CN1057447C

CN1057447C - Quick-acting antidiarrhea oral liquor for infant and preparation method thereof

Info

Publication number: CN1057447C
Application number: CN93101066A
Authority: CN
Inventors: 马军营; 李公营; 董汉青
Original assignee: Individual
Current assignee: Individual
Priority date: 1993-01-22
Filing date: 1993-01-22
Publication date: 2000-10-18
Anticipated expiration: 2013-01-22
Also published as: CN1089853A

Abstract

The present invention belongs to a Chinese herbal medicine preparation, which relates to quick-acting oral liquid with an a novel formula for treating an infant's diarrhea, a quantitative method for trace elements (electrolyte), a processing technology for enhancing the activity and stability of disaccharidase, etc. The oral liquid is composed of Chinese medicinal herb ingredients including agaric, atractylodes rhizome, wrinkled gianthyssop herb, pinellia tuber, malt, borneol, cherokee rose fruit, wherein red peony root, Chinese thorowax root, plantain seed, Chinese date, etc. can be added to the Chinese medicinal herb ingredients; the electrolytes, the disaccharidase, etc. of the Chinese medicinal herb ingredients are extracted. The oral liquid is a natural Chinese herbal medicine preparation which has the advantages of quick effect, comprehensive functions, low cost, convenient taking, etc. Through the certification of clinical research, the oral liquid can treat the infant's rotaviral enteritis and promote the functions of digestion and absorption of a human body. In addition, the cure rate of the oral liquid is 97.2%, and the total effective rate is 100%.

Description

A kind of oral liquid for the treatment of infantile diarrhea

The invention belongs to Chinese herbal and crude drugs preparations, relate to the quantitative approach of a kind of oral liquid (being the child antidiarrhea oral liquid again) for the treatment of infantile diarrhea and trace element (electrolyte) and improve the active and stable treatment technology of disaccharidase etc.

Do not find the oral liquid novel form of treatment children's diarrhae (rotavirus) at present as yet, nearest like product: in November, 92, new " children's is rushed down speed and the stopped " electuary of going into operation of Shiquan pharmaceutical factory was economized in effluent south, failed to solve and suffered from diarrhoea and problems such as the dehydration seen, electrolyte disturbance, disaccharidase deficiency; Children's is rushed down speed and is stopped electuary and prove through zoopery, enterokinesia there is obvious inhibitory action, and infect (rotavirus) property diarrhoea mainly be since this virus invades that epithelial cell-intestinal villi shortenings-epithelial cell mitochondrial swelling-endoplasmic reticulum of upper part of small intestine expands and the proper mucous membrane monokaryon soak into-make intestinal secretion water (electrolyte) ↑ → cause suffering from diarrhoea, little with the dynamic (dynamical) change relation of intestinal, so costive does not have obvious therapeutic action.

The oral liquid of the treatment infantile diarrhea that the present invention proposes, it can improve the activity of disaccharidase, reduces the enteral osmotic pressure, eliminate the intestinal epithelial cell mitochondrial swelling, reduce power and water and separate the matter secretory volume, thereby correct dehydration and electrolyte disturbance are treated watery diarrhea effectively.

The present invention's " electuary " that sugar content is higher changes the oral liquid of sugar-free (or few sugar) into.

The present invention removes and take new medicinal herb components in the selection of composition, on oral liquid preparation technology's in the past basis, has adopted the quantitative approach of trace element (electrolyte) and has improved the active and stable processing new technique of disaccharidase.

By traditional astringent therapy diarrhea-stopping exercise (to suppress the enterokinesia medicine), improveing is " diuretic diarrhea-stopping exercise " (based on water liquid metabolic function, reduction enteric cavity osmotic pressure medicine of adjusting kidney) on the material choice of the present invention.

Raw material of the present invention has: Polyporus, Rhizoma Atractylodis, Herba Pogostemonis, the Rhizoma Pinelliae, Fructus Hordei Germinatus, Dens Draconis, Fructus Rosae Laevigatae, can add Radix Paeoniae Rubra, Radix Bupleuri, Semen Plantaginis and Fructus Jujubae etc.; Wherein: with the Polyporus promoting diuresis to eliminate damp pathogen, Rhizoma Atractylodis are drying damp and strengthening spleen, and the Herba Pogostemonis removing dampness to restore normal function of the stomach is main; The Fructus Hordei Germinatus dyspepsia and intestinal stasis relieving, Fructus Rosae Laevigatae is transferred the kidney QI invigorating, and behavior is auxilliary under the Semen Plantaginis dampness removing; Radix Bupleuri is evacuated and is brought down a fever, the pain relieving of Radix Paeoniae Rubra yin fluid astringing, and Dens Draconis is calmed the nerves relieving convulsion for helping; Fructus Jujubae spleen reinforcing stomach reinforcing and all medicines with flavoring for making; All medicines share, and gather removing dampness antidiarrheal altogether, clearing away heat and resolving stagnation of food, reason spleen stomach function regulating, the merit of supplementing QI and nourishing YIN.

