0.10 1.32±0.68 * 32.93
5.0g/kg/d group 10 20.70±0.08 22.98±0.15 22.64±0.13 0.89±0.28 * 54.74
Annotate: *Compare p<0.05 with matched group
(2) the animal life extended period
Calculate increase in life span by following formula:
Increase in life span=experimental group The average survival time natural law-matched group The average survival time natural law/matched group The average survival time natural law * 100%
Control animals is all dead at the 18th day
Chemotherapy group (CTX) animal is all dead at the 45th day, compares p<0.01 with matched group (the 18th day)
2.5g/kg/D treated animal is all dead at the 27th day, compares p<0.01 with matched group (the 18th day)
5.0g/kg/D treated animal is all dead at the 42nd day, compares p<0.01 with matched group (the 18th day)
5.0g/kg/D treated animal is all dead at the 37th day, compares p<0.01 with matched group (the 18th day)
The influence that your caring soft capsule of table 3 tax prolongs white mice Emhorn ascites life (X ± S)
Group Number of animals (n) Body weight (g) Tumor heavy (g) Tumour inhibiting rate (%)
Matched group 10 21.94±0.13 15.5±4.18 ----
Chemotherapy group (CTX) 10 22.97±0.11 36.8±7.94# 137.4
2.5g/kg/d group 10 22.98±0.16 19.5±3.87# 25.80
5.0g/kg/d group 10 22.21±0.15 33.6±5.95 * 116.8
5.0g/kg/d the next day, organized 10 22.21±0.13 28.5±5.44 ** 83.87
Annotate: # and other each group be p<0.01 relatively
*With chemotherapy group p<0.05 relatively, group p<0.05 relatively next day of with 5.0g/kg/d, with matched group than p<0.01;
*Compare p<0.01 with matched group, compare p<0.01 with the 2.5g/kg/d group
Conclusion
1. the tax of various dose that caring soft capsule all has the obvious suppression effect to tumor animal S180.And the concomitant dosing agent is that pearl increases, and shown stronger tumor-inhibiting action; No matter shift to an earlier date or the delay administration, tangible Graft Versus Tumor all arranged.
2.2.5g/kg/d and the tax of 5.0g/kg/d various dose that caring soft capsule all has the obvious suppression effect to tumor animal H22.And the concomitant dosing agent is that pearl increases, obvious stronger tumor-inhibiting action; Compare with chemotherapy group, it is suitable to compose you the antineoplastic agent effect and the chemotherapeutic of caring soft capsule.
3. the tax of different dosing dosage and administering mode that caring soft capsule all can prolong the life cycle of ehrlich carcinoma white mice.The 2.5g/kg/d of low dosage group The average survival time natural law (19.5 days), with matched group (15.5 days) though the comparison not statistically significant still is higher than matched group, showing has certain antitumor action.
4. composing your caring soft capsule does not obviously influence the tumor animal body weight, points out its toxicity less, and animal has toleration preferably to this medicine.
The present invention's (composing that caring soft capsule) is the natural Chinese medicine preparation, extracts active component from terrestrial plant, insecticide, marine organisms etc., and is selected repeatedly, and scientific composition, change sanction form.Through extensive clinical verification in surplus ten years, to various middle and terminal cancers, tracing observation all had obvious curative effects.
Squalene has antitumor and immunoregulatory effect: pharmacological room of Shanghai medicine institute of the Chinese Academy of Sciences, the pharmacodynamics and the toxicological experiment research of system have been done, with Kunming kind outbreeding system Mus SC, select right leg muscle of sarcoma 37 (S37) ascites hepatocarcinoma 22 (H22) C57BL Mus or back SC inoculation Leswis pulmonary carcinoma for use.The result: to the S37 tumour inhibiting rate is 45-50%, is 43-52% to the H22 tumour inhibiting rate, is 50-76% to the Leswis tumour inhibiting rate.
Experiment shows: white mice acute toxicity of the present invention is very low, and the anticancer effect brilliance is taken continuously and had no side effect; The oral administration effect is obvious.
Application examples 2
Surplus the soft capsule clinical practice of the present invention existing ten year, hepatocarcinoma 292 examples wherein, gastric cancer 190 examples, esophageal carcinoma 112 examples, cervical cancer 41 examples.
1. hepatocarcinoma 292 examples belong to the middle and terminal cancer patient, lose the surgical engine meeting, male 165 people, and women 127 people take the present invention fully and compose your caring soft capsule.
Symptom: the tending to vomit of feeling sick, knot when half congealed during the abdominal distention stool.Bitter taste is vexed, and the food of receiving is owed flavor, with jaundice.Dimly red tongue, yellowish fur or white greasy, pulse condition is based on stringy pulse.
