CN100344301C - Orally medicine for treating vitiligo and production method thereof - Google Patents
Orally medicine for treating vitiligo and production method thereof Download PDFInfo
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Abstract
The present invention relates to an oral medicine for treating vitiligo, which is powder prepared from extracting, concentrating, drying or finely grinding 10 to 40 parts by weight of psoralea fruit, 5 to 20 parts by weight of fleece-flower root, 5 to 20 parts by weight of alkanna tinctoria, 5 to 20 parts by weight of pagodatree flower bud, 5 to 20 parts by weight of red sage root and 2 to 10 parts by weight of liquorice root. The oral medicine is a new oral medicine for treating vitiligo with the advantages of quick effect, high therapeutic effect and no toxic or side effect; besides, the effective rate and the cure rate reach 58%. The oral medicine for treating vitiligo is applicable to patients with various types of vitiligo, namely patients with hypopigmentation diseases.
Description
Technical field
The present invention relates to the dermopathic medicine of a kind of treatment, particularly relate to a kind of oral drugs and manufacture method thereof for the treatment of leucoderma disease.
Background technology
Vitiligo is a kind of common skin disease, and is commonplace, and it is wide to distribute, and it is on the rise to fall ill in recent years, is the difficult pertinacious disease of a kind of department of dermatologry of generally acknowledging both at home and abroad, the numerous patients' of grievous injury physical and mental health.Though current this sick method of treatment and medicine are a lot, can not reach desirable curative effect, for example, laser, skin-grafting, Therapeutic Method such as freezing, not only weak curative effect is returned skin and is stayed scar; Also there is slow, the shortcoming such as the course of treatment is long, effective percentage is low that takes effect in multiple oral and external used medicine as vitiligo capsule tincture, cream, powder etc.
Summary of the invention
The objective of the invention is to overcome above-mentioned prior art exist not enough, provide a kind of through the inventor study intensively exploitation and long-term clinical practice for many years and make a kind ofly have that instant effect, treatment phase are short, effective percentage and cure rate height, easy to use, a new generation's treatment leucoderma disease oral drugs and the manufacture method thereof that have no side effect.
Treatment leucoderma disease oral drugs provided by the invention are by following raw materials in weight portion, through pure water extract, concentrate, dry or hyperfine pulverizing and the oral drugs (powder) made:
Fructus Psoraleae 10-40 Radix Arnebiae (Radix Lithospermi) 5-20 Radix Polygoni Multiflori 5-20
Flos Sophorae Immaturus 5-20 Radix Salviae Miltiorrhizae 5-20 Radix Glycyrrhizae 2-10
In the treatment leucoderma disease oral drugs provided by the invention, described raw materials in weight portion is preferably:
Fructus Psoraleae 15-25 Radix Arnebiae (Radix Lithospermi) 8-15 Radix Polygoni Multiflori 8-15
Flos Sophorae Immaturus 8-15 Radix Salviae Miltiorrhizae 8-15 Radix Glycyrrhizae 2-8
In the treatment leucoderma disease oral drugs provided by the invention, described raw materials in weight portion more preferably:
Fructus Psoraleae 20 Radix Arnebiae (Radix Lithospermi)s 10 Radix Polygoni Multiflori 10
The Flos Sophorae Immaturus 10 Radix Salviae Miltiorrhizaes 10 Radix Glycyrrhizaes 5
In treatment leucoderma disease oral drugs provided by the invention, described leucoderma disease is a kind of worldwide refractory skin, the cause of disease is intricate, so far also do not understand pathogenesis fully, it has been generally acknowledged that by endogenous cause of ill and exopathogenic factor factors and cause that meridians are not smooth, the obstructed imbalance of QI and blood, the hepatic and renal YIN deficiency, causing blood not support skin etc., is because due to people's the positive QI-insufficiency from traditional Chinese medical science angle; Doctor trained in Western medicine is because people's immune system dysfunction is low, due to the reasons such as certain endocrine disturbance.
