JPS62114917A - Production of sterilized pills containing crude drugs as major active ingredients - Google Patents

Abstract

PURPOSE:Crude drugs are dipped in a certain volume of ethanol of a certain concentration, mixed with an excipient heat-dried under certian conditions and made into pilled in a usual manner to give the objective crude drug pills sterilized without deterioration of active ingredients. CONSTITUTION:Crude drugs are dipped in ethyl alcohol of about 71-81vol% as the final concentration in an amount of 2-3 times the weight of the drugs for about 24-48hr. Then, an excipient such as starch or wheat flour which has been heat-dried at about 110-115 deg.C for about 3hr is mixed the drugs and prepared into pills according to the pilling process described in Japanese Pharmacopoeia to give pills containin less than 10,000 microorganisms. The process according to the present invention can be applied to all of the crude drugs which are not denatured by ethanol and can be advantageously applied to production of pills containing less amounts of crude drugs based on the excipient.

Description

DETAILED DESCRIPTION OF THE INVENTION The present invention relates to a method for producing sterile pills containing crude drugs as the main ingredient.

Pills have long been used as a suitable dosage form for administering drugs that are difficult to take due to their unpleasant taste and odor, and for taking small amounts of herbal medicines over long periods of time. Nowadays, when tablets and capsules have become popular, it feels like their value has declined a little, but they still have characteristics such as ease of drug absorption and action, and a sense of mystery in their dosage form. Today, this dosage form is sometimes preferred, and this tendency is particularly strong for pharmaceuticals whose main ingredients are crude drugs.

However, one of the drawbacks of pills based on herbal medicines is that it is very difficult to sterilize various fungi derived from herbal medicines. When crude drug pills manufactured by normal pill-making operations are tested using the daily cycle general test method 37 sterility test method, it is not uncommon to find more than 100,000 bacteria per tablet. It is almost impossible to eradicate with sterilization methods. Of course, heat sterilization, steam sterilization, etc. are highly likely to cause changes in the active ingredients in the herbal medicine, and cannot be used at all.

As a result of intensive research into a method for effectively sterilizing crude drug pills without deteriorating the active ingredients, the present inventor has found that (+) crude drugs with a holly degree of approximately 75 to 3 times their weight
Sterilize by immersing in 81 (volume)% ethyl alcohol for about 24 to 48 hours, while (2) heating and drying sterilize excipients such as starch, wheat flour, and Kanbai powder at about 110 to 115 ° C. for about 3 hours, (3) Mix the materials (immersion mixture and heat-dried excipient) that have been sterilized separately using the above method, and
The present invention was completed based on the discovery that pills containing 10,000 or less bacteria can be produced by formulating pills according to the pill manufacturing method.

The method of the present invention can be applied to all crude drug pills that do not contain active ingredients that are substantially denatured by alcohol; It's advantageous.

The present invention will be explained in more detail with reference to Examples below.

Practical lecture P 8 cardiotonic pills Soak 350 g of Senso in 700 g of sterile warm water, soften it, pass through a sieve (I mesh), and add Nichido Musk 10 to this.
0g, 250g of diurnal gourd, 120g of diurnal bear bile, 120g of sour fur powder, 120g of diurnal ginseng powder, and 120g of diurnal rhinoceros powder were crushed into a fine powder, and mixed with Otsu, which was made into a fine powder. Add 2,500ml of alcohol to soak, moisten and leave for 48 hours.

Separately, 300g of Kanbai powder,) Umo [1 starch 1900g
g, 1] Mix appropriate amount of grass powder (210g) and heat at 115℃
sterilized by hot air drying for 3 hours, 5 g of sodium dehydroacetate, and if necessary kneading water sterilized by boiling were added to the above alcohol soaking mixture and mixed well, and the diurnal preparation general rules 6. 200,000 pills are made according to the pill manufacturing method and dried in a sterile room at room temperature or with warm air.

Example 2 Laxative 900g of diurnal rhubarb powder, 750g of diurnal senna powder.

A mixture of 450 g of local aloe powder, 100 g of Kengon powder, 750 g of diurnal senkyu powder, 250 g of diurnal cinnamon powder, and 250 g of diurnal fenugreek powder, and 7 ml of pharmacopoeia edyl alcohol.
Add 000 to 7500 m12 and immerse and moisten 48
Leave it for a while.

Separately, mix 660 g of Kanbai powder, 2 g of diurnal medicinal charcoal, and an appropriate amount of JP corn starch (approx. 450 g), and heat at 115℃ for 30 minutes.
Sterilized by hot air drying for 1 hour, and sodium dehydroacetate 4g 1 day carboxymethyl cellulose calcium 3
0g1 and, if necessary, boiling sterilized kneading water, mix well with the alcohol soaking mixture, and follow the general rules for diurnal preparations 6. 80,000 pills are made using the same pill manufacturing method and dried in a sterile room at room temperature or with warm air.

The number of bacteria present in the pills prepared according to Example I was determined according to diurnal general test method 37. When tested using a sterility test method, the results shown in Table 1 below were obtained.

table! As is clear from the above table, the number of viable bacteria contained in the pills manufactured by the method of the present invention is 10,000 or less for all lots. I understand.

Claims (1)

[Claims] 1. (1) The crude drug at a final concentration of approximately 75 times its weight.
The immersion mixture obtained in (1) was soaked in ~81% (by volume) ethyl alcohol for about 24-48 hours, while (2) the excipient was heated and dried at about 110-115°C for about 3 hours, and the dipping mixture obtained in (1) was soaked in (2). ) A method for producing sterilized pills containing crude drugs as the main ingredient, which consists of mixing the dry excipients obtained in step 1 and then producing pills according to a conventional method.