CN1314424C - Chinese traditional medicine for treating liver cancer and preparation technique thereof - Google Patents
Chinese traditional medicine for treating liver cancer and preparation technique thereof Download PDFInfo
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- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
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Abstract
The present invention relates to a Chinese traditional medicine for treating liver cancer and a preparation process thereof, the product name of which is Sanjiepian. The Chinese traditional medicine is prepared from the following medicinal raw materials of the weight ratio: typhonii: dittany bark: green peel of juglans mandshurica: artificial bezoar is 1950 to 300:1400 to 600:160 to 120:6 to 3. The preparation process comprises: taking the typhonii, the dittany bark and the green peel of the juglans mandshurica according to the weight ratio of the medicinal raw materials for decocting with water for two times; firstly adding water with quality of 12 times of the total weight of the medicinal raw materials for decocting for 2 hours; secondarily adding the water with quantity of 8 times of the total weight of the medicinal raw materials for decocting for 1 hour; filtering; concentrating filter liquor to clear paste with relative density of 1.35 to 1.38 and temperature of 70 DEG C; decreasing pressure and drying; pulverizing; adding artificial bezoar fine powder and auxiliary materials; uniformly mixing; granulating with 75% of ethanol; drying; pressing into tablets; coating film coats. The present invention has the advantages that the present invention has the effects of clearing heat and removing toxicity, softening hard lumps, dispelling nodes, activating blood circulation to dissipate blood stasis, increasing organic immune functions and inhibiting alpha-fetoprotein, and the present invention has obvious anti-cancer effects.
Description
Technical field
The present invention relates to a kind of Chinese medicine and preparation technology thereof who treats hepatocarcinoma, its name of product is---liver cancer tablet.
Background technology
In recent years, primary hepatocarcinoma is one of disease of serious harm people life and health, because this disease is asymptomatic in early days, seldom can in time be found except that generaI investigation; And the mid and late liver cancer PD is fast, and most patients have lost the chance of operation because of the later of discovery.In treatment, how insensitive primary hepatocarcinoma is to chemotherapy, radiotherapy, and chemotherapy and radiation can produce intensive side effect to human body, and weak curative effect, patient death rate height.Therefore, developing a kind of medicine that can treat hepatocarcinoma effectively is one of important topic in the current oncotherapy.
The applicant applied for patent of invention to State Patent Office on 16th in December in 1993; its application number is " 93115971.7 "; this patent documentation discloses a kind of liver cancer tablet and preparation method thereof; this Chinese medicine liver cancer tablet is made up of Rhizoma Typhonium Gigantei (Rhizoma Typhonii), Cortex Dictamni, Fructus Juglandis mandshuricae and Calculus Bovis, and its weight ratio is 300: 267: 45: 1.Prove by clinical trial,, cause the effect of its treatment hepatocarcinoma relatively poor because of its prescription and proportioning are perfect inadequately.Therefore, need courageously improve and innovate, prescription and proportioning are tending towards rationally, each component synergism just can make it to hepatocarcinoma raising evident in efficacy.
Summary of the invention
The present invention is directed to the technical problem of above-mentioned existence and a kind of Chinese medicine and preparation technology thereof who treats hepatocarcinoma is provided, it has broken through the forbidden zone of present Chinese medicine dosage, and with Semen Juglandis peel replacement Fructus Juglandis mandshuricae the effect of treatment hepatocarcinoma is significantly increased.
The present invention treats the Chinese medicine of hepatocarcinoma and is made up of by weight following medicinal raw material:
Rhizoma Typhonii: Cortex Dictamni: Semen Juglandis peel: artificial Calculus Bovis=1950-300: 1400-600: 160-120: 6-3.
The present invention treats the Chinese medicine of hepatocarcinoma and is made up of by optimum weight ratio following medicinal raw material:
Rhizoma Typhonii: Cortex Dictamni: Semen Juglandis peel: artificial Calculus Bovis=1900: 900: 135: 3.