Side's medicine: the present invention composes your caring soft capsule
The course of treatment: the 2-4 course of treatment (one month each course of treatment)
(1) stagnation of liver-QI with deficiency of the spleen (108 examples, male 64 people, women 44 people)
Clinical efficacy: CR (focus absorbs fully): 0 example
PR (focus dwindles 50%): 61 examples
NC (focus dwindle 50% or enlarge less than 25%): 13 examples
PD (focus enlarges 25% before the treatment): 34 examples
(2) stagnation of QI due to depression of the liver (184 examples, male 101 people, women 83 people)
Clinical efficacy: CR:0 example
The PR:78 example
The NC:48 example
The PD:58 example
2. gastric cancer 190 examples belong to the middle and terminal cancer patient, male 112 people, women 78 people.
(1) qi-deficiency of spleen and stomach (84 examples, male 58 people, women 26 people)
Primary symptom: vague epigastralgia, singultus vomiting, food back distension.Deep,thready and forceless pulse, light red tongue is fat, and tongue is thin in vain.
Side's medicine: the present invention composes your caring soft capsule
Treatment time: 2-4 course of treatment
Clinical efficacy: CR:0 example
The PR:24 example
The NC:48 example
The PD:58 example
(2) qi stagnation and blood stasis type (106 examples, male 54 people, women 52 people)
Side's medicine: the present invention composes your caring soft capsule
Curative effect time: 2-4 course of treatment
Clinical efficacy: CR:0 example
The PR:26 example
The NC:45 example
The PD:35 example
3. esophageal carcinoma 112 examples, male 72 people, women 40 people.
Belong to the middle and terminal cancer patient, do not have operation and accuse of.
(1) mental disorder mutual resistance type (48 examples, male 36 people, women 12 people)
Primary symptom: swallow and block, the chest and diaphragm feeling of fullness is with dull pain, the dry pharynx difficulty in defecation, and tongue fur is white, Mai Xian.
Side's medicine: the present invention composes your caring soft capsule
Treatment time: 2-4 course of treatment
Clinical efficacy: CR:0 example
The PR:13 example
The NC:21 example
The PD:14 example
(2) blood stasis phlegm stagnation type (64 examples, male 36 people, women 28 people)
Primary symptom: chest and diaphragm pain promptly spues spew such as bean antiperspirant, very then inappetence after the food.Big constipation, emaciated physique, squamous and dry skin, red tongue with a little fluid, thready pulse.
Side's medicine: the present invention composes your caring soft capsule
Treatment time: 2-4 course of treatment
Clinical efficacy: CR:0 example
The PR:29 example
The NC:15 example
The PD:20 example
4. cervical cancer, middle and terminal cancer 41 examples.Not having operation accuses of.
(1) warmly accumulates malicious type 26 examples
Primary symptom: leucorrhea is many, and color such as water from washing rice or dirt, gas are smelly, distention and pain in the lower abdomen, yellowish urine, example are done, xerostomia or have dirty smellyly, and dimly red tongue, tongue are greasy in vain, slippery and rapid pulse.The cervix uteri part is the cauliflower-like necrosis, or secondary infection.
Side's medicine: the present invention composes your caring soft capsule
Treatment time: 2-4 course of treatment
Clinical efficacy: CR:0 example
The PR:8 example
The NC:11 example
The PD:7 example
(2) sinking of QI of middle-JIAO type (15 example)
Primary symptom: pyobloody dysentery, the few abdomen of anus, vagina has bearing down, soreness of waist pain, two just must not, body of the tongue is light red, white and thin fur, thready pulse without strength.
Side's medicine: the present invention composes your caring soft capsule
Treatment time: 2-4 course of treatment
Clinical efficacy: CR:0 example
The PR:7 example
The NC:4 example
The PD:4 example
In sum, compose your caring soft capsule and have certain antitumor action, strengthen the effect of immune function of human body, certain curative effect is being arranged aspect the clinical treatment middle and terminal cancer.
Application examples 3
This example is treated stagnation of QI blood blood group cancer patient 25 examples altogether.Hepatocarcinoma 10 examples wherein, metastatic liver cancer 5 examples, intestinal cancer 5 examples.Male's 18 examples, women's 7 examples, 62.7 years old mean age.Diagnosis basis: image, pathology (cell, histology).
1. basic indication type: qi stagnation and blood stasis type.
2. main clinic symptoms: different parts lump, twinge, sore spot tenderness, by pain then very, cough, breathe hard, uncomfortable in chest, stomachache, abdominal distention, anorexia, stool are uncomfortable, purplish tongue or petechia, ecchymosis, yellow fur, stringy pulse are arranged and puckery.
3. curative effect determinate standard
(1) clinical symptoms: complete obiteration, cure; Disappear 6,4 of produce effects, effectively; Disappear below 4: invalid.