In the raw material of the present invention: Polyporus can replace with Poria, Rhizoma Atractylodis can be used Cortex Magnoliae Officinalis generation, Herba Pogostemonis can be used Herba Eupatorii generation, Dens Draconis can be used Os Draconis generations, the Rhizoma Pinelliae can bamboo soup oil generation, Radix Paeoniae Rubra can the Radix Paeoniae Alba, Radix Aucklandiae generation, Radix Bupleuri can Radix Puerariae, Herba Portulacae, Herba Patriniae generation, Fructus Hordei Germinatus can use Fructus Setariae Germinatus, Fructus Crataegi generation, Semen Plantaginis can use Herba Plantaginis, Rhizoma Imperatae, Rhizoma Alismatis generation, and Fructus Rosae Laevigatae can use Fructus Mume, catechu, Fructus Corni, Semen Lablab Album, Semen Euryales, Herba Euphorbiae Humifusae, Cortex Ziziphi spinosae Radicis, Fructus punicae granati skin to replace.

Electrolytical extraction and quantitative approach:

To contain trace element (potassium, sodium, chlorine, calcium etc.) Chinese medicine, promptly use Dens Draconis (or Os Draconis) and Semen Plantaginis (or Herba Plantaginis) in the raw material of the present invention, be solvent with water earlier, extract its effective ingredient, add ethanol again and regulate concentration, reach 50-60% and 70-80% respectively, successively remove destarching, impurity such as protein, when again concentration of alcohol being transferred to 80-90%, can be settled out inorganic salts (electrolyte), carry out quantitative analysis with ultraviolet spectra or thin layer chromatography then, allow potassium, sodium, chlorine, it is conformance with standard that calcium ion content is equivalent to 1/3-1/2 " ORS " (oresol).

The extraction and the stability that transform carbohydrase (disaccharidase) are handled:

Use " saltouing-dialyse-freeze-drying ", promptly utilize different proteins in the saline solution of high concentration, dissolubility reduces and precipitates, thereby separates with other composition, remove inorganic salts a large amount of in the enzyme of being saltoutd through dialysis, again after lyophilization and the method for extracting.

Select for use Fructus Hordei Germinatus among the present invention (or Fructus Setariae Germinatus, Fructus Crataegi) aqueous extract as solvent, consumption be raw material weight 1-5 doubly.

Raw material: neutral salt, as ammonium sulfate, sodium sulfate, magnesium sulfate, sodium chloride etc.

Concentration: reach fractional precipitation in order to make range protein, the concentration of salt can increase progressively gradually, a certain protein behind salt precipitation, mother solution adds the salt of debita spissitudo again, make another kind of protein redeposition, can make range protein (enzyme) separate (general 50% → 60% → 70% → 80% → 90% → 100% one by one at last ...).

PH value: should grasp in the stability range of enzyme in principle, and should be away from the isoelectric point, IP (general PH7-7.4) of enzyme.

Temperature: 4 ℃ ± 0.5 ℃

Time: 5-30 minute

Also can select for use molecular screening (glucose gel Filtration) to extract disaccharidase (method is omitted, and sees national high medical college teaching material " pharmacy of Chinese materia medica " 1 edition P77-78 in 86 year November on probation for details) in addition.

Child antidiarrhea oral liquid of the present invention is the pure natural Chinese herbal and crude drugs preparations, and it is rapid to have an onset, and effect is comprehensively, and is with low cost, advantages such as taking convenience, and clinical research proves: this product can be treated infantile rotavirus enteritis, promotes the body digestive and absorptive functions.Zoopery shows: 1, can strengthen intestinal mucosa cell disaccharidase activity, reduce the enteral osmotic pressure; 2, can promote gastric secretion can make intestinal mucosa contraction and minimizing secretion again; 3, relieving spasm to stop pain, preventing or arresting vomiting, diuresis are arranged; 4, can suppress multiple diarrhea inducing virus and pathogen.Through follow-up observation 389 examples, cure 378 examples, account for 97.2%, 12 hours cure rates 71.5% wherein, total effective rate 100%.

The embodiment of the invention:

Raw material: peeling Polyporus 600g, Rhizoma Atractylodis (parched) 500g, Herba Pogostemonis 500g, Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) 300g, Radix Paeoniae Rubra (parched) 500g, Semen Plantaginis (processed with salt) 500g, calcined DENS DRACONIS 500g, Radix Bupleuri 500g, Fructus Rosae Laevigatae 500g, Fructus Hordei Germinatus 1000g, sodium benzoate 2.5g.