The Chinese medicine preparation technology that the present invention treats hepatocarcinoma is: the weight ratio by above-mentioned medicinal raw material is got Rhizoma Typhonii; Cortex Dictamni; Semen Juglandis peel decocts with water secondary; amount of water is 12 times that above-mentioned medicinal raw material weight adds up to for the first time; decocted 2 hours; amount of water is 8 times that above-mentioned medicinal raw material weight adds up to for the second time; decocted 1 hour, and filtered, it is 1.35～1.38 that merging filtrate is concentrated into relative density; temperature is 70 ℃ a clear paste; drying under reduced pressure is pulverized, and adds artificial Calculus Bovis's fine powder and adjuvant; mixing; use 75% alcohol granulation, drying, compacting is in flakes; the bag film-coat, promptly.
Advantageous effect of the present invention:
1, the present invention courageously improves and innovates, broken through the forbidden zone of present Chinese medicine dosage, as the dosage of Rhizoma Typhonii more than 20 times of Chinese medicine dosage, and replace Fructus Juglandis mandshuricae with Semen Juglandis peel, prescription of the present invention and proportioning are more reasonable, each component synergism is significantly increased the effect of treatment hepatocarcinoma.
2, the present invention has the heat of dispelling dispel temperature, detoxifcation pain relieving, blood stasis-eliminating and stagnation-dissipating function, the rich primary hepatocarcinoma of becoming main symptom of the wet stasis of blood there is certain cancer remission rate, disease to the rich knot card of the wet stasis of blood has some improvement simultaneously, improves patient's life quality, prolongs life cycle.
3, the present invention and intervention filling chemotherapy is share, and can improve the effective percentage of getting involved chemotherapy, and can play Attenuation.Can be used for hepatocarcinoma and digestive tract tumor, also can be used as the adjuvant therapy medicaments of cancer.But human body immunity improving function, inhibition alpha-fetoprotein have significant antitumaous effect.
The present invention treats the clinical experiment report of the Chinese medicine of hepatocarcinoma
Clinical experiment method of the present invention is as follows:
Treatment group now and matched group, existing liver cancer tablet group and former liver cancer tablet group compare, treatment group now is to be combined with the intervention chemotherapeutic by liver cancer tablet of the present invention case is treated, matched group is with getting involved chemotherapeutic case to be treated, existing liver cancer tablet group is with liver cancer tablet of the present invention case to be treated, and former liver cancer tablet is case to be treated for the former liver cancer tablet of " 93115971.7 " with application number.
Clinical trial drug usage of the present invention is as follows:
(1) liver cancer tablet usage:
1, medicine: liver cancer tablet of the present invention and former liver cancer tablet;
2, usage: every day three times, each six, oral.
(2) chemotherapeutic operational version:
1, chemotherapeutics: be homemade ministry standard.
Mitomycin 2mg/ bottle; Cisplatin 20mg/ bottle
2, chemotherapy regimen
Mitomycin 10mg tremulous pulse injects, and cisplatin 80mg tremulous pulse injects
One, total effects
The present invention's treatment group now total effective rate 61%, matched group total effective rate are 43%, two group relatively significant difference; Existing liver cancer tablet group total effective rate 32%, former liver cancer tablet group total effective rate 26.7%, existing liver cancer tablet group and former liver cancer tablet group relatively have significant difference; As shown in table 1, each phase efficacy analysis is as shown in table 2:
Table 1 total effects
| Example | Produce effects | Effectively | Invalid | Effective percentage % | |
| Treatment group now | 100 | 20 | 41 | 39 | 61.0 |
| Matched group | 100 | 11 | 32 | 57 | 43.0 |
| Existing liver cancer tablet group | 100 | 3 | 29 | 68 | 32.0 |
| Former liver cancer tablet group | 30 | 1 | 7 | 22 | 26.7 |
Treatment group now and matched group compare: u=2.43, P＜0.05
Table 2 is respectively organized each phase efficacy analysis