(2) lump: CR: alleviate fully; PR: dwindle 50% or more than; NC: dwindle less than 50% or enlarge less than 25%; PD: enlarge 25% or more than.
(3) life quality (Ka Shi integration)
Increase 〉=10 fens or more than: take a turn for the better; No change: stable; Reduce 〉=10 fens or more than: the progress.
4. observational technique and usage:
Carry out around the course of treatment above-mentioned observed content to statistical disposition when.The course of treatment: 30 days.The present invention composes your caring soft capsule: 4/time, day 3 times, oral.
5. observed result
(1) clinical symptoms: alleviate 2 examples fully and account for 8%; Alleviate 65 examples and account for 20%; Alleviate 4 11 examples and account for 44%; 7 examples below 4 account for 28%; Effective percentage is 72%.
(2) lump: CR:0 example; The PR:2 example accounts for 8%; The NC:14 example accounts for 56%; The PD:9 example accounts for 36%.Effective percentage PR+NC is 64%.
(3) life quality
The Ka Shi scoring increases 〉=10 fens, and 4 examples account for 16%; No change: 14 examples account for 56%; Reduce 〉=10 fens, 7 examples account for 28%.Effective percentage is 72%.
6. conclusion
(1) this medicine has certain curative effect to alleviating clinical symptoms.
(2) this medicine has certain curative effect to dwindling carcinous lump.
(3) this medicine has certain curative effect to improving life quality.
Composing your caring soft capsule is the broad-spectrum anti-tumor oral drugs that formed by modern preparation process by extracts such as Rhizoma Curcumae, Mylabris.The evidence of animal pharmacodynamics, you all have the obvious suppression effect to multiple tumor strain by caring soft capsule the tax of various dose, and the increase of concomitant dosing dosage, have shown stronger tumor-inhibiting action, and maximum tumour inhibiting rate is 60.59%.
Suddenly the poison test shows: experiment is respectively organized white mice through none only death in seven days, have no adverse reaction after the perfusion, movable normal, normal feed, drinking-water, weight increase, show that this medicine is to the white mice non-toxic reaction, or reaction is lower, can think the basic avirulence of this medicine, and clinical consumption is safe and reliable.
The clinical preliminary test observed result: to alleviating clinical symptoms, stablizing focus even cancer is dwindled has certain clinical effectiveness.
The introduction of typical case's case history:
Zhang, man, 74 years old, right lung adenocarcinoma.Lung CT sees: inferior lobe of right lung 5 * 6cm occupy-place, companion's right lung door and vertical diaphragm lymph enlargement, a small amount of hydrops of right thoracic cavity.Patient's chest pain during prescription on individual diagnosis, cough, breathe hard, composed your caring soft capsule in two months through taking continuously, symptom is obviously alleviated before the patient.Breast CT check is seen: inferior lobe of right lung 4 * 4cm occupy-place, and companion's right lung door and vertical phrenic lymph nodes enlargement, the right thoracic cavity hydrops disappears, and curative effect is partly alleviated.
Liu so-and-so, woman, 64 years old, hepatocarcinoma.Liver CT sees: multiple occupy-place kitchen range in the liver, maximum 6 * 8cm companion's portal vein tumor thrombus and seroperitoneum.Patient's pain, abdominal distention, lack of appetite during prescription on individual diagnosis.3cm under the palpation liver rib, the hard liver piece of about 8 * 8cm matter can be touched in nearly gastric area, and tenderness is obvious, ascites symptoms (+).Composed your caring soft capsule in two months through taking, patient's hepatalgia alleviates diet and increases, and liver CT sees: the occupy-place focus does not have significant change in the liver, and ascites is not seen increase, stable curative effect.
Li Jie's English, the woman, 48 years old, cervical cancer, pelvic cavity CT sees: 8 * 8cm, take your (two months) liver piece two courses of treatment of caring soft capsule of tax and come off.Obvious occupy-place is not seen in the CT check.
Tian Minghui, the man, 64 years old, esophageal carcinoma, hepatic metastases, liver CT sees: multiple occupy-place 7.8 * 7.6cm in the liver, take and compose your three courses of treatment of caring soft capsule (three months).Liver CT check, multiple occupy-place in the liver, maximum 2.0 * 1.2cm.Now still in taking medicine.
Modern pharmacology of the present invention studies show that: Rhizoma Curcumae extract, the ter penoids elemene has antitumor action.The life span of energy significant prolongation ehrlich carcinoma (ECA) and ascitic type reticulum cell sarcoma (ARS) white mice.Little folding Mus ehrlich ascites cell nucleic acid content is obviously reduced.Especially the content of (RNA) reduces more remarkable.Another effective ingredient curcumenol, dosage during at 75mg/kg to white mice sarcoma (S37), white mice cervical cancer (U14) and white mice ehrlich carcinoma all have the obvious suppression effect, and suppression ratio is more than 45%.