Described people's healthy energy is meant that each function of organization of the vital organs of the human body is vigorous, QI and blood abundance, equilibrium between yin and yang.It and lung, liver, kidney three be dirty important relationship.Lung governing qi master fur, insufficiency of lung-QI also can cause in the skin natural fibre line of meat solid, a little less than the deficiency of defensive qi, invade skin and cause exopathogen.Heresy occupies the skin cohesion and does not loose, and occupies heat-transformation for a long time, transconversion into heat poison of a specified duration, and poison has been encroached on the melanin in the skin.Liver storing blood, main relaxing led to, and deficiency of the liver then can cause the deficiency of YIN, and the deficiency of YIN is blood deficiency just.Qi as the commander of blood, blood being the mother of qi, and blood deficiency must cause the deficiency of vital energy.Deficient qi and blood, blood are not supported skin, are running into the invasion and attack of exopathogen, and exopathogen occupies skin for a long time and do not loose, and poison is given birth in heat-transformation, the melanin in the infringement skin.
The kidney generating marrow and dominating bone, main smart, the kidney being the origin of congenital constitution, suffers from a deficiency of the kidney, and can cause first deficiency of vital energy of people.People's immunologic function will reduce.After exopathogen is invaded skin, can occupy heat-transformation for a long time and give birth to poison, the infringement dermal melanin causes leucoderma disease.
In the treatment leucoderma disease oral drugs according to this, described Fructus Psoraleae: invigorating function of kidney and strengthening bone is arranged, and enhancing immunity strengthens the melanin effect; Its consumption is the 10-40 weight portion, is preferably the 15-25 weight portion, more preferably 20 weight portions.
Radix Polygoni Multiflori: liver and kidney tonifying is arranged, the effect of nocturnal control and yang nourishing enhance immunity; Its consumption is the 5-20 weight portion, is preferably the 8-15 weight portion, more preferably 10 weight portions.
The Flos Sophorae Immaturus: favourable lung QI invigorating, the effect of convergence consolidating superficial resistance.Its consumption is the 5-20 weight portion, is preferably the 8-15 weight portion, more preferably 10 weight portions.
Above-mentioned three flavor medicaments are monarch drug, play kidney tonifying, nourishing the liver, sharp lung jointly, in order to supporting vital QI to relieve the primary cause of disease, QI invigorating arranged, nourish blood, bone strengthening, consolidating superficial resistance, enhancing body immunity and increase melanic effect.
Described Radix Salviae Miltiorrhizae: dredge the meridian passage, blood circulation promoting and blood stasis dispelling, liver protection effect are arranged.Have microcirculation improvement, effect enhances metabolism.Its consumption is the 5-20 weight portion, is preferably the 8-15 weight portion, more preferably 10 weight portions.
Described Radix Arnebiae (Radix Lithospermi) has blood circulation promoting and blood stasis dispelling, strengthens the melanin effect.Its consumption is a Radix Arnebiae (Radix Lithospermi) 5-20 weight portion, is preferably Radix Arnebiae (Radix Lithospermi) 8-15 weight portion, more preferably Radix Arnebiae (Radix Lithospermi) 10 weight portions.
Described Radix Glycyrrhizae has antipyretic and antidote functions, concocts all medicines.Its consumption is a Radix Glycyrrhizae 2-10 weight portion, is preferably Radix Glycyrrhizae 2-8 weight portion, more preferably Radix Glycyrrhizae 5 weight portions.
Above-mentioned three flavor medicines are the effect that adjuvant drug can strengthen the monarch drug medicine, have blood circulation promoting and blood stasis dispelling, increase melanic growth and heat-clearing and toxic substances removing, separate the poison of all medicines, concoct the dual function of all medicines.
Because said medicine monarch drug, the full side's compatibility of adjuvant drug are mutually promoted, coordinated had both kept all medicines characteristic separately, and was collaborative by compatibility again, increased and medicament curative effect enhancement, had the kidney tonifying nourishing the liver, and it is main that sharp lung consolidating superficial resistance is set upright; Dredge the meridian passage, blood circulation promoting and blood stasis dispelling disappears that it is auxilliary to become, thereby improves skin microcirculation, promotes the formation of skin pigment, improves therapeutic effect, reaches the purpose of healing.
Treatment leucoderma disease oral drugs provided by the invention can by Chinese Chinese medicine traditional approach for example through pure water extract, concentrate, steps such as drying, sterilization make oral drugs (powder); wherein can with single raw material or together through pure water extract, concentrate, dry (being mixed) sterilization makes oral drugs, or the fine particle that adopts modern hyperfine crushing technology equipment to be ground into very easily to be absorbed by the body or the broken encapsulated method of SHENGCAO medicated powder of Ya Nami subparticle.