| Phase | The example number | Produce effects | Effectively | Invalid | |
| Treatment group now | I II | 100 | 20 | 41 | 39 |
| Matched group | I II | 100 | 11 | 32 | 57 |
| Existing liver cancer tablet group | II | 47 | 3 | 12 | 32 |
| Existing liver cancer tablet group | III | 53 | 0 | 17 | 36 |
| Former liver cancer tablet group | I II III | 30 | 1 | 7 | 26.7 |
I II phase treatment group now and matched group compare: u=2.43, P＜0.05
Two, cancer curative effect
According to WHO cancer evaluation criteria, the cancer remission rate of the present invention's treatment group now was 52% (I II phase), and matched group cancer remission rate was 35% (I II phase), and two groups relatively have the difference (P＜0.05) of highly significant as shown in table 3:
Table 3 cancer curative effect
| Example | Alleviate fully | Part is alleviated | Stable | Worsen | Total remission rate (%) | |
| Treatment group now | 100 | 0 | 20 | 41 | 39 | 52.0 |
| Matched group | 100 | 0 | 11 | 32 | 57 | 35.0 |
| Existing liver cancer tablet group | 100 | 0 | 4 | 70 | 26 | 4.0 |
| Former liver cancer tablet group | 30 | 0 | 1 | 18 | 11 | 3.3 |
Treatment group now and matched group compare: x
2=5.88, P＜0.05 (alleviating and not alleviating comparison)
Three, alpha-fetoprotein determination
Feminine gender totally 330 examples after measured, the alph-fetoprotein positive person is 284 examples, accounts for 86%, alpha-fetoprotein determination value distribution situation is not all having significant difference between existing treatment group and matched group, see table 4 for details:
Table 4 alpha-fetoprotein (ng/ml) distribution situation
| The example number | ＜25 | 25～ | 200～ | 400～ | |
| Treatment group now | 100 | 9 | 13 | 9 | 69 |
| Matched group | 100 | 15 | 6 | 7 | 72 |
| Existing liver cancer tablet group | 100 | 18 | 7 | 12 | 63 |
| Former liver cancer tablet group | 30 | 3 | 2 | 3 | 22 |
Treatment group now and matched group compare: u=0.15, P＞0.05
Four, life quality efficacy analysis
Life quality efficacy analysis of the present invention is totally 300 examples, and the life quality distribution situation of existing treatment group and matched group is shown in table 5,6:
Table 5 life quality efficacy analysis
| The example number | Produce effects | Effectively | Invalid | Effective percentage % | |
| Treatment group now | 100 | 9 | 46 | 45 | 55.0 |
| Matched group | 100 | 4 | 36 | 60 | 41.0 |
| Existing liver cancer tablet group | 100 | 0 | 44 | 56 | 44.0 |
Treatment group now and matched group be (Ridit): u=1.95 relatively, P＞0.05
Table 6 is respectively organized each phase life quality efficacy analysis
| Example | Phase | Invalid | Effectively | Produce effects | Effective percentage % | |
| Treatment group now | 100 | I II | 39 | 50 | 11 | 61.0 |
| Matched group | 100 | I II | 53 | 40 | 7 | 47.0 |
| Existing liver cancer tablet group | 47 | II | 31 | 13 | 3 | 34 |
| Existing liver cancer tablet group | 53 | III | 30 | 20 | 3 | 43 |
Treatment group now and matched group compare: u=1.95, P＞0.05
Untoward reaction:
(1) taking medicine afterwards, the cardiopalmus symptom can appear in small number of patients.
(2) there is small number of patients hematochrome, platelet, liver function, change in renal function to occur in the clinical trial of the present invention, but fails to judge relevant with use the present invention.
Curative effect of the present invention is summed up:
According to the clinical experiment data of several indexs, now the curative effect total effective rate of treatment group is 61% as can be known, and the curative effect total effective rate of matched group is 43%, existing treatment group and matched group comparison both there were significant differences, mainly reflect following several aspect:
1, liver cancer tablet of the present invention has certain tumor-inhibiting action, and its cancer remission rate is very obvious, share potentiation with chemotherapy and is significantly improved with the matched group ratio.
2, liver cancer tablet of the present invention and chemotherapy are share life quality and matched group than also improving.
Differentiate and detection
1, the character of liver cancer tablet of the present invention: be the blue membrane garment piece, remove and show sepia, gas burnt odor, mildly bitter flavor suffering behind the film-coat.