Method for making: (1) earlier with Dens Draconis decocting secondary, 3h first, and secondary 1.5h merges twice decocting liquid and filters, and filtrate is stored; Semen Plantaginis is wrapped the decocting secondary in addition, 2h first, secondary 1.5h merges decocting liquid after-filtration twice; The filtrate of preceding filtrate and Semen Plantaginis merges, and reuse ethanol transfers to 50-60%, 70-80% respectively with concentration, behind impurity such as destarching, phlegmatic temperament, protein, concentration is transferred to 80%-90% again, precipitation inorganic salts (KCl, CaCl ₂, NaCl, Ca ₂CO ₃Deng), through reclaim ethanol, decompression, concentrate, after the drying, using ultraviolet spectrometer carries out quantitative analysis, make potassium, sodium, chlorine, the suitable 1/3-1/2 of calcium ion content " oresol " standard in addition device store.

(2) with twice of Fructus Hordei Germinatus (or Fructus Setariae Germinatus, Fructus Crataegi) decocting, be respectively 2h, 1.5h, mix after-filtration, (concentration is by 50% → 60% → 70% → 80% for the refining NaCl powder of increment adding gradually ...) conversion carbohydrase, amylase, protease fractional precipitation in the Fructus Hordei Germinatus are got off, remove the inorganic salts of volume in the enzyme liquid of being saltoutd through " dialysis " again, after concentrating under reduced pressure, lyophilization and extract and transform carbohydrase (disaccharidase), amylase, protease, adorn seal up for safekeeping in No. 5 hard capsules standby.

(3) with Polyporus, Radix Paeoniae Rubra, Fructus Rosae Laevigatae decocting twice, 2h first, secondary 1.5h mixes decocting liquid after-filtration twice; With Rhizoma Atractylodis, the Rhizoma Pinelliae, Herba Pogostemonis, Radix Bupleuri vapor distillation method, extract volatile oil device storage in addition again.Residue filters after decocting with water 2h, during being concentrated into the 1ml medicinal liquid filtrate mixing and being equivalent to crude drug in whole 2g of filtrate and Polyporus, Radix Paeoniae Rubra, Fructus Rosae Laevigatae, Dens Draconis, Semen Plantaginis, Fructus Hordei Germinatus, put cold, triple 95% ethanol of adding medicinal liquid, stir evenly, static 24h, filter, add volatile oil, electrolyte, sodium benzoate, add an amount of distilled water again and transfer to 10000ml, cold preservation, filtration are sub-packed in the ampoule of 10ml, and 100 ℃ of sterilizations got final product in 30 minutes.

The present invention can be used for: removing dampness, reason spleen, antidiarrheal; Transfer kidney, yin fluid astringing, pain relieving; Heat clearing away, stomach function regulating, preventing or arresting vomiting are used for the treatment of infantile diarrhea, abdominal distention, stomachache, vomiting, poor appetite, oliguria, correct dehydration and electrolyte disturbance etc.

When it uses, will open, and pour into and shake up the back clothes in the medicinal liquid down with the capsule (disaccharidase) that oral liquid is equipped with.

Claims

1, a kind of oral liquid for the treatment of infantile diarrhea is characterized in that making according to following method with the raw material of following consumption:

Raw material: Polyporus 600g, Rhizoma Atractylodis 500g, Herba Pogostemonis 500g, Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) 300g, Radix Paeoniae Rubra 500g, Semen Plantaginis 500g, Dens Draconis 500g, Radix Bupleuri 500g, Fructus Rosae Laevigatae 500g, Fructus Hordei Germinatus 1000g, sodium benzoate 2.5g;

Method: with Dens Draconis, Semen Plantaginis difference decocting secondary, merging twice decocting liquid filters, add ethanol, concentration is transferred to 50-60%, 70-80% respectively, remove destarching, protein impurities, again concentration of alcohol is transferred to 80-90% and be settled out electrolyte, potassium, sodium, chlorine, calcium ion content are equivalent to the 1/3-1/2 oresol; With Fructus Hordei Germinatus decocting secondary, twice decocting liquid mixing after-filtration, with twice of Polyporus, Radix Paeoniae Rubra, Fructus Rosae Laevigatae decocting, mixing twice decocting liquid filters, with Rhizoma Atractylodis, Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens), Herba Pogostemonis, Radix Bupleuri water vapour distillation volatile oil, filtrate after residue decocted with water is mixed with the filtrate of Polyporus, Radix Paeoniae Rubra, Fructus Rosae Laevigatae, Dens Draconis, Semen Plantaginis, Fructus Hordei Germinatus and is concentrated 95% ethanol that adds the medicinal liquid triplication, add volatile oil, electrolyte, sodium benzoate after static 24 hours, add distilled water again and transfer to 10000mL, cold preservation, filtration, sterilization.

2, a kind of oral liquid for the treatment of infantile diarrhea according to claim 1 is characterized in that the Dens Draconis in the raw material substitutes with Os Draconis.

3, a kind of oral liquid for the treatment of infantile diarrhea according to claim 1 is characterized in that the Fructus Hordei Germinatus in the raw material substitutes with Fructus Setariae Germinatus or Fructus Crataegi.