Shark liver extract zamene 8.5,17 and 34g/kg all can prolong connect (EAC) cell white mice mean survival time be 87-153% and have the 10-40% white mice to inoculate back 60 days still survival reaches basic healing, and the single 60 days survival rates of white mice of contrast are 0%.In anticancer research, to Kunming kind white mice inoculation sarcoma 37 (S37) and ascites hepatocarcinoma 22 (H22), Lewis lung cancer.As a result, Squalene is 45-50% to (S37) tumour inhibiting rate, is 43-52% to the H22 suppression ratio, is 50-76% to the Lewis lung cancer suppression ratio.
The main active cantharidin of Mylabris extract directly suppresses tumor cell and proteinic synthetic.Suppress growth, propagation and the diffusion of tumor cell.Can destroy and stop tumor vascular growth and blood supply, simultaneously, cantharidin can promote the ripe and differentiation of marrow hemopoietic stem cells, and leukocyte is raise, and improves the content of immunoglobulin in the blood, thereby transfers the anti-tumor function of body self.
Characteristics:
1. by the special affine factor, identification enters tumor cell automatically, makes it at the intralesional directional blasting, has direct repression thoroughly to treat tumor to tumor.
2. auxiliary " rising white ", alleviate put, side effect such as vomiting that chemotherapy process causes, alopecia, inappetence.
3. to operation and the middle and advanced stage tumour patient that can't perform the operation, have calmness, pain relieving, prevent the effect of cancerous cell diffusion transfer.
4. suppress inflammatory exudation and inflammatory hyperplasia, control or eliminate tumor and inflammation and edema on every side, the pressurized that improves internal organs with block, recover whole body or partial blood circulation.
5. there is good inhibition to duplicate and outgrowth effect the diffusion path of having blocked cancerous cell to tumor cell.
6. lure into to produce a large amount of lysosomes in the cancerous cell, make its destruction of cancer cells suicidally.
7. obviously the ameliorate tumor patient improves chemotherapy effect to the drug resistance and the Drug resistance of chemotherapeutics.
8. can leukocyte increasing, activated lymphocyte hypertrophy, human body immunity improving function.
9. can enter in the brain by blood brain barrier, impel brain inner cell tumor to dwindle, suppress the brain tumor cell growth.
Clinical treatment tumour obtains obvious curative effects, and this medical instrument of animal experimental observation has the effect that presses down tumor and prolong the animal survival phase.

Claims (3)

1. anticancer soft capsule, it is characterized in that: its raw material is counted by weight ratio, Oleum Curcumae 3-15g, cantharidin 8-200mg, Squalene 100-500g, fabaceous lecithin 5-50g, vitamin E 1-5g, Oleum Sesami 1-5g.
2. according to the described anticancer soft capsule of claim 1, it is characterized in that: its raw material is counted by weight ratio, Oleum Curcumae 5-15g, cantharidin 8-80mg, Squalene 100-270g, bean squama fat 10-50g, vitamin E 1-5g, Oleum Sesami 1-5g.
3. the preparation method of the described anticancer soft capsule of claim 1 is characterized in that: get it filled by the described prescription of claim 1, get Squalene and put in the enamelled vessel, be heated to 50-55 ℃, constant temperature adds fabaceous lecithin and stirs, treat that phospholipid dissolves after, the cooling of beginning nature; Add Oleum Sesami, vitamin E, Oleum Curcumae, cantharidin, stir and make it even, promptly get required medicine.
CNB2005100472198A 2005-09-16 2005-09-16 Anticancer soft capsule and its preparation process Expired - Fee Related CN100522237C (en)

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103142931A (en) * 2013-03-06 2013-06-12 北京亚东生物制药有限公司 Traditional Chinese medicine composite for treating liver cancer and preparation method thereof
CN103948042A (en) * 2014-05-19 2014-07-30 中国林业科学研究院林产化学工业研究所 Preparation method of squalene microcapsules
CN104068397A (en) * 2014-06-12 2014-10-01 浙江海力生生物科技有限公司 Soft capsule health food capable of protecting liver and preparation method of food

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103142931A (en) * 2013-03-06 2013-06-12 北京亚东生物制药有限公司 Traditional Chinese medicine composite for treating liver cancer and preparation method thereof
CN103948042A (en) * 2014-05-19 2014-07-30 中国林业科学研究院林产化学工业研究所 Preparation method of squalene microcapsules
CN104068397A (en) * 2014-06-12 2014-10-01 浙江海力生生物科技有限公司 Soft capsule health food capable of protecting liver and preparation method of food
CN104068397B (en) * 2014-06-12 2016-07-06 浙江海力生生物科技股份有限公司 A kind of hepatoprotective capsule health food containing and preparation method thereof

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