2, differentiate:
(1) get 10 of the present invention, remove film-coat, porphyrize adds chloroform 50ml, and supersound process 30 minutes filters, and flings to chloroform, and residue adds methanol 2ml makes dissolving, as need testing solution.Other gets Cortex Dictamni control medicinal material 2g, shines medical material solution in pairs with legal system.Test according to thin layer chromatography (appendix VIB of Chinese Pharmacopoeia version in 2000), draw need testing solution 10-15 μ l, control medicinal material solution 1-3 μ l, put respectively in same and contain on the silica gel g thin-layer plate that Sodium Tvlose is an adhesive, with normal hexane-ethyl acetate (3: 2) is developing solvent, launch, take out, dry, spray is with 10% ethanol solution of sulfuric acid, and it is clear to be heated to the speckle colour developing in 105 ℃.In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the speckle of same color.
(2) get 4 of the present invention, remove film-coat, porphyrize adds dehydrated alcohol 10ml, grind dissolving, filter, filtrate is concentrated into about 1ml, as need testing solution, other gets cholic acid, Hyodeoxycholic Acid reference substance, adds dehydrated alcohol and makes the mixed solution that every 1ml contains 1ml, in contrast product solution.Test according to thin layer chromatography (appendix VIB of Chinese Pharmacopoeia version in 2000), draw need testing solution 10-15 μ l, reference substance solution 2 μ l, put respectively in same be on the silica gel g thin-layer plate of adhesive with the sodium carboxymethyl cellulose, with chloroform-ether-glacial acetic acid (5: 5: 2) is developing solvent, launch, take out, dry, spray is with 10% phosphomolybdic acid ethanol solution, and it is clear to be heated to the speckle colour developing in 105 ℃.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color.
3, check: should meet every regulation relevant under the tablet item (appendix ID of Chinese Pharmacopoeia version in 2000).
4, assay: get 20 of the present invention, remove film-coat, the accurate title, decide, porphyrize, precision take by weighing the about 1.5g of fine powder, put in the tool plug conical flask, the accurate methanol 50ml that adds, close plug claims to decide weight, supersound process 30 minutes is put coldly, claims to decide weight, supply the weight that subtracts mistake with methanol, shake up, filter, precision is measured subsequent filtrate 25ml, and evaporate to dryness, residue add 20% sodium hydroxide solution 10ml, reflux 2 hours, cooling adds dilute hydrochloric acid and transfers pH to acid, with 4 (25ml of ethyl acetate extraction, 25ml, 20ml, 20ml), ethyl acetate liquid all filters by the same absorbent cotton that is covered with a small amount of anhydrous sodium sulfate, merge extractive liquid,, evaporate to dryness in the water-bath, residue add dissolve with methanol and are transferred in the 10ml measuring bottle, add methanol to scale, shake up, as need testing solution.Precision takes by weighing the cholic acid reference substance that is dried to constant weight through 105 ℃ in addition, adds methanol and makes the solution that every 1ml contains 0.45mg, in contrast product solution.Test according to thin layer chromatography (appendix VIB of Chinese Pharmacopoeia version in 2000), the accurate need testing solution 10 μ l that draw, reference substance solution 1 μ l and 3 μ l, respectively the cross point in same be on the silica gel g thin-layer plate of adhesive with the sodium carboxymethyl cellulose, (20: 25: 2: upper solution 3) was developing solvent with hexane-ethyl acetate-acetic acid-methanol, launch, take out, dry, spray is with 10% ethanol solution of sulfuric acid, and it is clear to be heated to the speckle colour developing in 105 ℃, takes out, on lamellae, cover onesize glass plate, use immobilization with adhesive tape on every side.Scan wavelength according to thin layer chromatography (an appendix VIB of Chinese Pharmacopoeia version in 2000 thin layer chromatography scanning): λ
s=380mm, λ
R=650mm measures test sample trap integrated value and reference substance trap integrated value, calculates, promptly.