A kind of fabrication scheme of treatment leucoderma disease oral drugs provided by the invention medical herbs of making a living is pulverized encapsulated method, and wherein said SHENGCAO medicine is the former Chinese herbal medicine component of raw material components Chinese herbal medicine un-extracted.This method comprises:
1. clean oven dry: Fructus Psoraleae, Radix Arnebiae (Radix Lithospermi), Radix Polygoni Multiflori, the Flos Sophorae Immaturus, Radix Salviae Miltiorrhizae, Radix Glycyrrhizae are cleaned respectively, behind the decontamination, and dry.
2. pulverize: Fructus Psoraleae, Radix Arnebiae (Radix Lithospermi), the Radix Polygoni Multiflori, the Flos Sophorae Immaturus, Radix Salviae Miltiorrhizae, the Radix Glycyrrhizae that 1. step is obtained respectively stirs well even together by its weight portion, for example wave pulverizer (commercially available) is ground into impalpable powder or the Ya Nami impalpable powder for example can reach 200-2000 purpose impalpable powder at super pulverizer.
3. encapsulated: with the impalpable powder that 2. above-mentioned steps obtains, use filling apparatus, fill becomes the capsule of 0.3-0.5 gram.
4. sterilization: the medicament capsule that 3. above-mentioned steps the is obtained sterilization back bottling that carries out disinfection.
Another fabrication scheme of treatment leucoderma disease oral drugs provided by the invention is:
Single medicinal material concentrated granular method,
In commercially available Chinese medicine concentrated granular equipment, Fructus Psoraleae, Radix Arnebiae (Radix Lithospermi), Radix Polygoni Multiflori, the Flos Sophorae Immaturus, Radix Salviae Miltiorrhizae, Radix Glycyrrhizae are made concentrated granular respectively by its weight portion, mix then and stir evenly the capsule of dressing up the 0.3-0.5 gram.Sterilization back bottling again carries out disinfection.
The Chinese medicine classical production process of treatment leucoderma disease oral drugs provided by the invention is:
1. extract Chinese medicine decoction
Fructus Psoraleae, Radix Polygoni Multiflori, Radix Salviae Miltiorrhizae, Radix Arnebiae (Radix Lithospermi), the Flos Sophorae Immaturus, the whole medicine materials of Radix Glycyrrhizae are put into the Chinese medicine extraction jar by above-mentioned weight portion proportioning and appropriate amount of purified water, use conventional extraction method, extract Chinese medicine decoction.
2. concentrate
The Chinese medicine decoction that 1. above-mentioned steps is obtained with the normal pressure concentration tank routinely method refine into the Chinese medicine unguentum.
3. spray drying
The Chinese medicine unguentum that 2. above-mentioned steps obtains is made the meticulous powder oral drugs of Chinese medicine powder with the spray drying device spray drying.
4. allotment
If desired the meticulous powder oral drugs of the Chinese medicine that 3. above-mentioned steps is obtained powder with the fill capsule device routinely maneuver dress up for example 0.3-0.5 gram/capsules, pack into the capsule sealing of reuse plastic bottle.
In manufacturing treatment leucoderma disease oral drugs provided by the invention and manufacture method thereof, described Chinese medicine single concentrated granular equipment and wave pulverizer all are commercially available equipment and known communication method using commons.The Chinese medicine extraction jar is that commercially available Chinese medicine extraction jar is generally adopted in this area in the described extraction Chinese medicine decoction, and extracting method also is known communication method using common.Described suitable quantity of water is meant that water consumption does not have strict the qualification, usually medicine submergence adding can be as the criterion, should not be too much or very little, consider that the thorough active ingredient of energy extracts and do not make concentration step to increase for a long time and is advisable, for example be 1: 3 (weight ratio), drop into 3 times of each material component gross weights usually.All there is explanation extraction time when using described Chinese medicine extraction jar.Described normal pressure concentration tank and spray drying device and fill capsule device all are commercially available equipment known in the art, and its working procedure also is regulation, known conventional method.
The meticulous powder of described Chinese medicine is a mealy medicine.Can directly make oral drugs powder, for the ease of oral, can be made into various forms of oral powders, for example tablet, capsule etc. are preferably capsule oral powder.Treatment leucoderma disease oral drugs provided by the invention in use, adapting to all types of leucoderma diseases is hypopigmentation disease.
Consumption: the adult once obeys the 2-3 grain, and clothes were 3 times on 1st.Children's's decrement.
The specific embodiment
The present invention will further specify the present invention with the following example, but protection scope of the present invention is not limited to the following example, and those of ordinary skill is changed prescription of the present invention and manufacture method in the art, still in protection domain of the present invention.
Embodiment 1
With Fructus Psoraleae, Radix Polygoni Multiflori, Radix Arnebiae (Radix Lithospermi), Radix Salviae Miltiorrhizae, the Flos Sophorae Immaturus, Radix Glycyrrhizae, put into the Chinese medicine extraction jar by weight in the table 1 and 195 kilograms of pure water, according to extraction pot explanation, with conventional known extraction method extract Chinese medicine decoction.Then the Chinese medicine decoction that obtains is condensed into thickness Chinese medicine unguentum in the normal pressure concentration tank.The reuse spray drying device, dry above-mentioned Chinese medicine unguentum gets 4.88 kilograms in the meticulous powder of Chinese medicine.And then dress up the capsule of 0.5 gram/grain with the fill capsule device.
Embodiment 2
Embodiment 2 manufacturing steps are identical with the step of embodiment 1, and different is each medicament stock consumption is shown in (embodiment 2) in the table 1, and wherein obtaining the meticulous powder of Chinese medicine is 2.48 kilograms.
Embodiment 3
Embodiment 3 manufacturing steps are identical with the step of embodiment 1, and different is each medicament stock consumption is shown in (embodiment 3) in the table 1, and wherein obtaining the meticulous powder of Chinese medicine is 9.75 kilograms.
Embodiment 4
With Fructus Psoraleae, Radix Polygoni Multiflori, Radix Arnebiae (Radix Lithospermi), Radix Salviae Miltiorrhizae, the Flos Sophorae Immaturus, Radix Glycyrrhizae, clean respectively, dry then and mix by 1 each the crude drug weight of example in the table 1, in commercially available gas wave machine, be ground into 1000 order superfine powder, the reuse filling apparatus, fill becomes 0.5 gram capsule, and sterilization back bottling at last carries out disinfection.
Table 1
Medicine | Embodiment 1 | Embodiment 2 | Embodiment 3 |
Fructus Psoraleae (kilogram) | 20 | 10 | 40 |
Radix Polygoni Multiflori (kilogram) | 10 | 5 | 20 |
Radix Arnebiae (Radix Lithospermi) (kilogram) | 10 | 5 | 20 |
The Flos Sophorae Immaturus (kilogram) | 10 | 5 | 20 |
Radix Salviae Miltiorrhizae (kilogram) | 10 | 5 | 20 |
Radix Glycyrrhizae (kilogram) | 5 | 3 | 10 |
Pure water (kilogram) | 195 | 99 | 390 |
A kind of treatment leucoderma disease oral drugs powders provided by the invention (capsule) characteristics are:
1, instant effect: generally taking 30 days medicines can tell on.Part patient takes and can take effect in 15 days.
2, the treatment phase is short: can cure, cure in small number of patients 15-30 days in general patient 3-6 month.
3, effective percentage height and non-relapse after healing effective percentage are about 88%, and the cure rate height is about 58%.
4, pure Chinese medicinal preparation has no side effect through facing the art observation for many years.
5, because the powder impalpable powder easily is absorbed, dosage is few, taking convenience.
Adopt the clinical observation of treatment leucoderma disease oral drugs powders provided by the invention (capsule) curative effect as follows, from-2004 on the 6th March in 2003 JIUYUE 9 Nikkei Dingzhou City vitiligo hospitals, Dingzhou City dermatosis hospital and the standard compliant patients with vitiligo of the whole nation the 69 training disease research institute's common clinical observation of three tame hospitals totally 553 examples, use capsule oral to service once sooner or later every day, one time three, 90 days mean treatment phases, handle by statistics and draw in the 553 trouble vitiligo cases, effective percentage is 88.6% ± 2.55, and cure rate is 58.05% ± 6.69.