Every of the present invention contains the artificial Calculus Bovis with cholic acid (C
24H
40O
5) meter, must not be less than 0.15mg,
Item such as function and consumption
1, function cures mainly: have the heat of dispelling dispel temperature, detoxifcation pain relieving, blood stasis-eliminating and stagnation-dissipating function, the rich primary hepatocarcinoma of becoming main symptom of the wet stasis of blood there is certain cancer remission rate, disease to the rich knot card of the wet stasis of blood has some improvement simultaneously, improves patient's life quality, prolongs life cycle.Share with getting involved the filling chemotherapy, can improve the effective percentage of getting involved chemotherapy, and can play Attenuation.Can be used for hepatocarcinoma and digestive tract tumor, also can be used as the adjuvant therapy medicaments of cancer.
2, usage and dosage: use simultaneously with getting involved chemotherapy, oral, one time 6,3 times on the one, one after each meal.I, II phase patient 2 months were 1 course of treatment, and III phase patient 1 month was 1 course of treatment.
3, points for attention:
(1) the present invention should use under physician guidance.
(2) Rhizoma Typhonii large usage quantity in the present invention's prescription please notes control dosage, the course of treatment.
(3) in the use of the present invention, as tongue lip numbness appears, symptoms such as throat is scorching hot, tongue body is stiff, slurred speech, need vigilant Rhizoma Typhonii to poison drug withdrawal in time, processing.
4, taboo: period in a medicine is given up alcohol.
5, specification: every heavy 0.3g needs the sealing storage; Effect duration of the present invention is tentative to be 2 years.
6, packing: (1) plastic bottle, 72 slices/bottle; (2) aluminium foil, 12 * 3 plates/box.
The present invention is described in further detail below in conjunction with embodiment.
The specific embodiment
Embodiment 1:
The present invention treats the Chinese medicine of hepatocarcinoma and is made up of by weight following medicinal raw material:
Rhizoma Typhonii: Cortex Dictamni: Semen Juglandis peel: artificial Calculus Bovis=1950: 1400: 160: 6.
Semen Juglandis peel is the immature peel of walnut Juglans mandshurica Juglans Mandshurica Maxim.Pluck fruit and get peel the first tenday period of a month August in autumn, dries or cold drying.
The Chinese medicine preparation technology that the present invention treats hepatocarcinoma is:
By the weight ratio of above-mentioned medicinal raw material get Rhizoma Typhonii (Rhizoma Typhonium Gigantei (Rhizoma Typhonii)) 1950g, Cortex Dictamni 1400g, Semen Juglandis peel 160g decoct with water secondary; amount of water is 12 times that above-mentioned medicinal raw material weight adds up to for the first time; decocted 2 hours; amount of water is 8 times that above-mentioned medicinal raw material weight adds up to for the second time; decocted 1 hour, and filtered, it is 1.35～1.38 that merging filtrate is concentrated into relative density; temperature is 70 ℃ a clear paste; drying under reduced pressure is pulverized, and adds artificial Calculus Bovis fine powder 6g and adjuvant; mixing; use 75% alcohol granulation, drying is pressed into 1000; the bag film-coat, promptly.
Embodiment 2:
The present invention treats the Chinese medicine of hepatocarcinoma and is made up of by optimum weight ratio following medicinal raw material:
Rhizoma Typhonii: Cortex Dictamni: Semen Juglandis peel: artificial Calculus Bovis=1900: 900: 135: 3.
The Chinese medicine preparation technology that the present invention treats hepatocarcinoma is:
By the weight ratio of above-mentioned medicinal raw material get Rhizoma Typhonii 1900g, Cortex Dictamni 900g, Semen Juglandis peel 135g decocts with water secondary; amount of water is 12 times that above-mentioned medicinal raw material weight adds up to for the first time; decocted 2 hours; amount of water is 8 times that above-mentioned medicinal raw material weight adds up to for the second time; decocted 1 hour, and filtered, it is 1.35～1.38 that merging filtrate is concentrated into relative density; temperature is 70 ℃ a clear paste; drying under reduced pressure is pulverized, and adds artificial Calculus Bovis fine powder 3g and adjuvant; mixing; use 75% alcohol granulation, drying is pressed into 1000; the bag film-coat, promptly.
Embodiment 3:
The present invention treats the Chinese medicine of hepatocarcinoma and is made up of by weight following medicinal raw material:
Rhizoma Typhonii: Cortex Dictamni: Semen Juglandis peel: artificial Calculus Bovis=300: 600: 120: 5.
The Chinese medicine preparation technology that the present invention treats hepatocarcinoma is:
By the weight ratio of above-mentioned medicinal raw material get Rhizoma Typhonii 300g, Cortex Dictamni 600g, Semen Juglandis peel 120g decocts with water secondary; amount of water is 12 times that above-mentioned medicinal raw material weight adds up to for the first time; decocted 2 hours; amount of water is 8 times that above-mentioned medicinal raw material weight adds up to for the second time; decocted 1 hour, and filtered, it is 1.35～1.38 that merging filtrate is concentrated into relative density; temperature is 70 ℃ a clear paste; drying under reduced pressure is pulverized, and adds artificial Calculus Bovis fine powder 5g and adjuvant; mixing; use 75% alcohol granulation, drying, compacting is in flakes; the bag film-coat, promptly.
Claims (3)
1, a kind of Chinese medicine for the treatment of hepatocarcinoma is characterized in that it is to be prepared from by weight by following medicinal raw material:
Rhizoma Typhonii: Cortex Dictamni: Semen Juglandis peel: artificial Calculus Bovis=1950-300: 1400-600: 160-120: 6-3.
2, the Chinese medicine of treatment hepatocarcinoma according to claim 1 is characterized in that the weight ratio of described medicinal raw material is:
Rhizoma Typhonii: Cortex Dictamni: Semen Juglandis peel: artificial Calculus Bovis=1900: 900: 135: 3.
3, a kind of technology for preparing the Chinese medicine of the described treatment hepatocarcinoma of claim 1 is characterized in that preparation technology is:
Get Rhizoma Typhonii, Cortex Dictamni, Semen Juglandis peel by the weight ratio of above-mentioned medicinal raw material and decoct with water secondary; amount of water is 12 times that above-mentioned medicinal raw material weight adds up to for the first time; decocted 2 hours; amount of water is 8 times that above-mentioned medicinal raw material weight adds up to for the second time; decocted 1 hour, and filtered, it is 1.35～1.38 that merging filtrate is concentrated into relative density; temperature is 70 ℃ a clear paste; drying under reduced pressure is pulverized, and adds artificial Calculus Bovis's fine powder and adjuvant; mixing; use 75% alcohol granulation, drying, compacting is in flakes; the bag film-coat, promptly.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
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| CNB2004100507493A CN1314424C (en) | 2004-10-29 | 2004-10-29 | Chinese traditional medicine for treating liver cancer and preparation technique thereof |
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| Application Number | Priority Date | Filing Date | Title |
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| CNB2004100507493A CN1314424C (en) | 2004-10-29 | 2004-10-29 | Chinese traditional medicine for treating liver cancer and preparation technique thereof |
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| CN1314424C true CN1314424C (en) | 2007-05-09 |
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| CN100427099C (en) * | 2006-03-02 | 2008-10-22 | 上海交通大学 | Juglans mandshurica maxim pdysaccharide preparation capable of effectively treating brain cancer and its preapring method |
| CN106383195B (en) * | 2016-08-29 | 2018-08-21 | 贵州信邦制药股份有限公司 | The discrimination method of the root bark of shaggy-fruited dittany in anti-rheumatism medicinal liquor |
| CN113368179A (en) * | 2021-05-15 | 2021-09-10 | 珠海米迪泰克生物制药有限公司 | Preparation method of anti-liver cancer medicine tablet |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1095949A (en) * | 1993-12-16 | 1994-12-07 | 刘今方 | A kind of liver cancer tablet and preparation method thereof |
| CN1206597A (en) * | 1997-07-29 | 1999-02-03 | 刘今方 | Xiaojieling and preparation process thereof |
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- 2004-10-29 CN CNB2004100507493A patent/CN1314424C/en active Active
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1095949A (en) * | 1993-12-16 | 1994-12-07 | 刘今方 | A kind of liver cancer tablet and preparation method thereof |
| CN1206597A (en) * | 1997-07-29 | 1999-02-03 | 刘今方 | Xiaojieling and preparation process thereof |
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