553 case observation conclusive tables 2
More than 90 days 553 case mean treatment phases.Effective percentage is 88.6% ± 2.55, and cure rate is 58.05% ± 6.69.
Above table 2 data are handled by statistics and are drawn in the 553 trouble vitiligo cases, and effective percentage is 88.6% ± 2.55, and cure rate is 58.05% ± 6.69.
The efficacy assessment standard of medicine of the present invention in the table 2 (with reference to " new Chinese medicine faces art research guideline " of Ministry of Public Health formulation in 1993) is as follows:
(1) takes effect;
Occurring being of one of following various situations after the medication in 30 days takes effect.Position, affected part area promptly occurs and dwindle, dark spots appears combining in illing skin, and perhaps the illing skin color shows brown, red or wine-colored.
(2) effective:
Disease sites area disappearance 36-69% is called effectively.
(3) produce effects:
Disease sites area disappearance 70-94% is called produce effects.
(4) cure:
The disease sites area all disappear (or disease sites area disappear more than 95%) be called healing.
(5) invalid:
The disease sites area disappears 36% hereinafter referred to as invalid.
Hebei province Dingzhou City vitiligo hospital in March, 2003-2004 year JIUYUE to carry out two groups of therapeutic effect observed results as follows:
1. two groups of medicines that use are respectively the treatment group and use this treatment leucoderma disease oral drugs " white usefulness disappears " capsule to obey three times every day, press adaptive capacity at every turn and obey.Matched group uses other people commercially available " vitiligo capsule " oral drugs, obeys every day three times, presses the adaptive capacity clothes at every turn.
2. observe the course of treatment: two groups was a course of treatment with 30 days all, observed continuously 90 days.
Comparison of therapeutic:
Treatment group observation of curative effect table 3
Sex | Number (unit: the people) | Total number of persons (unit: the people) | Age (unit: year old) | Therapeutic effect | On average control | |||
Effectively | Produce effects | Cure | Invalid |
Comparison of therapeutic:
Matched group observation of curative effect table 4
Sex | Number (unit: the people) | Total number of persons (unit: the people) | Age (unit: year old) | Therapeutic effect | Mean treatment fate 90 days | |||
Effectively | Produce effects | Cure | Invalid | |||||
The man | 11 | 23 | 1-9 | 2 | 5 | 13 | 3 | |
The woman | 12 | |||||||
The man | 37 | 72 | 10-19 | 8 | 10 | 30 | 24 | |
The woman | 35 | |||||||
The man | 21 | 41 | 20-29 | 5 | 8 | 13 | 15 | |
The woman | 19 | |||||||
The man | 14 | 25 | 30-39 | 2 | 5 | 6 | 12 | |
The woman | 11 | |||||||
The man | 8 | 13 | 40-49 | 1 | 2 | 2 | 8 |
It is as follows that Dingzhou City vitiligo hospital carries out two groups of comparative results:
(1) treatment group effective percentage is 88.5% ± 2.40, and cure rate is 58.85% ± 5.48.90 days mean treatment phases.
(2) the matched group effective percentage is 62.9% ± 1.81, and cure rate is 34.95% ± 4.03.136 days mean treatment phases.
Treatment is organized in 186 cases: male's 95 examples wherein, women's 91 examples, the age is at 1-80 between year, 22.33 ± 1.5 years old mean age, the course of disease 64.65 (moon) ± 5.22 before on average everyone goes to a doctor, average everyone onset area accounts for 8.66% ± 1.64 of whole skin area before going to a doctor.In matched group 186 cases: male's 95 examples wherein, women's 91 examples, the age is at 1-80 between year, 23.17 ± 4.5 years old mean age, the course of disease 63.6 (moon) ± 10.8 before on average everyone goes to a doctor, average everyone onset area accounts for 8.48% ± 4.32 of whole skin area before going to a doctor.
According to male, women before above two groups of treatments and two groups of mean aves, average period of disease, average disease symptom, difference all has the significance meaning between two groups, and it is more reasonable, balanced to illustrate that grouping is controlled in this examination, has neat same comparability.
Two groups of data contrast efficacy analysis:
The effective percentage of treatment group, cure rate are apparently higher than matched group, and the treatment group treatment phase is short, effect is fast.89 routine patients take medicine and just produced effect in 15 days.Two group differences all have the significance meaning.Clinical observation shows: organize the fruit that takes effect after the medication in 15 days of 89 examples is organized in treatment in 186 examples in treatment.Matched group does not have this effect phenomenon.Treatment group effective percentage is higher than matched group 25.6, and treatment group cure rate is higher than matched group 23.91.Two groups are not all had and have side effects.
Claims (6)
1, a kind of treatment leucoderma disease oral drugs is characterized in that by following raw materials in weight portion, through pure water extract, concentrate, dry or hyperfine pulverizing and the oral drugs made:
Fructus Psoraleae 10-40 Radix Arnebiae (Radix Lithospermi) 5-20 Radix Polygoni Multiflori 5-20
Flos Sophorae Immaturus 5-20 Radix Salviae Miltiorrhizae 5-20 Radix Glycyrrhizae 2-10.
2, according to a kind of treatment leucoderma disease oral drugs of claim 1, it is characterized in that described raw materials in weight portion is:
Fructus Psoraleae 15-25 Radix Arnebiae (Radix Lithospermi) 8-15 Radix Polygoni Multiflori 8-15
Flos Sophorae Immaturus 8-15 Radix Salviae Miltiorrhizae 8-15 Radix Glycyrrhizae 2-8.
3, according to a kind of treatment leucoderma disease oral drugs of claim 2, it is characterized in that described raw materials in weight portion is:
Fructus Psoraleae 20 Radix Arnebiae (Radix Lithospermi)s 10 Radix Polygoni Multiflori 10
The Flos Sophorae Immaturus 10 Radix Salviae Miltiorrhizaes 10 Radix Glycyrrhizaes 5.
4, according to the manufacture method of the arbitrary treatment leucoderma disease of claim 1-3 oral drugs, comprise the following steps:
1. clean oven dry: Fructus Psoraleae, Radix Arnebiae (Radix Lithospermi), Radix Polygoni Multiflori, the Flos Sophorae Immaturus, Radix Salviae Miltiorrhizae, Radix Glycyrrhizae are cleaned respectively, behind the decontamination, oven dry;
2. pulverize: Fructus Psoraleae, Radix Arnebiae (Radix Lithospermi), the Radix Polygoni Multiflori, the Flos Sophorae Immaturus, Radix Salviae Miltiorrhizae, the Radix Glycyrrhizae that 1. step is obtained respectively stirs well even together by its weight portion, be ground into impalpable powder or Ya Nami impalpable powder in super pulverizer;
3. encapsulated: with the fine powder that 2. above-mentioned steps obtains, use filling apparatus, fill becomes the capsule of 0.3-0.5 gram;
4. sterilization: the medicament capsule that 3. above-mentioned steps the is obtained sterilization back bottling that carries out disinfection.
5, according to the manufacture method of the arbitrary treatment leucoderma disease of claim 1-3 oral drugs, be included in the Chinese medicine concentrated granular equipment, Fructus Psoraleae, Radix Arnebiae (Radix Lithospermi), Radix Polygoni Multiflori, the Flos Sophorae Immaturus, Radix Salviae Miltiorrhizae, Radix Glycyrrhizae are made concentrated granular respectively by its weight portion, mix then and stir evenly the capsule of dressing up the 0.3-0.5 gram, sterilization back bottling again carries out disinfection.
6, according to the manufacture method of the arbitrary treatment leucoderma disease of claim 1-3 oral drugs, comprise the following steps:
1. extract Chinese medicine decoction
Fructus Psoraleae, Radix Polygoni Multiflori, Radix Salviae Miltiorrhizae, Radix Arnebiae (Radix Lithospermi), the Flos Sophorae Immaturus, the whole medicine materials of Radix Glycyrrhizae are put into the Chinese medicine extraction jar by above-mentioned weight portion proportioning and appropriate amount of purified water, use conventional extraction method, extract Chinese medicine decoction;
2. concentrate
The Chinese medicine decoction that 1. above-mentioned steps is obtained with the normal pressure concentration tank routinely method refine into the Chinese medicine unguentum;
3. spray drying
The Chinese medicine unguentum that 2. above-mentioned steps obtains is made the meticulous powder oral drugs of Chinese medicine powder with the spray drying device spray drying.
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CN1219540A (en) * | 1998-10-16 | 1999-06-16 | 范伟光 | Chemical synthetic preparation method for new erythromycin A |
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